<?xml version="1.0" encoding="UTF-8"?>
<FEDREG xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:noNamespaceSchemaLocation="FRMergedXML.xsd">
    <VOL>86</VOL>
    <NO>88</NO>
    <DATE>Monday, May 10, 2021</DATE>
    <UNITNAME>Contents</UNITNAME>
    <CNTNTS>
        <AGCY>
            <EAR>Agency</EAR>
            <PRTPAGE P="iii"/>
            <HD>Agency for International Development</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Procurement of Certain Essential Medical Supplies To Address the COVID-19 Pandemic, </DOC>
                      
                    <PGS>24708-24710</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="2">2021-09821</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Agriculture</EAR>
            <HD>Agriculture Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Forest Service</P>
            </SEE>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Civil Monetary Penalty Inflation Adjustments for 2021, </DOC>
                      
                    <PGS>24699-24703</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="4">2021-09542</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>24839-24840</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09798</FRDOCBP>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09826</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Centers Disease</EAR>
            <HD>Centers for Disease Control and Prevention</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Conditional Sailing Order Technical Instructions and Operations Manual, </DOC>
                    <PGS>24865-24866</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09895</FRDOCBP>
                </DOCENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Advisory Committee on Immunization Practices, </SJDOC>
                    <PGS>24866-24867</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09893</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Centers Medicare</EAR>
            <HD>Centers for Medicare &amp; Medicaid Services</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Medicare Program:</SJ>
                <SJDENT>
                    <SJDOC>Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board, </SJDOC>
                      
                    <PGS>24735-24739</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="4">2021-08889</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Medicare Program:</SJ>
                <SJDENT>
                    <SJDOC>Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes to the Medicare Shared Savings Program, </SJDOC>
                    <PGS>25070-25790</PGS>
                    <FRDOCBP T="10MYP2.sgm" D="720">2021-08888</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Children</EAR>
            <HD>Children and Families Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Single-Source Awards:</SJ>
                <SJDENT>
                    <SJDOC>Residential (Shelter) and Transitional Foster Care Services, and for Finger Print Services for Unaccompanied Children, </SJDOC>
                    <PGS>24867</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09758</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Coast Guard</EAR>
            <HD>Coast Guard</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Safety Zone:</SJ>
                <SJDENT>
                    <SJDOC>Lower Mississippi River, Mile Marker 770, Randolph Bluff, TN, </SJDOC>
                      
                    <PGS>24710-24712</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="2">2021-09865</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Safety Zone:</SJ>
                <SJDENT>
                    <SJDOC>July 4th Holiday Fireworks in the Coast Guard Captain of the Port Maryland-National Capital Region Zone, </SJDOC>
                    <PGS>24807-24809</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="2">2021-09947</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Commerce</EAR>
            <HD>Commerce Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Foreign-Trade Zones Board</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>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>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Patent and Trademark Office</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Comptroller</EAR>
            <HD>Comptroller of the Currency</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Tax Allocation Agreements, </DOC>
                    <PGS>24755-24770</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="15">2021-09047</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Drug</EAR>
            <HD>Drug Enforcement Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Designation of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), and alpha-phenylacetoacetamide (APAA) as List I Chemicals, </DOC>
                      
                    <PGS>24703-24708</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="5">2021-09697</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>Rural, Insular, Native Achievement Programs Progress Update—Outlying Areas and the Republic of Palau, </SJDOC>
                    <PGS>24853</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09847</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Employment and Training</EAR>
            <HD>Employment and Training Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>National Farmworker Jobs Program Proposed Modifications to Allotment Formula:</SJ>
                <SJDENT>
                    <SJDOC>Program Year 2021, </SJDOC>
                    <PGS>24891-24895</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="4">2021-09799</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Workforce Information Advisory Council, </DOC>
                    <PGS>24890-24891</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09792</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Energy Department</EAR>
            <HD>Energy Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Energy Regulatory Commission</P>
            </SEE>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Energy Conservation Program:</SJ>
                <SJDENT>
                    <SJDOC>Coverage Determination for Commercial and Industrial Fans, </SJDOC>
                    <PGS>24752-24755</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="3">2021-09723</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>24854</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09812</FRDOCBP>
                </DOCENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Environmental Management Site-Specific Advisory Board, Oak Ridge, </SJDOC>
                    <PGS>24854-24855</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09818</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Environmental Management Site-Specific Advisory Board, Paducah, </SJDOC>
                    <PGS>24853-24854</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09819</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Environmental Management Site-Specific Advisory Board, Portsmouth, </SJDOC>
                    <PGS>24855</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09817</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Environmental Protection</EAR>
            <HD>Environmental Protection Agency</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Air Quality State Implementation Plans; Approvals and Promulgations:</SJ>
                <SJDENT>
                    <SJDOC>Arizona; Miami Copper Smelter Sulfur Dioxide Control Measures, </SJDOC>
                      
                    <PGS>24726-24728</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="2">2021-09634</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Louisiana; Infrastructure State Implementation Plan Requirements for the National Ambient Air Quality Standards, </SJDOC>
                      
                    <PGS>24715-24716</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="1">2021-09625</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>South Dakota; Revisions to Air Rules of South Dakota, </SJDOC>
                      
                    <PGS>24713-24715</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="2">2021-09863</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Texas; Reasonable Further Progress Plan for the Houston-Galveston-Brazoria Ozone Nonattainment Area, </SJDOC>
                      
                    <PGS>24717-24718</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="1">2021-09626</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Utah; R307-204 Emission Standards: Smoke Management, </SJDOC>
                      
                    <PGS>24728-24730</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="2">2021-09240</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <PRTPAGE P="iv"/>
                    <SJDOC>Washington; Spokane Regional Clean Air Agency, </SJDOC>
                      
                    <PGS>24718-24726</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="8">2021-09368</FRDOCBP>
                </SJDENT>
                <SJ>State Plans for Designated Facilities and Pollutants; Approvals and Promulgations:</SJ>
                <SJDENT>
                    <SJDOC>Wisconsin; Large Municipal Waste Combustors Negative Declaration Withdrawal for Designated Facilities and Pollutants, </SJDOC>
                      
                    <PGS>24730-24731</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="1">2021-09808</FRDOCBP>
                </SJDENT>
                <SJ>Tolerance Exemption:</SJ>
                <SJDENT>
                    <SJDOC>Poly(oxy-1,2-ethanediyl), a, a'-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[-hydroxy-, monosodium salt, </SJDOC>
                      
                    <PGS>24731-24735</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="4">2021-09911</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Air Quality State Implementation Plans; Approvals and Promulgations:</SJ>
                <SJDENT>
                    <SJDOC>California; Imperial County Air Pollution Control District, </SJDOC>
                    <PGS>24835-24837</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="2">2021-09635</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Finding of Failure to Attain the 2008 Lead and 2010 Sulfur Dioxide Standards; Arizona; Hayden and Miami Nonattainment Areas, </SJDOC>
                    <PGS>24829-24835</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="6">2021-09215</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>West Mojave Desert, CA; 2008 8-Hour Ozone Nonattainment Area Requirements, </SJDOC>
                    <PGS>24809-24829</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="20">2021-09842</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Ethylene Oxide Commercial Sterilization Facilities National Emission Standards for Hazardous Air Pollutants Technology Review, </SJDOC>
                    <PGS>24862-24863</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09794</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Emission Standards for Hazardous Air Pollutants for Shipbuilding and Ship Repair Facilities—Surface Coating, </SJDOC>
                    <PGS>24861</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09791</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Notice of Supplemental Distribution of a Registered Pesticide Product, </SJDOC>
                    <PGS>24860</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09795</FRDOCBP>
                </SJDENT>
                <SJ>Cross-Media Electronic Reporting:</SJ>
                <SJDENT>
                    <SJDOC>Authorized Program Revision Approval, State of New Hampshire, </SJDOC>
                    <PGS>24864-24865</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09793</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Draft Total Maximum Daily Load for Sediment in the Indian Creek Watershed in Montgomery County, PA, </DOC>
                    <PGS>24861-24862</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09762</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Public Water System Supervision Program Revision for the State of Nevada, </DOC>
                    <PGS>24863-24864</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09843</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>Eastern United States, </SJDOC>
                    <PGS>24801-24803</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="2">2021-09311</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Northcentral United States, </SJDOC>
                    <PGS>24798-24800</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="2">2021-09757</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Pocahontas, IA, </SJDOC>
                    <PGS>24800-24801</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="1">2021-09480</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Port Huron, MI, </SJDOC>
                    <PGS>24797-24798</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="1">2021-09476</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Saratoga, WY, </SJDOC>
                    <PGS>24805-24807</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="2">2021-09339</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Standish, MI, </SJDOC>
                    <PGS>24792-24794</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="2">2021-09477</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Vicinity of Erie, PA, </SJDOC>
                    <PGS>24794-24795</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="1">2021-09668</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>VOR Federal Airways V-36 and V-316; and VOR Federal Airway V-180, </SJDOC>
                    <PGS>24803-24805</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="2">2021-09756</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>York, PA, </SJDOC>
                    <PGS>24795-24797</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="2">2021-09815</FRDOCBP>
                </SJDENT>
                <SJ>Airworthiness Directives:</SJ>
                <SJDENT>
                    <SJDOC>Airbus Helicopters, </SJDOC>
                    <PGS>24783-24786</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="3">2021-09760</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Airbus SAS Airplanes, </SJDOC>
                    <PGS>24790-24792</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="2">2021-09789</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Leonardo S.p.a. (Type Certificate Previously Held by Agusta S.p.A.) Helicopters, </SJDOC>
                    <PGS>24780-24783</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="3">2021-09759</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>The Boeing Company Airplanes, </SJDOC>
                    <PGS>24778-24780, 24786-24789</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="2">2021-09345</FRDOCBP>
                    <FRDOCBP T="10MYP1.sgm" D="3">2021-09761</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Funding Opportunity:</SJ>
                <SJDENT>
                    <SJDOC>Environmental Mitigation Pilot Program, </SJDOC>
                    <PGS>25060-25061</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09856</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Communications</EAR>
            <HD>Federal Communications Commission</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Television Broadcasting Services:</SJ>
                <SJDENT>
                    <SJDOC>Savannah, GA, </SJDOC>
                      
                    <PGS>24741-24742</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="1">2021-09693</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Television Broadcasting Services:</SJ>
                <SJDENT>
                    <SJDOC>Butte, MT, </SJDOC>
                    <PGS>24837-24838</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="1">2021-09694</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Deposit</EAR>
            <HD>Federal Deposit Insurance Corporation</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>False Advertising, Misrepresentation of Insured Status, and Misuse of the FDIC's Name or Logo, </DOC>
                    <PGS>24770-24778</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="8">2021-08690</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Tax Allocation Agreements, </DOC>
                    <PGS>24755-24770</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="15">2021-09047</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Termination of Receiverships, </DOC>
                    <PGS>24865</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09868</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Emergency</EAR>
            <HD>Federal Emergency Management Agency</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Suspension of Community Eligibility, </DOC>
                      
                    <PGS>24739-24741</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="2">2021-09860</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Final Flood Hazard Determinations, </DOC>
                    <PGS>24877-24880</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="3">2021-09632</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Energy</EAR>
            <HD>Federal Energy Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Combined Filings, </DOC>
                    <PGS>24857-24860</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="2">2021-09830</FRDOCBP>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09831</FRDOCBP>
                </DOCENT>
                <SJ>Complaint:</SJ>
                <SJDENT>
                    <SJDOC>Luna Valley Solar I, LLC v.  Pacific Gas and Electric Co. and  California Independent System Operator Corp., </SJDOC>
                    <PGS>24858</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09827</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Macquarie Energy LLC v. PacifiCorp, </SJDOC>
                    <PGS>24855-24856</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09833</FRDOCBP>
                </SJDENT>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Atlantic Coast Pipeline, LLC, Eastern Gas Transmission and Storage, Inc.; Atlantic Coast Pipeline Disposition and Restoration Plan, Supply Header Project Restoration Plan, </SJDOC>
                    <PGS>24856-24857</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09828</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Reserve</EAR>
            <HD>Federal Reserve System</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Tax Allocation Agreements, </DOC>
                    <PGS>24755-24770</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="15">2021-09047</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Fish</EAR>
            <HD>Fish and Wildlife Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Endangered and Threatened Wildlife and Plants:</SJ>
                <SJDENT>
                    <SJDOC>Draft Recovery Plan for Kuenzler Hedgehog Cactus, </SJDOC>
                    <PGS>24881-24882</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09810</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Draft Recovery Plan for Mount Charleston Blue Butterfly, </SJDOC>
                    <PGS>24883-24884</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09763</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Food and Drug</EAR>
            <HD>Food and Drug Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>24867-24868</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09811</FRDOCBP>
                </DOCENT>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Recommended Content of Medical Product Communications That are Consistent with the Food and Drug Administration-Required Labeling and Recommendations for Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities, </SJDOC>
                    <PGS>24868-24871</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="3">2021-09809</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution, </SJDOC>
                    <PGS>24871-24874</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="3">2021-09805</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Foreign Trade</EAR>
            <HD>Foreign-Trade Zones Board</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Proposed Production Activity:</SJ>
                <SJDENT>
                    <SJDOC>STIHL, Inc., Foreign-Trade Zone 20, Norfolk, VA, </SJDOC>
                    <PGS>24841</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09864</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Forest</EAR>
            <PRTPAGE P="v"/>
            <HD>Forest Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, </SJDOC>
                    <PGS>24840-24841</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09806</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>Children and Families Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Food and Drug Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Institutes of Health</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Homeland</EAR>
            <HD>Homeland Security Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Coast Guard</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Emergency Management Agency</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Transportation Security Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>U.S. Citizenship and Immigration Services</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Housing</EAR>
            <HD>Housing and Urban Development Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Survey to Assess Operational and Capacity Status of Housing Counseling Agencies  Due to Disaster/National Emergency, </SJDOC>
                    <PGS>24880-24881</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09854</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Indian Affairs</EAR>
            <HD>Indian Affairs Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Rate Adjustments for Indian Irrigation Projects, </DOC>
                    <PGS>24884-24889</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="5">2021-09222</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Industry</EAR>
            <HD>Industry and Security Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Application for NATO International Bidding, </SJDOC>
                    <PGS>24842</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09859</FRDOCBP>
                </SJDENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Emerging Technology Technical Advisory Committee, </SJDOC>
                    <PGS>24841-24842</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09790</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Interior</EAR>
            <HD>Interior Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Fish and Wildlife Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Indian Affairs Bureau</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>International Trade Adm</EAR>
            <HD>International Trade Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Antidumping or Countervailing Duty Investigations, Orders, or Reviews:</SJ>
                <SJDENT>
                    <SJDOC>Certain Chassis and Subassemblies Thereof from the People's Republic of China, </SJDOC>
                    <PGS>24844-24845</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09848</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Certain Magnesia Carbon Bricks from Mexico and the People's Republic of China:, </SJDOC>
                    <PGS>24847-24848</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09801</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Certain Magnesia Carbon Bricks from the People's Republic of China, </SJDOC>
                    <PGS>24848-24849</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09802</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Certain Pasta from Italy, </SJDOC>
                    <PGS>24845-24846</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09866</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Certain Steel Nails from the Socialist Republic of Vietnam, </SJDOC>
                    <PGS>24849-24850</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09803</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Oil Country Tubular Goods from the Republic of Turkey, </SJDOC>
                    <PGS>24842-24843</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09840</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Prestressed Concrete Steel Wire Strand from the People's Republic of China, </SJDOC>
                    <PGS>24850</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09841</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>International Trade Com</EAR>
            <HD>International Trade Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Investigations; Determinations, Modifications, and Rulings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Certain Welded Line Pipe from Korea and Turkey, </SJDOC>
                    <PGS>24889-24890</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09787</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Justice Department</EAR>
            <HD>Justice Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Drug Enforcement Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Labor Department</EAR>
            <HD>Labor Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Employment and Training Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Mine Safety and Health Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Occupational Safety and Health Administration</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Privacy Act; System of Records, </DOC>
                    <PGS>24895-24896</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09669</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Mine</EAR>
            <HD>Mine Safety and Health Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Occupational Noise Exposure, </SJDOC>
                    <PGS>24897-24898</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09797</FRDOCBP>
                </SJDENT>
                <SJ>Petition for Modification:</SJ>
                <SJDENT>
                    <SJDOC>Application of Existing Mandatory Safety Standards, </SJDOC>
                    <PGS>24896-24897</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09796</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Archives</EAR>
            <HD>National Archives and Records Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>24900</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09765</FRDOCBP>
                </DOCENT>
            </CAT>
        </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>24874-24875, 24877</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09834</FRDOCBP>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09836</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Clinical Center, </SJDOC>
                    <PGS>24875-24876</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09838</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Eunice Kennedy Shriver National Institute of Child Health and Human Development, </SJDOC>
                    <PGS>24876</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09814</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Center for Advancing Translational Sciences, </SJDOC>
                    <PGS>24877</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09837</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Heart, Lung, and Blood Institute, </SJDOC>
                    <PGS>24874, 24876-24877</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09835</FRDOCBP>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09839</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Mental Health, </SJDOC>
                    <PGS>24874</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09813</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute on Minority Health and Health Disparities, </SJDOC>
                    <PGS>24877</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09832</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Oceanic</EAR>
            <HD>National Oceanic and Atmospheric Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic:</SJ>
                <SJDENT>
                    <SJDOC>Dolphin and Wahoo Fishery of the Atlantic; Amendment 12, </SJDOC>
                      
                    <PGS>24742-24745</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="3">2021-09851</FRDOCBP>
                </SJDENT>
                <SJ>Fisheries of the Exclusive Economic Zone off Alaska:</SJ>
                <SJDENT>
                    <SJDOC>Removing the Processing Restrictions on Incidentally Caught Squid and Sculpin Species in the Gulf of Alaska and Bering Sea and Aleutian Islands Groundfish Fisheries, </SJDOC>
                      
                    <PGS>24746-24749</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="3">2021-09845</FRDOCBP>
                </SJDENT>
                <SJ>Fisheries of the Northeastern United States:</SJ>
                <SJDENT>
                    <SJDOC>Atlantic Sea Scallop Fishery; 2021 Closure of the Northern Gulf of Maine Scallop Management Area to the Limited Access General Category Fishery, </SJDOC>
                      
                    <PGS>24745-24746</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="1">2021-09869</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Takes of Marine Mammals Incidental to Specified Activities:</SJ>
                <SJDENT>
                    <SJDOC>North Jetty Maintenance and Repairs Project in Coos Bay, OR, </SJDOC>
                    <PGS>24850-24852</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="2">2021-09867</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Science</EAR>
            <PRTPAGE P="vi"/>
            <HD>National Science Foundation</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Proposal Review, </SJDOC>
                    <PGS>24900</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09850</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Nuclear Regulatory</EAR>
            <HD>Nuclear Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Voluntary Reporting of Performance Indicators, </SJDOC>
                    <PGS>24901-24902</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09825</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Occupational Safety Health Adm</EAR>
            <HD>Occupational Safety and Health Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Grant of Expansion of Recognition and Modification to the Nationally Recognized Testing Laboratory Program's List of Appropriate Test Standards:</SJ>
                <SJDENT>
                    <SJDOC>FM Approvals, LLC, </SJDOC>
                    <PGS>24898-24900</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="2">2021-09800</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Patent</EAR>
            <HD>Patent and Trademark Office</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Grant of Interim Extension of the Term of U.S. Patent:</SJ>
                <SJDENT>
                    <SJDOC>No. 9,364,354; Reducer, </SJDOC>
                    <PGS>24852</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09846</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Pipeline</EAR>
            <HD>Pipeline and Hazardous Materials Safety Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hazardous Materials:</SJ>
                <SJDENT>
                    <SJDOC>Actions on Special Permits, </SJDOC>
                    <PGS>25061-25063</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="2">2021-09823</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Applications for Modifications to Special Permits, </SJDOC>
                    <PGS>25063-25064</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09822</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Applications for New Special Permits, </SJDOC>
                    <PGS>25063</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09824</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Postal Service</EAR>
            <HD>Postal Service</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Bylaws of the Board of Governors of the United States Postal Service, </DOC>
                      
                    <PGS>24712-24713</PGS>
                      
                    <FRDOCBP T="10MYR1.sgm" D="1">2021-09714</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Privacy Act; System of Records, </DOC>
                    <PGS>24902-24909</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="5">2021-09752</FRDOCBP>
                    <FRDOCBP T="10MYN1.sgm" D="2">2021-09755</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Presidential Documents</EAR>
            <HD>Presidential Documents</HD>
            <CAT>
                <HD>PROCLAMATIONS</HD>
                <SJ>Special Observances:</SJ>
                <SJDENT>
                    <SJDOC>National Day of Prayer (Proc. 10203), </SJDOC>
                    <PGS>24697-24698</PGS>
                    <FRDOCBP T="10MYD0.sgm" D="1">2021-09946</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>ADMINISTRATIVE ORDERS</HD>
                <DOCENT>
                    <DOC>Central African Republic; Continuation of National Emergency (Notice of May 6, 2021), </DOC>
                    <PGS>25795</PGS>
                    <FRDOCBP T="10MYO1.sgm" D="0">2021-09995</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Iraq; Continuation of National Emergency Respecting Stabilization (Notice of May 6, 2021), </DOC>
                    <PGS>25797</PGS>
                    <FRDOCBP T="10MYO2.sgm" D="0">2021-09996</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Syria; Continuation of National Emergency Respecting Government Actions (Notice of May 6, 2021), </DOC>
                    <PGS>25791-25794</PGS>
                    <FRDOCBP T="10MYO0.sgm" D="3">2021-09993</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Securities</EAR>
            <HD>Securities and Exchange Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>24956, 25026</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09939</FRDOCBP>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09940</FRDOCBP>
                </DOCENT>
                <SJ>Self-Regulatory Organizations; Proposed Rule Changes:</SJ>
                <SJDENT>
                    <SJDOC>Cboe BYX Exchange, Inc., </SJDOC>
                    <PGS>25016-25026</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09768</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Cboe BZX Exchange, Inc., </SJDOC>
                    <PGS>24931-24941</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09769</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Cboe C2 Exchange, Inc., </SJDOC>
                    <PGS>24911-24921</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09785</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Cboe EDGA Exchange, Inc., </SJDOC>
                    <PGS>24956-24966</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09766</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Cboe EDGX Exchange, Inc., </SJDOC>
                    <PGS>25004-25014</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09786</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Cboe Exchange, Inc., </SJDOC>
                    <PGS>24966-24976, 25026-25033</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09767</FRDOCBP>
                    <FRDOCBP T="10MYN1.sgm" D="7">2021-09774</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Investors Exchange, LLC, </SJDOC>
                    <PGS>24976-24979</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="3">2021-09781</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>MEMX, LLC, </SJDOC>
                    <PGS>24951-24956</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="5">2021-09776</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Nasdaq BX, Inc., </SJDOC>
                    <PGS>25045-25055</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09777</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Nasdaq GEMX, LLC, </SJDOC>
                    <PGS>24979-24989, 25033-25035</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="2">2021-09771</FRDOCBP>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09784</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Nasdaq ISE, LLC, </SJDOC>
                    <PGS>25035-25045</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09782</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Nasdaq MRX, LLC, </SJDOC>
                    <PGS>24994-25004, 25057-25059</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="2">2021-09772</FRDOCBP>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09780</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Nasdaq PHLX, LLC, </SJDOC>
                    <PGS>24941-24951, 25014-25016</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="2">2021-09773</FRDOCBP>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09778</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Securities Clearing Corp., </SJDOC>
                    <PGS>24989-24994</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="5">2021-09788</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>New York Stock Exchange, LLC, </SJDOC>
                    <PGS>24909-24911</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="2">2021-09775</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>The Nasdaq Stock Market, LLC, </SJDOC>
                    <PGS>24921-24931, 25055-25057</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="2">2021-09770</FRDOCBP>
                    <FRDOCBP T="10MYN1.sgm" D="10">2021-09779</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Small Business</EAR>
            <HD>Small Business Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Major Disaster Declaration:</SJ>
                <SJDENT>
                    <SJDOC>Mississippi; Public Assistance Only, </SJDOC>
                    <PGS>25059-25060</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09857</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Oregon; Public Assistance Only, </SJDOC>
                    <PGS>25060</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09858</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>Pipeline and Hazardous Materials Safety Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Transportation Statistics Bureau</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Security</EAR>
            <HD>Transportation Security Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Law Enforcement Officer Reimbursement Request, </SJDOC>
                    <PGS>24880</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09804</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Transportation Statistics</EAR>
            <HD>Transportation Statistics Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Annual Tank Car Facility Survey, </SJDOC>
                    <PGS>25064-25065</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09816</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Treasury</EAR>
            <HD>Treasury Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Comptroller of the Currency</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>United States Mint</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Requests for Nominations:</SJ>
                <SJDENT>
                    <SJDOC>Advisory Committee on Risk-Sharing Mechanisms, </SJDOC>
                    <PGS>25065-25066</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09753</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>U.S. Citizenship</EAR>
            <HD>U.S. Citizenship and Immigration Services</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Collection and Use of Biometrics; Withdrawal, </DOC>
                    <PGS>24750-24751</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="1">2021-09671</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Employment Authorization for Certain Classes of Aliens with Final Orders of Removal; Withdrawal, </DOC>
                    <PGS>24751-24752</PGS>
                    <FRDOCBP T="10MYP1.sgm" D="1">2021-09670</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Unified</EAR>
            <HD>Unified Carrier Registration Plan</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>25066-25067</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09924</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>U.S. Mint</EAR>
            <HD>United States Mint</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>2021 Pricing of Numismatic Gold, Commemorative Gold, Platinum, and Palladium Products Grid, </DOC>
                    <PGS>25066</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="0">2021-09764</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>Supplemental Income Questionnaire (for Philippine Claims Only), </SJDOC>
                    <PGS>25067-25068</PGS>
                    <FRDOCBP T="10MYN1.sgm" D="1">2021-09870</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <PTS>
            <HD SOURCE="HED">Separate Parts In This Issue</HD>
            <HD>Part II</HD>
            <DOCENT>
                <DOC>Health and Human Services Department, Centers for Medicare &amp; Medicaid Services, </DOC>
                <PGS>25070-25790</PGS>
                <FRDOCBP T="10MYP2.sgm" D="720">2021-08888</FRDOCBP>
            </DOCENT>
            <PRTPAGE P="vii"/>
            <HD>Part III</HD>
            <DOCENT>
                <DOC>Presidential Documents, </DOC>
                <PGS>25791-25795, 25797</PGS>
                <FRDOCBP T="10MYO1.sgm" D="0">2021-09995</FRDOCBP>
                <FRDOCBP T="10MYO2.sgm" D="0">2021-09996</FRDOCBP>
                <FRDOCBP T="10MYO0.sgm" D="3">2021-09993</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>88</NO>
    <DATE>Monday, May 10, 2021</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <RULES>
        <RULE>
            <PREAMB>
                <PRTPAGE P="24699"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <CFR>7 CFR Part 3</CFR>
                <DEPDOC>[Docket No. USDA-2020-0011]</DEPDOC>
                <RIN>RIN 0503-AA72</RIN>
                <SUBJECT>Civil Monetary Penalty Inflation Adjustments for 2021</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Secretary, USDA.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This final rule amends the U.S. Department of Agriculture's civil monetary penalty regulations by making inflation adjustments as mandated by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective May 10, 2021.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Mr. Stephen O'Neill, Office of Budget and Program Analysis, USDA, 1400 Independence Avenue SW, Washington, DC 20250-1400, (202) 720-0038.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>On November 2, 2015, the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), which further amended the Federal Civil Penalties Inflation Adjustment Act of 1990, was signed into law to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Act requires agencies to adjust for inflation annually.</P>
                <P>This rule amends 7 CFR part 3 to update the amount of civil monetary penalties that may be levied by U.S. Department of Agriculture (USDA) agencies to reflect inflationary adjustments for 2021 in accordance with the 2015 Act. As required by the 2015 Act, the annual adjustment was made for inflation based on the Consumer Price Index for the month of October 2020 and rounded to the nearest dollar after an initial adjustment. The civil monetary penalties are listed according to the applicable administering agency.</P>
                <HD SOURCE="HD1">II. Notice and Comment Not Required</HD>
                <P>
                    This rule is required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, with no issue of policy discretion. Accordingly, pursuant to the administrative procedure provisions in 5 U.S.C. 553, we find upon good cause that prior notice and other public procedure with respect to this action are not necessary. We also find good cause for making this action effective less than 30 days after publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD1">III. Procedural Requirements</HD>
                <HD SOURCE="HD2">Executive Order 12866</HD>
                <P>The Office of Management and Budget has determined that this regulatory action does not meet the criteria for significant regulatory action pursuant to Executive Order 12866, Regulatory Planning and Review.</P>
                <P>This rule contains inflation adjustments in compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The great majority of individuals, organizations, and entities participating in the programs affected by this regulation do not engage in prohibited activities and practices that would result in civil monetary penalties being incurred. Accordingly, we believe that any aggregate economic impact of this revised regulation will be minimal, affecting only the limited number of program participants that may engage in prohibited behavior in violation of the statutes.</P>
                <HD SOURCE="HD2">Regulatory Flexibility Act</HD>
                <P>The provisions of the Regulatory Flexibility Act relating to an initial and final regulatory flexibility analysis (5 U.S.C. 603, 604) are not applicable to this final rule because USDA was not required to publish notice of proposed rulemaking under 5 U.S.C. 553 or any other law. Accordingly, a regulatory flexibility analysis is not required.</P>
                <HD SOURCE="HD2">Paperwork Reduction Act</HD>
                <P>This final rule imposes no new reporting or recordkeeping requirements necessitating clearance by OMB.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 7 CFR Part 3</HD>
                    <P>Administrative practice and procedure, Claims, Government employees, Income taxes, Loan programs-agriculture, Penalties, Reporting and recordkeeping requirements, Wages.</P>
                </LSTSUB>
                <P>Accordingly, we are amending 7 CFR part 3, subpart I, as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 3—DEBT MANAGEMENT</HD>
                </PART>
                <REGTEXT TITLE="7" PART="3">
                    <AMDPAR>1. The authority citation for part 3, subpart I, continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> 28 U.S.C. 2461 note.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="3">
                    <AMDPAR>2. Section 3.91 is amended by revising paragraphs (a)(2) and (b) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 3.91 </SECTNO>
                        <SUBJECT>Adjusted civil monetary penalties.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>
                            (2) 
                            <E T="03">Timing.</E>
                             Any increase in the dollar amount of a civil monetary penalty listed in paragraph (b) of this section applies only to violations occurring after May 10, 2021.
                        </P>
                        <STARS/>
                        <P>
                            (b) 
                            <E T="03">Penalties</E>
                            —(1) 
                            <E T="03">Agricultural Marketing Service.</E>
                             (i) Civil penalty for improper record keeping codified at 7 U.S.C. 136i-1(d), has: A maximum of $975 in the case of the first offense, and a minimum of $1,894 in the case of subsequent offenses, except that the penalty will be less than $1,894 if the Secretary determines that the person made a good faith effort to comply.
                        </P>
                        <P>(ii) Civil penalty for a violation of the unfair conduct rule under the Perishable Agricultural Commodities Act, in lieu of license revocation or suspension, codified at 7 U.S.C. 499b(5), has a maximum of $5,308.</P>
                        <P>(iii) Civil penalty for violation of the licensing requirements under the Perishable Agricultural Commodities Act, codified at 7 U.S.C. 499c(a), has a maximum of $1,695 for each such offense and not more than $423 for each day it continues, or a maximum of $423 for each offense if the Secretary determines the violation was not willful.</P>
                        <P>(iv) Civil penalty in lieu of license suspension under the Perishable Agricultural Commodities Act, codified at 7 U.S.C. 499h(e), has a maximum penalty of $3,388 for each violative transaction or each day the violation continues.</P>
                        <P>
                            (v) Civil penalty for a violation of the Export Apple Act, codified at 7 U.S.C. 586, has a minimum of $153 and a maximum of $15,481.
                            <PRTPAGE P="24700"/>
                        </P>
                        <P>(vi) Civil penalty for a violation of the Export Grape and Plum Act, codified at 7 U.S.C. 596, has a minimum of $296 and a maximum of $29,622.</P>
                        <P>(vii) Civil penalty for a violation of an order issued by the Secretary under the Agricultural Adjustment Act, reenacted with amendments by the Agricultural Marketing Agreement Act of 1937, codified at 7 U.S.C. 608c(14)(B), has a maximum of $2,963. Each day the violation continues is a separate violation.</P>
                        <P>(viii) Civil penalty for failure to file certain reports under the Agricultural Adjustment Act, reenacted by the Agricultural Marketing Agreement Act of 1937, codified at 7 U.S.C. 610(c), has a maximum of $296.</P>
                        <P>(ix) Civil penalty for a violation of a seed program under the Federal Seed Act, codified at 7 U.S.C. 1596(b), has a minimum of $101 and a maximum of $2,020.</P>
                        <P>(x) Civil penalty for failure to collect any assessment or fee for a violation of the Cotton Research and Promotion Act, codified at 7 U.S.C. 2112(b), has a maximum of $2,963.</P>
                        <P>(xi) Civil penalty for failure to pay, collect, or remit any assessment or fee for a violation of a program under the Potato Research and Promotion Act, codified at 7 U.S.C. 2621(b)(1), has a minimum of $1,328 and a maximum of $12,247.</P>
                        <P>(xii) Civil penalty for failure to obey a cease and desist order under the Potato Research and Promotion Act, codified at 7 U.S.C. 2621(b)(3), has a maximum of $1,328. Each day the violation continues is a separate violation.</P>
                        <P>(xiii) Civil penalty for failure to pay, collect, or remit any assessment or fee or for a violation of a program under the Egg Research and Consumer Information Act, codified at 7 U.S.C. 2714(b)(1), has a minimum of $1,535 and a maximum of $15,353.</P>
                        <P>(xiv) Civil penalty for failure to obey a cease and desist order under the Egg Research and Consumer Information Act, codified at 7 U.S.C. 2714(b)(3), has a maximum of $1,535. Each day the violation continues is a separate violation.</P>
                        <P>(xv) Civil penalty for failure to remit any assessment or fee or for a violation of a program under the Beef Research and Information Act, codified at 7 U.S.C. 2908(a)(2), has a maximum of $11,977.</P>
                        <P>(xvi) Civil penalty for failure to remit any assessment or for a violation of a program regarding wheat and wheat foods research, codified at 7 U.S.C. 3410(b), has a maximum of $2,963.</P>
                        <P>(xvii) Civil penalty for failure to pay, collect, or remit any assessment or fee or for a violation of a program under the Floral Research and Consumer Information Act, codified at 7 U.S.C. 4314(b)(1), has a minimum of $1,394 and a maximum of $13,940.</P>
                        <P>(xviii) Civil penalty for failure to obey a cease and desist order under the Floral Research and Consumer Information Act, codified at 7 U.S.C. 4314(b)(3), has a maximum of $1,394. Each day the violation continues is a separate violation.</P>
                        <P>(xix) Civil penalty for violation of an order under the Dairy Promotion Program, codified at 7 U.S.C. 4510(b), has a maximum of $2,577.</P>
                        <P>(xx) Civil penalty for pay, collect, or remit any assessment or fee or for a violation of the Honey Research, Promotion, and Consumer Information Act, codified at 7 U.S.C. 4610(b)(1), has a minimum of $774 and a maximum of $7,939.</P>
                        <P>(xxi) Civil penalty for failure to obey a cease and desist order under the Honey Research, Promotion, and Consumer Information Act, codified at 7 U.S.C. 4610(b)(3), has a maximum of $794. Each day the violation continues is a separate violation.</P>
                        <P>(xxii) Civil penalty for a violation of a program under the Pork Promotion, Research, and Consumer Information Act of 1985, codified at 7 U.S.C. 4815(b)(1)(A)(i), has a maximum of $2,396.</P>
                        <P>(xxiii) Civil penalty for failure to obey a cease and desist order under the Pork Promotion, Research, and Consumer Information Act of 1985, codified at 7 U.S.C. 4815(b)(3)(A), has a maximum of $1,198. Each day the violation continues is a separate violation.</P>
                        <P>(xxiv) Civil penalty for failure to pay, collect, or remit any assessment or fee or for a violation of a program under the Watermelon Research and Promotion Act, codified at 7 U.S.C. 4910(b)(1), has a minimum of $1,198 and a maximum of $11,977.</P>
                        <P>(xxv) Civil penalty for failure to obey a cease and desist order under the Watermelon Research and Promotion Act, codified at 7 U.S.C. 4910(b)(3), has a maximum of $1,198. Each day the violation continues is a separate violation.</P>
                        <P>(xxvi) Civil penalty for failure to pay, collect, or remit any assessment or fee or for a violation of a program under the Pecan Promotion and Research Act of 1990, codified at 7 U.S.C. 6009(c)(1), has a minimum of $1,951 and a maximum of $19,496.</P>
                        <P>(xxvii) Civil penalty for failure to obey a cease and desist order under the Pecan Promotion and Research Act of 1990, codified at 7 U.S.C. 6009(e), has a maximum of $1,949.</P>
                        <P>(xxviii) Civil penalty for failure to pay, collect, or remit any assessment or fee or for a violation of a program under the Mushroom Promotion, Research, and Consumer Information Act of 1990, codified at 7 U.S.C. 6107(c)(1), has a minimum of $948 and a maximum of $9,476.</P>
                        <P>(xxix) Civil penalty for failure to obey a cease and desist order under the Mushroom Promotion, Research, and Consumer Information Act of 1990, codified at 7 U.S.C. 6107(e), has a maximum of $948. Each day the violation continues is a separate violation.</P>
                        <P>(xxx) Civil penalty for failure to pay, collect, or remit any assessment or fee or for a violation of the Lime Research, Promotion, and Consumer Information Act of 1990, codified at 7 U.S.C. 6207(c)(1), has a minimum of $948 and a maximum of $9,476.</P>
                        <P>(xxxi) Civil penalty for failure to obey a cease and desist order under the Lime Research, Promotion, and Consumer Information Act of 1990, codified at 7 U.S.C. 6207(e), has a maximum of $948. Each day the violation continues is a separate violation.</P>
                        <P>(xxxii) Civil penalty for failure to pay, collect, or remit any assessment or fee or for a violation of a program under the Soybean Promotion, Research, and Consumer Information Act, codified a 7 U.S.C. 6307(c)(1)(A), has a maximum of $1,951.</P>
                        <P>(xxxiii) Civil penalty for failure to obey a cease and desist order under the Soybean Promotion, Research, and Consumer Information Act, codified at 7 U.S.C. 6307(e), has a maximum of $9,706. Each day the violation continues is a separate violation.</P>
                        <P>(xxxiv) Civil penalty for failure to pay, collect, or remit any assessment or fee or for a violation of a program under the Fluid Milk Promotion Act of 1990, codified at 7 U.S.C. 6411(c)(1)(A), has a minimum of $948 and a maximum of $9,476, or in the case of a violation that is willful, codified at 7 U.S.C. 6411(c)(1)(B), has a minimum of $18,623 and a maximum of $189,510.</P>
                        <P>(xxxv) Civil penalty for failure to obey a cease and desist order under the Fluid Milk Promotion Act of 1990, codified at 7 U.S.C. 6411(e), has a maximum of $9,753. Each day the violation continues is a separate violation.</P>
                        <P>
                            (xxxvi) Civil penalty for knowingly labeling or selling a product as organic except in accordance with the Organic Foods Production Act of 1990, codified at 7 U.S.C. 6519(c), has a maximum of $18,951.
                            <PRTPAGE P="24701"/>
                        </P>
                        <P>(xxxvii) Civil penalty for failure to pay, collect, or remit any assessment or fee or for a violation of a program under the Fresh Cut Flowers and Fresh Cut Greens Promotion and Information Act of 1993, codified at 7 U.S.C. 6808(c)(1)(A)(i), has a minimum of $893 and a maximum of $8,935.</P>
                        <P>(xxxviii) Civil penalty for failure to obey a cease and desist order under the Fresh Cut Flowers and Fresh Cut Greens Promotion and Information Act of 1993, codified at 7 U.S.C. 6808(e)(1), has a maximum of $8,935. Each day the violation continues is a separate violation.</P>
                        <P>(xxxix) Civil penalty for a violation of a program under the Sheep Promotion, Research, and Information Act of 1994, codified at 7 U.S.C. 7107(c)(1)(A), has a maximum of $1,742.</P>
                        <P>(xl) Civil penalty for failure to obey a cease and desist order under the Sheep Promotion, Research, and Information Act of 1994, codified at 7 U.S.C. 7107(e), has a maximum of $870. Each day the violation continues is a separate violation.</P>
                        <P>(xli) Civil penalty for a violation of an order or regulation issued under the Commodity Promotion, Research, and Information Act of 1996, codified at 7 U.S.C. 7419(c)(1), has a minimum of $1,644 and a maximum of $16,449 for each violation.</P>
                        <P>(xlii) Civil penalty for failure to obey a cease and desist order under the Commodity Promotion, Research, and Information Act of 1996, codified at 7 U.S.C. 7419(e), has a minimum of $1,644 and a maximum of $16,449. Each day the violation continues is a separate violation.</P>
                        <P>(xliii) Civil penalty for a violation of an order or regulation issued under the Canola and Rapeseed Research, Promotion, and Consumer Information Act, codified at 7 U.S.C. 7448(c)(1)(A)(i), has a maximum of $1,644 for each violation.</P>
                        <P>(xliv) Civil penalty for failure to obey a cease and desist order under the Canola and Rapeseed Research, Promotion, and Consumer Information Act, codified at 7 U.S.C. 7448(e), has a maximum of $8,224. Each day the violation continues is a separate violation.</P>
                        <P>(xlv) Civil penalty for violation of an order or regulation issued under the National Kiwifruit Research, Promotion, and Consumer Information Act, codified at 7 U.S.C. 7468(c)(1), has a minimum of $823 and a maximum of $8,224 for each violation.</P>
                        <P>(xlvi) Civil penalty for failure to obey a cease and desist order under the National Kiwifruit Research, Promotion, and Consumer Information Act, codified at 7 U.S.C. 7468(e), has a maximum of $823. Each day the violation continues is a separate violation.</P>
                        <P>(xlvii) Civil penalty for a violation of an order or regulation under the Popcorn Promotion, Research, and Consumer Information Act, codified at 7 U.S.C. 7487(a), has a maximum of $1,644 for each violation.</P>
                        <P>(xlviii) Civil penalty for certain violations under the Egg Products Inspection Act, codified at 21 U.S.C. 1041(c)(1)(A), has a maximum of $9,476 for each violation.</P>
                        <P>(xlix) Civil penalty for violation of an order or regulation issued under the Hass Avocado Promotion, Research, and Information Act of 2000, codified at 7 U.S.C. 7807(c)(1)(A)(i), has a minimum of $1,495 and a maximum of $14,965 for each violation.</P>
                        <P>(l) Civil penalty for failure to obey a cease and desist order under the Hass Avocado Promotion, Research, and Information Act of 2000, codified at 7 U.S.C. 7807(e)(1), has a maximum of $14,965 for each offense. Each day the violation continues is a separate violation.</P>
                        <P>(li) Civil penalty for violation of certain provisions of the Livestock Mandatory Reporting Act of 1999, codified a 7 U.S.C. 1636b(a)(1), has a maximum of $15,481 for each violation.</P>
                        <P>(lii) Civil penalty for failure to obey a cease and desist order under the Livestock Mandatory Reporting Act of 1999, codified a 7 U.S.C. 1636b(g)(3), has a maximum of $15,481 for each violation. Each day the violation continues is a separate violation.</P>
                        <P>(liii) Civil penalty for failure to obey an order of the Secretary issued pursuant to the Dairy Product Mandatory Reporting program, codified at 7 U.S.C. 1637b(c)(4)(D)(iii), has a maximum of $14,965 for each offense.</P>
                        <P>(liv) Civil penalty for a willful violation of the Country of Origin Labeling program by a retailer or person engaged in the business of supplying a covered commodity to a retailer, codified at 7 U.S.C. 1638b(b)(2), has a maximum of $1,202 for each violation.</P>
                        <P>(lv) Civil penalty for violations of the Dairy Research Program, codified at 7 U.S.C. 4535 and 4510(b), has a maximum of $2,577 for each violation.</P>
                        <P>(lvi) Civil penalty for a packer or swine contractor violation, codified at 7 U.S.C. 193(b), has a maximum of $29,616.</P>
                        <P>(lvii) Civil penalty for a livestock market agency or dealer failure to register, codified at 7 U.S.C. 203, has a maximum of $2,019 and not more than $101 for each day the violation continues.</P>
                        <P>(lviii) Civil penalty for operating without filing, or in violation of, a stockyard rate schedule, or of a regulation or order of the Secretary made thereunder, codified at 7 U.S.C. 207(g), has a maximum of $2,020 and not more than $101 for each day the violation continues.</P>
                        <P>(lix) Civil penalty for a stockyard owner, livestock market agency, or dealer, who engages in or uses any unfair, unjustly discriminatory, or deceptive practice or device in connection with determining whether persons should be authorized to operate at the stockyards, or with receiving, marketing, buying, or selling on a commission basis or otherwise, feeding, watering, holding, delivery, shipment, weighing, or handling of livestock, codified at 7 U.S.C. 213(b), has a maximum of $29,616.</P>
                        <P>(lx) Civil penalty for a stockyard owner, livestock market agency, or dealer, who knowingly fails to obey any order made under the provisions of 7 U.S.C. 211, 212, or 213, codified at 7 U.S.C. 215(a), has a maximum of $2,020.</P>
                        <P>(lxi) Civil penalty for live poultry dealer violations, codified at 7 U.S.C. 228b-2(b), has a maximum of $86,156.</P>
                        <P>(lxii) Civil penalty for a violation, codified at 7 U.S.C. 86(c), has a maximum of $289,430.</P>
                        <P>(lxiii) Civil penalty for failure to comply with certain provisions of the U.S. Warehouse Act, codified at 7 U.S.C. 254, has a maximum of $37,412 per violation if an agricultural product is not involved in the violation.</P>
                        <P>
                            (2) 
                            <E T="03">Animal and Plant Health Inspection Service.</E>
                             (i) Civil penalty for a violation of the imported seed provisions of the Federal Seed Act, codified at 7 U.S.C. 1596(b), has a minimum of $101 and a maximum of $2,020.
                        </P>
                        <P>(ii) Civil penalty for a violation of the Animal Welfare Act, codified at 7 U.S.C. 2149(b), has a maximum of $12,023, and knowing failure to obey a cease and desist order has a civil penalty of $1,803.</P>
                        <P>(iii) Civil penalty for any person that causes harm to, or interferes with, an animal used for the purposes of official inspection by USDA, codified at 7 U.S.C. 2279e(a), has a maximum of $14,965.</P>
                        <P>(iv) Civil penalty for a violation of the Swine Health Protection Act, codified at 7 U.S.C. 3805(a), has a maximum of $30,077.</P>
                        <P>
                            (v) Civil penalty for any person that violates the Plant Protection Act (PPA), or that forges, counterfeits, or, without authority from the Secretary, uses, alters, defaces, or destroys any certificate, permit, or other document 
                            <PRTPAGE P="24702"/>
                            provided for in the PPA, codified a 7 U.S.C. 7734(b)(1), has a maximum of the greater of: $74,824 in the case of any individual (except that the civil penalty may not exceed $1,496 in the case of an initial violation of the PPA by an individual moving regulated articles not for monetary gain), $374,119 in the case of any other person for each violation, $601,152 for all violations adjudicated in a single proceeding if the violations do not include a willful violation, and $1,202,304 for all violations adjudicated in a single proceeding if the violations include a willful violation; or twice the gross gain or gross loss for any violation, forgery, counterfeiting, unauthorized us, defacing, or destruction of a certificate, permit, or other document provided for in the PPA that results in the person deriving pecuniary gain or causing pecuniary loss to another.
                        </P>
                        <P>(vi) Civil penalty for any person (except as provided in 7 U.S.C. 8309(d)) that violates the Animal Health Protection Act (AHPA), or that forges, counterfeits, or, without authority from the Secretary, uses, alters, defaces, or destroys any certificate, permit, or other document provided under the AHPA, codified at 7 U.S.C. 8313(b)(1), has a maximum of the greater of: $71,811 in the case of any individual, except that the civil penalty may not exceed $1,437 in the case of an initial violation of the AHPA by an individual moving regulated articles not for monetary gain, $359,054 in the case of any other person for each violation, $601,152 for all violations adjudicated in a single proceeding if the violations do not include a willful violation, and $1,202,304 for all violations adjudicated in a single proceeding if the violations include a willful violation; or twice the gross gain or gross loss for any violation, forgery, counterfeiting, unauthorized use, defacing, or destruction of a certificate, permit, or other document provided under the AHPA that results in the person's deriving pecuniary gain or causing pecuniary loss to another person.</P>
                        <P>(vii) Civil penalty for any person that violates certain regulations under the Agricultural Bioterrorism Protection Act of 2002 regarding transfers of listed agents and toxins or possession and use of listed agents and toxins, codified at 7 U.S.C. 8401(i)(1), has a maximum of $359,054 in the case of an individual and $718,110 in the case of any other person.</P>
                        <P>(viii) Civil penalty for violation of the Horse Protection Act, codified at 15 U.S.C. 1825(b)(1), has a maximum of $5,925.</P>
                        <P>(ix) Civil penalty for failure to obey Horse Protection Act disqualification, codified at 15 U.S.C. 1825(c), has a maximum of $11,579.</P>
                        <P>(x) Civil penalty for knowingly violating, or, if in the business as an importer or exporter, violating, with respect to terrestrial plants, any provision of the Endangered Species Act of 1973, any permit or certificate issued thereunder, or any regulation issued pursuant to section 9(a)(1)(A) through (F), (a)(2)(A) through (D), (c), (d) (other than regulations relating to record keeping or filing reports), (f), or (g), as specified at 16 U.S.C. 1540(a)(1), has a maximum of $54,158 for each violation.</P>
                        <P>(xi) Civil penalty for knowingly violating, or, if in the business as an importer or exporter, violating, with respect to terrestrial plants, any other regulation under the Endangered Species Act of 1973, as specified at 16 U.S.C. 1540(a)(1), has a maximum of $25,935 for each violation.</P>
                        <P>(xii) Civil penalty for violating, with respect to terrestrial plants, the Endangered Species Act of 1973, or any regulation, permit, or certificate issued thereunder, as specified at 16 U.S.C. 1540(a)(1), has a maximum of $1,367 for each violation.</P>
                        <P>(xiii) Civil penalty for knowingly and willfully violating 49 U.S.C. 80502 with respect to the transportation of animals by any rail carrier, express carrier, or common carrier (except by air or water), a receiver, trustee, or lessee of one of those carriers, or an owner or master of a vessel, codified at 49 U.S.C. 80502(d), has a minimum of $170 and a maximum of $870.</P>
                        <P>(xiv) Civil penalty for a violation of the Commercial Transportation of Equine for Slaughter Act, 7 U.S.C. 1901 note, and its implementing regulations in 9 CFR part 88, as specified in 9 CFR 88.6, has a maximum of $822. Each horse transported in violation of 9 CFR part 88 is a separate violation.</P>
                        <P>(xv) Civil penalty for knowingly violating section 3(d) or 3(f) of the Lacey Act Amendments of 1981, or for violating any other provision provided that, in the exercise of due care, the violator should have known that the plant was taken, possessed, transported, or sold in violation of any underlying law, treaty, or regulation, has a maximum of $26,930 for each violation, as specified in 16 U.S.C. 3373(a)(1) (but if the plant has a market value of less than $360, and involves only the transportation, acquisition, or receipt of a plant taken or possessed in violation of any law, treaty, or regulation of the United States, any Indian tribal law, any foreign law, or any law or regulation of any State, the penalty will not exceed the maximum provided for violation of said law, treaty, or regulation, or $26,930, whichever is less).</P>
                        <P>(xvi) Civil penalty for violating section 3(f) of the Lacey Act Amendments of 1981, as specified in 16 U.S.C. 3373(a)(2), has a maximum of $673.</P>
                        <P>
                            (3) 
                            <E T="03">Food and Nutrition Service.</E>
                             (i) Civil penalty for violating a provision of the Food and Nutrition Act of 2008 (Act), or a regulation under the Act, by a retail food store or wholesale food concern, codified at 7 U.S.C. 2021(a) and (c), has a maximum of $120,231 for each violation.
                        </P>
                        <P>(ii) Civil penalty for trafficking in food coupons, codified at 7 U.S.C. 2021(b)(3)(B), has a maximum of $43,325 for each violation, except that the maximum penalty for violations occurring during a single investigation is $78,017.</P>
                        <P>(iii) Civil penalty for the sale of firearms, ammunitions, explosives, or controlled substances for coupons, codified at 7 U.S.C. 2021(b)(3)(C), has a maximum of $39,009 for each violation, except that the maximum penalty for violations occurring during a single investigation is $78,017.</P>
                        <P>(iv) Civil penalty for any entity that submits a bid to supply infant formula to carry out the Special Supplemental Nutrition Program for Women, Infants and Children and discloses the amount of the bid, rebate, or discount practices in advance of the bid opening or for any entity that makes a statement prior to the opening of bids for the purpose of influencing a bid, codified at 42 U.S.C. 1786(h)(8)(H)(i), has a maximum of $183,629,453.</P>
                        <P>(v) Civil penalty for a vendor convicted of trafficking in food instruments, codified at 42 U.S.C. 1786(o)(1)(A) and 42 U.S.C. 1786(o)(4)(B), has a maximum of $15,877 for each violation, except that the maximum penalty for violations occurring during a single investigation is $63,509.</P>
                        <P>(vi) Civil penalty for a vendor convicted of selling firearms, ammunition, explosive, or controlled substances in exchange for food instruments, codified at 42 U.S.C. 1786(o)(1)(B) and 42 U.S.C. 1786(o)(4)(B), has a maximum of $15,487 for each violation, except that the maximum penalty for violations occurring during a single investigation is $63,509.</P>
                        <P>
                            (4) 
                            <E T="03">Food Safety and Inspection Service.</E>
                             (i) Civil penalty for certain violations under the Egg Products Inspection Act, codified at 21 U.S.C. 1041(c)(1)(A), has a maximum of $9,476 for each violation.
                        </P>
                        <P>
                            (ii) [Reserved]
                            <PRTPAGE P="24703"/>
                        </P>
                        <P>
                            (5) 
                            <E T="03">Forest Service.</E>
                             (i) Civil penalty for willful disregard of the prohibition against the export of unprocessed timber originating from Federal lands, codified at 16 U.S.C. 620d(c)(1)(A), has a maximum of $975,230 per violation or three times the gross value of the unprocessed timber, whichever is greater.
                        </P>
                        <P>(ii) Civil penalty for a violation in disregard of the Forest Resources Conservation and Shortage Relief Act or the regulations that implement such Act regardless of whether such violation caused the export of unprocessed timber originating from Federal lands, codified in 16 U.S.C. 620d(c)(2)(A)(i), has a maximum of $146,285 per violation.</P>
                        <P>(iii) Civil penalty for a person that should have known that an action was a violation of the Forest Resources Conservation and Shortage Relief Act or the regulations that implement such Act regardless of whether such violation caused the export of unprocessed timber originating from Federal lands, codified at 16 U.S.C. 620d(c)(2)(A)(ii), has a maximum of $97,523 per violation.</P>
                        <P>(iv) Civil penalty for a willful violation of the Forest Resources Conservation and Shortage Relief Act or the regulations that implement such Act regardless of whether such violation caused the export of unprocessed timber originating from Federal lands, codified in 16 U.S.C. 620d(c)(2)(A)(iii), has a maximum of $975,230.</P>
                        <P>(v) Civil penalty for a violation involving protections of caves, codified at 16 U.S. C. 4307(a)(2), has a maximum of $21,314.</P>
                        <P>(6) [Reserved]</P>
                        <P>
                            (7) 
                            <E T="03">Federal Crop Insurance Corporation.</E>
                             (i) Civil penalty for any person who willfully and intentionally provides any false or inaccurate information to the Federal Crop Insurance Corporation or to an approved insurance provider with respect to any insurance plan or policy that is offered under the authority of the Federal Crop Insurance Act, or who fails to comply with a requirement of the Federal Crop Insurance Corporation, codified in 7 U.S.C. 1515(h)(3)(A), has a maximum of the greater of: The amount of the pecuniary gain obtained as a result of the false or inaccurate information or the noncompliance; or $12,650.
                        </P>
                        <P>(ii) [Reserved]</P>
                        <P>
                            (8) 
                            <E T="03">Rural Housing Service.</E>
                             (i) Civil penalty for a violation of section 536 of Title V of the Housing Act of 1949, codified in 42 U.S.C. 1490p(e)(2), has a maximum of $207,313 in the case of an individual, and a maximum of $2,073,133 in the case of an applicant other than an individual.
                        </P>
                        <P>(ii) Civil penalty for equity skimming under section 543(a) of the Housing Act of 1949, codified in 42 U.S.C. 1490s(a)(2), has a maximum of $37,412.</P>
                        <P>(iii) Civil penalty under section 543b of the Housing Act of 1949 for a violation of regulations or agreements made in accordance with Title V of the Housing Act of 1949, by submitting false information, submitting false certifications, failing to timely submit information, failing to maintain real property in good repair and condition, failing to provide acceptable management for a project, or failing to comply with applicable civil rights laws and regulations, codified in 42 U.S.C. 1490s(b)(3)(A), has a maximum of the greater of: Twice the damages USDA, guaranteed lender, or project that is secured for a loan under Title V suffered or would have suffered as a result of the violation; or $74,824 per violation.</P>
                        <P>(9) [Reserved]</P>
                        <P>
                            (10) 
                            <E T="03">Commodity Credit Corporation.</E>
                             (i) Civil penalty for willful failure or refusal to furnish information, or willful furnishing of false information under of section 156 of the Federal Agricultural Improvement and Reform Act of 1996, codified at 7 U.S.C. 7272(g)(5), has a maximum of $16,449 for each violation.
                        </P>
                        <P>(ii) Civil penalty for willful failure or refusal to furnish information or willful furnishing of false data by a processor, refiner, or importer of sugar, syrup and molasses under section 156 of the Federal Agriculture Improvement and Reform Act of 1996, codified at 7 U.S.C. 7272(g)(5), has a maximum of $16,449 for each violation.</P>
                        <P>(iii) Civil penalty for filing a false acreage report that exceeds tolerance under section 156 of the Federal Agriculture Improvement and Reform Act of 1996, codified at 7 U.S.C. 7272(g)(5), has a maximum of $16,449 for each violation.</P>
                        <P>(iv) Civil penalty for knowingly violating any regulation of the Secretary of the Commodity Credit Corporation pertaining to flexible marketing allotments for sugar under section 359h(b) of the Agricultural Adjustment Act of 1938, codified at 7 U.S.C. 1359hh(b), has a maximum of $12,023 for each violation.</P>
                        <P>(v) Civil penalty for knowing violation of regulations promulgated by the Secretary pertaining to cotton insect eradication under section 104(d) of the Agricultural Act of 1949, codified at 7 U.S.C. 1444a(d), has a maximum of $14,811 for each offense.</P>
                        <P>
                            (11) 
                            <E T="03">Office of the Secretary.</E>
                             (i) Civil penalty for making, presenting, submitting or causing to be made, presented or submitted, a false, fictitious, or fraudulent claim as defined under the Program Fraud Civil Remedies Act of 1986, codified at 31 U.S.C. 3802(a)(1), has a maximum of $11,804.
                        </P>
                        <P>(ii) Civil penalty for making, presenting, submitting or causing to be made, presented or submitted, a false, fictitious, or fraudulent written statement as defined under the Program Fraud Civil Remedies Act of 1986, codified at 31 U.S.C. 3802(a)(2), has a maximum of $11,804.</P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <NAME>John Rapp,</NAME>
                    <TITLE>Acting Director, Office of Budget and Program Analysis. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09542 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3410-90-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Drug Enforcement Administration</SUBAGY>
                <CFR>21 CFR Part 1310</CFR>
                <DEPDOC>[Docket No. DEA-542]</DEPDOC>
                <SUBJECT>Designation of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), and alpha-phenylacetoacetamide (APAA) as List I Chemicals</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Drug Enforcement Administration, Department of Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Drug Enforcement Administration is finalizing a December 21, 2020, notice of proposed rulemaking to designate three chemicals, known as PMK glycidate, PMK glycidic acid, and APAA, as list I chemicals under the Controlled Substances Act (CSA). PMK glycidate and PMK glycidic acid are used in and are important to the manufacture of the schedule I controlled substance 3,4-methylenedioxymethamphetamine (MDMA) and other “ecstasy”-type substances, and APAA is used in and is important to the manufacture of the schedule II controlled substances amphetamine and methamphetamine. This final rulemaking subjects handlers (manufacturers, distributors, importers, and exporters) of PMK glycidate, PMK glycidic acid, and APAA to the chemical regulatory provisions of the CSA and its implementing regulations.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective June 9, 2021.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-3249.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <PRTPAGE P="24704"/>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This final rule designates the following chemicals as list I chemicals and subjects them to the regulatory requirements applicable to list I chemicals:</P>
                <P>• 3,4-MDP-2-P methyl glycidate (PMK glycidate), including its optical and geometric isomers;</P>
                <P>• 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), including its salts, optical and geometric isomers, and salts of isomers; and</P>
                <P>
                    • 
                    <E T="03">alpha</E>
                    -phenylacetoacetamide (APAA), including its optical isomers,.
                </P>
                <HD SOURCE="HD1">Legal Authority</HD>
                <P>
                    The Controlled Substances Act (CSA) and the Drug Enforcement Administration's (DEA) implementing regulations give the Attorney General, as delegated to the Administrator of DEA, the authority to specify, by regulation, a chemical as a “list I chemical.” 
                    <SU>1</SU>
                    <FTREF/>
                     This term refers to a chemical that is used in manufacturing a controlled substance in violation of subchapter I (Control and Enforcement) of the CSA and is important to the manufacture of the controlled substance.
                    <SU>2</SU>
                    <FTREF/>
                     The current list of all list I chemicals is available in 21 CFR 1310.02(a).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         21 U.S.C. 802(34) and 871(b) and 21 CFR 1310.02(c).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         21 U.S.C. 802(34) and 21 CFR 1300.02(b).
                    </P>
                </FTNT>
                <P>In addition, the United States is a Party to the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988 Convention), December 20, 1988, 1582 U.N.T.S. 95. Under Article 12 of the 1988 Convention, when the United States receives notification that a chemical has been added to Table I or Table II (tables annexed to such Convention), the United States must take measures it deems appropriate to monitor the manufacture and distribution of that chemical within the United States and to prevent its diversion, including measures related to international trade.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    In a letter dated May 23, 2019, the Secretary-General of the United Nations, in accordance with Article 12, paragraph 6 of the 1988 Convention, informed the United States Secretary of State that the Commission on Narcotic Drugs (CND) voted to place the chemicals 3,4-MDP-2-P methyl glycidate (PMK glycidate) (and all stereoisomers), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) (and all stereoisomers), and 
                    <E T="03">alpha</E>
                    -phenylacetoacetamide (APAA) (and all optical isomers) in Table I of the 1988 Convention (CND Decisions 62/10, 62/11, and 62/12, respectively) at its 62nd Session on March 19, 2019.
                </P>
                <P>
                    On December 21, 2020, DEA published a notice of proposed rulemaking (NPRM) [85 FR 82984] to designate 3,4-MDP-2-P methyl glycidate (PMK glycidate), including its optical and geometric isomers; 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), including its salts, optical and geometric isomers, and salts of isomers; and 
                    <E T="03">alpha</E>
                    -phenylacetoacetamide (APAA), including its optical isomers, as list I chemicals under the CSA.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         DEA proposed to control the same set of chemicals specified by the CND. However, DEA used more precise terms that relate to the specific chemical and variations that can actually exist.
                    </P>
                </FTNT>
                <P>PMK glycidate, PMK glycidic acid, and APAA are close chemical relatives of controlled list I precursor 3,4 methylenedioxyphenyl-2-propanone (3,4-MDP-2-P), and have been made specifically to circumvent existing precursor controls. DEA has not identified any known legitimate uses for these chemicals, other than possible research purposes. The first two substances, PMK glycidate and PMK glycidic acid, are closely related in chemical structure to precursors of 3,4-methylenedioxymethamphetamine (MDMA) (schedule I) and other “ecstasy”-type substances in schedule I. APAA is a precursor of schedule II controlled substances amphetamine and methamphetamine.</P>
                <P>
                    All three chemicals are used for the illicit manufacture of two precursors listed in Table I of the 1988 Convention (3,4-MDP-2-P and 1-phenyl-2-propanone (P-2-P)). For years, countries have reported to the International Narcotics Control Board (INCB) the illicit trafficking and use of these chemicals in manufacturing controlled substances, with increasing frequency and amounts reported in 2018 and 2019.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Precursors and Chemicals Frequently Used in the Illicit Manufacture of Narcotic Drugs and Psychotropic Substances: Report of the International Narcotics Control Board for 2018 on the Implementation of Article 12 of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 (E/INCB/2018/4, Released March 5, 2019) and Report of the International Narcotics Control Board for 2019 on the Implementation of Article 12 of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 (E/INCB/2019/1, Released February 27. 2020)
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Comments Received and Designation of PMK Glycidate, PMK Glycidic Acid, and APAA as List I Chemicals</HD>
                <P>In response to the December 21, 2020, NPRM, DEA received one anonymous comment expressing general opposition to the “war on drugs” and to the addition of more substances to the list and under CSA control. DEA considers the general comment about the war on drugs to be outside the scope of this rulemaking.</P>
                <P>Regarding the general opposition to listing more substances, DEA notes that it proposed to designate and add these three specific chemicals to the list as they met the statutory and regulatory definition of a list I chemical, and DEA is using its legal authority to so designate these chemicals as list I chemicals.</P>
                <P>Therefore, for the reasons discussed in the NPRM, and reiterated in the above background section, the Acting Administrator of DEA finds that PMK glycidate, PMK glycidic acid, and APAA are used in the manufacture of controlled substances in violation of the CSA, and are important to the manufacture of these controlled substances. Therefore, the Acting Administrator designates PMK glycidate, PMK glycidic acid, and APAA as list I chemicals.</P>
                <HD SOURCE="HD1">Chemical Mixtures of PMK Glycidate, PMK Glycidic Acid or APAA</HD>
                <P>Pursuant to this final rulemaking, chemical mixtures containing any of these three chemicals are subject to regulatory requirements at any concentration unless a manufacturer submits to DEA an application for exemption of a chemical mixture, DEA accepts the application for filing, and DEA exempts the chemical mixture in accordance with 21 CFR 1310.13 (Exemption of chemical mixtures; application). Since even a small amount of these three chemicals can potentially yield a significant amount of controlled substances, DEA believes that regulation of chemical mixtures containing any amount of these three chemicals is necessary to prevent their illicit extraction, isolation, and use. This rule modifies the “Table of Concentration Limits” in 21 CFR 1310.12(c) to reflect the fact that chemical mixtures containing any amount of these three chemicals are subject to CSA chemical control provisions, including 21 CFR parts 1309, 1310, 1313, and 1316.</P>
                <HD SOURCE="HD1">Application Process for Exemption of Chemical Mixtures</HD>
                <P>
                    DEA has implemented an application process to exempt certain chemical mixtures from the requirements of the CSA and its implementing regulations.
                    <SU>5</SU>
                    <FTREF/>
                     Manufacturers may submit an 
                    <PRTPAGE P="24705"/>
                    application for exemption for those mixtures that do not meet the category criteria set forth in 21 CFR 1310.12(d) for an automatic exemption. DEA may grant an exemption of a chemical mixture if the Administrator determines that the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance, and the listed chemical or chemicals contained in the chemical mixture cannot be readily recovered (
                    <E T="03">i.e.,</E>
                     the chemical mixture meets the conditions set forth in 21 U.S.C. 802(39)(A)(vi) and 21 CFR 1310.13(a)(1)-(2)).
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         21 CFR 1310.13 specifies that this chemical mixture is a chemical mixture consisting of two or more chemical components, at least one of which is not a list I or list II chemical, and the mixture and its listed chemical(s) must meet certain other conditions.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Requirements for Handling List I Chemicals</HD>
                <P>The designation of these three chemicals as list I chemicals subjects handlers (manufacturers, distributors, importers, and exporters) and proposed handlers to all of the regulatory controls and administrative, civil, and criminal actions applicable to the manufacture, distribution, importation, and exportation of a list I chemical. Upon the effective date of this final rulemaking, persons potentially handling these three chemicals, including regulated chemical mixtures containing any of these three chemicals, are required to comply with the following list I chemical regulations:</P>
                <P>
                    1. 
                    <E T="03">Registration.</E>
                     Any person who handles (manufactures, distributes, imports, or exports), or proposes to engage in such handling of any of these three chemicals must obtain a registration pursuant to 21 U.S.C. 822, 823, 957, and 958. Regulations describing registration for list I chemical handlers are set forth in 21 CFR part 1309. DEA regulations require separate registrations for manufacturing, distributing, importing, and exporting of any of these three chemicals.
                    <SU>6</SU>
                    <FTREF/>
                     Further, a separate registration is required for each principal place of business at one general physical location where list I chemicals are manufactured, distributed, imported, or exported by a person.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         21 CFR 1309.21.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         21 CFR 1309.23(a). See also 21 U.S.C. 822(e)(1) with separate registration requirements pertaining to manufacturing or distributing a list I chemical.
                    </P>
                </FTNT>
                <P>
                    DEA notes that under the CSA, a “warehouseman” is not required to register and may lawfully possess a list I chemical, if the possession of the chemical is in the usual course of business or employment.
                    <SU>8</SU>
                    <FTREF/>
                     Under DEA implementing regulations, the warehouse in question must receive the list I chemical from a DEA registrant, and shall only distribute the list I chemical back to the DEA registrant and registered location from which it was received.
                    <SU>9</SU>
                    <FTREF/>
                     A warehouse that distributes list I chemicals to persons other than the registrant and registered location from which they were obtained is conducting distribution activities and is required to register as such.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         21 U.S.C. 822(c)(2) and 21 U.S.C. 957(b)(1)(B).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         See 21 CFR 1309.23(b)(1).
                    </P>
                </FTNT>
                <P>Upon the effective date of this final rulemaking, any person manufacturing, distributing, importing, or exporting any of these three chemicals will become subject to the registration requirement under the CSA. DEA recognizes, however, that it is not possible for persons subject to the registration requirement to immediately complete and submit an application for registration and for DEA to immediately issue registrations for those activities. Therefore, to allow continued legitimate commerce in these three chemicals, DEA is establishing in 21 CFR 1310.09 a temporary exemption from the registration requirement for persons desiring to engage in activities with any of these three chemicals, provided that DEA receives a properly completed application for registration or application for exemption of chemical mixtures on or before June 9, 2021. The temporary exemption for such persons will remain in effect until DEA takes final action on their application for registration or application for exemption of a chemical mixture.</P>
                <P>The temporary exemption applies solely to the registration requirement; all other chemical control requirements, including recordkeeping and reporting, will become effective on the effective date of the final rule. Therefore, all transactions of these three chemicals and chemical mixtures containing any of these three chemicals will be regulated while an application for registration or exemption is pending. This is necessary because failing to regulate these transactions could result in increased diversion of chemicals desirable to drug traffickers.</P>
                <P>Additionally, the temporary exemption does not suspend applicable federal criminal laws relating to these three chemicals, nor does it supersede State or local laws or regulations. All handlers of any of these three chemicals must comply with applicable State and local requirements in addition to the CSA regulatory controls.</P>
                <P>
                    2. 
                    <E T="03">Records and Reports.</E>
                     Every DEA registrant must maintain records and submit reports to DEA with respect to these three chemicals pursuant to 21 U.S.C. 830(a) and (b)(1) and (2) and in accordance with 21 CFR 1310.04 and 1310.05. Pursuant to 21 CFR 1310.04(a), a record must be made and maintained for two years after the date of a transaction involving a listed chemical, provided the transaction is a regulated transaction.
                </P>
                <P>
                    Each regulated bulk manufacturer of a listed chemical must submit to DEA manufacturing, inventory, and use data on an annual basis.
                    <SU>10</SU>
                    <FTREF/>
                     Existing standard industry reports containing the required information are acceptable, provided the information is separate or readily retrievable from the report.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         21 CFR 1310.05(d). See also 21 U.S.C. 830(b)(2).
                    </P>
                </FTNT>
                <P>
                    The CSA and its implementing regulations require that each regulated person must report to DEA any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of subchapter I of the CSA or 21 CFR part 1310. In addition, regulated persons must report any proposed regulated transaction with a person whose description or other identifying characteristics DEA has previously furnished to the regulated person, any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person, and any in-transit loss in which the regulated person is the supplier.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         21 U.S.C. 830(b)(1)(A)-(C) and 21 CFR 1310.05(a) and (b)(1).
                    </P>
                </FTNT>
                <P>
                    3. 
                    <E T="03">Importation and Exportation.</E>
                     All importation and exportation of these three chemicals must be done in compliance with 21 U.S.C. 957, 958, and 971 and in accordance with 21 CFR part 1313.
                </P>
                <P>
                    4. 
                    <E T="03">Security.</E>
                     All applicants and registrants must provide effective controls against theft and diversion in accordance with 21 CFR 1309.71-1309.73.
                </P>
                <P>
                    5. 
                    <E T="03">Administrative Inspection.</E>
                     Places, including factories, warehouses, or other establishments and conveyances, where registrants or other regulated persons may lawfully hold, manufacture, distribute, or otherwise dispose of a list I chemical or where records relating to those activities are maintained, are controlled premises as defined in 21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA allows for administrative inspections of these controlled premises as provided in 21 CFR part 1316, subpart A. 21 U.S.C. 880(b).
                    <PRTPAGE P="24706"/>
                </P>
                <P>
                    6. 
                    <E T="03">Liability.</E>
                     Any activity involving these three chemicals not authorized by, or in violation of, the CSA is unlawful, and may subject the person to administrative, civil, and/or criminal action.
                </P>
                <HD SOURCE="HD1">Regulatory Analyses</HD>
                <HD SOURCE="HD2">Executive Orders 12866 and 13563, Regulatory Planning and Review and Improving Regulation and Regulatory Review</HD>
                <P>This rule was developed in accordance with the principles of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866.</P>
                <P>E.O. 12866 classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the E.O. DEA has determined that this rule is not a “significant regulatory action” under E.O. 12866, section 3(f).</P>
                <P>As finalized, PMK glycidate, PMK glycidic acid, and APAA are subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importing, and exporting of list I chemicals. The first two chemicals, PMK glycidate and PMK glycidic acid, are closely related in chemical structure to precursors of MDMA and other “ecstasy”-type substances, as discussed in the above background section. APAA is a precursor of amphetamine and methamphetamine. All three chemicals are highly suitable for the illicit manufacture of precursors listed in Table I of the 1988 Convention (3,4-methylenedioxyphenyl-2-propanone (3,4-MDP-2-P) and 1-phenyl-2-propanone (P-2-P)). As noted earlier, incidents of illicit manufacture and tracking of these three chemicals have been reported for many years to the INCB, with an increase in the frequency and amounts reported in 2018 and 2019.</P>
                <P>In making its assessment pursuant to Article 12, paragraph 4 of the 1988 Convention, the CND found that there was no known legitimate manufacture of and trade in any of the three chemicals and that their use was limited, in small amounts, to research, development, laboratory, and analytical purposes. DEA also searched information in the public domain for legitimate uses of these three chemicals, and likewise, did not identify any known legitimate use for any of these chemicals, other than possibly for research purposes. DEA evaluated the costs and benefits of this action.</P>
                <P>DEA cannot rule out the possibility that minimal quantities of PMK glycidate, PMK glycidic, or APAA are used for the manufacturing of legitimate pharmaceutical substances. However, DEA did not receive any public comments to that effect in response to the NPRM.</P>
                <HD SOURCE="HD3">Costs</HD>
                <P>As stated above, the only use for PMK glycidate and PMK glycidic acid is as intermediaries for the manufacturing of MDMA and other “ecstasy”-type substances. Similarly, the only use for APAA is as a precursor for amphetamine and methamphetamine. Any manufacturer, distributor, importer, or exporter of any of these three chemicals for legitimate pharmaceutical commerce, if they exist at all, will incur costs if they are not already registered for handling List I chemicals. The primary costs associated with this rule are the annual registration fees ($3,047 for manufacturers and $1,523 for distributors, importers, and exporters). Moreover, any manufacturer that uses any of these three chemicals for legitimate pharmaceutical purposes is likely to already be registered with DEA and have all security and other handling processes in place, resulting in minimal cost.</P>
                <P>DEA has identified ten domestic suppliers of one or more of these chemicals, PMK glycidate, PMK glycidic acid, and APAA; nine of these suppliers are not currently registered with DEA to handle list I chemicals. The amount of these three chemicals distributed by these suppliers is unknown. It is common for chemical distributors to have items on their catalog while not actually having any material level of sales. Based on the discussion above, DEA believes any quantity of sales from these distributors for legitimate pharmaceutical purposes is minimal. As finalized, suppliers for the legitimate use of PMK glycidate, PMK glycidic acid, and APAA are expected to choose the least-cost option, which in many cases may lead them to stop selling the minimal quantities, if any, of PMK glycidate, PMK glycidic acid, and APAA, rather than incur the registration cost. Therefore, DEA estimates that the cost of foregone sales is minimal; and thus, the cost of this rule is minimal.</P>
                <P>This analysis excludes consideration of any economic impact to those businesses that facilitate the manufacturing and distribution of PMK glycidate, PMK glycidic acid, or APAA for the illicit production of amphetamine, methamphetamine, MDMA, or other “ecstasy”-type substances.</P>
                <HD SOURCE="HD3">Benefits</HD>
                <P>Controlling PMK glycidate, PMK glycidic acid, and APAA is expected to prevent, curtail, and limit the unlawful manufacture and distribution of amphetamine, methamphetamine, and MDMA and other “ecstasy”-type substances. This action is also expected to assist in the prevention of possible theft or diversion of PMK glycidate, PMK glycidic acid, and APAA from any legitimate firms. DEA also believes control is necessary to prevent unscrupulous chemists from synthesizing PMK glycidate, PMK glycidic acid, and APAA and selling them (as an unregulated material) through the internet and other channels to individuals who may wish to acquire unregulated intermediary chemicals for the purpose of manufacturing illicit amphetamine, methamphetamine, or MDMA or other “ecstasy”-type substances.</P>
                <P>In summary, DEA conducted a qualitative analysis of costs and benefits. DEA believes this action will minimize the diversion of PMK glycidate, PMK glycidic acid, and APAA. DEA believes the legitimate market for PMK glycidate, PMK glycidic acid, and APAA for legitimate pharmaceutical purposes is minimal. Thus, any potential cost resulting from this regulation is minimal.</P>
                <HD SOURCE="HD2">Executive Order 12988, Civil Justice Reform</HD>
                <P>
                    This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard 
                    <PRTPAGE P="24707"/>
                    for affected conduct, and promote simplification and burden reduction.
                </P>
                <HD SOURCE="HD2">Executive Order 13132, Federalism</HD>
                <P>This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the states, on the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government.</P>
                <HD SOURCE="HD2">Executive Order 13175, Consultation and Coordination With Indian Tribal Governments</HD>
                <P>This rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.</P>
                <HD SOURCE="HD2">Regulatory Flexibility Act (RFA)</HD>
                <P>
                    The Acting Administrator, in accordance with the RFA,
                    <SU>12</SU>
                    <FTREF/>
                     has reviewed this rule, and by approving, it certifies that it will not have a significant economic impact on a substantial number of small entities.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         5 U.S.C. 601-612.
                    </P>
                </FTNT>
                <P>As discussed above, PMK glycidate, PMK glycidic acid, and APAA will now become subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, and exportation of list I chemicals. PMK glycidate and PMK glycidic acid are closely related in chemical structure to precursors of MDMA and other “ecstasy”-type substances. APAA is a precursor of amphetamine and methamphetamine. All three chemicals are highly suitable for the illicit manufacture of precursors listed in Table I of the 1988 Convention (3,4-methylenedioxyphenyl-2-propanone (3,4-MDP-2-P) and 1-phenyl-2-propanone (P-2-P)). DEA has not identified any legitimate industrial use for PMK glycidate, PMK glycidic acid, or APAA, other than as intermediary chemicals in the production of amphetamine, methamphetamine, and MDMA or other “ecstasy”-type substances. Therefore, DEA believes the vast majority, if not all, of PMK glycidate, PMK glycidic acid, and APAA is used for the illicit manufacturing of amphetamine, methamphetamine, and MDMA or other “ecstasy”-type substances. The primary costs associated with this rule are the annual registration fees ($3,047 for manufacturers and $1,523 for distributors, importers, and exporters), but only if they are not already registered to handle any list I chemicals.</P>
                <P>DEA has identified ten domestic suppliers of one or more of the chemicals, PMK glycidate, PMK glycidic acid, and APAA; nine of these suppliers are currently not registered with DEA to handle list I chemicals. All nine non-registered domestic suppliers are affected, and all nine (94.5 percent, based on Small Business Administration size standard for chemical distributors and Statistics of U.S. Businesses data) are estimated to be small entities. The quantity of these three chemicals distributed by these suppliers is unknown. It is common for chemical distributors to have items on their catalog while not actually having any material level of sales. Based on the discussion above, DEA believes any quantity of sales from these distributors for legitimate pharmaceutical purposes is minimal. DEA did not receive any comments to the contrary in response to the NPRM. DEA estimates that this rule will not have a significant economic impact on a substantial number of small entities.</P>
                <HD SOURCE="HD2">Unfunded Mandates Reform Act of 1995 (UMRA)</HD>
                <P>
                    In accordance with the UMRA, 2 U.S.C. 1501 
                    <E T="03">et seq.,</E>
                     DEA has determined and certifies that this rule will not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any 1 year. . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under the UMRA.
                </P>
                <HD SOURCE="HD2">Paperwork Reduction Act</HD>
                <P>The action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. This action will not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. 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>
                <HD SOURCE="HD2">Congressional Review Act</HD>
                <P>This final rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects 21 CFR Part 1310</HD>
                    <P>Administrative practice and procedure, Drug traffic control, Exports, Imports, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <P>Accordingly, for the reasons set forth in the preamble, DEA amends 21 CFR part 1310 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 1310—RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES</HD>
                </PART>
                <REGTEXT TITLE="21" PART="1310">
                    <AMDPAR>1. The authority citation for part 1310 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> 21 U.S.C. 802, 827(h), 830, 871(b), 890.</P>
                    </AUTH>
                </REGTEXT>
                  
                <REGTEXT TITLE="21" PART="1310">
                    <AMDPAR>2. In § 1310.02, add paragraphs (a)(34) through (36) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1310.02 </SECTNO>
                        <SUBJECT>Substances covered.</SUBJECT>
                        <STARS/>
                        <P>(a) * * *</P>
                        <P>(34) 3,4-MDP-2-P methyl glycidate (PMK glycidate) and its optical and geometric isomers 8535</P>
                        <P>(35) 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its salts, optical and geometric isomers, and salts of isomers 8525</P>
                        <P>(36) Alpha-phenylacetoacetamide (APAA) and its optical isomers 8515</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="21" PART="1310">
                    <AMDPAR>3. In § 1310.04:</AMDPAR>
                    <AMDPAR>a. Redesignate paragraphs (g)(1)(vii) through (xiii) as paragraphs (g)(1)(x) through (xvi), respectively;</AMDPAR>
                    <AMDPAR>b. Redesignate paragraphs (g)(1)(i) through (vi) as paragraphs (g)(1)(ii) through (vii), respectively; and</AMDPAR>
                    <AMDPAR>c. Add new paragraphs (g)(1)(i), (viii), and (ix).</AMDPAR>
                    <P>The additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 1310.04 </SECTNO>
                        <SUBJECT>Maintenance of records.</SUBJECT>
                        <STARS/>
                        <P>(g) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) Alpha-phenylacetoacetamide (APAA) and its optical isomers</P>
                        <STARS/>
                        <P>(viii) 3,4-MDP-2-P methyl glycidate (PMK glycidate) and its optical and geometric isomers</P>
                        <P>(ix) 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its salts, optical and geometric isomers, and salts of isomers</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                  
                <REGTEXT TITLE="21" PART="1310">
                    <AMDPAR>4. In § 1310.09, add paragraph (q) to read as follows:</AMDPAR>
                    <SECTION>
                        <PRTPAGE P="24708"/>
                        <SECTNO>§ 1310.09 </SECTNO>
                        <SUBJECT>Temporary exemption from registration.</SUBJECT>
                        <STARS/>
                        <P>
                            (q)(1) Each person required under 21 U.S.C. 822 and 957 to obtain a registration to manufacture, distribute, import, or export regulated forms of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), and 
                            <E T="03">alpha</E>
                            -phenylacetoacetamide (APAA), including regulated chemical mixtures pursuant to § 1310.12, is temporarily exempted from the registration requirement, provided that DEA receives a properly completed application for registration or application for exemption for a chemical mixture containing regulated forms of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), or 
                            <E T="03">alpha</E>
                            -phenylacetoacetamide (APAA) pursuant to § 1310.13 on or before (30 days after publication of a rule implementing regulations regarding these three chemicals). The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.
                        </P>
                        <P>
                            (2) Any person who manufactures, distributes, imports or exports a chemical mixture containing regulated forms of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), or 
                            <E T="03">alpha</E>
                            -phenylacetoacetamide (APAA) whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for those persons whose applications for exemption are denied, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.
                        </P>
                    </SECTION>
                </REGTEXT>
                  
                <REGTEXT TITLE="21" PART="1310">
                    <AMDPAR>
                        5. In § 1310.12, in paragraph (c), add in alphanumerical order entries for 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), and 
                        <E T="03">alpha</E>
                        -phenylacetoacetamide (APAA) in the table “Table of Concentration Limits” to read as follows:
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1310.12 </SECTNO>
                        <SUBJECT>Exempt chemical mixtures.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <GPOTABLE COLS="4" OPTS="L1,i1" CDEF="s50,9,r25,r50">
                            <TTITLE>Table of Concentration Limits</TTITLE>
                            <BOXHD>
                                <CHED H="1"> </CHED>
                                <CHED H="1">DEA chemical code no.</CHED>
                                <CHED H="1">Concentration</CHED>
                                <CHED H="1">Special conditions</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">3,4-MDP-2-P methyl glycidate (PMK glycidate) and its optical and geometric isomers</ENT>
                                <ENT>8535</ENT>
                                <ENT>Not exempt at any concentration</ENT>
                                <ENT>Chemical mixtures containing any amount of this chemical are not exempt.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its salts, optical and geometric isomers, and salts of isomers</ENT>
                                <ENT>8525</ENT>
                                <ENT>Not exempt at any concentration</ENT>
                                <ENT>Chemical mixtures containing any amount of this chemical are not exempt.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Alpha-phenylacetoacetamide (APAA) and its optical isomers</ENT>
                                <ENT>8515</ENT>
                                <ENT>Not exempt at any concentration</ENT>
                                <ENT>Chemical mixtures containing any amount of this chemical are not exempt.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <NAME>D. Christopher Evans,</NAME>
                    <TITLE>Acting Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09697 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-09-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">AGENCY FOR INTERNATIONAL DEVELOPMENT</AGENCY>
                <CFR>22 CFR Part 228</CFR>
                <DEPDOC>[AID-2020-0004]</DEPDOC>
                <RIN>RIN 0412-AB09</RIN>
                <SUBJECT>Procurement of Certain Essential Medical Supplies To Address the COVID-19 Pandemic</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Agency for International Development.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; technical amendments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On October 23, 2020, the United States Agency for International Development (USAID) issued a Temporary Final Rule (TFR) amending our regulations to allow USAID to waive “Source and Nationality” rules to provide for increased flexibility, targeting, and speed of procurement of Essential Medical Supplies required to address the COVID-19 pandemic worldwide. The TFR was effective through April 30, 2021. This document reverts the amended sections to the text of those sections as they existed prior to the issuance of the TFR, with minor technical updates. This reversion to the original text is applicable upon the expiration of the TFR.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective May 10, 2021. As stated in the October 23, 2020, final rule, the TFR was effective from October 23, 2020, through April 30, 2021. The amendments in this rule are applicable beginning May 1, 2021, after the expiration of the TFR.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may review the docket by searching for Docket ID [AID-2020-0004], via the Federal eRulemaking Portal: 
                        <E T="03">http://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Greg Marchand, Assistant General Counsel, Office of the General Counsel, USAID, 1300 Pennsylvania Ave. NW, Washington, DC 20523, 202-215-3409, 
                        <E T="03">GCFEDREGMailbox@usaid.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This document affects 22 CFR 228.01, which was amended by the TFR published in the 
                    <E T="04">Federal Register</E>
                     on October 23, 2020 (85 FR 67443) and subsequently corrected on December 16, 2020 (85 FR 81390). The TFR and its subsequent correction revised the definitions in §  228.01 by adding a new definition for “Essential medical supplies.” This document reinstates the definitions in §  228.01 exactly as they existed prior to the issuance of the TFR. This document also reverts 22 CFR 228.11 and 228.30, which were also amended by the TFR published in the 
                    <E T="04">Federal Register</E>
                     on October 23, 2020 (85 FR 67443). The TFR amended these sections to create a 
                    <PRTPAGE P="24709"/>
                    new approval requirement and basis for waivers for the source and nationality of essential medical supplies. This document reverts the language of both sections to the text as it existed prior to the issuance of the TFR, with minor technical updates.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 22 CFR Part 228</HD>
                    <P>Government procurement.</P>
                </LSTSUB>
                <P>
                    The Deputy General Counsel of USAID, Suk J. Jin, having reviewed and approved this document, is delegating the authority to electronically sign this document to Gregory A. Marchand, Assistant General Counsel for USAID, for purposes of publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <NAME>Gregory A. Marchand,</NAME>
                    <TITLE>Assistant General Counsel, U.S. Agency for International Development.</TITLE>
                </SIG>
                <P>For reasons stated in the preamble, USAID amends 22 CFR part 228 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 228—RULES FOR PROCUREMENT OF COMMODITIES AND SERVICES FINANCED BY USAID</HD>
                </PART>
                <REGTEXT TITLE="22" PART="228">
                    <AMDPAR>1. The authority citation for 22 CFR part 228 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> Sec. 621, Pub. L. 87-195, 75 Stat. 445 (22 U.S.C. 2381), as amended, E.O. 12163, Sept. 29, 1979, 44 FR 56673: 3 CFR 1979 Comp., p. 435.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="22" PART="228">
                    <AMDPAR>2. Revise §  228.01 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 228.01 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <P>As used in this part, the following terms shall have the following meanings:</P>
                        <P>
                            <E T="03">Advanced developing countries</E>
                             mean those countries that are categorized by the World Bank as upper middle income countries according to their gross national income per capita, except for those countries in which USAID provides assistance. USAID will maintain a list of advanced developing countries primarily based on the most recent World Bank determinations, and will make the list available in USAID's Automated Directives System, ADS 310. This list will include determinations made under §  228.17.
                        </P>
                        <P>
                            <E T="03">Available for purchase</E>
                             means for commodities, that the commodity is offered for sale in a country in the authorized principal geographic code at the time of purchase from the supplier, irrespective of the place of manufacture or production, unless it is a prohibited source country. If applicable, the commodity must also be able to be serviced, and, if warrantied, have a valid warranty. For services, available for purchase means the service is offered from a vendor which has complied with nationality and foreign government-owned organization requirements of this regulation, and is otherwise organized in a country in the authorized principal geographic code designated in an implementing instrument. This definition does not apply to procurements under the geographic Code 935, see §  228.03, because that geographic code is for any country or area except for prohibited source countries.
                        </P>
                        <P>
                            <E T="03">Commission</E>
                             means any payment or allowance by a supplier to any person for the contribution which that person has made to secure the sale or contract for the supplier or which that person makes to securing on a continuing basis similar sales or contracts for the supplier.
                        </P>
                        <P>
                            <E T="03">Commodities</E>
                             or 
                            <E T="03">goods</E>
                             means any material, article, supply, good, or equipment.
                        </P>
                        <P>
                            <E T="03">Commodity-related services</E>
                             means delivery services and/or incidental services.
                        </P>
                        <P>
                            <E T="03">Cooperating country</E>
                             or 
                            <E T="03">recipient country</E>
                             means the country receiving the USAID assistance subject to this part, and includes all the countries receiving assistance under a regional program or project.
                        </P>
                        <P>
                            <E T="03">Delivery</E>
                             means the transfer to, or for the account of, an importer of the right to possession of a commodity, or, with respect to a commodity-related service, the rendering to, or for the account of, an importer of any such service.
                        </P>
                        <P>
                            <E T="03">Delivery service</E>
                             means any service customarily performed in a commercial export or import transaction which is necessary to affect a physical transfer of commodities to the cooperating/recipient country. Examples of such services are the following: export packing, local drayage in the source country (including waiting time at the dock), ocean and other freight, loading, heavy lift, wharfage, tollage, switching, dumping and trimming, lighterage, insurance, commodity inspection services, and services of a freight forwarder. “Delivery service” may also include work and materials necessary to meet USAID marking requirements.
                        </P>
                        <P>
                            <E T="03">Developing countries</E>
                             means those countries that are categorized by the World Bank as low or lower middle income economies according to their gross national income per capita, and also includes all countries to which USAID provides assistance. USAID will maintain a list of developing countries primarily based on the most recent World Bank determinations, and will make the list available in USAID's Automated Directives System, ADS 310.
                        </P>
                        <P>
                            <E T="03">Free Port</E>
                             or 
                            <E T="03">Bonded Warehouse</E>
                             is a special customs area with favorable customs regulations (or no customs duties and controls for transshipment).
                        </P>
                        <P>
                            <E T="03">Implementing instrument</E>
                             means a binding relationship established between USAID and an outside party or parties to carry out USAID programs, by authorizing the use of USAID funds and/or nonfinancial resources for the procurement of services or commodities and/or commodity related services. Implementing instruments include specific conditions that apply to each such procurement. Examples of such instruments include contracts, grants, cooperating agreements, and interagency agreements.
                        </P>
                        <P>
                            <E T="03">Incidental services</E>
                             means services such as installation, erection, maintenance, or upgrading of USAID-financed equipment, or the training of personnel in the maintenance, operation and use of such equipment, or similar services provided for the authorized disposition of such commodities.
                        </P>
                        <P>
                            <E T="03">Long term lease</E>
                             means, for purposes of subpart B of this part, a single lease of more than 180 calendar days; or repetitive or intermittent leases under a single award within a one-year period, which cumulatively total more than 180 calendar days. A single lease may consist of lease of one or more of the same type of commodity within the same lease term.
                        </P>
                        <P>
                            <E T="03">Motor vehicles</E>
                             means self-propelled vehicles with passenger carriage capacity, such as highway trucks, passenger cars and buses, motorcycles, scooters, motorized bicycles, ATVs, and utility vehicles. Excluded from this definition are ambulances, snowmobiles, industrial vehicles for materials handling and earthmoving, such as lift trucks, tractors, graders, scrapers, off-the-highway trucks (such as off-road dump trucks), boats, and other vehicles that are not designed for travel at normal road speeds (40 kilometers per hour and above).
                        </P>
                        <P>
                            <E T="03">Mission</E>
                             means the USAID Mission, office or representative in a cooperating/recipient country.
                        </P>
                        <P>
                            <E T="03">Nationality</E>
                             refers to the place of legal organization, ownership, citizenship, or lawful permanent residence (or equivalent immigration status to live and work on a continuing basis) of suppliers of commodities and services.
                        </P>
                        <P>
                            <E T="03">Pharmaceutical</E>
                             means any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in humans or animals; any substances (other than food) intended to affect the structure or any function of the body of humans or animals; and, any substance intended for use as a component in the above. The term includes drugs, vitamins, oral rehydration salts, biologicals, and some 
                            <PRTPAGE P="24710"/>
                            in-vitro diagnostic reagents/test kits; but does not include devices or their components, parts, or accessories. Contraceptives, including condoms, are not included in this definition.
                        </P>
                        <P>
                            <E T="03">Prohibited sources</E>
                             means countries to which assistance is prohibited by the annual appropriations acts of Congress or other statutes, or those subject to other executive branch restrictions, such as applicable sanctions administered by the U.S. Treasury Department's Office of Foreign Assets Control. USAID maintains a list of prohibited sources, available in USAID's Automated Directives System, ADS 310.
                        </P>
                        <P>
                            <E T="03">Recipients and contractors. Recipient</E>
                             has the same meaning as defined in 22 CFR 226.02, except that it shall include non-U.S. individuals, entities and organizations, as well as subrecipients. 
                            <E T="03">Contractors</E>
                             mean those entities which enter into a contract, as the term is defined in 48 CFR part 2, with the U.S. Government, and includes subcontractors.
                        </P>
                        <P>
                            <E T="03">Services</E>
                             means the performance of identifiable tasks, rather than the delivery of an end item of supply.
                        </P>
                        <P>
                            <E T="03">Source</E>
                             means the country from which a commodity is shipped to the cooperating/recipient country or the cooperating/recipient country itself if the commodity is located therein at the time of the purchase, irrespective of the place of manufacture or production, unless it is a prohibited source country. Where, however, a commodity is shipped from a free port or bonded warehouse in the form in which received therein, “source” means the country from which the commodity was shipped to the free port or bonded warehouse.
                        </P>
                        <P>
                            <E T="03">Supplier</E>
                             means any person or organization, governmental or otherwise, who furnishes services, commodities, and/or commodity related services, including delivery or incidental services, financed by USAID.
                        </P>
                        <P>
                            <E T="03">United States</E>
                             means the United States of America, any State(s) of the United States, the District of Columbia, and areas of U.S. associated sovereignty, including commonwealths, territories, and possessions.
                        </P>
                        <P>
                            <E T="03">USAID</E>
                             means the United States Agency for International Development or any successor agency, including when applicable, each USAID Mission or office abroad.
                        </P>
                        <P>
                            <E T="03">USAID Principal Geographic Code</E>
                             means a USAID code which designates a country, a group of countries, or an otherwise defined area. The USAID principal geographic codes for purposes of procurement are described in §  228.03.
                        </P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="22" PART="228">
                    <AMDPAR>3. Revise §  228.11 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 228.11 </SECTNO>
                        <SUBJECT>Source of commodities.</SUBJECT>
                        <P>The source of all commodities financed with Federal program funds appropriated under the Foreign Assistance Act of 1961, as amended, shall be Code 937 (unless Code 935 or 110 are designated in the implementing instrument). Procurements of agricultural commodities, motor vehicles, and pharmaceuticals must also comply with the special procurement rules in §  228.19. Recipients and contractors are prohibited from engaging suppliers of commodities in an authorized country to import commodities from a country outside of the authorized principal geographic codes for the purposes of circumventing the requirements of this section. Any violation of the prohibition in the preceding sentence will result in the disallowance by USAID of the cost of the procurement of the subject commodity.</P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="22" PART="228">
                    <AMDPAR>4. Revise §  228.30 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 228.30 </SECTNO>
                        <SUBJECT>General.</SUBJECT>
                        <P>USAID may waive the rules contained in subparts A, B, and C of this part (except for prohibited sources as defined in §  228.01, and §§  228.21 and 228.22), in order to accomplish project or program objectives. For any waivers authorized, the principal geographic code shall be Code 935, any area or country but excluding prohibited sources. All waivers must be in writing, and where applicable, are limited to the term established by the waiver. All waiver decisions will be made solely on the basis of the following criteria:</P>
                        <P>(a) Waivers to permit procurement outside of Code 937 or 110 must be based on a case by case determination that:</P>
                        <P>(1) The provision of assistance requires commodities or services of the type that are not produced in and available for purchase in Code 937 or 110;</P>
                        <P>(2) It is important to permit procurement from a country not specified in Code 937 or 110 to meet unforeseen circumstances; or</P>
                        <P>(3) To promote efficiency in the use of United States foreign assistance resources, including to avoid impairment of foreign assistance objectives.</P>
                        <P>(b) Case by case waivers under paragraph (a) of this section may be made on the basis of a commodity or service type or category, rather than processing repeat, individual waivers for an identical or substantially similar commodity or service. Such waivers may be approved on a regional, country, or program basis. For purposes of paragraph (a)(1) of this section, “produced in and available for purchase in” shall have the same meaning as the definition of “available for purchase” in §  228.01. A waiver under paragraph (a)(1) of this section may also be based on the fact that a commodity is not available for purchase in Code 937 or 110 in sufficient, reasonable, and available quantities or sufficient and reasonable quality that is fit for the intended purpose.</P>
                        <P>(c) A waiver to authorize procurement from outside the United States of agricultural commodities, motor vehicles, and pharmaceuticals must meet the requirements of §  228.19.</P>
                        <P>(d) Any individual transaction not exceeding $25,000 (excluding those covered by special procurement rules in §  228.19, and excluding procurements from prohibited sources) does not require a waiver and is hereby authorized.</P>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09821 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6116-02-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <CFR>33 CFR Part 165</CFR>
                <DEPDOC>[Docket Number USCG-2021-0287]</DEPDOC>
                <RIN>RIN 1625-AA00</RIN>
                <SUBJECT> Safety Zone; Lower Mississippi River, Mile Marker 770, Randolph Bluff, TN</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Temporary final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Coast Guard is establishing a temporary safety zone for all navigable waters of the Lower Mississippi River (LMR), Mile Marker 762 through 782. The safety zone is needed to protect persons, property, and the marine environment from the potential safety hazards associated with a rock replacement project in the vicinity of Randolph Bluff, TN. Entry of persons or vessels into this zone is prohibited unless authorized by the Captain of the Port Sector Lower Mississippi River or a designated representative.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective without actual notice from May 10, 2021 until May 31, 2021. For the purposes of enforcement, actual notice will be used from April 27, 2021, until May 10, 2021.</P>
                </DATES>
                <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-2021-0287 in the “SEARCH” box and click 
                        <PRTPAGE P="24711"/>
                        “SEARCH.” Click on Open Docket Folder on the line associated with this rule.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you have questions on this rule, call or email MSTC Lindsey Swindle, U.S. Coast Guard; telephone 901-521-4813, email 
                        <E T="03">Lindsey.M.Swindle@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">COTP Captain of the Port Sector Lower Mississippi River</FP>
                    <FP SOURCE="FP-1">DHS Department of Homeland Security</FP>
                    <FP SOURCE="FP-1">FR Federal Register</FP>
                    <FP SOURCE="FP-1">NPRM Notice of proposed rulemaking</FP>
                    <FP SOURCE="FP-1">§ Section </FP>
                    <FP SOURCE="FP-1">U.S.C. United States Code</FP>
                </EXTRACT>
                <HD SOURCE="HD1">II. Background Information and Regulatory History</HD>
                <P>The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. Immediate action is needed to protect persons and property from the potential safety hazards associated with the rock replacement project. The NPRM process would delay the establishment of the safety zone until after the date of the event and compromise public safety. We must establish this temporary safety zone immediately and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.</P>
                <P>
                    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the 
                    <E T="04">Federal Register</E>
                    . Delaying the effective date of this rule would be contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with the rock replacement project in the vicinity of Randolph Bluff, TN.
                </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 Lower Mississippi River (COTP) has determined that potential hazards associated with the rock replacement project, would be a safety concern for all persons and vessels on the Lower Mississippi River between Mile Marker (MM) 762 and MM 782 in the vicinity of Randolph Bluff, TN. This rule is needed to protect persons, property, infrastructure, and the marine environment in all waters of the LMR within the safety zone while the rock replacement project are being conducted.</P>
                <HD SOURCE="HD1">IV. Discussion of the Rule</HD>
                <P>This rule establishes a temporary safety zone from April 27, 2021 through May 31, 2021. The safety zone will cover all navigable waters of the LMR from MM 762 through MM 782 in the vicinity of Randolph Bluff, TN. The duration of this safety zone is intended to ensure the safety of waterway users on these navigable waters during the rock replacement project.</P>
                <P>Entry of persons or vessels into this safety zone is prohibited unless authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Lower Mississippi River. Persons or vessels seeking to enter the safety zones must request permission from the COTP or a designated representative on VHF-FM channel 16 or by telephone at 901-521-4822. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative. The COTP or a designated representative will inform the public of the enforcement times and date for this safety zone through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), as appropriate.</P>
                <HD SOURCE="HD1">V. Regulatory Analyses</HD>
                <P>We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.</P>
                <HD SOURCE="HD2">A. Regulatory Planning and Review</HD>
                <P>Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).</P>
                <P>This regulatory action determination is based on the size, location, and duration of the safety zone. This emergency safety zone will temporarily restrict navigation on the LMR at MM 762 through 782 in the vicinity of Randoloh Bluff, TN., from April 27, 2021 through May 31, 2021. Moreover, The Coast Guard will issue Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), as appropriate. The rule allows 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 temporary safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.</P>
                <P>
                    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please 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 
                    <PRTPAGE P="24712"/>
                    small entities that question or complain about this rule or any policy or action of the Coast Guard.
                </P>
                <HD SOURCE="HD2">C. Collection of Information</HD>
                <P>This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).</P>
                <HD SOURCE="HD2">D. Federalism and Indian Tribal Governments</HD>
                <P>A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.</P>
                <P>Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.</P>
                <HD SOURCE="HD2">E. Unfunded Mandates Reform Act</HD>
                <P>The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.</P>
                <HD SOURCE="HD2">F. Environment</HD>
                <P>
                    We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone on the LMR at MM 762 through 782 in the vicinity of Randolph Bluff, TN, that will prohibit entry into this zone. The safety zone will only be enforced while operations preclude the safe navigation of the established channel. It is categorically excluded from further review under paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the 
                    <E T="02">ADDRESSES</E>
                     section of this preamble.
                </P>
                <HD SOURCE="HD2">G. Protest Activities</HD>
                <P>
                    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 33 CFR Part 165</HD>
                    <P>Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS.</HD>
                </PART>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>1. The authority citation for part 165 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>2. Add § 165.T08-0287 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 165.T08-0287 </SECTNO>
                        <SUBJECT>Safety Zone; Lower Mississippi River, Mile Marker 770, Randolph Bluff, TN.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Location.</E>
                             The following area is a safety zone: All navigable waters of the Lower Mississippi River at Mile Marker (MM) 762 through 782 in the vicinity of Randolph Bluff, TN.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Regulations.</E>
                             (1) Under the general safety zone regulations in subpart C of this part, you may not enter the safety zone described in paragraph (a) of this section unless authorized by the Captain of the Port Sector Lower Mississippi River (COTP) or the COTP's designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Lower Mississippi River.
                        </P>
                        <P>(2) To seek permission to enter, contact the COTP or the COTP's representative via VHF-FM channel 16 or by telephone at 901-521-4822. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.</P>
                        <P>
                            (c) 
                            <E T="03">Effective period.</E>
                             This section is effective from April 27, 2021 until May 31, 2021.
                        </P>
                        <P>
                            (d)
                            <E T="03"> Information broadcasts.</E>
                             The COTP or a designated representative will inform the public of the enforcement times and date for this safety zone through Broadcast Notices to Mariners, Local Notices to Mariners, and/or Safety Marine Information Broadcasts, as appropriate.
                        </P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: April 22, 2021.</DATED>
                    <NAME>R.S. Rhodes,</NAME>
                    <TITLE>Captain, U.S. Coast Guard, Captain of the Port Sector Lower Mississippi River.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09865 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">POSTAL SERVICE</AGENCY>
                <CFR>39 CFR Parts 3 and 10</CFR>
                <SUBJECT>Bylaws of the Board of Governors of the United States Postal Service</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; technical amendments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This document includes several technical edits to the Bylaws of the Board of Governors to follow recent amendments to these regulations. This document also updates the provisions concerning financial reporting.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective May 10, 2021.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael J. Elston, Secretary of the Board of Governors, 
                        <E T="03">michael.j.elston@usps.gov,</E>
                         202-268-4800.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On November 13, 2020, the Board of Governors approved amendments to its Bylaws to address a variety of issues. The Postal Service published the revised Bylaws in the 
                    <E T="04">Federal Register</E>
                     on February 18, 2021, and the changes were effective as of this same date. The Postal Service is now making several technical corrections following these changes. In addition, the Postal Service is updating the Bylaw provisions that concern financial reporting for the Board of Governors.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>39 CFR Part 3</CFR>
                    <P>
                        Board of Governors.
                        <PRTPAGE P="24713"/>
                    </P>
                    <CFR>39 CFR Part 10</CFR>
                    <P>Rules of Conduct for Postal Service Governors.</P>
                </LSTSUB>
                <P>For the reasons stated in the preamble, the Postal Service amends 39 CFR chapter I as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 3—BOARD OF GOVERNORS</HD>
                </PART>
                <REGTEXT TITLE="39" PART="3">
                    <AMDPAR>1. The authority citation for part 3 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>39 U.S.C. 202, 203, 205, 401 (2), (10), 402, 404(b), 414, 416, 1003, 2005, 2011, 2802-2804, 3013, 3622, 3632, 3642, 3652, 3654, 3691; 5 U.S.C. 552b(g), (j); 5 U.S.C. App.; Pub. L. 107-67, 115 Stat. 514 (2001). </P>
                    </AUTH>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 3.3 </SECTNO>
                    <SUBJECT>[Amended] </SUBJECT>
                </SECTION>
                <REGTEXT TITLE="39" PART="3">
                    <AMDPAR>2. Amend § 3.3 by removing the erroneous paragraph (3) following paragraph (b) and removing paragraphs (o), (p), (q), and (r).</AMDPAR>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 3.6 </SECTNO>
                    <SUBJECT>[Amended] </SUBJECT>
                </SECTION>
                <REGTEXT TITLE="39" PART="3">
                    <AMDPAR>3. Amend § 3.6 by removing the semicolon at the end of paragraph (a)(5) and adding a period in its place and by removing paragraph (a)(6).</AMDPAR>
                </REGTEXT>
                <REGTEXT TITLE="39" PART="3">
                    <AMDPAR>4. In § 3.7, revise paragraph (b) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 3.7 </SECTNO>
                        <SUBJECT>Information furnished to Board—program review.</SUBJECT>
                        <STARS/>
                        <P>(b) To enable the Board to review the effectiveness of the Postal Service's equal employment opportunity program, performance data relating to this program shall be furnished to the Board at least annually. These data shall be categorized in such manner as the Board, from time to time, specifies.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 10—RULES OF CONDUCT FOR POSTAL SERVICE GOVERNORS</HD>
                </PART>
                <REGTEXT TITLE="39" PART="10">
                    <AMDPAR>5. The authority citation for part 10 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> 39 U.S.C. 401(2), (10).</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="39" PART="10">
                    <AMDPAR>6. Revise § 10.4 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 10.4 </SECTNO>
                        <SUBJECT>Financial disclosure reports.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Requirement of submission of reports</E>
                            —(1) 
                            <E T="03">Upon nomination.</E>
                             At the time of their nomination, Governors complete a financial disclosure report which, under the practice of the Senate Homeland Security and Governmental Affairs Committee, is kept confidential.
                        </P>
                        <P>
                            (2) 
                            <E T="03">After confirmation.</E>
                             Because the Director of the Office of Government Ethics has concluded that Governors who do not perform the duties of their office for more than 60 days in any calendar year are not required to file financial disclosure reports that are open to the public, Governors file non-public reports annually, in accordance with this section. A Governor who performs the duties of his or her office for more than 60 days in a particular calendar year is required to file a public report in accordance with 5 CFR 2634.204(c).
                        </P>
                        <P>
                            (b) 
                            <E T="03">Person with whom reports should be filed and time for filing.</E>
                             (1) A Governor shall file a financial disclosure report with the Associate General Counsel on or before May 15 of each year when the Governor has been in office for more than 60 consecutive calendar days during the previous year.
                        </P>
                        <P>(2) The Associate General Counsel may, for good cause shown, grant to a Governor one or more extensions totaling not more than 90 days.</P>
                        <P>
                            (c) 
                            <E T="03">Information required to be reported.</E>
                             Each report shall be a full and complete statement, on the form prescribed by the Associate General Counsel and the Office of Government Ethics and in accordance with instructions issued by him or her.
                        </P>
                        <P>
                            (d) 
                            <E T="03">Reviewing reports.</E>
                             (1) Financial disclosure reports filed in accordance with the provisions of this section shall, within 60 days after the date of filing, be reviewed by the Associate General Counsel who shall either approve the report, or make an initial determination that a conflict or appearance thereof exists. If the Associate General Counsel determines initially that a conflict or the appearance of a conflict exists, he or she shall inform the Governor of his or her determination.
                        </P>
                        <P>(2) If the Associate General Counsel considers that additional information is needed to complete the report or to allow an adequate review to be conducted, he or she shall request the reporting Governor to furnish that information by a specified date.</P>
                        <P>(3) The Associate General Counsel shall refer to the Chairman of the Board of Governors or the Vice Chairman the name of any Governor he or she has reasonable cause to believe has wrongfully failed to file a report or has falsified or wrongfully failed to report required information.</P>
                        <P>
                            (e) 
                            <E T="03">Custody of and public access to reports</E>
                            —(1) 
                            <E T="03">Retention of reports.</E>
                             Each report filed with the Associate General Counsel shall be retained by him or her for a period of six years. After the six-year period, the report shall be destroyed unless needed in connection with an investigation then pending.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Confidentiality of reports.</E>
                             Unless a public report is required by this section, the financial disclosure reports filed by Governors shall not be made public.
                        </P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <NAME>Michael J. Elston,</NAME>
                    <TITLE>Secretary of the Board of Governors. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09714 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R08-OAR-2020-0739; FRL-10023-50-Region 8]</DEPDOC>
                <SUBJECT>Approval and Promulgation of Implementation Plans; South Dakota; Revisions to Air Rules of South Dakota</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of South Dakota on January 3, 2020 that revises the Administrative Rules of South Dakota (ARSD), Air Pollution Control Program, updating the chapter pertaining to definitions. The EPA is taking this action pursuant to the Clean Air Act (CAA).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket ID No. EPA-R08-OAR-2020-0739. All documents in the docket are listed on the 
                        <E T="03">http://www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">e.g.,</E>
                         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">http://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.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kate Gregory, (303) 312-6175, 
                        <E T="03">gregory.kate@epa.gov.</E>
                         Mail can be directed to the Air and Radiation Division, U.S. EPA, Region 8, Mail-code 8ARD-QP, 1595 Wynkoop Street, Denver, Colorado 80202-1129.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Throughout this document “we,” “us,” and “our” means the EPA.
                    <PRTPAGE P="24714"/>
                </P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>On January 3, 2020 the State of South Dakota submitted revisions and additions to the ARSD. In this action, we are approving the additions to the ARSD pertaining to the definitions section. The subject of this action is described in detail in our notice of proposed rulemaking (NPRM) published on February 24, 2021 (86 FR 11211).</P>
                <HD SOURCE="HD1">II. Final Action</HD>
                <P>
                    In this rulemaking, the EPA is approving the revisions to the ARSD submitted by the State of South Dakota on January 3, 2020, specifically the additions of 74:36:01:01(71) and 74:36:01:01(72) in the definitions section of the ARSD.
                    <E T="51">1 2</E>
                    <FTREF/>
                     The subsections of the ARSD definitions section we are approving, 74:36:01:01(71) and 74:36:01:01(72), contain the definitions of `closed landfill' and `closed landfill subcategory,' respectively. In this action, we are approving the addition of the abovementioned subsections to the definitions section of the ARSD. Additional revisions and additions to the ARSD, related to content that includes `closed landfill' and `closed landfill subcategory' have been approved in a separate action [(85 FR 16538) Approval and Promulgation of State Plans for Designated Facilities and Pollutants; South Dakota; Control of Emissions From Existing Municipal Solid Waste Landfills].
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The additional revisions and additions to the ARSD as they relate to the SIP referenced in the January 3, 2020 ARSD rule revision submission by the State of South Dakota were approved in a prior rule: Air Quality State Implementation Plans; Approval and Promulgation of Implementation Plans; South Dakota; Infrastructure Requirements for the 2015 Ozone National Ambient Air Quality Standards; Revisions to Administrative Rules (85 FR 67653).
                    </P>
                    <P>
                        <SU>2</SU>
                         ARSD numbering in the notice of proposed rulemaking for this action (86 FR 11211) was listed as 74:36:01:01(74) and 74:36:01:01(75). The correct numbering of the ARSD we are acting on is listed in this notice of final rulemaking as 74:36:01:01(71) and 74:36:01:01(72). The definitions we are approving of `closed landfill' and `closed landfill subcategory' remain unchanged in both the proposal and final action.
                    </P>
                </FTNT>
                <P>In the table below, the key is as follows:</P>
                <P>
                    A—
                    <E T="03">Approve.</E>
                </P>
                <P>
                    D—
                    <E T="03">Disapprove.</E>
                </P>
                <GPOTABLE COLS="2" OPTS="L2,p1,8/9,i1" CDEF="s50,6C">
                    <TTITLE>Table 1—ARSD Additions That the EPA Is Approving</TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1"> </CHED>
                    </BOXHD>
                    <ROW EXPSTB="01" RUL="s">
                        <ENT I="21">
                            <E T="02">Additions the Administrative Rules of South Dakota (ARSD)</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">74:36:01:01(71)</ENT>
                        <ENT>A</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">74:36:01:01(72)</ENT>
                        <ENT>A</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">III. Incorporation by Reference</HD>
                <P>
                    In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of ARSD, Air Pollution Control Program, updating the ARSD chapters pertaining to definitions as is described in the preamble. The EPA has made, and will continue to make, these materials generally available through 
                    <E T="03">www.regulations.gov</E>
                     and at the EPA Region 8 Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         62 FR 27968 (May 22, 1997).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Statutory and Executive Order Reviews</HD>
                <P>Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the 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>• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;</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, 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 9, 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, 
                    <PRTPAGE P="24715"/>
                    and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Carbon monoxide, Greenhouse gases, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated:  May 4, 2021. </DATED>
                    <NAME>Debra H. Thomas,</NAME>
                    <TITLE>Acting Regional Administrator,  Region 8.</TITLE>
                </SIG>
                <P>40 CFR part 52 is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS</HD>
                </PART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>1. The authority citation for part 52 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                            42 U.S.C. 7401 
                            <E T="03">et seq.</E>
                        </P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart QQ—South Dakota</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>2. In § 52.2170, the table in paragraph (c) is amended by revising the entry for “74:36:01:01” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.2170 </SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <GPOTABLE COLS="6" OPTS="L1,tp0,i1" CDEF="s50,r50,10,10,r50,r50">
                            <BOXHD>
                                <CHED H="1">Rule No.</CHED>
                                <CHED H="1">Rule title</CHED>
                                <CHED H="1">
                                    State
                                    <LI>effective</LI>
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">EPA effective date</CHED>
                                <CHED H="1">Final rule citation, date</CHED>
                                <CHED H="1">Comments</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">74:36:01:01</ENT>
                                <ENT>Definitions</ENT>
                                <ENT>11/25/2019</ENT>
                                <ENT>6/9/2021</ENT>
                                <ENT>
                                    [insert 
                                    <E T="02">Federal Register</E>
                                     citation], 5/10/2021
                                </ENT>
                                <ENT/>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09863 Filed 5-7-21; 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-R06-OAR-2021-0604; FRL-10023-14-Region 6]</DEPDOC>
                <SUBJECT>Air Plan Approval; Louisiana; Infrastructure State Implementation Plan Requirements for the National Ambient Air Quality Standards</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>
                        Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving the State Implementation Plan (SIP) submittal from Louisiana submitted on November 4, 2020 for the 2015 ozone, as well as the 2006 PM
                        <E T="52">2.5</E>
                        , 2008 ozone, 2010 nitrogen dioxide, 2010 sulfur dioxide and the 2012 PM
                        <E T="52">2.5</E>
                         National Ambient Air Quality Standards. This submittal addresses how the existing SIP contains adequate provisions prohibiting emissions which interfere with required measures in any other State to protect visibility with respect to the 2015 ozone NAAQS as well as the 2006 PM
                        <E T="52">2.5</E>
                        , 2008 ozone, 2010 nitrogen dioxide, 2010 sulfur dioxide and the 2012 PM
                        <E T="52">2.5</E>
                         NAAQS.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on June 9, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2020-0604. All documents in the docket are listed on the 
                        <E T="03">https://www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">e.g.,</E>
                         Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet. Publicly available docket materials are available electronically through 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jennifer Huser, EPA Region 6 Office, Air and Radiation Division—State Planning and Implementation Branch, 214-665-7347, 
                        <E T="03">huser.jennifer@epa.gov.</E>
                         Out of an abundance of caution for members of the public and our staff, the EPA Region 6 office will be closed to the public to reduce the risk of transmitting COVID-19. Please call or email the contact listed above if you need alternative access to material indexed but not provided in the docket.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document “we,” “us,” and “our” means the EPA.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    The background for this action is discussed in detail in our February 22, 2021 proposal (86 FR 10509). In that document we proposed to approve the State Implementation Plan (SIP) submittal from Louisiana submitted on November 4, 2020 for the 2015 ozone (O3), 2006 PM
                    <E T="52">2.5</E>
                    , 2008 ozone, 2010 nitrogen dioxide, 2010 sulfur dioxide and the 2012 PM
                    <E T="52">2.5</E>
                     National Ambient Air Quality Standards (NAAQS). This submittal addresses Prong 4 of the CAA (also referred to as visibility transport) that requires states to demonstrate that their SIP contains adequate measures that prohibit emissions from any source within a state from interfering with the visibility protection measures of other states. The submittal addresses how the existing SIP contains adequate provisions to meet the requirements with respect to the 2015 ozone NAAQS as well as the 2006 PM
                    <E T="52">2.5</E>
                    , 2008 ozone, 2010 nitrogen dioxide, 2010 sulfur dioxide and the 2012 PM
                    <E T="52">2.5</E>
                     NAAQS, as Louisiana now has a fully approved Regional Haze SIP. We did not receive any comments regarding our proposal.
                </P>
                <HD SOURCE="HD1">II. Final Action</HD>
                <P>
                    We are approving the SIP revision submitted on November 4, 2020 which addresses the Prong 4 requirements for the following NAAQS: 2015 Ozone, 2006 PM
                    <E T="52">2.5</E>
                    , 2008 Ozone, 2010 Nitrogen dioxide, 2010 Sulfur Dioxide, and the 2012 PM
                    <E T="52">2.5</E>
                    . This action is being taken under section 110 of the Act.
                </P>
                <HD SOURCE="HD1">III. 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, 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:
                    <PRTPAGE P="24716"/>
                </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 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 9, 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, Visibility transport.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: April 30, 2021.</DATED>
                    <NAME>David Gray,</NAME>
                    <TITLE>Acting Regional Administrator, Region 6.</TITLE>
                </SIG>
                <P>For the reasons stated in the preamble, the Environmental Protection Agency 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>
                <SUBPART>
                    <HD SOURCE="HED">Subpart T—Louisiana</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>
                        2. Amend § 52.970(e) by adding the entry “Visibility Transport SIP for the 2015 ozone, 2012 PM
                        <E T="52">2.5</E>
                        , 2010 NO
                        <E T="52">2</E>
                        , 2010 SO
                        <E T="52">2</E>
                        , 2008 ozone and 2006 PM
                        <E T="52">2.5</E>
                         NAAQS” at the end of the second table titled “EPA Approved Louisiana Nonregulatory Provisions and Quasi-Regulatory Measures” to read as follows:
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.970 </SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(e) * * *</P>
                        <GPOTABLE COLS="5" OPTS="L1,i1" CDEF="s50,xs60,13,r50,r100">
                            <TTITLE>EPA Approved Louisiana Nonregulatory Provisions and Quasi-Regulatory Measures</TTITLE>
                            <BOXHD>
                                <CHED H="1">Name of SIP provision</CHED>
                                <CHED H="1">
                                    Applicable
                                    <LI>geographic or</LI>
                                    <LI>nonattainment</LI>
                                    <LI>area</LI>
                                </CHED>
                                <CHED H="1">
                                    State
                                    <LI>submittal date/</LI>
                                    <LI>effective date</LI>
                                </CHED>
                                <CHED H="1">
                                    EPA approval
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">Explanation</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">
                                    Visibility Transport SIP for the 2015 ozone, 2012 PM
                                    <E T="0732">2.5</E>
                                    , 2010 NO
                                    <E T="0732">2</E>
                                    , 2010 SO
                                    <E T="0732">2</E>
                                    , 2008 ozone and 2006 PM
                                    <E T="0732">2.5</E>
                                     NAAQS
                                </ENT>
                                <ENT>Statewide</ENT>
                                <ENT>11/4/2020</ENT>
                                <ENT>
                                    5/10/2021, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>
                                    Adequate provisions prohibiting emissions which interfere with visibility protection measures in any other State with respect to the 2015 ozone, 2012 PM
                                    <E T="0732">2.5</E>
                                    , 2010 NO
                                    <E T="0732">2</E>
                                    , 2010 SO
                                    <E T="0732">2</E>
                                    , 2008 ozone and 2006 PM
                                    <E T="0732">2.5</E>
                                     NAAQS.
                                </ENT>
                            </ROW>
                        </GPOTABLE>
                    </SECTION>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 52.996 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>3. Remove and reserve § 52.996(b).</AMDPAR>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09625 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <PRTPAGE P="24717"/>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R06-OAR-2020-0300; FRL-10019-45-Region 6]</DEPDOC>
                <SUBJECT>Air Plan Approval; Texas; Reasonable Further Progress Plan for the Houston-Galveston-Brazoria Ozone 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>Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving revisions to the Texas State Implementation Plan (SIP) to meet the Reasonable Further Progress (RFP) requirements for the Houston-Galveston-Brazoria (HGB) serious ozone nonattainment area for the 2008 ozone National Ambient Air Quality Standard (NAAQS). Specifically, EPA is approving the RFP demonstration and associated Motor Vehicle Emission Budgets (MVEBs), and a revised 2011 base year emissions inventory (EI) for the HGB area. EPA is also notifying the public of the status of EPA's adequacy determination for the MVEBs for the HGB area. EPA is not finalizing the proposed approval of revisions to the SIP to address contingency measure requirements in the HGB area for the 2008 Ozone NAAQS at this time.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2020-0300. All documents in the docket are listed on the 
                        <E T="03">https://www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">e.g.,</E>
                         Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet. Publicly available docket materials are available electronically through 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Carrie Paige, EPA Region 6 Office, Infrastructure &amp; Ozone Section, 214-665-6521, 
                        <E T="03">paige.carrie@epa.gov.</E>
                         Out of an abundance of caution for members of the public and our staff, the EPA Region 6 office may be closed to the public to reduce the risk of transmitting COVID-19. Please call or email the contact listed above if you need alternative access to material indexed but not provided in the docket.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document “we,” “us,” and “our” means the EPA.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    The background for this action is discussed in detail in our September 29, 2020 proposal (85 FR 60928). In that action we proposed to approve only the HGB portion of the May 13, 2020, Texas SIP submittal that addressed RFP requirements for the 2008 8-hour ozone NAAQS for the two serious ozone nonattainment areas in Texas (“the TCEQ submittal”). These two areas are the HGB and the Dallas-Fort Worth (DFW) areas. The TCEQ submittal also establishes MVEBs for the year 2020 and includes contingency measures for each of the HGB and DFW areas, should the areas fail to make reasonable further progress, or to attain the NAAQS by the applicable attainment date. The portion of the TCEQ submittal that refers to the DFW area will be addressed in a separate rulemaking action.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Our proposal to approve the RFP plan for the DFW area was published on October 9, 2020 (85 FR 64084). We have not issued a final rule for the DFW area.
                    </P>
                </FTNT>
                <P>Our September 29, 2020 proposal provided a detailed description of the revisions and the rationale for EPA's proposed actions, together with a discussion of the opportunity to comment. The public comment period for these actions closed on October 29, 2020. We did not receive comments regarding our proposal. Therefore, with one exception, we are finalizing our action as proposed.</P>
                <P>
                    On January 29, 2021, the U.S. Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued a decision in response to challenges to EPA's 2015 and 2018 rules implementing the NAAQS for ozone, (80 FR 12264 (March 6, 2015) and 83 FR 62998 (December 6, 2018)). 
                    <E T="03">Sierra Club, et al.</E>
                     v. 
                    <E T="03">EPA,</E>
                     985 F.3d 1055 (D.C. Cir. 2021). Among the rulings in this decision, the D.C. Circuit vacated EPA's interpretation of the CAA to allow states to rely on already implemented control measures to meet the statutory requirements of section 172(c)(9) or 182(c)(9) for contingency measures in nonattainment plans for the ozone NAAQS (see 83 FR 62998, 63026-27). The EPA is reexamining the contingency measures portion of the TCEQ submission for the HGB area in light of the D.C. Circuit decision. Therefore, we are not taking final action at this time on the contingency measures submitted as part of the May 13, 2020, TCEQ SIP submission for the HGB area included in the proposed action. EPA expects to address the contingency measures in a separate future action.
                </P>
                <HD SOURCE="HD1">II. Final Action</HD>
                <P>We are approving revisions to the Texas SIP that address the RFP requirements for the HGB serious ozone nonattainment area for the 2008 ozone NAAQS. Specifically, we are approving the RFP demonstration and associated MVEBs, and the revised 2011 base year EI for the HGB area.</P>
                <P>
                    We are also notifying the public that EPA finds the newly established MVEBs for Nitrogen Oxides (NO
                    <E T="52">X</E>
                    ) and Volatile Organic Compounds (VOC) for the HGB area adequate for the purpose of transportation conformity. Within 24 months from this final rule, the transportation partners will need to demonstrate conformity to the new NO
                    <E T="52">X</E>
                     and VOC MVEBs pursuant to 40 CFR 93.104(e)(3).
                </P>
                <HD SOURCE="HD1">III. 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, 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 
                    <PRTPAGE P="24718"/>
                    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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 9, 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, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: April 30, 2021.</DATED>
                    <NAME>David Gray,</NAME>
                    <TITLE>Acting Regional Administrator, Region 6.</TITLE>
                </SIG>
                <P>For the reasons stated in the preamble, the Environmental Protection Agency 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>
                <SUBPART>
                    <HD SOURCE="HED">Subpart SS—Texas</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>2. In § 52.2270(e), the table titled “EPA Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the Texas SIP” is amended by adding the entry “Reasonable Further Progress Plan (RFP), RFP Motor Vehicle Emission Budgets for 2020, and Revised 2011 Base Year Emissions Inventory” at the end of the table to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.2270 </SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(e) * * *</P>
                        <GPOTABLE COLS="5" OPTS="L1,i1" CDEF="s50,r50,12,r25,12">
                            <TTITLE>EPA Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the Texas SIP</TTITLE>
                            <BOXHD>
                                <CHED H="1">Name of SIP provision</CHED>
                                <CHED H="1">Applicable geographic or non-attainment area</CHED>
                                <CHED H="1">
                                    State
                                    <LI>submittal/</LI>
                                    <LI>effective</LI>
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">
                                    EPA
                                    <LI>approval</LI>
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">Comments</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Reasonable Further Progress Plan (RFP), RFP Motor Vehicle Emission Budgets for 2020, and Revised 2011 Base Year Emissions Inventory</ENT>
                                <ENT>Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, and Waller Counties, TX</ENT>
                                <ENT>3/4/2020</ENT>
                                <ENT>
                                    5/10/2021 [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09626 Filed 5-7-21; 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-R10-OAR-2020-0650; FRL-10022-48-Region 10]</DEPDOC>
                <SUBJECT>Air Plan Approval; Washington; Spokane Regional Clean Air Agency</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is approving a revision to the Washington State Implementation Plan (SIP) that was submitted by the Department of Ecology (Ecology) in coordination with the Spokane Regional Clean Air Agency (SRCAA). This revision updates the SIP with local SRCAA regulations that apply in lieu of, or in supplement to, Ecology's statewide general air quality regulations for SRCAA's jurisdiction. We are also approving SRCAA's adoption by reference of certain Ecology general air quality regulations, which do not have local agency replacement corollaries, to apply in SRCAA's jurisdiction.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective June 9, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2020-0650. All documents in the docket are listed on the 
                        <E T="03">https://www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">e.g.,</E>
                         Confidential Business Information or other information the disclosure of which is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly 
                        <PRTPAGE P="24719"/>
                        available only in hard copy form. Publicly available docket materials are available at 
                        <E T="03">https://www.regulations.gov,</E>
                         or please contact the person listed in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section for additional availability information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jeff Hunt, EPA Region 10, 1200 Sixth Avenue—Suite 155, Seattle, WA 98101, at (206) 553-0256, or 
                        <E T="03">hunt.jeff@epa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document, wherever “we,” “us,” or “our” is used, it means the EPA.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>On February 24, 2021, we proposed to approve an update to the SRCAA regulations in the SIP, remove obsolete regulations, and approve a subset of Ecology's general air quality regulations adopted by reference to apply in SRCAA's jurisdiction (86 FR 11204). The reasons for our proposed approval were stated in the proposed rulemaking and will not be re-stated here. The public comment period for our proposed action ended on March 26, 2021. We received no comments. Therefore, we are finalizing our action as proposed.</P>
                <HD SOURCE="HD1">II. Final Action</HD>
                <HD SOURCE="HD2">A. Regulations Approved and Incorporated by Reference Into the SIP</HD>
                <P>
                    The EPA is approving and incorporating by reference into the Washington SIP at 40 CFR 52.2470(c)—
                    <E T="03">Table 9—Additional Regulations Approved for the Spokane Regional Clean Air Agency (SRCAA) Jurisdiction,</E>
                     the following SRCAA regulatory sections effective September 1, 2020:
                </P>
                <P>• 1.01, 1.02, 1.03, 1.04, 1.05, 2.08, 2.09, 2.13, 2.14, 4.03, 4.04, 4.05, 5.02, 5.03, 5.04, 5.05, 5.06, 5.07, 5.08, 5.09, 5.10, 5.11, 5.12, 5.13, 5.14, 5.15, 6.04, 6.05, 6.07, 6.14, and 6.15.</P>
                <P>
                    The EPA is also approving and incorporating by reference the following Chapter 173-400 Washington Administrative Code (WAC) sections adopted by reference in 
                    <E T="03">Regulation I,</E>
                     subsection 2.14(A)(1) that SRCAA and Ecology submitted to apply within SRCAA's jurisdiction (effective date):
                </P>
                <P>• 173-400-020 (12/29/2012), 173-400-030 (9/16/2018), 173-400-040 (9/16/2018), 173-400-050 (9/16/2018), 173-400-060 (11/25/2018), 173-400-091 (4/1/2011), 173-400-105 (11/25/2018), 173-400-112 (12/29/2012), 173-400-113 (12/29/2012), 173-400-117 (12/29/2012), 173-400-118 (12/29/2012), 173-400-131 (4/1/2011), 173-400-136 (12/29/2012), 173-400-151 (2/10/2005), 173-400-175 (2/10/2005), 173-400-200 (2/10/2005), 173-400-560 (12/29/2012), 173-400-800 (4/1/2011), 173-400-810 (7/1/2016), 173-400-820 (12/29/2012), 173-400-830 (7/1/2016), 173-400-840 (7/1/2016), 173-400-850 (7/1/2016), and 173-400-860 (4/1/2011).</P>
                <P>Please see the amendatory text for more detailed information about the provisions submitted and approved in this action, including local agency corollaries which replace certain Chapter 173-400 WAC provisions and exclusions to our approval.</P>
                <HD SOURCE="HD2">B. Approved but Not Incorporated by Reference Regulations</HD>
                <P>
                    In addition to the regulations approved and incorporated by reference described in section II.A. of this preamble, the EPA reviews and approves state and local clean air agency submissions to ensure they provide adequate enforcement authority and other general authority to implement and enforce the SIP. However, regulations describing such agency enforcement and other general authority are generally not incorporated by reference so as to avoid potential conflict with the EPA's independent authorities. Therefore, we are approving the following updates to SRCAA's general provisions for inclusion in 40 CFR 52.2470(e), 
                    <E T="03">Table 1—Approved but Not Incorporated by Reference Regulations:</E>
                     2.01, 2.02, 2.03, 2.04, 2.05, 2.06, 2.10, 2.11, and 2.12. We also note that SRCAA adopts by reference WAC 173-400-220, 173-400-230, 173-400-240, 173-400-250, and 173-400-260 to apply within its jurisdiction in the approved but not incorporated by reference section of the SIP. Please see the amendatory text for more detailed information about the provisions submitted and approved in this action, including local agency corollaries which replace certain Chapter 173-400 WAC provisions and exclusions to our approval.
                </P>
                <HD SOURCE="HD2">C. Regulations to Remove From the SIP</HD>
                <P>
                    As discussed in the proposal for this action, we are removing from the SIP for SRCAA's jurisdiction any formerly approved Chapter 173-400 WAC provisions which are replaced by local agency corollaries. We are also removing WAC 173-400-100 
                    <E T="03">Registration</E>
                     from the SIP for SRCAA's jurisdiction because it is not a required SIP element. Lastly, we are removing the outdated and subsequently repealed Regulation II, section 4.01 because these requirements were replaced by SRCAA's adoption by reference of WAC 173-400-050 and WAC 173-400-060.
                </P>
                <HD SOURCE="HD2">D. Scope of Proposed Action</HD>
                <P>This revision to the SIP applies specifically to the SRCAA jurisdiction incorporated into the SIP at 40 CFR 52.2470(c), Table 9. As discussed in our proposal, local air agency jurisdiction in Washington is generally defined on a geographic basis; however, there are exceptions. By statute, SRCAA does not have authority for sources under the jurisdiction of the Energy Facilities Site Evaluation Council (EFSEC). See Revised Code of Washington Chapter 80.50. Under the applicability provisions of WAC 173-405-012, 173-410-012, and 173-415-012, SRCAA also does not have jurisdiction for kraft pulp mills, sulfite pulping mills, and primary aluminum plants. For these sources, Ecology retains statewide, direct jurisdiction. Ecology and EFSEC also retain statewide, direct jurisdiction for issuing Prevention of Significant Deterioration (PSD) permits. Therefore, the EPA is not approving into 40 CFR 52.2470(c), Table 9 those provisions of Chapter 173-400 WAC related to the PSD program. Specifically, these provisions are WAC 173-400-116 and WAC 173-400-700 through 173-400-750, which the EPA has already approved as applying state-wide under 40 CFR 52.2470(c), Tables 2 and 3.</P>
                <P>Also, as described in our proposal for this action, jurisdiction to implement the visibility permitting program contained in WAC 173-400-117 varies depending on the situation. Ecology and EFSEC retain authority to implement WAC 173-400-117 as it relates to PSD permits. However, for facilities subject to major nonattainment new source review (NSR) under the applicability provisions of WAC 173-400-800, we are approving SRCAA's implementation of those parts of WAC 173-400-117 as they relate to major nonattainment NSR permits. Therefore, we are modifying the visibility protection Federal Implementation Plan contained in 40 CFR 52.2498 to reflect the approval of WAC 173-400-117 as it applies to implementation of the major nonattainment NSR program in SRCAA's jurisdiction.</P>
                <P>Lastly, this SIP revision is not approved to apply on any Indian reservation land within Spokane County and is also not approved to apply in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction.</P>
                <HD SOURCE="HD1">III. 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 
                    <PRTPAGE P="24720"/>
                    51.5, we are finalizing the incorporation by reference of certain provisions as described in section II.A. and removing provisions from the SIP as described in section II.C. of this preamble. The EPA has made, and will continue to make, materials incorporated by reference generally available through 
                    <E T="03">https://www.regulations.gov</E>
                     and at the EPA Region 10 Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally-enforceable under sections 110 and 113 of the CAA as of the effective date of the final rule of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         62 FR 27968 (May 22, 1997).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Statutory and Executive Order Review</HD>
                <P>Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves State law as meeting federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this 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 it does not address technical standards; 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>This SIP revision is not approved to apply on any Indian reservation land within Spokane County and is also not approved to apply in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 9, 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, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: April 28, 2021.</DATED>
                    <NAME>Michelle L. Pirzadeh,</NAME>
                    <TITLE>Acting Regional Administrator, Region 10.</TITLE>
                </SIG>
                <P>For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS</HD>
                </PART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>1. The authority citation for part 52 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             42 U.S.C. 7401 
                            <E T="03">et seq.</E>
                        </P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart WW—Washington</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>2. Amend § 52.2470 by revising Table 9 of paragraph (c) and Table 1 of paragraph (e) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.2470 </SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) * * *
                            <PRTPAGE P="24721"/>
                        </P>
                        <GPOTABLE COLS="5" OPTS="L2,nj,i1" CDEF="xs60,r50,10,r50,r100">
                            <TTITLE>Table 9—Additional Regulations Approved for the Spokane Regional Clean Air Agency (SRCAA) Jurisdiction</TTITLE>
                            <TDESC>[Applicable in Spokane county, excluding facilities subject to Energy Facilities Site Evaluation Council (EFSEC) jurisdiction; facilities subject to the Washington Department of Ecology's direct jurisdiction under Chapters 173-405, 173-410, and 173-415 Washington Administrative Code (WAC); Indian reservations; any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction; and the Prevention of Significant Deterioration (PSD) permitting of facilities subject to the applicability sections of WAC 173-400-700.]</TDESC>
                            <BOXHD>
                                <CHED H="1">
                                    State/local
                                    <LI>citation</LI>
                                </CHED>
                                <CHED H="1">Title/subject</CHED>
                                <CHED H="1">
                                    State/local
                                    <LI>effective</LI>
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">EPA approval date</CHED>
                                <CHED H="1">Explanations</CHED>
                            </BOXHD>
                            <ROW EXPSTB="04">
                                <ENT I="21">
                                    <E T="02">Spokane Regional Clean Air Agency Regulation I</E>
                                </ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="21">
                                    <E T="02">Article I—Policy, Short Title, and Definitions</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">1.01</ENT>
                                <ENT>Policy</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Subsections (A) and (B) replace WAC 173-400-010.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">1.02</ENT>
                                <ENT>Name of Agency</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">1.03</ENT>
                                <ENT>Short Title</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">1.04</ENT>
                                <ENT>General Definitions</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except subsections (17), (41), (52), (60), (74), (101), (112), (119), and (122). Section 1.04 replaces WAC 173-400-030 except the WAC 173-400-030 definitions list below.</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">1.05</ENT>
                                <ENT>Acronym Index</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Article II—General Provisions</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">2.08</ENT>
                                <ENT>Falsification of Statements or Documents, and Treatment of Documents</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Subsections (E) and (F) only. Subsection (E) replaces WAC 173-400-105(6). Subsection (F) replaces WAC 173-400-105(8).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.09</ENT>
                                <ENT>Source Tests</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Section 2.09 replaces WAC 173-400-105(4).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.13</ENT>
                                <ENT>Federal and State Regulation Reference Date</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Subsection (A) replaces WAC 173-400-025.</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">2.14</ENT>
                                <ENT>Washington Administrative Codes (WACS)</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Subsection (A)(1) only, and only with respect to those revised Chapter 173-400 WAC provisions that are identified for incorporation by reference in the table below.</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Article IV—Registration</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">4.03</ENT>
                                <ENT>Registration Exemptions</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Subsections (B) and (C) only.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">4.04</ENT>
                                <ENT>Stationary Sources and Source Categories Subject to Registration</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except subsections (A)(3)(u), (A)(3)(v), (A)(5)(b), (A)(5)(e)(9), or any other provision as it relates to the regulation of toxic air pollutants or odors.</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">4.05</ENT>
                                <ENT>Closure of a Stationary Source or Emissions Unit(s)</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Article V—New Source Review for Stationary Sources and Portable Sources</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">5.02</ENT>
                                <ENT>New Source Review—Applicability and when Required</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except subsections (C)(5) and (I). Section 5.02 Replaces WAC 173-400-110. Subsection (F) replaces WAC 173-400-111(2).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">5.03</ENT>
                                <ENT>NOC and PSP Fees</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">5.04</ENT>
                                <ENT>Information Required</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except subsection (A)(8). Collectively, sections 5.04, 5.06, 5.07, 5.10, 5.13, and 5.14 replace the permitting procedures in WAC 173-400-111.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">5.05</ENT>
                                <ENT>Public Involvement</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except subsection (C)(15). Section 5.05 replaces WAC 173-400-171.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">5.06</ENT>
                                <ENT>Application Completeness Determination</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Collectively, sections 5.04, 5.06, 5.07, 5.10, 5.13, and 5.14 replace the permitting procedures in WAC 173-400-111.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">5.07</ENT>
                                <ENT>Processing NOC Applications for Stationary Sources</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except subsections (A)(1)(g) and (B). Collectively, sections 5.04, 5.06, 5.07, 5.10, 5.13, and 5.14 replace the permitting procedures in WAC 173-400-111, and subsection 5.07(A)(7) replaces WAC 173-400-110(2)(a).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">5.08</ENT>
                                <ENT>Portable Sources</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except subsection (A)(6). Section 5.08 replaces WAC 173-400-036.</ENT>
                            </ROW>
                            <ROW>
                                <PRTPAGE P="24722"/>
                                <ENT I="01">5.09</ENT>
                                <ENT>Operating Requirements for Order of Approval and Permission to Operate</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except subsection (C).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">5.10</ENT>
                                <ENT>Changes to an Order of Approval or Permission to Operate</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Collectively, sections 5.04, 5.06, 5.07, 5.10, 5.13, and 5.14 replace the permitting procedures in WAC 173-400-111.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">5.11</ENT>
                                <ENT>Notice of Startup of a Stationary Source or a Portable Source</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">5.12</ENT>
                                <ENT>Work Done Without an Approval</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">5.13</ENT>
                                <ENT>Order of Approval Construction Time Limits</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Collectively, sections 5.04, 5.06, 5.07, 5.10, 5.13, and 5.14 replace the permitting procedures in WAC 173-400-111.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">5.14</ENT>
                                <ENT>Appeals</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Collectively, sections 5.04, 5.06, 5.07, 5.10, 5.13, and 5.14 replace the permitting procedures in WAC 173-400-111.</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">5.15</ENT>
                                <ENT>Obligation to Comply</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Article VI—Emissions Prohibited</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">6.04</ENT>
                                <ENT>Emission of Air Contaminant: Detriment to Person or Property</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Subsections (A), (B), (C), and (H) only and excepting provisions in RCW 70.94.640 (incorporated by reference) that relate to odor. Subsection (C) replaces WAC 173-400-040(6).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">6.05</ENT>
                                <ENT>Particulate Matter &amp; Preventing Particulate Matter from Becoming Airborne</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except subsection (A). Section 6.05 supplements but does not replace WAC 173-400-040(4) and (9).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">6.07</ENT>
                                <ENT>Emission of Air Contaminant Concealment and Masking Restricted</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Section 6.07 replaces WAC 173-400-040(8).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">6.14</ENT>
                                <ENT>Standards for Control of Particulate Matter on Paved Surfaces</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Section 6.14 supplements but does not replace WAC 173-400-040(9).</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">6.15</ENT>
                                <ENT>Standards for Control of Particulate Matter on Unpaved Roads</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Section 6.15 supplements but does not replace WAC 173-400-040(9).</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Article VIII—Solid Fuel Burning Device Standards</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">8.01</ENT>
                                <ENT>Purpose</ENT>
                                <ENT>9/02/14</ENT>
                                <ENT>9/28/15, 80 FR 58216</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">8.02</ENT>
                                <ENT>Applicability</ENT>
                                <ENT>9/02/14</ENT>
                                <ENT>9/28/15, 80 FR 58216</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">8.03</ENT>
                                <ENT>Definitions</ENT>
                                <ENT>9/02/14</ENT>
                                <ENT>9/28/15, 80 FR 58216</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">8.04</ENT>
                                <ENT>Emission Performance Standards</ENT>
                                <ENT>9/02/14</ENT>
                                <ENT>9/28/15, 80 FR 58216</ENT>
                                <ENT>Except the incorporation by reference of WAC 173-433-130, 173-433-170, and 173-433-200.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">8.05</ENT>
                                <ENT>Opacity Standards</ENT>
                                <ENT>9/02/14</ENT>
                                <ENT>9/28/15, 80 FR 58216</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">8.06</ENT>
                                <ENT>Prohibited Fuel Types</ENT>
                                <ENT>9/02/14</ENT>
                                <ENT>9/28/15, 80 FR 58216</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">8.07</ENT>
                                <ENT>Curtailment</ENT>
                                <ENT>9/02/14</ENT>
                                <ENT>9/28/15, 80 FR 58216</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">8.08</ENT>
                                <ENT>Exemptions</ENT>
                                <ENT>9/02/14</ENT>
                                <ENT>9/28/15, 80 FR 58216</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">8.09</ENT>
                                <ENT>Procedure to Geographically Limit Solid Fuel Burning Devices</ENT>
                                <ENT>9/02/14</ENT>
                                <ENT>9/28/15, 80 FR 58216</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">8.10</ENT>
                                <ENT>Restrictions on Installation of Solid Fuel Burning Devices</ENT>
                                <ENT>9/02/14</ENT>
                                <ENT>9/28/15, 80 FR 58216</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Washington Administrative Code, Chapter 173-400—General Regulations for Air Pollution Sources: Adopted by Reference in SRCAA Regulation I, Subsection 2.14(A)(1)</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">173-400-020</ENT>
                                <ENT>Applicability</ENT>
                                <ENT>12/29/12</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <PRTPAGE P="24723"/>
                                <ENT I="01">173-400-030(24)</ENT>
                                <ENT>Definitions</ENT>
                                <ENT>3/22/91</ENT>
                                <ENT>6/2/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-030</ENT>
                                <ENT>Definitions</ENT>
                                <ENT>9/16/18</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Only the following definitions: Adverse Impact on Visibility; Capacity Factor; Class I Area; Dispersion Technique; Emission Threshold; Excess Stack Height; Existing Stationary Facility; Federal Class I Area; Federal Land Manager; Fossil Fuel-fired Steam Generator; General Process Unit; Greenhouse Gases; Industrial Furnace; Mandatory Class I Federal Area; Natural Conditions; Projected Width; Reasonably Attributable; Sulfuric Acid Plant; and Wood Waste.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-040(1)(a) &amp; (b)</ENT>
                                <ENT>General Standards for Maximum Emissions</ENT>
                                <ENT>3/22/91</ENT>
                                <ENT>6/2/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-040</ENT>
                                <ENT>General Standards for Maximum Emissions</ENT>
                                <ENT>9/16/18</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except: 173-400-040(2); 173-400-040(3); 173-400-040(5); 173-400-040(6); 173-400-040(8).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-050</ENT>
                                <ENT>Emission Standards for Combustion and Incineration Units</ENT>
                                <ENT>9/16/18</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except: 173-400-050(2); 173-400-050(4); 173-400-050(5); 173-400-050(6).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-060</ENT>
                                <ENT>Emission Standards for General Process Units</ENT>
                                <ENT>11/25/18</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-070</ENT>
                                <ENT>Emission Standards for Certain Source Categories</ENT>
                                <ENT>3/22/91</ENT>
                                <ENT>6/2/95, 60 FR 28726</ENT>
                                <ENT>Except (7).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-081</ENT>
                                <ENT>Startup and Shutdown</ENT>
                                <ENT>9/20/93</ENT>
                                <ENT>6/2/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-091</ENT>
                                <ENT>Voluntary Limits on Emissions</ENT>
                                <ENT>4/1/11</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>9/20/93 version continues to be approved under the authority of CAA Section 112(l) with respect to Section 112 hazardous air pollutants. See 60 FR 28726 (June 2, 1995).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-105</ENT>
                                <ENT>Records, Monitoring and Reporting</ENT>
                                <ENT>11/25/18</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except: 173-400-105(3); 173-400-105(4); 173-400-105(6); 173-400-105(8).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-107</ENT>
                                <ENT>Excess Emissions</ENT>
                                <ENT>9/20/93</ENT>
                                <ENT>6/2/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-112</ENT>
                                <ENT>Requirements for New Sources in Nonattainment Areas</ENT>
                                <ENT>12/29/12</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except (8).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-113</ENT>
                                <ENT>Requirements for New Sources in Attainment or Unclassifiable Areas</ENT>
                                <ENT>12/29/12</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except: 173-400-113(3), second sentence.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-117</ENT>
                                <ENT>Special Protection Requirements for Federal Class I Areas</ENT>
                                <ENT>12/29/12</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-118</ENT>
                                <ENT>Designation of Class I, II, and III Areas</ENT>
                                <ENT>12/29/12</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-131</ENT>
                                <ENT>Issuance of Emission Reduction Credits</ENT>
                                <ENT>4/1/11</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-136</ENT>
                                <ENT>Use of Emission Reduction Credits (ERC)</ENT>
                                <ENT>12/29/12</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-151</ENT>
                                <ENT>Retrofit Requirements for Visibility Protection</ENT>
                                <ENT>2/10/05</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-161</ENT>
                                <ENT>Compliance Schedules</ENT>
                                <ENT>3/22/91</ENT>
                                <ENT>6/2/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-175</ENT>
                                <ENT>Public Information</ENT>
                                <ENT>2/10/05</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-190</ENT>
                                <ENT>Requirements for Nonattainment Areas</ENT>
                                <ENT>3/22/91</ENT>
                                <ENT>6/2/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-200</ENT>
                                <ENT>Creditable Stack Height and Dispersion Techniques</ENT>
                                <ENT>2/10/05</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-205</ENT>
                                <ENT>Adjustment for Atmospheric Conditions</ENT>
                                <ENT>3/22/91</ENT>
                                <ENT>6/2/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-210</ENT>
                                <ENT>Emission Requirements of Prior Jurisdictions</ENT>
                                <ENT>3/22/91</ENT>
                                <ENT>6/2/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-560</ENT>
                                <ENT>General Order of Approval</ENT>
                                <ENT>12/29/12</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Except: The part of 173-400-560(1)(f) that says, “173-460 WAC”.</ENT>
                            </ROW>
                            <ROW>
                                <PRTPAGE P="24724"/>
                                <ENT I="01">173-400-800</ENT>
                                <ENT>Major Stationary Source and Major Modification in a Nonattainment Area</ENT>
                                <ENT>4/1/11</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>
                                    EPA did not review WAC 173-400-800 through 860 for consistency with the August 24, 2016 PM
                                    <E T="0732">2.5</E>
                                     implementation rule (81 FR 58010); nor does SRCAA have an obligation to submit rule revisions to address the 2016 PM
                                    <E T="0732">2.5</E>
                                     implementation rule at this time.
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-810</ENT>
                                <ENT>Major Stationary Source and Major Modification Definitions</ENT>
                                <ENT>7/1/16</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-820</ENT>
                                <ENT>Determining if a New Stationary Source or Modification to a Stationary Source is Subject to these Requirements</ENT>
                                <ENT>12/29/12</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-830</ENT>
                                <ENT>Permitting Requirements</ENT>
                                <ENT>7/1/16</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-840</ENT>
                                <ENT>Emission Offset Requirements</ENT>
                                <ENT>7/1/16</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-850</ENT>
                                <ENT>Actual Emissions Plantwide Applicability Limitation (PAL)</ENT>
                                <ENT>7/1/16</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-860</ENT>
                                <ENT>Public Involvement Procedures</ENT>
                                <ENT>4/1/11</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                        <P>(e) * * *</P>
                        <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="xs60,r50,10,r50,r100">
                            <TTITLE>Table 1—Approved But Not Incorporated By Reference Regulations</TTITLE>
                            <BOXHD>
                                <CHED H="1">
                                    State/local
                                    <LI>citation</LI>
                                </CHED>
                                <CHED H="1">Title/subject</CHED>
                                <CHED H="1">
                                    State/local
                                    <LI>effective</LI>
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">EPA approval date</CHED>
                                <CHED H="1">Explanations</CHED>
                            </BOXHD>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Washington Department of Ecology Regulations</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">173-400-220</ENT>
                                <ENT>Requirements for Board Members</ENT>
                                <ENT>3/22/91</ENT>
                                <ENT>6/02/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-230</ENT>
                                <ENT>Regulatory Actions</ENT>
                                <ENT>3/20/93</ENT>
                                <ENT>6/02/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-240</ENT>
                                <ENT>Criminal Penalties</ENT>
                                <ENT>3/22/91</ENT>
                                <ENT>6/02/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-250</ENT>
                                <ENT>Appeals</ENT>
                                <ENT>9/20/93</ENT>
                                <ENT>6/02/95, 60 FR 28726</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-260</ENT>
                                <ENT>Conflict of Interest</ENT>
                                <ENT>7/01/16</ENT>
                                <ENT>10/06/16, 81 FR 69385</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">173-433-200</ENT>
                                <ENT>Regulatory Actions and Penalties</ENT>
                                <ENT>10/18/90</ENT>
                                <ENT>1/15/93, 58 FR 4578</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Energy Facility Site Evaluation Council Regulations</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">463-78-135</ENT>
                                <ENT>Criminal Penalties</ENT>
                                <ENT>11/11/04</ENT>
                                <ENT>5/30/17, 82 FR 24533</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">463-78-140</ENT>
                                <ENT>Appeals Procedure</ENT>
                                <ENT>3/26/06</ENT>
                                <ENT>5/30/17, 82 FR 24533</ENT>
                                <ENT>Except (3) and (4).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">463-78-170</ENT>
                                <ENT>Conflict of Interest</ENT>
                                <ENT>11/11/04</ENT>
                                <ENT>5/30/17, 82 FR 24533</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">463-78-230</ENT>
                                <ENT>Regulatory Actions</ENT>
                                <ENT>11/11/04</ENT>
                                <ENT>5/30/17, 82 FR 24533</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Benton Clean Air Agency Regulations</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">2.01</ENT>
                                <ENT>Powers and Duties of the Benton Clean Air Agency (BCAA)</ENT>
                                <ENT>12/11/14</ENT>
                                <ENT>11/17/15, 80 FR 71695</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.02</ENT>
                                <ENT>Requirements for Board of Directors Members</ENT>
                                <ENT>12/11/14</ENT>
                                <ENT>11/17/15, 80 FR 71695</ENT>
                                <ENT>Replaces WAC 173-400-220.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.03</ENT>
                                <ENT>Powers and Duties of the Board of Directors</ENT>
                                <ENT>12/11/14</ENT>
                                <ENT>11/17/15, 80 FR 71695</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.04</ENT>
                                <ENT>Powers and Duties of the Control Officer</ENT>
                                <ENT>12/11/14</ENT>
                                <ENT>11/17/15, 80 FR 71695</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.05</ENT>
                                <ENT>Severability</ENT>
                                <ENT>12/11/14</ENT>
                                <ENT>11/17/15, 80 FR 71695</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <PRTPAGE P="24725"/>
                                <ENT I="01">2.06</ENT>
                                <ENT>Confidentiality of Records and Information</ENT>
                                <ENT>12/11/14</ENT>
                                <ENT>11/17/15, 80 FR 71695</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Northwest Clean Air Agency Regulations</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">103</ENT>
                                <ENT>Duties and Powers</ENT>
                                <ENT>8/21/05</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">105</ENT>
                                <ENT>Separability</ENT>
                                <ENT>8/21/05</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">110</ENT>
                                <ENT>Investigation and Studies</ENT>
                                <ENT>8/21/05</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">111</ENT>
                                <ENT>Interference or Obstruction</ENT>
                                <ENT>8/21/05</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">112</ENT>
                                <ENT>False and Misleading Oral Statement: Unlawful Reproduction or Alteration of Documents</ENT>
                                <ENT>8/21/05</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">113</ENT>
                                <ENT>Service of Notice</ENT>
                                <ENT>12/22/07</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">114</ENT>
                                <ENT>Confidential Information</ENT>
                                <ENT>12/22/07</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">120</ENT>
                                <ENT>Hearings</ENT>
                                <ENT>12/22/07</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">123</ENT>
                                <ENT>Appeal of Orders</ENT>
                                <ENT>4/14/13</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">124</ENT>
                                <ENT>Display of Orders, Certificates and Other Notices: Removal or Mutilation Prohibited</ENT>
                                <ENT>8/21/05</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">131</ENT>
                                <ENT>Notice to Violators</ENT>
                                <ENT>4/14/13</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">132</ENT>
                                <ENT>Criminal Penalty</ENT>
                                <ENT>9/13/15</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">133</ENT>
                                <ENT>Civil Penalty</ENT>
                                <ENT>9/13/15</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">134</ENT>
                                <ENT>Restraining Orders—Injunction</ENT>
                                <ENT>8/21/05</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">135</ENT>
                                <ENT>Assurance of Discontinuance</ENT>
                                <ENT>12/22/07</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">303</ENT>
                                <ENT>Work Done Without an Approval</ENT>
                                <ENT>5/12/19</ENT>
                                <ENT>6/15/20, 85 FR 36156</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Olympic Region Clean Air Agency Regulations</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00" RUL="s">
                                <ENT I="01">8.1.6</ENT>
                                <ENT>Penalties</ENT>
                                <ENT>5/22/10</ENT>
                                <ENT>10/03/13, 78 FR 61188</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Puget Sound Clean Air Agency Regulations</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">3.01</ENT>
                                <ENT>Duties and Powers of the Control Officer</ENT>
                                <ENT>11/01/99</ENT>
                                <ENT>4/22/20, 85 FR 22357</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">3.05</ENT>
                                <ENT>Investigations by the Control Officer</ENT>
                                <ENT>3/17/94</ENT>
                                <ENT>4/22/20, 85 FR 22357</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">3.07</ENT>
                                <ENT>Compliance Tests</ENT>
                                <ENT>5/01/06</ENT>
                                <ENT>4/22/20, 85 FR 22357</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">3.09</ENT>
                                <ENT>Violations—Notice</ENT>
                                <ENT>9/12/91</ENT>
                                <ENT>4/22/20, 85 FR 22357</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">3.11</ENT>
                                <ENT>Civil Penalties</ENT>
                                <ENT>11/01/19</ENT>
                                <ENT>4/22/20, 85 FR 22357</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">3.13</ENT>
                                <ENT>Criminal Penalties</ENT>
                                <ENT>9/12/91</ENT>
                                <ENT>4/22/20, 85 FR 22357</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">3.15</ENT>
                                <ENT>Additional Enforcement</ENT>
                                <ENT>9/12/91</ENT>
                                <ENT>4/22/20, 85 FR 22357</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">3.17</ENT>
                                <ENT>Appeal of Orders</ENT>
                                <ENT>11/14/98</ENT>
                                <ENT>4/22/20, 85 FR 22357</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">3.19</ENT>
                                <ENT>Confidential Information</ENT>
                                <ENT>9/12/91</ENT>
                                <ENT>4/22/20, 85 FR 22357</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">3.21</ENT>
                                <ENT>Separability</ENT>
                                <ENT>9/12/91</ENT>
                                <ENT>4/22/20, 85 FR 22357</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Southwest Clean Air Agency Regulations</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">400-220</ENT>
                                <ENT>Requirements for Board Members</ENT>
                                <ENT>3/18/01</ENT>
                                <ENT>4/10/17, 82 FR 17136</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">400-230</ENT>
                                <ENT>Regulatory Actions and Civil Penalties</ENT>
                                <ENT>10/9/16</ENT>
                                <ENT>4/10/17, 82 FR 17136</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">400-240</ENT>
                                <ENT>Criminal Penalties</ENT>
                                <ENT>3/18/01</ENT>
                                <ENT>4/10/17, 82 FR 17136</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">400-250</ENT>
                                <ENT>Appeals</ENT>
                                <ENT>11/9/03</ENT>
                                <ENT>4/10/17, 82 FR 17136</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">400-260</ENT>
                                <ENT>Conflict of Interest</ENT>
                                <ENT>3/18/01</ENT>
                                <ENT>4/10/17, 82 FR 17136</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">400-270</ENT>
                                <ENT>Confidentiality of Records and Information</ENT>
                                <ENT>11/9/03</ENT>
                                <ENT>4/10/17, 82 FR 17136</ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="01">400-280</ENT>
                                <ENT>Powers of Agency</ENT>
                                <ENT>3/18/01</ENT>
                                <ENT>4/10/17, 82 FR 17136</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Spokane Regional Clean Air Agency Regulations</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">2.01</ENT>
                                <ENT>Powers and Duties of the Board</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.02</ENT>
                                <ENT>Control Office's Duties and Powers</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Section 2.02(E) replaces WAC 173-400-105(3).</ENT>
                            </ROW>
                            <ROW>
                                <PRTPAGE P="24726"/>
                                <ENT I="01">2.03</ENT>
                                <ENT>Confidential or Proprietary Information</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.04</ENT>
                                <ENT>Violations</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Replaces WAC 173-400-230(1)&amp;(6).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.05</ENT>
                                <ENT>Orders and Hearings</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.06</ENT>
                                <ENT>Appeal of Board Orders</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Replaces WAC 173-400-250.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.10</ENT>
                                <ENT>Severability</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.11</ENT>
                                <ENT>Penalties, Civil Penalties, and Additional Means for Enforcement</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Replaces WAC 173-400-230(2)&amp;(3).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">2.12</ENT>
                                <ENT>Restraining Orders—Injunctions</ENT>
                                <ENT>09/01/20</ENT>
                                <ENT>
                                    5/10/21, [Insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Replaces WAC 173-400-230(4).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">8.11</ENT>
                                <ENT>Regulatory Actions and Penalties</ENT>
                                <ENT>9/02/14</ENT>
                                <ENT>9/28/15, 80 FR 58216</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>3. Amend § 52.2498 by revising paragraph (a)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.2498 </SECTNO>
                        <SUBJECT>Visibility protection.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(1) Sources subject to the jurisdiction of local air authorities (except Benton Clean Air Agency, Northwest Clean Air Agency, Puget Sound Clean Air Agency, Southwest Clean Air Agency, and Spokane Regional Clean Air Agency);</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09368 Filed 5-7-21; 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-2020-0735; FRL-10022-52-Region 9]</DEPDOC>
                <SUBJECT>Air Plan Approval; Arizona; Miami Copper Smelter Sulfur Dioxide Control Measures</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 Arizona State Implementation Plan (SIP). This revision concerns emissions of sulfur dioxide (SO
                        <E T="52">2</E>
                        ) from the copper smelter in Miami, Arizona. We are approving the rescission of two Arizona Department of Environmental Quality (ADEQ) Arizona Administrative Code (A.A.C.) provisions from the Arizona SIP that are no longer needed to regulate this emission source under the Clean Air Act (CAA or the “Act”).
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket ID No. EPA-R09-OAR-2020-0735. 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>
                        Kevin Gong, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105. By phone: (415) 972-3073 or by email at 
                        <E T="03">gong.kevin@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 March 3, 2021 (86 FR 12310), the EPA proposed to approve the following revision into the Arizona SIP.</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="xs60,r50,r100,xs70,xs80">
                    <TTITLE>Table 1—Rule for Which Rescission From the SIP Is Requested</TTITLE>
                    <BOXHD>
                        <CHED H="1">Local agency</CHED>
                        <CHED H="1">Citation</CHED>
                        <CHED H="1">Rule title</CHED>
                        <CHED H="1">Adopted</CHED>
                        <CHED H="1">SIP approval date</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">ADEQ</ENT>
                        <ENT>A.A.C. R18-2-715(F)(2) and (H)</ENT>
                        <ENT>Standards of Performance for Existing Primary Copper Smelters; Site-specific Requirements</ENT>
                        <ENT>March 7, 2009</ENT>
                        <ENT>September 23, 2014.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>We proposed to approve this revision because we determined that it complies with the relevant CAA requirements. Our proposed action contains more information on the revision 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 
                    <PRTPAGE P="24727"/>
                    this period, we received one comment (with four duplicates) that were supportive of our action.
                </P>
                <HD SOURCE="HD1">III. EPA Action</HD>
                <P>No comments were submitted that change our assessment of the revision as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving the rescission of A.A.C. R18-2-715, sections (F)(2) and (H) from the Arizona SIP.</P>
                <HD SOURCE="HD1">IV. Incorporation by Reference</HD>
                <P>In this rule, the EPA is amending regulatory text that includes incorporation by reference. The EPA is removing A.A.C. R18-2-715(F)(2) and (H), as described in Table 1 of this preamble, from the Arizona SIP, 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 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 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 July 9, 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, Reporting and recordkeeping requirements, Sulfur oxides.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: April 30, 2021.</DATED>
                    <NAME>Deborah Jordan,</NAME>
                    <TITLE>Acting Regional Administrator, Region IX.</TITLE>
                </SIG>
                <P>Part 52, 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 D—Arizona</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>2. In §  52.120, amend table 2 in paragraph (c), under the heading “Article 7 (Existing Stationary Source Performance Standards),” by removing the entry reading “R18-2-715, sections F, G, and H” and adding in its place the entry “R18-2-715, section F, excluding (F)(2), and section G” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.120 </SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <PRTPAGE P="24728"/>
                        <GPOTABLE COLS="5" OPTS="L1,i1" CDEF="s50,r50,r25,r50,r50">
                            <TTITLE>Table 2—EPA-Approved Arizona Regulations</TTITLE>
                            <BOXHD>
                                <CHED H="1">State citation</CHED>
                                <CHED H="1">Title/subject</CHED>
                                <CHED H="1">
                                    State
                                    <LI>effective</LI>
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">EPA approval date</CHED>
                                <CHED H="1">
                                    Additional
                                    <LI>explanation</LI>
                                </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Article 7 (Existing Stationary Source Performance Standards)</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">R18-2-715, section F, excluding (F)(2), and section G</ENT>
                                <ENT>Standards of Performance for Existing Primary Copper Smelters: Site-Specific Requirements</ENT>
                                <ENT>March 7, 2009</ENT>
                                <ENT>
                                    September 23, 2014, 79 FR 56655; May 10, 2021, [INSERT 
                                    <E T="02">Federal Register</E>
                                     CITATION]
                                </ENT>
                                <ENT>EPA approved the rescission of sections (F)(2) and (H) on May 10, 2021.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09634 Filed 5-7-21; 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-R08-OAR-2020-0541; FRL-10022-97-Region 8]</DEPDOC>
                <SUBJECT>Approval and Promulgation of Implementation Plans; Utah; R307-204 Emission Standards: Smoke Management</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 state implementation plan (SIP) revisions submitted by State of Utah on November 5, 2019. The revisions amend R307-204 to meet the requirements set forth in Utah's 2019 House Bill (H.B.) 155. This action is being taken under section 110 of the Clean Air Act (CAA).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket ID No. EPA-R08-OAR-2020-0541. All documents in the docket are listed on the 
                        <E T="03">http://www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">e.g.,</E>
                         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">http://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.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Amrita Singh, Air and Radiation Division, EPA, Region 8, Mailcode 8ARD-QP, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6103, 
                        <E T="03">singh.amrita@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document wherever “we,” “us” or “our” is used, we mean the EPA.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>On February 25, 2021 (86 FR 11687), the EPA proposed approval of the revisions to the Utah Divison of Administrative Rules, specifically: R307-204-1. Purpose and Goals; R307-204-2. Applicability; R307-204-3. Definitions; R307-204-4. General Requirements; R307-204-5. Burn Schedule; R307-204-6. Small Prescribed Fires (de minimis); R307-204-7. Small Prescribed Pile Fires (de minimis); R307-204-8. Large Prescribed Fires; R307-204-9. Large Prescribed Pile Fires; and R307-204-10. Requirements for Wildland Fire Use events that were submitted by the State on November 5, 2019.</P>
                <P>The rule revisions for R307-204 were submitted to align with the recent 2019 H.B. 155 which removes outdated terminology and language regarding adjusting fire emission factors and combines sections R307-204-6. Small Prescribed Fires (de minimis), R307-204-7. Small Prescribed Pile Fires (de minimis), R307-204-8. Large Prescribed Fires, and R307-204-9. Large Prescribed Pile Fires to reduce redundancies.</P>
                <HD SOURCE="HD1">II. Response to Comments</HD>
                <P>The comment period for our February 25, 2021 (86 FR 11687) proposed rule was open for 30 days. The EPA did not receive any comments.</P>
                <HD SOURCE="HD1">III. Final Action</HD>
                <P>For the reasons stated in our February 25, 2021 proposed rule, the EPA is finalizing approval of SIP revisions submitted by the State of Utah on November 5, 2019. EPA is approving:</P>
                <P>• Revisions to sections: R307-204-1. Purpose and Goals; R307-204-2. Applicability; R307-204-3. Definitions; R307-204-4. General Requirements; and R307-204-5. Burn Schedule.</P>
                <P>• Revisions to combine R307-204-6. Small Prescribed Fires (de minimis) and R307-204-7. Small Prescribed Pile Fires (de minimis), under R307-204-6. Small Prescribed Fires (de minimis) to streamline and reduce redundancies.</P>
                <P>• Revisions to combine R307-204-8. Large Prescribed Fires and R307-204-9. Large Prescribed Pile Fires, under R307-204-7, and to retitle R307-204-7 to “Large Prescribed Fires,” which will streamline and reduce redundancies.</P>
                <P>• Removal of R307-204-10. Requirements for Wildland Fire Use events. This deletion is removing outdated smoke policy terminology, such as, wildland fire use.</P>
                <P>The revisions for R307-204 meet the applicable CAA requirements and contains smoke management requirements for land managers within the State of Utah as required by 40 CFR 51.309(d)(6).</P>
                <HD SOURCE="HD1">IV. Incorporation by Reference</HD>
                <P>
                    In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is incorporating by reference R307-204-1; R307-204-2; R307-204-3; R307-204-4; R307-204-5; combination of R307-204-6 and R307-204-7, under R307-204-6 for streamlining; combination of R307-204-8 and R307-204-9, under R307-204-7; and the removal of R307-204-10 due to outdated information. The EPA has 
                    <PRTPAGE P="24729"/>
                    made, and will continue to make, these materials generally available through 
                    <E T="03">www.regulations.gov</E>
                     and at the EPA Region 8 Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         62 FR 27968 (May 22, 1997).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">V. Statutory and Executive Orders Review</HD>
                <P>Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the 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 proposes to approve state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this 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>• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;</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 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>
                <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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 9, 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 dioxide, 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: April 28, 2021. </DATED>
                    <NAME>Debra H. Thomas,</NAME>
                    <TITLE>Acting Regional Administrator, Region 8.</TITLE>
                </SIG>
                <P>40 CFR part 52 is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS</HD>
                </PART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>1. The authority citation for part 52 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             42 U.S.C. 7401 
                            <E T="03">et seq.</E>
                        </P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart TT—Utah</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>2. In § 52.2320, the table in paragraph (c) is amended by:</AMDPAR>
                    <AMDPAR>a. Revising the entries for “R307-204-01”, “R307-204-02”, “R307-204-03”, “R307-204-04”, “R307-204-05”, “R307-204-06”, and “R307-204-07”.</AMDPAR>
                    <AMDPAR>b. Removing the entries for “R307-204-08”, R307-204-09”, and “R307-204-10”.</AMDPAR>
                    <P>The revisions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 52.2320 </SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <GPOTABLE COLS="5" OPTS="L1,tp0,i1" CDEF="xs60,r50,12,r50,12">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">Rule No.</CHED>
                                <CHED H="1">Rule title</CHED>
                                <CHED H="1">
                                    State
                                    <LI>effective</LI>
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">Final rule citation, date</CHED>
                                <CHED H="1">Comments</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">R307-204. Emission Standards: Smoke Management</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">R307-204-01</ENT>
                                <ENT>Purpose and Goals</ENT>
                                <ENT>11/5/2019</ENT>
                                <ENT>
                                    [insert 
                                    <E T="02">Federal Register</E>
                                     citation], 5/10/2021
                                </ENT>
                            </ROW>
                            <ROW>
                                <PRTPAGE P="24730"/>
                                <ENT I="01">R307-204-02</ENT>
                                <ENT>Applicability</ENT>
                                <ENT>11/5/2019</ENT>
                                <ENT>
                                    [insert 
                                    <E T="02">Federal Register</E>
                                     citation], 5/10/2021
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">R307-204-03</ENT>
                                <ENT>Definitions</ENT>
                                <ENT>11/5/2019</ENT>
                                <ENT>
                                    [insert 
                                    <E T="02">Federal Register</E>
                                     citation], 5/10/2021
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">R307-204-04</ENT>
                                <ENT>General Requirements</ENT>
                                <ENT>11/5/2019</ENT>
                                <ENT>
                                    [insert 
                                    <E T="02">Federal Register</E>
                                     citation], 5/10/2021
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">R307-204-05</ENT>
                                <ENT>Burn Schedule</ENT>
                                <ENT>11/5/2019</ENT>
                                <ENT>
                                    [insert 
                                    <E T="02">Federal Register</E>
                                     citation], 5/10/2021
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">R307-204-06</ENT>
                                <ENT>Small Prescribed Fires (de minimis)</ENT>
                                <ENT>11/5/2019</ENT>
                                <ENT>
                                    [insert 
                                    <E T="02">Federal Register</E>
                                     citation], 5/10/2021
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">R307-204-07</ENT>
                                <ENT>Large Prescribed Fires</ENT>
                                <ENT>11/5/2019</ENT>
                                <ENT>
                                    [insert 
                                    <E T="02">Federal Register</E>
                                     citation], 5/10/2021
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09240 Filed 5-7-21; 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 62</CFR>
                <DEPDOC>[EPA-R05-OAR-2020-0518; FRL-10023-60-Region 5]</DEPDOC>
                <SUBJECT>Air Plan Approval; Wisconsin; Large Municipal Waste Combustors Negative Declaration Withdrawal for Designated Facilities and Pollutants</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 Wisconsin's request for withdrawal of the previously approved Large Municipal Waste Combustors (LMWC) Negative Declaration. The Wisconsin Department of Natural Resources (WDNR) submitted its LMWC Negative Declaration withdrawal on September 25, 2020, certifying that the State of Wisconsin has only one LMWC unit currently operating and requesting that the Federal Plan continue to apply to the single source in the State.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective on June 9, 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-2020-0518. 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 Margaret Sieffert, Environmental Engineer, at (312) 353-1151 before visiting the Region 5 office.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Margaret Sieffert, Environmental Engineer, Environmental Protection Agency, Region 5, 77 West Jackson Boulevard (AT-18J), Chicago, Illinois 60604, (312) 353-1151, 
                        <E T="03">sieffert.margaret@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</HD>
                <P>On September 25, 2020, WDNR submitted its LMWC negative declaration withdrawal, in which it certifies that there is one LMWC unit currently operating in Wisconsin. The only LMWC unit is at Xcel French Island, located in La Crosse, WI. Because there is only one source, WDNR is requesting that the previously approved negative declaration be withdrawn and that the Federal Plan continue to apply to the source.</P>
                <P>On March 1, 2021 (86 FR 11916), EPA published a notice of proposed rulemaking (NPRM) proposing approval of Wisconsin's LMWC Negative Declaration withdrawal. The specific details of Wisconsin's request and the rationale for EPA's approval are discussed in the NPRM and will not be restated here. EPA did not receive any comments on the proposed action.</P>
                <HD SOURCE="HD1">II. What action is EPA taking?</HD>
                <P>EPA is approving Wisconsin's request for withdrawal of a previously approved Negative Declaration and its request to amend 40 CFR part 62 to reflect WDNR's withdrawal. WDNR submitted its LMWC Negative Declaration withdrawal on September 25, 2020, certifying that there is only one LMWC unit, as defined under 40 CFR 60.31b, currently operating in the State of Wisconsin, and requested that the Federal Plan apply to the single source in the State. EPA understands that the extensive work that would be required by WDNR to prepare an approved State Plan would be disproportionate to the single affected source in Wisconsin, and proposed to approve the withdrawal and have the Federal Plan continue to apply to the known affected source.</P>
                <P>In this action, EPA is finalizing its approval. EPA is also revising 40 CFR 62.12360 to reflect this withdrawal.</P>
                <HD SOURCE="HD1">III. Statutory and Executive Order Reviews</HD>
                <P>In reviewing section 111(d)/129 plan submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act (CAA). With regard to withdrawals for designated facilities received by EPA from states, EPA's role is to notify the public of the approval of the State's withdrawal and revise 40 CFR part 62 accordingly. Accordingly, this action merely notifies the public of EPA's approval for a withdrawal of a previously approved LMWC negative declaration and does not impose additional requirements. 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 
                    <PRTPAGE P="24731"/>
                    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, this 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 July 9, 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 62</HD>
                    <P>Environmental protection, Air pollution control, Administrative practice and procedure, Intergovernmental relations, Large municipal waste combustors, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: May 4, 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 62 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 62—APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED FACILITIES AND POLLUTANTS</HD>
                </PART>
                <REGTEXT TITLE="40" PART="62">
                    <AMDPAR>1. The authority citation for part 62 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="62">
                    <AMDPAR>2. Section 62.12360 is revised to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 62.12360 </SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <P>On September 25, 2020, the Wisconsin Department of Natural Resources submitted a withdrawal letter to EPA certifying that there is only one Large Municipal Waste Combustor unit in the State of Wisconsin subject to the emissions guidelines at 40 CFR part 60, subpart Eb, and requested that the Federal Plan at subpart FFF of this part, apply.</P>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09808 Filed 5-7-21; 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 180</CFR>
                <DEPDOC>[EPA-HQ-OPP-2019-0607; FRL-10022-79]</DEPDOC>
                <SUBJECT>Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt; Exemption From the Requirement of a Tolerance</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>This regulation establishes an exemption from the requirement of a tolerance for residues of Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt when used as an inert ingredient (colorant) in pesticide formulations applied to seed treatment slurries for raw agricultural commodities and not to exceed 20% weight/weight (wt/wt). Milliken Chemical submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        This regulation is effective May 10, 2021. Objections and requests for hearings must be received on or before July 9, 2021, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        ).
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2019-0607, is 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>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Marietta Echeverria, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: 
                        <E T="03">RDFRNotices@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>
                    You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather 
                    <PRTPAGE P="24732"/>
                    provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
                </P>
                <P>• Crop production (NAICS code 111).</P>
                <P>• Animal production (NAICS code 112).</P>
                <P>• Food manufacturing (NAICS code 311).</P>
                <P>• Pesticide manufacturing (NAICS code 32532).</P>
                <HD SOURCE="HD2">B. How can I get electronic access to other related information?</HD>
                <P>
                    You may access a frequently updated electronic version of 40 CFR part 180 through the Government Publishing Office's e-CFR site at 
                    <E T="03">http://www.ecfr.gov/cgi-bin/text-idx?&amp;c=ecfr&amp;tpl=/ecfrbrowse/Title40/40tab_02.tpl.</E>
                </P>
                <HD SOURCE="HD2">C. How can I file an objection or hearing request?</HD>
                <P>Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2019-0607 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before July 9, 2021. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).</P>
                <P>In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2019-0607, by one of the following methods:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal: http://www.regulations.gov.</E>
                     Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
                </P>
                <P>
                    • 
                    <E T="03">Mail:</E>
                     OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
                </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">http://www.epa.gov/dockets/contacts.html.</E>
                </P>
                <P>
                    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>
                <HD SOURCE="HD1">II. Petition for Exemption</HD>
                <P>
                    In the 
                    <E T="04">Federal Register</E>
                     of February 11, 2020 (85 FR 7708) (FRL-10005-02), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11359) by Milliken Chemical, 920 Milliken Rd., M-209 Spartanburg, SC 29303. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt (CAS Reg. No. N/A) when used as an inert ingredient (colorant) in pesticide formulations applied to seed treatment slurries for raw agricultural commodities not to exceed 20% (wt/wt). That document referenced a summary of the petition prepared by Milliken Chemical, the petitioner, which is available in the docket, 
                    <E T="03">http://www.regulations.gov.</E>
                     There were no comments received in response to the notice of filing.
                </P>
                <HD SOURCE="HD1">III. Inert Ingredient Definition</HD>
                <P>Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.</P>
                <HD SOURCE="HD1">IV. Aggregate Risk Assessment and Determination of Safety</HD>
                <P>Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) and (c)(2)(B) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”</P>
                <P>EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.</P>
                <P>
                    Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-
                    <PRTPAGE P="24733"/>
                    ethanediyl}bis[ω-hydroxy-, monosodium salt follows.
                </P>
                <HD SOURCE="HD2">A. Toxicological Profile</HD>
                <P>EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.</P>
                <P>
                    In acute studies, exposure to Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt resulted in no observable or minimal toxicity. The acute oral median lethal dose (LD
                    <E T="52">50</E>
                    ) in rats is &gt;2,000 mg/kg. Minimal dermal irritation was observed in an acute dermal study with rabbits. No indications of sensitization have been observed in local lymph node assay.
                </P>
                <P>Two reverse mutation assays (OECD 471), a mouse lymphoma assay (OECD 476) and an in vitro micronucleus test (OECD 487) found Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt to not be mutagenic.</P>
                <P>In a combined repeat dose developmental/reproduction study (OECD 422), there were no adverse effects from oral administration of Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt up to 1000 mg/kg/day on any parameter measured, including gonadal function, mating performance, conception, development of the conceptus or parturition. The NOAEL for these parameters was 1000 mg/kg/day for males and females. The NOAEL for reproductive performance and fetal/developmental toxicity was also considered to be 1,000 mg/kg/day.</P>
                <HD SOURCE="HD2">B. Toxicological Points of Departure/Levels of Concern</HD>
                <P>Based on available studies provided for Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt, no toxicological endpoint of concern was identified, and a quantitative risk assessment is not required for this compound.</P>
                <HD SOURCE="HD2">C. Exposure Assessment</HD>
                <P>
                    1. 
                    <E T="03">Dietary exposure from food and feed uses.</E>
                     In evaluating dietary exposure to Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt in food as follows:
                </P>
                <P>Dietary exposure (food and drinking water) to Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt is not expected to occur due to its intended use as a colorant for seed treatment. Seed treatment formulas containing Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt will be applied directly to seeds and if released into the environment, the colorant would not be taken up by the germinating seedling and translocated within the plant vascular system to result in crop residues and dietary exposures.</P>
                <P>
                    2. 
                    <E T="03">Dietary exposure from drinking water.</E>
                     Since a hazard endpoint of concern was not identified for the acute and chronic dietary assessment, a quantitative dietary exposure risk assessment for drinking water was not conducted.
                </P>
                <P>
                    3. 
                    <E T="03">From non-dietary exposure.</E>
                     The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (
                    <E T="03">e.g.,</E>
                     textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).
                </P>
                <P>Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt may be used in pesticide products and non-pesticide products used in and around the home that would have residential exposures. However, because no toxicological endpoint of concern was identified, a quantitative residential exposure assessment for Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt was not conducted.</P>
                <P>
                    4. 
                    <E T="03">Cumulative effects from substances with a common mechanism of toxicity.</E>
                     Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or exemption, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt to share a common mechanism of toxicity with any other substances, and Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has assumed that poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at 
                    <E T="03">http://www.epa.gov/pesticides/cumulative.</E>
                </P>
                <HD SOURCE="HD2">D. Safety Factor for Infants and Children</HD>
                <P>Based on the lack of threshold effects, EPA has not identified any toxicological endpoints of concern and is conducting a qualitative assessment of poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt. That qualitative assessment does not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children. Based on an assessment of poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children.</P>
                <HD SOURCE="HD2">E. Aggregate Risks and Determination of Safety</HD>
                <P>
                    Taking into consideration all available information on poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt when used as an inert 
                    <PRTPAGE P="24734"/>
                    ingredient (colorant) in pesticide formulations applied to seed treatment slurries for raw agricultural commodities and not to exceed 20% (wt/wt), EPA has determined that there is a reasonable certainty that no harm to the general population or any population subgroup, including infants and children, will result from aggregate exposure to poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.920 for residues of poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt when used as an inert ingredient (colorant) in pesticide formulations applied to seed treatment slurries for raw agricultural commodities and not to exceed 20% (wt/wt), is safe under FFDCA section 408.
                </P>
                <HD SOURCE="HD1">V. Other Considerations</HD>
                <HD SOURCE="HD2">A. Analytical Enforcement Methodology</HD>
                <P>An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.</P>
                <HD SOURCE="HD2">B. International Residue Limits</HD>
                <P>In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). Codex is a joint United Nation Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.</P>
                <P>The Codex has not established a MRL for poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt.</P>
                <HD SOURCE="HD1">VI. Conclusions</HD>
                <P>Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt (CAS Reg. No. N/A) when used as an inert ingredient (colorant) in pesticide formulations applied to seed treatment slurries for raw agricultural commodities and not to exceed 20% (wt/wt).</P>
                <HD SOURCE="HD1">VII. Statutory and Executive Order Reviews</HD>
                <P>
                    This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).
                </P>
                <P>
                    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ), do not apply.
                </P>
                <P>
                    This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <P>This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).</P>
                <HD SOURCE="HD1">VIII. Congressional Review Act</HD>
                <P>
                    Pursuant to the Congressional Review Act (5 U.S.C. 801 
                    <E T="03">et seq.</E>
                    ), EPA will submit a report containing this rule 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>
                    . This action is not a “major rule” as defined by 5 U.S.C. 804(2).
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 180</HD>
                    <P>Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Marietta Echeverria,</NAME>
                    <TITLE>Acting Director, Registration Division, Office of Pesticide Programs.</TITLE>
                </SIG>
                <P>Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD</HD>
                </PART>
                <REGTEXT TITLE="40" PART="180">
                    <AMDPAR>1. The authority citation for part 180 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 21 U.S.C. 321(q), 346a and 371.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="180">
                    <AMDPAR>2. In § 180.920, amend the table by adding in alphabetical order the inert ingredient “Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 180.920 </SECTNO>
                        <SUBJECT>Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance.</SUBJECT>
                        <STARS/>
                        <PRTPAGE P="24735"/>
                        <GPOTABLE COLS="3" OPTS="L1,tp0,i1" CDEF="s100,r50,xs50">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">Inert ingredients</CHED>
                                <CHED H="1">Limits</CHED>
                                <CHED H="1">Uses</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Poly(oxy-1,2-ethanediyl), α, α′-{[[4-[(3-sulfophenyl)azo]phenyl]imino]di-2,1-ethanediyl}bis[ω-hydroxy-, monosodium salt</ENT>
                                <ENT>Not to exceed 20% by weight of pesticide formulation</ENT>
                                <ENT>Colorant.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09911 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                <CFR>42 CFR Part 412</CFR>
                <DEPDOC>[CMS-1762-IFC]</DEPDOC>
                <RIN>RIN 0938-AU56</RIN>
                <SUBJECT>Medicare Program; Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (MGCRB)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Centers for Medicare &amp; Medicaid Services (CMS), Health and Human Services, (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Interim final rule with comment period.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This interim final rule with comment period (IFC) amends our current regulations to allow hospitals with a rural redesignation under the Social Security Act (the Act) to reclassify through the Medicare Geographic Classification Review Board (MGCRB) using the rural reclassified area as the geographic area in which the hospital is located. These regulatory changes align our policy with the decision in 
                        <E T="03">Bates County Memorial Hospital</E>
                         v. 
                        <E T="03">Azar,</E>
                         effective with reclassifications beginning with fiscal year (FY) 2023. We would also apply the policy in this IFC when deciding timely appeals before the Administrator of applications for reclassifications beginning with FY 2022 that were denied by the MGCRB due to the current policy, which does not permit hospitals with rural redesignations to use the rural area's wage data for purposes of reclassifying under the MGCRB.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Effective date:</E>
                         These regulations are effective on May 10, 2021.
                    </P>
                    <P>
                        <E T="03">Comment date:</E>
                         To be assured consideration, comments must be received at one of the addresses provided below by June 28, 2021.
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>In commenting, please refer to file code CMS-1762-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.</P>
                    <P>Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):</P>
                    <P>
                        1. Electronically. You may (and we encourage you to) submit electronic comments on this regulation to 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the instructions under the “submit a comment” tab.
                    </P>
                    <P>2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services, Attention: CMS-1762-IFC, P.O. Box 8013, Baltimore, MD 21244-1850.</P>
                    <P>Please allow sufficient time for mailed comments to be received before the close of the comment period.</P>
                    <P>3. By express or overnight mail. You may send written comments via express or overnight mail to the following address ONLY: Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services, Attention: CMS-1762-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.</P>
                    <P>
                        For information on viewing public comments, we refer readers to the beginning of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Tehila Lipschutz, (410) 786-1344 or Dan Schroder, (410) 786-7452.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P SOURCE="NPAR">
                    <E T="03">Inspection of Public Comments:</E>
                     All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: 
                    <E T="03">http://regulations.gov.</E>
                     Follow the search instructions on that website to view public comments.
                </P>
                <P>Comments received timely will be also available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare &amp; Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <HD SOURCE="HD2">A. Wage Index for Acute Care Hospitals Paid Under the Hospital Inpatient Prospective Payment System (IPPS)</HD>
                <P>Under section 1886(d) of the Social Security Act (the Act), hospitals are paid based on prospectively set rates. To account for geographic area wage level differences, section 1886(d)(3)(E) of the Act requires that the Secretary of the Department of Health and Human Services (the Secretary) adjust the standardized amounts by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the hospital, as compared to the national average hospital wage level. We currently define hospital labor market areas based on the delineations of statistical areas established by the Office of Management and Budget (OMB). The current statistical areas (which were implemented beginning with FY 2015) are based on revised OMB delineations issued on February 28, 2013, in OMB Bulletin No. 13-01, with updates as reflected in OMB Bulletins Nos. 15-01, 17-01, and 18-04. We refer readers to the FY 2015 IPPS/LTCH PPS final rule (79 FR 49951 through 49963) for a full discussion of our implementation of the new OMB labor market area delineations beginning with the FY 2015 wage index, and to the FY 2021 IPPS/LTCH PPS final rule (85 FR 58743 through 58755) for a discussion of the latest updates to these delineations.</P>
                <P>
                    Section 1886(d)(3)(E) of the Act requires the Secretary to update the wage index of hospitals annually, and to base the update on a survey of wages and wage-related costs of short-term, acute care hospitals. Under section 1886(d)(8)(D) of the Act, the Secretary is required to adjust the standardized amounts so as to ensure that aggregate payments under the IPPS, after 
                    <PRTPAGE P="24736"/>
                    implementation of the provisions of sections 1886(d)(8)(B), 1886(d)(8)(C), and 1886(d)(10) of the Act, regarding geographic reclassification of hospitals, are equal to the aggregate prospective payments that would have been made absent these provisions.
                </P>
                <HD SOURCE="HD2">B. Hospital Reclassifications Under Sections 1886(d)(8)(E) and 1886(d)(10) of the Act</HD>
                <P>Hospitals may seek to have their geographic designation reclassified. Under section 1886(d)(8)(E) of the Act, a qualifying prospective payment hospital located in an urban area may apply for rural status. Specifically, section 1886(d)(8)(E) of the Act states that “[f]or purposes of this subsection, not later than 60 days after the receipt of an application (in a form and manner determined by the Secretary) from a subsection (d) hospital described in clause (ii), the Secretary shall treat the hospital as being located in the rural area (as defined in paragraph (2)(D)) of the state in which the hospital is located.” The regulations governing these geographic redesignations are codified in § 412.103, and such hospitals are commonly referred to as “§ 412.103 hospitals”.</P>
                <P>In a separate process, hospitals may also reclassify for purposes of the wage index under the IPPS under section 1886(d)(10) of the Act by applying to the Medicare Geographic Classification Review Board (MGCRB). Hospitals must apply to the MGCRB to reclassify not later than 13 months prior to the start of the fiscal year for which reclassification is sought, generally by September 1. (However, we note that this deadline has been extended for applications for FY 2022 reclassifications to 15 days after the public display date of the FY 2021 IPPS/LTCH final rule at the Office of the Federal Register, using our authority under section 1135(b)(5) the Act due to the COVID-19 Public Health Emergency.) Generally, hospitals must be proximate to the labor market area to which they are seeking reclassification and must demonstrate characteristics similar to hospitals located in that area. The MGCRB issues its decisions by the end of February for reclassifications that become effective for the following fiscal year (beginning October 1). The regulations applicable to reclassifications by the MGCRB are located in §§ 412.230 through 412.280.</P>
                <P>
                    Prior to a court decision in 
                    <E T="03">Geisinger Community Medical</E>
                     v. 
                    <E T="03">Secretary, United States Department of Health and Human Services,</E>
                     794 F.3d 383 (3d Cir. 2015) 
                    <E T="03">(“Geisinger”),</E>
                     hospitals were only able to hold one reclassification at a time: either under § 412.103 or through the MGCRB under section 1886(d)(10) of the Act. The Court of Appeals in Geisinger ruled that CMS's prohibition of dual § 412.103 and MGCRB reclassifications was unlawful, since section 1886(d)(8)(E)(i) of the Act requires that “the Secretary shall treat the hospital as being located in the rural area,” inclusive of MGCRB reclassification purposes. Therefore, on April 21, 2016, we published an interim final rule with comment period (the April 21, 2016 IFC) in the 
                    <E T="04">Federal Register</E>
                     (81 FR 23428 through 23438) that included provisions amending our regulations to allow hospitals nationwide to have simultaneous § 412.103 and MGCRB reclassifications.
                </P>
                <HD SOURCE="HD1">II. Provisions of the Interim Final Rule With Comment Period</HD>
                <P>Pursuant to our April 21, 2016 IFC, for reclassifications effective beginning FY 2018, a hospital may acquire rural status under § 412.103 and subsequently apply for a reclassification under the MGCRB using the distance and average hourly wage criteria designated for rural hospitals. Hospitals with a § 412.103 redesignation seeking additional reclassification under the MGCRB use the rural distance and average hourly wage criteria under § 412.230(b)(1), (d)(1)(iii)(C), and (d)(1)(iv)(E). For example, under our current policy, a § 412.103 hospital geographically located in the urban CBSA of Buffalo-Cheektowaga, NY seeking to reclassify under the MGCRB would demonstrate that their wages are at least 106 percent (and not 108 percent, as urban hospitals must demonstrate) of the average hourly wage of Buffalo-Cheektowaga, NY, to meet the criteria at § 412.230(d)(1)(iii)(C).</P>
                <P>However, our current policy compares the average hourly wage of a § 412.103 hospital to its geographic urban location, rather than the rural reclassified area, for purposes of satisfying certain wage comparison criteria. In response to a comment on our April 21, 2016 IFC (81 FR 56925), we stated: “The commenter is correct that the rural distance and average hourly wage criteria will be used for hospitals with a § 412.103 redesignation. However, the commenter's statement that the average hourly wage of a hospital with a § 412.103 redesignation is compared to the average hourly wage of hospitals in the State's rural area under § 412.230(d)(1)(iii)(C) is incorrect. Instead, the hospital's average hourly wage would be compared to the average hourly wage of all other hospitals in its urban geographic location using the rural distance and average hourly wage criteria.”</P>
                <P>
                    On May 14, 2020, the United States District Court for the District of Columbia issued a decision in 
                    <E T="03">Bates County Memorial Hospital</E>
                     v. 
                    <E T="03">Azar,</E>
                     464 F. Supp. 3d 43 (D.D.C. 2020) (
                    <E T="03">Bates</E>
                    ). Bates County Memorial Hospital and five other geographically urban hospitals were reclassified to rural under § 412.103. They also applied for reclassification under the MGCRB, but were denied because their wages were not at least 106 percent of the geographic urban area in which the hospitals were located. Each of the hospitals' average hourly wages were at least 106 percent of the 3-year average hourly wage of all other hospitals in the rural area of the state in which the hospitals are located.
                </P>
                <P>
                    The Court agreed with the Plaintiffs that the statute at section 1886(d)(8)(E)(i) of Act requires that CMS treat qualifying hospitals as being located in the rural area for purposes of section 1886(d) of the Act, including MGCRB reclassification. The 
                    <E T="03">Bates</E>
                     decision requires that CMS consider the rural area to be the area in which the hospital is located for the wage comparisons required for MGCRB reclassifications. For example, pursuant to 
                    <E T="03">Bates,</E>
                     a § 412.103 hospital geographically located in the urban CBSA of Buffalo-Cheektowaga, NY seeking to reclassify under the MGCRB would demonstrate that their wages are at least 106 percent of the average hourly wage of rural NY, rather than that of Buffalo-Cheektowaga.
                </P>
                <P>
                    As a result of the 
                    <E T="03">Bates</E>
                     court's decision, we are revising our policy so that the redesignated rural area, and not the hospital's geographic urban area, will be considered the area a § 412.103 hospital is located in for purposes of meeting MGCRB reclassification criteria. Similarly, we are revising the regulations to consider the redesignated rural area, and not the geographic urban area, as the area a § 412.103 hospital is located in for the prohibition at § 412.230(a)(5)(i) on reclassifying to an area with a pre-reclassified average hourly wage lower than the pre-reclassified average hourly wage for the area in which the hospital is located.
                </P>
                <P>
                    Specifically, to align our policy with the court's decision in 
                    <E T="03">Bates,</E>
                     we are amending the regulations at § 412.230(a)(1) by adding (a)(1)(iii) to state that an urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of this section. We are also making conforming changes to the regulation at § 412.230(a)(5)(i) because 
                    <PRTPAGE P="24737"/>
                    § 412.230(a)(1) except paragraph (a)(5). Because § 412.230(a)(1) excepts paragraph (a)(5), we believe it is necessary to make a specific conforming revision to § 412.230(a)(5)(i), in addition to the general rule at § 412.230(a)(1)(iii), to clarify that the general rule at § 412.230(a)(1)(iii) applies to § 412.230(a)(5)(i) as well. That is, we are amending the regulation at § 412.230(a)(5)(i) to add language stating that an urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of paragraph (a)(5)(i).
                </P>
                <P>
                    These changes implement the 
                    <E T="03">Bates</E>
                     court's interpretation of the requirement at section 1886(d)(8)(E)(i) of the Act that “the Secretary shall treat the hospital as being located in the rural area.” That is, a § 412.103 hospital would be considered to be located in the rural area of the state for all purposes of MGCRB reclassification, including the average hourly wage comparisons required by § 412.230(a)(5)(i) and (d)(1)(iii)(C). For example, for purposes of § 412.230(d)(1)(iii)(C), the § 412.103 hospital would compare its average hourly wage to the average hourly wage of all other hospitals in the state's rural area. In addition, for purposes of § 412.230(a)(5)(i), a § 412.103 hospital may not be redesignated to another area if the pre-classified average hourly wage for that area is lower than the pre-reclassified average hourly wage of the rural area of the state in which the hospital is located (thus, a § 412.103 hospital could potentially reclassify to any area with a pre-reclassified average hourly wage that is higher than the pre-reclassified average hourly wage for the rural area of the state, if it meets all other applicable reclassification criteria).
                </P>
                <P>Therefore, effective for reclassification applications due to the MGCRB on September 1, 2021, for reclassification first effective for FY 2023, a § 412.103 hospital could apply for a reclassification under the MGCRB using the state's rural area as the area in which the hospital is located. We would also apply the policy in this IFC when deciding timely appeals before the Administrator under § 412.278 for reclassifications beginning in FY 2022 that were denied by the MGCRB due to existing policy, which did not permit § 412.103 hospitals to be considered located in the state's rural area.</P>
                <HD SOURCE="HD1">III. Waiver of Proposed Rulemaking and Delay in Effective Date</HD>
                <P>
                    We ordinarily publish a notice of proposed rulemaking in the 
                    <E T="04">Federal Register</E>
                     and invite public comment on the proposed rule before the provisions of the rule are finalized, either as proposed or as amended, in response to public comments and take effect, in accordance with the Administrative Procedure Act (APA) (Pub. L. 79-404), 5 U.S.C. 553 and, where applicable, section 1871 of the Act. Specifically, 5 U.S.C. 553 requires the agency to publish a notice of proposed rulemaking in the 
                    <E T="04">Federal Register</E>
                     that includes a reference to the legal authority under which the rule is proposed, and the terms and substances of the proposed rule or a description of the subjects and issues involved. Section 553(c) of the APA further requires the agency to give interested parties the opportunity to participate in the rulemaking through public comment before the provisions of the rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the 
                    <E T="04">Federal Register</E>
                     and a period of not less than 60 days for public comment for rulemaking carrying out the administration of the insurance programs under Title XVIII of the Act. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize the agency to waive these procedures, however, if the agency finds good cause that notice and comment procedures are impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued.
                </P>
                <P>
                    Section 553(d) of the APA ordinarily requires a 30-day delay in the effective date of a final rule from the date of its publication in the 
                    <E T="04">Federal Register</E>
                    . This 30-day delay in effective date can be waived, however, if an agency finds good cause to support an earlier effective date. Section 1871(e)(1)(B)(i) of the Act also prohibits a substantive rule from taking effect before the end of the 30-day period beginning on the date the rule is issued or published. However, section 1871(e)(1)(B)(ii) of the Act permits a substantive rule to take effect before 30 days if the Secretary finds that a waiver of the 30-day period is necessary to comply with statutory requirements or that the 30-day delay would be contrary to the public interest. Finally, the Congressional Review Act (CRA) (Pub. L. 104-121, Title II) requires a 60-day delay in the effective date for major rules unless an agency finds good cause that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, in which case the rule shall take effect at such time as the agency determines 5 U.S.C. 801(a)(3) and 808(2).
                </P>
                <P>We find good cause for waiving notice-and comment rulemaking and a delay in effective date given the decision of the district court and the public interest in expeditious implementation of the court's interpretation of the statute. Revising the regulation text by adding § 412.230(a)(1)(iii) and revising the regulation at § 412.230(a)(5)(i) through an IFC rather than through the normal notice-and comment rulemaking cycle and waiving the delay of effective date will ensure an expeditious implementation of the court's interpretation by allowing this policy to be applied to FY 2023 MGCRB reclassification decisions and cases before the Administrator for reclassifications effective beginning FY 2022. Absent this IFC, the earliest effective date of this revision to the regulations would be October 1, 2021 (FY 2022) following the normal IPPS/LTCH PPS notice-and comment rulemaking cycle. An effective date of FY 2022 would only allow the MGCRB to approve hospitals' applications qualifying under this policy for applications due September 1, 2022 for reclassifications effective beginning FY 2024 (applications are due to the MGCRB 13 months prior to the start of the fiscal year). Additionally, implementing the court's interpretation via an IFC allows this policy to be applied to cases before the Administrator for reclassifications effective beginning in FY 2022, which supports an expeditious implementation of this policy. Therefore, we find good cause to waive the notice of proposed rulemaking as well as the delay of effective date and to issue this final rule on an interim basis. Even though we are waiving notice of proposed rulemaking requirements and are issuing these provisions on an interim basis, we are providing a 60-day public comment period.</P>
                <HD SOURCE="HD1">IV. Collection of Information Requirements</HD>
                <P>
                    This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <HD SOURCE="HD1">V. Regulatory Impact Statement</HD>
                <P>
                    We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation 
                    <PRTPAGE P="24738"/>
                    and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).
                </P>
                <P>Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A Regulatory Impact Analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule.</P>
                <P>The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $8.0 million to $41.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this IFC would not have a significant economic impact on a substantial number of small entities. Also, our revision to the regulatory text is a consequence of a court decision. We are amending the regulations to align our policy with the court's decision in Bates and implement the Bates court's interpretation of the requirement at section 1886(d)(8)(E)(i) of the Act that “the Secretary shall treat the hospital as being located in the rural area.”</P>
                <P>In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital for Medicare payment regulations as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this IFC would not have a significant impact on the operations of a substantial number of small rural hospitals.</P>
                <P>Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2021, that threshold is approximately $158 million. This rule will have no consequential effect on state, local, or tribal governments or on the private sector.</P>
                <P>Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.</P>
                <P>Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.</P>
                <P>We estimate that this rule is “significant” but not “economically significant,” as measured by the $100 million threshold. However, we have prepared an impact analysis that presents our best estimate of the costs and benefits of this rule for FY 2022 since section 3(f) of Executive Order 12866 defines a “significant regulatory action” as a rule that raises novel legal or policy issues arising out of legal mandates.</P>
                <P>
                    With regard to our impact analysis, as a result of this IFC, for FY 2022, there are approximately 22 hospitals that may qualify for a reclassification to a new or different urban area with a higher wage index than they might otherwise have received based on the information currently available to us (for example, applications submitted to the MGCRB.) For FY 2022, if these hospitals qualify for and accept reclassification to a new or different urban area with a higher wage index than they might otherwise have received, we estimate a total increase in payments to these hospitals of approximately $50 million in aggregate. However, wage index adjustments such as these are made in a manner that ensures that aggregate payments to hospitals are unaffected. This is accomplished through the application of a wage index budget neutrality adjustment as described more fully in the FY 2022 IPPS/LTCH proposed rule. Therefore, as a consequence of the court's decision in 
                    <E T="03">Bates,</E>
                     even though an urban hospital may be able to qualify for a reclassification to a new or different urban area with a higher wage index, this would not increase aggregate hospital payments. We estimate that in FY 2022 the wage index budget neutrality adjustment could increase by one-half of a percentage point as a result of an increase in the wage index to these 22 hospitals.
                </P>
                <P>We do not know as a result of this IFC: (1) How many additional hospitals will elect to apply to the MGCRB by September 1, 2021 for reclassification beginning FY 2023 that would not otherwise have applied; (2) how many hospitals that apply will qualify for a wage index higher than they otherwise would have received; (3) for those that qualify for a higher wage index how much higher that wage index will be; and, (4) how many hospitals may elect to retain or acquire § 412.103 urban-to rural reclassification that would not otherwise have done so. The MGCRB makes determinations on reclassification requests, and hospitals make final decisions whether to accept reclassifications approved by the MGCRB.</P>
                <P>
                    We also note that OMB requested public comment on the recommendations it received from the Metropolitan and Micropolitan Statistical Area Standards Review Committee for changes to OMB's metropolitan and micropolitan statistical area standards (86 FR 5263). These standards determine the 
                    <PRTPAGE P="24739"/>
                    procedures for delineating and updating the statistical areas as new data become available. If changes to the standards are adopted by OMB and if those changes would affect the OMB delineations used for the IPPS wage index, we would address any such changes and impacts in future rulemaking.
                </P>
                <P>In accordance with the provisions of Executive Order 12866, this IFC was reviewed by the Office of Management and Budget.</P>
                <HD SOURCE="HD1">VI. Response to Comments</HD>
                <P>
                    Because of the large number of public comments we normally receive on 
                    <E T="04">Federal Register</E>
                     documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the 
                    <E T="02">DATES</E>
                     section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
                </P>
                <P>
                    <E T="03">I, Elizabeth Richter, Acting Administrator of the Centers for Medicare &amp; Medicaid Services, approved this document on April 16, 2021.</E>
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 42 CFR Part 412</HD>
                    <P>Administrative practice and procedure, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <P>For the reasons set forth in the preamble, the Centers for Medicare &amp; Medicaid Services amends 42 CFR chapter IV, part 412, as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 412—PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES</HD>
                </PART>
                <REGTEXT TITLE="42" PART="412">
                    <AMDPAR>1. The authority for part 412 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> 42 U.S.C. 1302 and 1395hh. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="42" PART="412">
                    <AMDPAR>2. Section 412.230 is amended by adding paragraph (a)(1)(iii) and revising paragraph (a)(5)(i) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 412.230 </SECTNO>
                        <SUBJECT>Criteria for an individual hospital seeking redesignation to another rural area or an urban area.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(1) * * *</P>
                        <P>(iii) An urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of this section.</P>
                        <STARS/>
                        <P>(5) * * *</P>
                        <P>(i) An individual hospital may not be redesignated to another area for purposes of the wage index if the pre-reclassified average hourly wage for that area is lower than the pre-reclassified average hourly wage for the area in which the hospital is located. An urban hospital that has been granted redesignation as rural under § 412.103 is considered to be located in the rural area of the state for the purposes of this paragraph (a)(5)(i).</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: April 23, 2021.</DATED>
                    <NAME>Xavier Becerra,</NAME>
                    <TITLE>Secretary, Department of Health and Human Services.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-08889 Filed 4-27-21; 4:45 pm]</FRDOC>
            <BILCOD>BILLING CODE 4120-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Federal Emergency Management Agency</SUBAGY>
                <CFR>44 CFR Part 64</CFR>
                <DEPDOC>[Docket ID FEMA-2021-0003; Internal Agency Docket No. FEMA-8679]</DEPDOC>
                <SUBJECT>Suspension of Community Eligibility</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Emergency Management Agency, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur. Information identifying the current participation status of a community can be obtained from FEMA's CSB available at 
                        <E T="03">www.fema.gov/flood-insurance/work-with-nfip/community-status-book.</E>
                         Please note that per Revisions to Publication Requirements for Community Eligibility Status Information Under the National Flood Insurance Program, notices such as this one for scheduled suspension will no longer be published in the 
                        <E T="04">Federal Register</E>
                         as of June 2021 but will be available at National Flood Insurance Community Status and Public Notification | 
                        <E T="03">FEMA.gov.</E>
                         Individuals without internet access will be able to contact their local floodplain management official and/or State NFIP Coordinating Office directly for assistance.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Adrienne L. Sheldon, PE, CFM, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 400 C Street SW, Washington, DC 20472, (202) 674-1087. Details regarding updated publication requirements of community eligibility status information under the NFIP can be found on the CSB section at 
                        <E T="03">www.fema.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives, new and substantially improved construction, and development in general from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with NFIP regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date listed in the third column. As of that date, flood insurance will no longer be available in the community. FEMA recognizes communities may adopt and submit the required documentation after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. Their current NFIP participation status can be verified at anytime on the CSB section at 
                    <E T="03">fema.gov.</E>
                </P>
                <P>
                    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the published FIRM is indicated in the fourth column of the table. No direct federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for 
                    <PRTPAGE P="24740"/>
                    communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.
                </P>
                <P>Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.</P>
                <P>
                    <E T="03">National Environmental Policy Act.</E>
                     FEMA has determined that the community suspension(s) included in this rule is a non-discretionary action and therefore the National Environmental Policy Act of 1969 (42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ) does not apply.
                </P>
                <P>
                    <E T="03">Regulatory Flexibility Act.</E>
                     The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.
                </P>
                <P>
                    <E T="03">Regulatory Classification.</E>
                     This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.
                </P>
                <P>
                    <E T="03">Executive Order 13132, Federalism.</E>
                     This rule involves no policies that have federalism implications under Executive Order 13132.
                </P>
                <P>
                    <E T="03">Executive Order 12988, Civil Justice Reform.</E>
                     This rule meets the applicable standards of Executive Order 12988.
                </P>
                <P>
                    <E T="03">Paperwork Reduction Act.</E>
                     This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 44 CFR Part 64</HD>
                    <P>Flood insurance, Floodplains.</P>
                </LSTSUB>
                <P>Accordingly, 44 CFR part 64 is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 64—[AMENDED]</HD>
                </PART>
                <REGTEXT TITLE="44" PART="64">
                    <AMDPAR>1. The authority citation for Part 64 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                             42 U.S.C. 4001 
                            <E T="03">et seq.;</E>
                             Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp.; p. 376. 
                        </P>
                    </AUTH>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 64.6 </SECTNO>
                    <SUBJECT>[Amended] </SUBJECT>
                </SECTION>
                <REGTEXT TITLE="44" PART="64">
                    <AMDPAR>2. The tables published under the authority of § 64.6 are amended as follows:</AMDPAR>
                    <GPOTABLE COLS="5" OPTS="L2,nj,tp0,i1" CDEF="s50,11,xl50,xs60,xs60">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">State and location</CHED>
                            <CHED H="1">Community No.</CHED>
                            <CHED H="1">Effective date authorization/cancellation of sale of flood insurance in community</CHED>
                            <CHED H="1">Current effective map date</CHED>
                            <CHED H="1">
                                Date certain
                                <LI>federal</LI>
                                <LI>assistance</LI>
                                <LI>no longer</LI>
                                <LI>available in SFHAs</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="21">
                                <E T="02">Region 3</E>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Pennsylvania:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Barry, Township of, Schuylkill County</ENT>
                            <ENT>421997</ENT>
                            <ENT>August 5, 1975, Emerg; May 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>May 18, 2021</ENT>
                            <ENT>May 18, 2021.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Eldred, Township of, Schuylkill County</ENT>
                            <ENT>422005</ENT>
                            <ENT>August 5, 1975, Emerg; September 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do *</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Foster, Township of, Schuylkill County</ENT>
                            <ENT>422006</ENT>
                            <ENT>April 21, 1975, Emerg; September 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Frackville, Borough of, Schuylkill County</ENT>
                            <ENT>420771</ENT>
                            <ENT>July 9, 1975, Emerg; May 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Girardville, Borough of, Schuylkill County</ENT>
                            <ENT>420772</ENT>
                            <ENT>April 29, 1975, Emerg; February 2, 1990, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Mahanoy, Township of, Schuylkill County</ENT>
                            <ENT>422011</ENT>
                            <ENT>August 20, 1975, Emerg; September 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Middleport, Borough of, Schuylkill County</ENT>
                            <ENT>420777</ENT>
                            <ENT>September 27, 1974, Emerg; September 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Minersville, Borough of, Schuylkill County</ENT>
                            <ENT>420778</ENT>
                            <ENT>April 4, 1974, Emerg; March 2, 1989, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">New Castle, Township of, Schuylkill County</ENT>
                            <ENT>422012</ENT>
                            <ENT>December 3, 1979, Emerg; August 13, 1982, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">North Union, Township of, Schuylkill County</ENT>
                            <ENT>422014</ENT>
                            <ENT>July 11, 1975, Emerg; September 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Norwegian, Township of, Schuylkill County</ENT>
                            <ENT>422015</ENT>
                            <ENT>April 21, 1975, Emerg; July 9, 1982, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Pottsville, City of, Schuylkill County</ENT>
                            <ENT>420785</ENT>
                            <ENT>June 28, 1973, Emerg; July 5, 1977, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Reilly, Township of, Schuylkill County</ENT>
                            <ENT>422017</ENT>
                            <ENT>April 7, 1975, Emerg; May 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Schuylkill, Township of, Schuylkill County</ENT>
                            <ENT>422020</ENT>
                            <ENT>May 27, 1975, Emerg; March 11, 1983, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Shenandoah, Borough of, Schuylkill County</ENT>
                            <ENT>420788</ENT>
                            <ENT>May 16, 1973, Emerg; May 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Tower City, Borough of, Schuylkill County</ENT>
                            <ENT>420790</ENT>
                            <ENT>April 29, 1975, Emerg; September 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>May 18, 2021</ENT>
                            <ENT>May 18, 2021.</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="24741"/>
                            <ENT I="03">Tremont, Borough of, Schuylkill County</ENT>
                            <ENT>420791</ENT>
                            <ENT>April 26, 1973, Emerg; June 4, 1980, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Tremont, Township of, Schuylkill County</ENT>
                            <ENT>422023</ENT>
                            <ENT>March 19, 1975, Emerg; September 5, 1979, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Union, Township of, Schuylkill County</ENT>
                            <ENT>422024</ENT>
                            <ENT>July 24, 1975, Emerg; September 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Wayne, Township of, Schuylkill County</ENT>
                            <ENT>422027</ENT>
                            <ENT>November 13, 1979, Emerg; September 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="21">
                                <E T="02">Region 6</E>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Oklahoma:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Hammon, Town of, Custer and Roger Mills Counties</ENT>
                            <ENT>400386</ENT>
                            <ENT>April 21, 1978, Emerg; July 13, 1982, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Roger Mills County, Unincorporated Areas</ENT>
                            <ENT>400542</ENT>
                            <ENT>June 20, 1994, Emerg; August 9, 2000, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="21">
                                <E T="02">Region 7</E>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Iowa:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Clermont, City of, Fayette County</ENT>
                            <ENT>190374</ENT>
                            <ENT>September 14, 1983, Emerg; March 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Elgin, City of, Fayette County</ENT>
                            <ENT>190125</ENT>
                            <ENT>June 18, 1975, Emerg; August 4, 1987, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Fayette, City of, Fayette County</ENT>
                            <ENT>190376</ENT>
                            <ENT>April 27, 1978, Emerg; September 1, 1987, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Fayette County, Unincorporated Areas</ENT>
                            <ENT>190866</ENT>
                            <ENT>November 27, 1990, Emerg; July 1, 1991, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Maynard, City of, Fayette County</ENT>
                            <ENT>190377</ENT>
                            <ENT>September 29, 1976, Emerg; August 1, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Oelwein, City of, Fayette County</ENT>
                            <ENT>190126</ENT>
                            <ENT>October 14, 1975, Emerg; July 4, 1988, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Waucoma, City of, Fayette County</ENT>
                            <ENT>190381</ENT>
                            <ENT>July 15, 1983, Emerg; September 29, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">West Union, City of, Fayette County</ENT>
                            <ENT>190706</ENT>
                            <ENT>N/A, Emerg; December 17, 2012, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>May 18, 2021</ENT>
                            <ENT>May 18, 2021.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="21">
                                <E T="02">Region 8</E>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Colorado:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Fort Morgan, City of, Morgan County</ENT>
                            <ENT>080131</ENT>
                            <ENT>February 4, 1982, Emerg; February 5, 1986, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Morgan County, Unincorporated Areas</ENT>
                            <ENT>080129</ENT>
                            <ENT>April 22, 1980, Emerg; September 29, 1989, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Otis, Town of, Washington County</ENT>
                            <ENT>080178</ENT>
                            <ENT>June 23, 1978, Emerg; August 19, 1985, Reg; May 18, 2021, Susp.</ENT>
                            <ENT>......do</ENT>
                            <ENT>  Do.</ENT>
                        </ROW>
                        <TNOTE>* do = Ditto.</TNOTE>
                        <TNOTE>Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension.</TNOTE>
                    </GPOTABLE>
                </REGTEXT>
                <SIG>
                    <NAME>Eric J. Letvin,</NAME>
                    <TITLE>Deputy Assistant Administrator for Mitigation, Federal Insurance and Mitigation Administration—FEMA Resilience, Department of Homeland Security, Federal Emergency Management Agency.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09860 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-12-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <CFR>47 CFR Part 73</CFR>
                <DEPDOC>[MB Docket No. 21-57; RM-11882; DA 21-480; FR ID 24753]</DEPDOC>
                <SUBJECT>Television Broadcasting Services Savannah, Georgia</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Communications Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        On February 22, 2021, the Media Bureau, Video Division (Bureau) issued a 
                        <E T="03">Notice of Proposed Rulemaking</E>
                         in response to a petition for rulemaking filed by Gray Television Licensee, LLC (Gray), the licensee of WTOC-TV, channel 11 (CBS), Savannah, Georgia, requesting the substitution of channel 23 for channel 11 at Savannah in the DTV Table of Allotments. For the reasons set forth in the 
                        <E T="03">Report and Order</E>
                         referenced below, the Bureau amends FCC regulations to substitute channel 23 for channel 11 at Savannah.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective May 10, 2021.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Andrew Manley, Media Bureau, at (202) 418-0596 or 
                        <E T="03">AndrewManley@fcc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The proposed rule was published at 86 FR 12898 on March 5, 2021. Gray filed comments in support of the petition reaffirming its commitment to applying for channel 23. No other comments were received. In support, Gray states that the Commission has recognized that VHF channels have certain propagation 
                    <PRTPAGE P="24742"/>
                    characteristics which may cause reception issues for some viewers, and that many of its viewers experience significant difficulty receiving WTOC's signal. Gray also demonstrated that all of the terrain-limited service area of WTOC's licensed channel 11 will receive terrain-limited service from the proposed channel 23, and that operation on channel 23 will not result in any predicted loss of service. The Bureau believes the public interest would be served by the channel substitution because it will result in improved service.
                </P>
                <P>
                    This is a synopsis of the Commission's 
                    <E T="03">Report and Order,</E>
                     MB Docket No. 21-61; RM-11885; DA 21-477, adopted April 26, 2021, and released April 26, 2021. The full text of this document is available for download at 
                    <E T="03">https://www.fcc.gov/edocs.</E>
                     To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to 
                    <E T="03">fcc504@fcc.gov</E>
                     or call the Consumer &amp; Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).
                </P>
                <P>
                    This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 
                    <E T="03">see</E>
                     44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to this proceeding.
                </P>
                <P>
                    The Commission will send a copy of this 
                    <E T="03">Report and Order</E>
                     in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, 
                    <E T="03">see</E>
                     5 U.S.C. 801(a)(1)(A).
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 47 CFR Part 73</HD>
                    <P>Television.</P>
                </LSTSUB>
                <SIG>
                    <FP>Federal Communications Commission.</FP>
                    <NAME>Thomas Horan,</NAME>
                    <TITLE>Chief of Staff, Media Bureau.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Final Rule</HD>
                <P>For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 73—RADIO BROADCAST SERVICE</HD>
                </PART>
                <REGTEXT TITLE="47" PART="73">
                    <AMDPAR>1. The authority citation for part 73 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 47 U.S.C. 154, 155, 301, 303, 307, 309, 310, 334, 336, 339.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="47" PART="73">
                    <AMDPAR>2. In § 73.622(i), amend the Post-Transition Table of DTV Allotments, under Georgia, by revising the entry for Savannah to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 73.622 </SECTNO>
                        <SUBJECT>Digital television table of allotments.</SUBJECT>
                        <STARS/>
                        <P>(i) * * *</P>
                        <GPOTABLE COLS="2" OPTS="L1,tp0,i1" CDEF="s25,r25">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">Community</CHED>
                                <CHED H="1">Channel No.</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="28">*   *   *   *   *</ENT>
                            </ROW>
                            <ROW EXPSTB="01" RUL="s">
                                <ENT I="21">
                                    <E T="02">GEORGIA</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*   *   *   *   *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Savannah</ENT>
                                <ENT>* 9, 22, 23, 39</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*   *   *   *   *</ENT>
                            </ROW>
                        </GPOTABLE>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09693 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 622</CFR>
                <DEPDOC>[Docket No. 210504-0099]</DEPDOC>
                <RIN>RIN 0648-BK22</RIN>
                <SUBJECT>Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Dolphin and Wahoo Fishery of the Atlantic; Amendment 12</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS issues regulations to implement Amendment 12 to the Fishery Management Plan (FMP) for the Dolphin and Wahoo Fishery of the Atlantic (Dolphin Wahoo FMP), as prepared and submitted by the South Atlantic Fishery Management Council (Council). This final rule adds bullet mackerel and frigate mackerel to the Dolphin Wahoo FMP and designates them as ecosystem component (EC) species. The purpose of this final rule and Amendment 12 is to acknowledge the ecological role of bullet mackerel and frigate mackerel as forage fish and to achieve the ecosystem management objectives in the Dolphin Wahoo FMP.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective June 9, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Electronic copies of Amendment 12, which includes a fishery impact statement and a regulatory impact review, may be obtained from the Southeast Regional Office website at 
                        <E T="03">https://www.fisheries.noaa.gov/action/amendment-12-add-bullet-mackerel-and-frigate-mackerel-ecosystem-component-species.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Nikhil Mehta, telephone: 727-824-5305, or email: 
                        <E T="03">nikhil.mehta@noaa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The dolphin and wahoo fishery of the Atlantic is managed under the FMP. The FMP was prepared by the Council and implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).</P>
                <P>On January 29, 2021, NMFS published a notice of availability for Amendment 12 and requested public comment (86 FR 7524). NMFS approved Amendment 12 on April 26, 2021. On March 2, 2021, NMFS published a proposed rule for Amendment 12 and requested public comment (86 FR 12166). The proposed rule and Amendment 12 outline the rationale for the actions contained in this final rule. A summary of the management measures described in Amendment 12 and implemented by this final rule is described below.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The Council manages dolphin and wahoo under the Dolphin Wahoo FMP in Federal waters off the Atlantic states from Maine south to the Florida Keys in the Atlantic. In the western North Atlantic, bullet mackerel are found from Cape Cod to the Gulf of Mexico, and frigate mackerel are found mostly from North Carolina to Florida. As described in Amendment 12, both bullet mackerel and frigate mackerel are found in the diets of dolphin and wahoo in the North Atlantic. In particular, wahoo has been demonstrated to have a strong dietary reliance on bullet mackerel and frigate mackerel, indicating that these mackerel species are the most dominant forage species observed in the diets of wahoo. Dolphin tend to have more diverse diets than wahoo and have a lower reliance on these mackerel species as prey. Additionally, bullet mackerel and frigate mackerel have been identified as important forage species for other offshore pelagic predatory species in the Atlantic such as blue marlin and yellowfin tuna. Bullet mackerel feed on a variety of prey, especially clupeoids (
                    <E T="03">i.e.,</E>
                     herrings and sardines), crustaceans, and squids. Frigate mackerel feed on a variety of fish, squid, and small crustaceans. Therefore, given their presence as a common forage fish and 
                    <PRTPAGE P="24743"/>
                    prey food source, bullet mackerel and frigate mackerel are an important component of the marine environment in the Atlantic. There is no stock assessment for dolphin, wahoo, bullet mackerel, or frigate mackerel. In Atlantic Federal waters, dolphin and wahoo are targeted both commercially and recreationally. Annual reported commercial and recreational landings of bullet mackerel and frigate mackerel are low along the entire Atlantic coastline.
                </P>
                <P>Regulations implemented under the Magnuson-Stevens Act define EC species as “stocks that a Council or the Secretary has determined do not require conservation and management, but desire to list in a FMP in order to achieve ecosystem management objectives” (50 CFR 600.305(d)(13)). National Standards (NS) General guidelines state that a Council should consider a non-exhaustive list of 10 factors when deciding whether additional stocks require Federal conservation and management (50 CFR 600.305(c)(1)). The EC designation for bullet mackerel and frigate mackerel was recommended to the Council by the Council's Scientific and Statistical Committee (SSC), their Dolphin Wahoo Advisory Panel (AP), and the Habitat Protection and Ecosystem-Based Management (Habitat) AP, and received extensive positive comments from the public during scoping of Amendment 12. The Dolphin Wahoo AP and Habitat AP members acknowledged that wahoo, in particular, target these mackerel species as prey. The AP members also stated that the Council should consider a conservative approach to ensure there are no major increases in the harvest of bullet mackerel and frigate mackerel in the foreseeable future as a result of any EC designation. This designation addresses the Council's growing emphasis on developing ecosystem management approaches to fisheries management and advancing ecosystem management objectives in the Dolphin Wahoo FMP.</P>
                <P>The extent to which the low landings of bullet mackerel and frigate mackerel occur within the dolphin and wahoo fishery is unknown; however, it is unlikely that these species are often harvested in conjunction with efforts to target dolphin and wahoo, especially in the commercial sector. Bullet and frigate mackerel have largely been landed commercially in the Mid-Atlantic region using gill net, pound net, float trap, and otter trawl gear, none of which are allowable gear types in the dolphin and wahoo fishery. Recreational landings of bullet and frigate mackerel have largely occurred in the South Atlantic Region, with some limited catches reported from the Mid-Atlantic Region. Furthermore, recreational fishermen have also noted that these species are used as bait for tuna and billfish, such as blue marlin. NMFS and the Council have determined that bullet mackerel and frigate mackerel are currently not in need of conservation and management, making them eligible for consideration as EC species. This eligibility determination was done after consideration of the provisions within the NS Guidelines and requirements of the Magnuson-Stevens Act. Furthermore, adding bullet mackerel and frigate mackerel to the Dolphin Wahoo FMP as EC species meets the FMP's ecosystem management objectives (50 CFR 600.305(c)(5) and 600.310(d)(1)).</P>
                <HD SOURCE="HD1">Management Measures Contained in This Final Rule</HD>
                <P>This final rule adds bullet mackerel and frigate mackerel to the Dolphin Wahoo FMP and designates them as EC species. This final rule adds no additional management measures to the Dolphin Wahoo FMP as a result of this EC species designation, either for bullet mackerel and frigate mackerel, or for dolphin and wahoo.</P>
                <P>The final rule is expected to result in potential indirect benefits such as increased awareness among the fishermen, fishing communities, data collecting agencies, and regulatory entities managing dolphin, wahoo, bullet mackerel, and frigate mackerel. If landings for these two mackerel species were to greatly increase in the future to unsustainable levels, fisheries managers could be made aware of the changing stock status before the stocks are depleted, which may have subsequent beneficial effects on populations of several economically important predatory fish species, including dolphin, wahoo, blue marlin, and yellowfin tuna.</P>
                <HD SOURCE="HD1">Comments and Responses</HD>
                <P>NMFS received 24 comments during the public comment period on the notice of availability and proposed rule for Amendment 12. Comment submissions were from the general public, sport-fishing associations, and non-governmental organizations. The majority of the comments were in support of adding bullet mackerel and frigate mackerel to the Dolphin Wahoo FMP as EC species. NMFS acknowledges the comments in favor of the action in the notice of availability and proposed rule and agrees with them. One comment was outside the scope of Amendment 12 and is not responded to in this final rule. Comments in opposition and that requested additional information about the action contained in the notice of availability and proposed rule are summarized below, along with NMFS' responses.</P>
                <P>
                    <E T="03">Comment 1:</E>
                     NMFS and the Council should consider more proactive methods of monitoring the conditions of bullet and frigate mackerel and collect more data to study abundance and population trends.
                </P>
                <P>
                    <E T="03">Response:</E>
                     NMFS agrees that more data would aid in obtaining a better understanding of abundance and population trends for bullet mackerel and frigate mackerel. However, these species are not directly targeted by commercial and recreational fishers in the Atlantic. Commercial landings of bullet mackerel and frigate mackerel have been variable, but typically are relatively low, averaging 4,395 lb (1,994 kg), round weight, annually over the past 20 years of available data (1999 through 2018), 1,569 lb, (712 kg), round weight, annually over the past 10 years (2009 through 2018), and 1,939 lb (880 kg), round weight, over the past 5 years (2014 through 2018). Recreational landings have been variable and sporadic, averaging 1,189 lb (539 kg), round weight, for bullet mackerel, and 3,569 lb (1,619 kg), round weight, for frigate mackerel annually over the past 20 years of available data (1999 through 2018).
                </P>
                <P>
                    In terms of data collection, vessels with Federal commercial dolphin wahoo permits already report all landings that are sold to a federally permitted dealer, including species that are not federally managed. Beginning January 4, 2020, the final rule for the South Atlantic for-hire electronic reporting program requires that federally permitted for-hire snapper-grouper, dolphin wahoo, and coastal migratory pelagic vessels in the Atlantic report all landings including species that are not subject to Federal management (85 FR 47917; August 7, 2020). The Marine Recreational Information Program captures information on all species caught by recreational fishers. Furthermore, North Carolina has introduced fish identification codes in its state trip ticket forms for these mackerel species since 2018. Public education and awareness of the EC designation may encourage fishers to report landings of these two mackerel species more than before, thereby providing more data. If landings for bullet mackerel and frigate mackerel were to increase in the future, further proactive and active measures within the Council's jurisdiction could be explored in a future amendment.
                    <PRTPAGE P="24744"/>
                </P>
                <P>
                    <E T="03">Comment 2:</E>
                     The proposed rule does not achieve the stated purpose of Amendment 12 to provide awareness regarding bullet mackerel and frigate mackerel, and is a waste of taxpayer dollars. If there are no benefits for the dolphin and wahoo fishery from this action, then it would make sense that there should be no cost, or at least minimal cost, for this proposed rule. However, NMFS calculates an estimated cost of $34,499.00 for an action that will have no benefits.
                </P>
                <P>
                    <E T="03">Response:</E>
                     NMFS disagrees that there are no benefits to the action. The purpose of Amendment 12 and its rulemaking is to acknowledge the ecological role of bullet mackerel and frigate mackerel as forage fish by adding them to the Dolphin Wahoo FMP as EC species. Peer-reviewed scientific studies have found scombrids such as bullet mackerel and frigate mackerel are the dominant prey (43.7 percent frequency of occurrence and 41.7 percent by mass) in wahoo diets, showing that a wahoo have a high reliance on scombrids and suggesting that wahoo specialize on this prey group, just as they do in other regions throughout their range. Bullet and frigate mackerel are also important in the diets of dolphin, blue marlin, and yellowfin tuna. The action in Amendment 12 brings awareness among the fishers, fishing communities, data collecting agencies, and regulatory entities managing dolphin, wahoo, bullet mackerel, and frigate mackerel. As noted in the response to 
                    <E T="03">Comment 1,</E>
                     there is very little interest among fishers in these two mackerel species at present, but, if they were to be targeted in the future, adding them in the FMP as EC species will aid in considering other measures in a future action, if warranted. Indeed, the Mid-Atlantic Fishery Management Council has discussed plans to establish possession limits for bullet mackerel and frigate mackerel. In the western Atlantic, bullet mackerel are found from Cape Cod to the Gulf of Mexico and feed on a variety of prey, especially clupeoids (
                    <E T="03">i.e.,</E>
                     herrings and sardines), crustaceans, and squids. Frigate mackerel are mostly found from North Carolina to Florida and feed on a variety of fish, squids, and small crustaceans. By acknowledging the role of bullet mackerel and frigate mackerel in the ecosystem as forage fish, implementation of Amendment 12 will increase ecosystem-wide awareness. NMFS and the Council determined that bullet mackerel and frigate mackerel are currently not in need of conservation and management, and, as such, are eligible for consideration as EC species under provisions found within the NS Guidelines (50 CFR 600.305(c)(1)), in compliance with the requirements of the Magnuson-Stevens Act and other applicable laws.
                </P>
                <P>
                    There are no expected notable effects for the dolphin and wahoo fishery from this action, because bullet mackerel and frigate mackerel are not targeted in this fishery, and are not caught by the gear authorized in the dolphin and wahoo fishery. Landings for these species have been very low over the last 20 years (see response to 
                    <E T="03">Comment 1</E>
                    ). Bullet mackerel and frigate mackerel have largely been landed commercially in the Mid-Atlantic region using gill net, pound net, float trap, and otter trawl gear, none of which are allowable gear types in the dolphin and wahoo fishery. Recreational catches of bullet mackerel and frigate mackerel have largely occurred in the South Atlantic Region, with some limited catches reported from the Mid-Atlantic Region. Also, recreational fishers have noted that these species are used as bait.
                </P>
                <P>NMFS conducted an economic analysis for Amendment 12 to comply with Executive Order (E.O.) 12866. The analysis estimated costs resulting from this action in the amount of $34,499.00 (2018 dollars), which are considered minimal. This estimate represents the administrative costs to the Council and NMFS associated with Amendment 12 and this rulemaking as there are no direct costs to the private sector.</P>
                <P>In addition, while this final rule is not expected to result in any direct benefits, it is expected to result in indirect benefits. Consistent with Circular A-4 from the Office of Management and Budget, which provides guidance on how to conduct analyses to comply with E.O. 12866, the analysis should consider favorable effects from the rule that are typically unrelated or secondary to the purpose of the rulemaking. If it is not feasible to monetize or quantify such effects, they should at least be considered qualitatively. As discussed in Amendment 12, indirect economic benefits are expected to arise from designating bullet and frigate mackerel as EC species by enhancing public education and awareness of these species, which in turn is expected to improve data reporting and monitoring of landings. If landings for the two mackerel species greatly increase in the future to unsustainable levels, fisheries managers could be made aware before the stocks are depleted. The ability to preclude such stock depletions is expected to indirectly benefit fisheries for several economically important predatory fish species in the future, including dolphin and wahoo. These indirect benefits were determined to outweigh the minimal administrative costs that have already been largely incurred by the Council and NMFS, and therefore this regulatory action is expected to increase net benefits to the Nation.</P>
                <P>
                    <E T="03">Comment 3:</E>
                     Lower landing rates for both bullet mackerel and frigate mackerel are not just because of less interest in fishing for these species. Rather, the population of these species has decreased drastically.
                </P>
                <P>
                    <E T="03">Response:</E>
                     NMFS disagrees. There is no stock assessment available for bullet mackerel or frigate mackerel. Therefore, it is not possible to determine if the populations have decreased or increased in a manner that would negatively or positively affect their stock status. As mentioned in responses to 
                    <E T="03">Comments 1</E>
                     and 
                    <E T="03">2,</E>
                     these species are typically caught incidentally to other species and are not the targets of a directed fishery, which is consistent with the low levels of landings. Adding bullet mackerel and frigate mackerel to the Dolphin Wahoo FMP does meet ecosystem management objectives (50 CFR 600.305(d)(13)). The EC designation recognizes the ecosystem role of these mackerel species as prey for many economically important species such as wahoo and other billfish. Increased awareness of the importance of these species could aid in more data reporting and collection, which would help towards any possible future stock assessment, if necessary.
                </P>
                <HD SOURCE="HD1">Classification</HD>
                <P>Pursuant to section 304(b)(3) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with Amendment 12, the Dolphin Wahoo FMP, other provisions of the Magnuson-Stevens Act, and other applicable laws.</P>
                <P>This final rule has been determined to be not significant for purposes of Executive Order 12866.</P>
                <P>
                    The Magnuson-Stevens Act provides the legal basis for this final rule. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting and record-keeping requirements are introduced by this final rule. This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995. A description of this final rule, why it is being considered, and the purposes of this final rule are contained in the preamble and in the 
                    <E T="02">SUMMARY</E>
                     section of this final rule. The objective of this final rule is to acknowledge the ecological role of bullet mackerel and frigate mackerel as forage fish in general and specifically as prey for wahoo.
                    <PRTPAGE P="24745"/>
                </P>
                <P>
                    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) during the proposed rule stage that this rule would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. NMFS did not receive any comments from SBA's Office of Advocacy or the public regarding the certification in the proposed rule. NMFS received one public comment on the economic analysis in Amendment 12; see 
                    <E T="03">Comment #2</E>
                     in the preamble. No changes to this final rule were made in response to public comments. As a result, a final regulatory flexibility analysis was not required and none was prepared.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 50 CFR Part 622</HD>
                    <P>Atlantic, Dolphin, Ecosystem species, Fisheries, Fishing, Wahoo.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: May 5, 2021.  </DATED>
                    <NAME>Samuel D. Rauch, III,</NAME>
                    <TITLE>Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.</TITLE>
                </SIG>
                <P>For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 622—FISHERIES OF THE CARIBBEAN, GULF OF MEXICO, AND SOUTH ATLANTIC</HD>
                </PART>
                <REGTEXT TITLE="50" PART="622">
                    <AMDPAR>1. The authority citation for part 622 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             16 U.S.C. 1801 
                            <E T="03">et seq.</E>
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="50" PART="622">
                    <AMDPAR>2. Add Table 6 to appendix A to part 622 to read as follows:</AMDPAR>
                    <HD SOURCE="HD1">Appendix A to Part 622—Species Tables</HD>
                    <STARS/>
                    <EXTRACT>
                        <HD SOURCE="HD1">Table 6 of Appendix A to Part 622—Atlantic Dolphin and Wahoo</HD>
                        <FP SOURCE="FP-1">
                            Dolphin, 
                            <E T="03">Coryphaena equiselis or Coryphaena hippurus</E>
                             Wahoo, 
                            <E T="03">Acanthocybium solandri</E>
                        </FP>
                        <P>The following species are designated as ecosystem component species:</P>
                        <FP SOURCE="FP-1">
                            Bullet mackerel, 
                            <E T="03">Auxis rochei</E>
                        </FP>
                        <FP SOURCE="FP-1">
                            Frigate mackerel, 
                            <E T="03">Auxis thazard</E>
                        </FP>
                    </EXTRACT>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09851 Filed 5-7-21; 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 648</CFR>
                <DEPDOC>[Docket No. 200325-0088; RTID 0648-XB071]</DEPDOC>
                <SUBJECT>Fisheries of the Northeastern United States; Atlantic Sea Scallop Fishery; 2021 Closure of the Northern Gulf of Maine Scallop Management Area to the Limited Access General Category Fishery</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Temporary rule; closure.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS announces the closure of the Northern Gulf of Maine Scallop Management Area for the remainder of the 2021 fishing year for Limited Access General Category vessels. Regulations require this action once NMFS projects that 100 percent of the Limited Access General Category total allowable catch for the Northern Gulf of Maine Scallop Management Area will be harvested. This action is intended to prevent the overharvest of the 2021 total allowable catch allocated to the Limited Access General Category Fishery.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective 0001 hr local time, May 6, 2021, through March 31, 2022.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Louis Forristall, Fishery Management Specialist, (978) 281-9321.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The regulations governing fishing activity in the Northern Gulf of Maine (NGOM) Scallop Management Area are located in 50 CFR 648.54 and 648.62. These regulations authorize vessels issued a valid Federal scallop permit to fish in the NGOM Scallop Management Area under specific conditions, including a default total allowable catch (TAC) of 167,500 lb (75,976 kg) for the Limited Access General Category (LAGC) fleet for the 2021 fishing year, and a State Waters Exemption Program for the State of Maine and Commonwealth of Massachusetts. Section 648.62(b)(2) requires the NGOM Scallop Management Area to be closed to scallop vessels issued Federal LAGC scallop permits, except as provided below, for the remainder of the fishing year once the NMFS Greater Atlantic Regional Administrator determines that 100 percent of the LAGC TAC for the fishing year is projected to be harvested. Any vessel that holds a Federal NGOM (LAGC B) or Individual Fishing Quota (IFQ) (LAGC A) permit may continue to fish in the Maine or Massachusetts state waters portion of the NGOM Scallop Management Area under the State Waters Exemption Program found in § 648.54 provided it has a valid Maine or Massachusetts state scallop permit and fishes only in that state's respective waters.</P>
                <P>Based on trip declarations by federally permitted LAGC scallop vessels fishing in the NGOM Scallop Management Area and analysis of fishing effort, we project that the 2021 LAGC TAC will be harvested as of May 6, 2021. Therefore, in accordance with § 648.62(b)(2), the NGOM Scallop Management Area is closed to all federally permitted LAGC scallop vessels as of May 6, 2021. As of this date, no vessel issued a Federal LAGC scallop permit may fish for, possess, or land scallops in or from the NGOM Scallop Management Area after 0001 local time, May 6, 2021, unless the vessel is fishing exclusively in state waters and is participating in an approved state waters exemption program as specified in § 648.54. Any federally permitted LAGC scallop vessel that has declared into the NGOM Scallop Management Area, complied with all trip notification and observer requirements, and crossed the vessel monitoring system demarcation line on the way to the area before 0001, May 6, 2021, may complete its trip and land scallops. This closure is in effect until the end of the 2021 scallop fishing year, through March 31, 2022. This closure does not apply to the Limited Access (LA) scallop fleet, which was allocated a separate TAC of 97,500 lb (44,225 kg) for the 2021 fishing year under Framework Adjustment 32 to the Atlantic Sea Scallop Fishery Management Plan. Vessels that are participating in the 2021 scallop Research Set-Aside Program and have been issued letters of authorization to conduct compensation fishing activities will harvest the 2021 LA TAC.</P>
                <HD SOURCE="HD1">Classification</HD>
                <P>This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.</P>
                <P>
                    The Assistant Administrator for fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be contrary to the public interest and impracticable. NMFS also finds, pursuant to 5 U.S.C. 553(d)(3), good cause to waive the 30-day delayed effectiveness period for the reasons noted below. The NGOM Scallop Management Area opened for the 2021 
                    <PRTPAGE P="24746"/>
                    fishing year on April 1, 2021. The regulations at § 648.60(b)(2) require this closure to ensure that federally permitted scallop vessels do not harvest more than the allocated LAGC TAC for the NGOM Scallop Management Area. NMFS can only make projections for the NGOM closure date as trips into the area occur on a real-time basis and as activity trends appear. As a result, NMFS can typically make an accurate projection only shortly before the TAC is harvested. The rapid harvest rate that has occurred in the last 2 weeks makes it more difficult to project a closure well in advance. To allow federally permitted LAGC scallop vessels to continue taking trips in the NGOM Scallop Management Area during the period necessary to publish and receive comments on a proposed rule would result in vessels harvesting more than the 2021 LAGC TAC for the NGOM Scallop Management Area. This would result in excessive fishing effort in the area thereby undermining conservation objectives of the Atlantic Sea Scallop Fishery Management Plan and requiring more restrictive future management measures to make up for the excessive harvest. Also, the public had prior notice and full opportunity to comment on this closure process when we put the final NGOM management provisions in place for the 2021 fishing year on March 31, 2020 (85 FR 17754).
                </P>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        16 U.S.C. 1801 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <NAME>Jennifer M. Wallace,</NAME>
                    <TITLE>Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09869 Filed 5-5-21; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 679</CFR>
                <DEPDOC>[Docket No. 210504-0098]</DEPDOC>
                <RIN>RIN 0648-BK18</RIN>
                <SUBJECT>Fisheries of the Exclusive Economic Zone Off Alaska; Removing the Processing Restrictions on Incidentally Caught Squid and Sculpin Species in the Gulf of Alaska and Bering Sea and Aleutian Islands Groundfish Fisheries</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS issues regulations to remove the regulatory restriction that limits processing of squids and sculpins to fishmeal only. This final rule is necessary to allow the processing and sale of squids and sculpins as products other than fishmeal and thereby to help prevent waste of the incidental catch of these ecosystem component (EC) species. This final rule is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the Fishery Management Plans (FMP) for Groundfish of the Gulf of Alaska (GOA) and Bering Sea and Aleutian Islands Management Area (BSAI) (Groundfish FMPs), and other applicable laws.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective June 9, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Electronic copies of the Regulatory Impact Review (referred to as the “Analysis”) and the National Environmental Policy Act Categorical Exclusion prepared for this final rule may be obtained from 
                        <E T="03">www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Megan Mackey, 907-586-7228.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Authority for Action</HD>
                <P>
                    NMFS manages the groundfish fisheries in the exclusive economic zone (EEZ) of the BSAI and GOA under the Groundfish FMPs. The North Pacific Fishery Management Council (Council) prepared the Groundfish FMPs under the authority of the Magnuson-Stevens Act, 16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                     Regulations governing U.S. fisheries and implementing the Groundfish FMPs appear at 50 CFR parts 600 and 679.
                </P>
                <P>
                    The proposed rule to implement this action was published in the 
                    <E T="04">Federal Register</E>
                     on February 26, 2021, with comments invited through March 29, 2021 (86 FR 11716). NMFS received 5 comment letters containing a total of 3 unique comments. The comments are summarized and responded to under the heading Comments and Responses below.
                </P>
                <P>A detailed review of the provisions and rationale for this action is provided in the preamble to the proposed rule (86 FR 11716, February 26, 2021) and is briefly summarized in this final rule.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>Squids and sculpins are defined in the EC category of the Groundfish FMPs. Directed fishing for EC species is prohibited. Incidental catch of squid species is retained in some groundfish fisheries and often utilized to prevent waste. Typically, sculpins are not retained but can be in some circumstances.</P>
                <P>The Council's 2017 and 2019 actions to reclassify squids and sculpins, respectively, into the EC category of the Groundfish FMPs were based on the best available scientific information and were consistent with the National Standard (NS) guidelines. The Federal rulemakings to implement the Council's actions prohibited the use or sale of incidentally caught squids and sculpins unless processed into fishmeal, in accordance with the regulations governing other EC species (85 FR 41427, July 10, 2020 (sculpin); 83 FR 31460, July 6, 2018 (squid)). The purpose of this action is to provide flexibility for the use of incidentally caught squids and sculpins, thereby reducing the waste of these EC species, and aligning the regulations with the long-standing use of incidentally caught squid species as bait.</P>
                <P>The following sections of this preamble provide:</P>
                <P>• A brief history of the restriction on processing and sale of squids and sculpins,</P>
                <P>• The expected effects of and need for this action, and</P>
                <P>• A description of the regulatory change made by this final rule.</P>
                <HD SOURCE="HD1">Brief History of the Restriction on Processing and Sale of Squids and Sculpins</HD>
                <P>EC species are stocks that a fishery management council (council) or the Secretary of Commerce (Secretary) has determined do not require conservation and management, but desire to list in an FMP in order to achieve ecosystem management objectives (50 CFR 600.305(c)(5) and (d)(13) and 50 CFR 600.310(d)(1)). Retention and personal use of some EC species in the Groundfish FMPs (forage fish, grenadiers, squids, and sculpins) is allowed up to the applicable maximum retainable amount (MRA), which is the proportion or percentage of retained catch of a species closed for directed fishing (incidental catch species) to the retained catch of a species open for directed fishing (basis species) (50 CFR 679.20(e) and (i)). Current Federal regulations at 50 CFR 679.20(i)(4) and (5) prohibit the processing, barter, trade, and sale of EC species in Alaska (forage fish, grenadiers, squids, and sculpins) unless they are processed as fishmeal.</P>
                <P>
                    Amendment 96 to the BSAI FMP and Amendment 87 to the GOA FMP (Amendments 96/87) (75 FR 61639, October 6, 2010) established the EC category and designated prohibited species (defined in Table 2b to 50 CFR part 679, to include salmon, steelhead 
                    <PRTPAGE P="24747"/>
                    trout, crab, halibut, and herring) and forage fish (defined in Table 2c to 50 CFR part 679 and § 679.20(i)) as EC species in both the Groundfish FMPs.
                </P>
                <P>When Amendments 96/87 were recommended by the Council in 2010, the Council's stated intention was that prohibited species and forage fish would be in the new EC category. Because the retention, processing, and sale of prohibited species and forage fish was not permitted before their placement in the EC category, those restrictions remained in place and unchanged under Amendments 96/87. The Council did not indicate whether it intended that species added to the EC category at a later date would be subject to those same restrictions.</P>
                <P>When the Council took action to recommend reclassifying squids in the EC category in 2017, harvesters and processors expected that incidentally caught squids in the groundfish fisheries could be processed and sold as bait, consistent with long-standing and common practice. Similarly, when the Council recommended reclassifying sculpins in the EC category in 2019, there was some interest in exploring food fish markets for incidentally caught sculpins, which have rarely been retained or processed. However, once squids and sculpins were reclassified in the EC category, existing Federal regulations at 50 CFR 679.20(i) applied to all EC species and prohibited the processing, barter, trade, and sale of squids and sculpins as anything other than fishmeal.</P>
                <P>In October 2019, the Council initiated an analysis to reconsider the processing and sale restrictions on squids and sculpins in the EC category. No other species in the EC category were considered in this analysis. As a result, processing and sale restrictions will remain in place for prohibited species, forage fish, and grenadiers under this action.</P>
                <HD SOURCE="HD1">The Expected Effects of and Need for This Action</HD>
                <P>Pursuant to this action, NMFS continues to manage squids and sculpins as EC species in the Groundfish FMPs. Directed fishing of squids and sculpins continues to be prohibited, and retention of squids and sculpins up to the MRA of 20 percent continues to be permitted. Recordkeeping and reporting requirements are maintained. The only change to current regulations is to remove the processing restrictions limiting processing and sale of squids and sculpins to fishmeal and include new regulations on allowable fish products for squids and sculpins. Specifically, the regulations provide that retained catch of squids and sculpins not exceeding the MRA may be sold to a processor or processed into any product form—including (but not limited to) fishmeal, bait, and whole fish/food fish—for sale, barter, or trade. All other regulations pertaining to EC species remain in place.</P>
                <P>The Council determined, and NMFS agrees, that this action will provide groundfish harvesters and processors with additional flexibility to conduct their business in an efficient manner by providing them with more options for the processing and sale of incidentally caught squids and sculpins up to the MRA, and will help reduce waste of these incidentally caught species.</P>
                <HD SOURCE="HD1">Final Rule</HD>
                <P>This final rule removes the regulatory restriction that limits processing of incidentally caught squids and sculpins to fishmeal only and allows retained catch of squids and sculpins not exceeding the MRA to be sold to a processor or to be processed into any product form. This final rule is necessary to allow the processing and sale of squids and sculpins as products other than fishmeal and to help prevent waste of the incidental catch of these species. To make that change, this final rule revises language in 50 CFR 679.20(i).</P>
                <HD SOURCE="HD1">Comments and Responses</HD>
                <P>NMFS received 5 comment letters containing a total of 3 unique comments.</P>
                <P>
                    <E T="03">Comment 1:</E>
                     Three commenters expressed support for this action.
                </P>
                <P>
                    <E T="03">Response:</E>
                     NMFS acknowledges these comments.
                </P>
                <P>
                    <E T="03">Comment 2:</E>
                     One commenter expressed support while also noting a concern that this action could encourage the fishing industry to push the limits of the MRA for squids and sculpins to obtain profit.
                </P>
                <P>
                    <E T="03">Response:</E>
                     Based on the Analysis, there is limited profit reason to expect the MRA to be pushed to its limits given that squids are low value and there is no current market for sculpins. The primary use of incidentally caught squids would be bait, however squids do not represent a significant portion of production for any processing community in the BSAI or GOA. In addition, the existing MRA for squids and sculpins of 20 percent is an appropriate and effective way to restrict retention while still allowing flexibility in operations. The MRA of 20 percent for squids and sculpins has been in place even before these species were moved to the EC category when there were no processing restrictions. At that time the instances of exceeding the 20 percent MRA were very rare. Finally, catch monitoring is in place to monitor whether the MRA is exceeded. If there are overages, that would be a regulatory violation that could result in enforcement action.
                </P>
                <P>
                    <E T="03">Comment 3:</E>
                     One commenter stated that the classification of squids and sculpins as EC species is illegal and asserted that removing processing restrictions on squids and sculpins is inconsistent with the Magnuson-Stevens Act and NMFS's regulatory guidance. Specifically, the commenter stated that EC species do not have conservation and management measures and that NMFS is not able to prevent overfishing consistent with NS 1 without such measures. The commenter also stated that classifying species as EC species does not address NS 9's requirements to reduce bycatch to the extent practicable. Finally, the commenter asserts that the classification of squids and sculpins in the EC category is not consistent with the NS guidelines, and that the EC category is not authorized by, or consistent with, the Magnuson-Stevens Act.
                </P>
                <P>
                    <E T="03">Response:</E>
                     This general issue of the classification of EC species is outside the scope of this narrow rulemaking. However, we note that, when NMFS revised the NS guidelines in 2016 (81 FR 71858, October 18, 2016), NMFS included a new regulatory section addressing stocks in need of conservation and management (50 CFR 600.305(c)). The concept of EC species had been introduced in an even earlier 2009 rulemaking to revise the NS guidelines, and the 2016 rule was clear that it intended to provide further guidance on the question of what stocks require conservation and management without changing the previous 2009 guidance on the optional usage of EC species. NMFS addressed this in the 2016 final rule, and also responded to comments regarding whether 50 CFR 600.305(c) was consistent with the Magnuson-Stevens Act and its definition of “conservation and management” at 16 U.S.C. 1802(5) (81 FR 71858, see Comments and Responses Five, Seven, and Eleven). Those responses and the explanations regarding the 2009 and 2016 rulemakings are not repeated here.
                </P>
                <P>
                    While the commenter also argues that the classification of squids and sculpins as EC species was not consistent with the NS and NS guidelines, that issue is likewise outside the scope of this specific rulemaking. The classification of squids and sculpins as EC species occurred in previous rulemakings (85 
                    <PRTPAGE P="24748"/>
                    FR 41427, July 10, 2020 (sculpin); 83 FR 31460, July 6, 2018 (squid)). A detailed review of the provisions and rationale for those actions is provided in their accompanying rulemakings. This action does not change the EC status of squids and sculpins, MRAs for squids and sculpins, or recordkeeping and reporting requirements. The only change to current regulations is to remove the processing restrictions limiting processing and sale of squids and sculpins to fishmeal, and include new regulations on allowable fish products for squids and sculpins. As noted in Section 4.6 of the Analysis, this action would not be expected to increase the amount of squids and sculpins caught incidentally, as this action addresses only whether that incidental harvest could be processed and sold.
                </P>
                <P>In the prior actions classifying squids and sculpins as EC species, the Council and NMFS considered the Magnuson-Stevens Act's requirements, including the NS, and the NS guidelines. Regarding the EC status of squids and sculpins, if conservation and management is determined to be not necessary for a species, a council may recommend moving that species to the EC category of the FMP and adopting management measures for that species. Any recommendation by a council as to whether conservation and management is required for a species needs to be consistent with the NS of the Magnuson-Stevens Act. The NS general guidelines at 50 CFR 600.305(c) lay out a non-exhaustive list of 10 factors a council should consider when deciding whether stocks require conservation and management. The Council and NMFS considered these 10 factors for both squids and sculpins and determined in those prior actions that, because there is no directed fishing for these species and because there are few economic or ecological benefits to be gained by managing squids and sculpins as target stocks, moving these species to the EC category of the Groundfish FMPs was consistent with 50 CFR 600.305(c) and was consistent with the Magnuson-Stevens Act's NS. Both analyses for moving squids and sculpins to the EC category indicated that neither species was experiencing overfishing, and, in the absence of a directed fishery, squids and sculpins are very unlikely to become overfished. The 20 percent MRA for both species, which remains in place as it was before both species were moved to the EC, along with the retention of recordkeeping and reporting requirements, will ensure that there is no overfishing in accordance with NS 1.</P>
                <P>In addition, the Council and NMFS considered measures to minimize incidental catch and mortality of EC species, consistent with NS 9, and to protect their role in the ecosystem, consistent with 50 CFR 600.305(c)(5). EC species do not require specification of biological reference points, but will be monitored as new, pertinent scientific information becomes available to determine changes in their status or their vulnerability to groundfish fisheries. By prohibiting directed fishing, maintaining the MRA, and maintaining recordkeeping and reporting requirements, the Council and NMFS recognized in those prior actions that the status quo is effectively being maintained while precluding any significant increase in bycatch. Retention of recordkeeping and reporting requirements provides information necessary should bycatch increase to levels such that conservation and management become necessary.</P>
                <P>The Council has multiple tools to manage incidental catch, including maintaining a MRA to meet Council objectives. Contrary to the commenter's assertion that EC species do not have conservation and management measures, there are management measures in place for all EC species, consistent with 50 CFR 600.305(c)(5), and EC species continue to be listed and managed under the Groundfish FMPs. This includes a prohibition on directed fishing, a limit on retention (the 20 percent MRA for squids and sculpins), and recordkeeping and reporting requirements to track retention of EC species. As stated above, this rulemaking does not change any of these management measures for squids and sculpins (or any other EC species).</P>
                <P>With regard to this specific action (removing processing restrictions on squids and sculpins), these species would continue to be managed as EC species in the Groundfish FMPs. Targeting of squids and sculpins would continue to be prohibited, but retention of squids and sculpins up to the MRA of 20 percent would be permitted. Recordkeeping and reporting requirements would be maintained. The purpose of this action is to help prevent waste of the incidental catch of these species up to the 20 percent MRA and to align regulations with the longstanding use of squid bycatch as bait. Preventing waste of incidentally caught species increases net benefits to the nation. In sum, as Section 5 of the Analysis for this action indicates, this action is consistent with the Magnuson-Stevens Act, the NS, and NMFS regulatory guidance. Specifically, the removal of processing restrictions on squids and sculpins mitigates the waste of these incidentally caught species, while management measures remain in place as tools to minimize and monitor bycatch of these species, to protect the roles of these species in the ecosystem, and to determine if later changes are necessary to their EC status.</P>
                <HD SOURCE="HD1">Changes From the Proposed Rule</HD>
                <P>No changes were made from the proposed rule.</P>
                <HD SOURCE="HD1">Classification</HD>
                <P>Pursuant to section 304(b)(3) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the Council's regulatory amendment, the Groundfish FMPs, other provisions of the Magnuson-Stevens Act, and other applicable laws.</P>
                <P>This final rule has been determined to be not significant for the purposes of Executive Order 12866.</P>
                <HD SOURCE="HD2">Certification Under the Regulatory Flexibility Act</HD>
                <P>The Chief Counsel for Regulation for the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.</P>
                <P>This final rule contains no information collection requirements under the</P>
                <P>Paperwork Reduction Act of 1995.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 50 CFR Part 679</HD>
                    <P>Alaska, Fisheries, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <NAME>Samuel D. Rauch, III</NAME>
                    <TITLE>Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.</TITLE>
                </SIG>
                <P>For reasons set out in the preamble, NMFS amends 50 CFR part 679 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 679—FISHERIES OF THE EXCLUSIVE ECONOMIC ZONE OFF ALASKA</HD>
                </PART>
                <REGTEXT TITLE="50" PART="679">
                    <AMDPAR>1. The authority citation for part 679 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             16 U.S.C. 773 
                            <E T="03">et seq.;</E>
                             1801 
                            <E T="03">et seq.;</E>
                             3631 
                            <E T="03">et seq.;</E>
                             Pub. L. 108-447; Pub. L. 111-281.
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="50" PART="679">
                    <PRTPAGE P="24749"/>
                    <AMDPAR>2. In § 679.20, revise paragraph (i) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 679.20</SECTNO>
                        <SUBJECT> General limitations.</SUBJECT>
                        <STARS/>
                        <P>
                            (i) 
                            <E T="03">Forage fish, grenadiers, squids, and sculpins</E>
                            —(1) 
                            <E T="03">Definition.</E>
                             See Table 2c to this part.
                        </P>
                        <P>
                            (2) 
                            <E T="03">Applicability.</E>
                             The provisions of this paragraph (i) apply to all vessels fishing for groundfish in the BSAI or GOA, and to all vessels processing groundfish harvested in the BSAI or GOA.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Closure to directed fishing.</E>
                             Directed fishing for forage fish, grenadiers, squids, and sculpins is prohibited at all times in the BSAI and GOA.
                        </P>
                        <P>
                            (4) 
                            <E T="03">Limits on sale, barter, trade, and processing of forage fish and grenadiers.</E>
                             The sale, barter, trade, or processing of forage fish and grenadiers is prohibited, except as provided in paragraph (i)(5) of this section.
                        </P>
                        <P>
                            (5) 
                            <E T="03">Allowable fishmeal production of forage fish and grenadiers.</E>
                             Retained catch of forage fish or grenadiers not exceeding the maximum retainable amount may be processed into fishmeal for sale, barter, or trade.
                        </P>
                        <P>
                            (6) 
                            <E T="03">Allowable fish products for squids and sculpins.</E>
                             Retained catch of squids and sculpins not exceeding the maximum retainable amount may be sold to a processor or processed into any product form, including (but not limited to) fishmeal, bait, and whole fish/food fish, for sale, barter, or trade.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09845 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
    </RULES>
    <VOL>86</VOL>
    <NO>88</NO>
    <DATE>Monday, May 10, 2021</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <PRORULES>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="24750"/>
                <AGENCY TYPE="F">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>U.S. Citizenship and Immigration Services</SUBAGY>
                <CFR>8 CFR Parts 1, 103, 204, 207, 208, 209, 210, 212, 214, 215, 216, 235, 236, 240, 244, 245, 245a, 264, 287, 316, 333 and 335</CFR>
                <DEPDOC>[CIS No. 2644-19; DHS Docket No. USCIS-2019-0007]</DEPDOC>
                <RIN>RIN 1615-AC14</RIN>
                <SUBJECT>Collection and Use of Biometrics by U.S. Citizenship and Immigration Services; Withdrawal</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Citizenship and Immigration Services, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule; withdrawal.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of Homeland Security (DHS) is withdrawing a proposed rule that published on September 11, 2020. The notice of proposed rulemaking proposed to amend DHS regulations concerning the use and collection of biometrics in the enforcement and administration of immigration laws by U.S. Citizenship and Immigration Services, U.S. Customs and Border Protection, and U.S. Immigration and Customs Enforcement.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>DHS withdraws the proposed rule as of May 10, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The docket for this withdrawn proposed rule is available at 
                        <E T="03">http://www.regulations.gov.</E>
                         Please search for docket number USCIS-2019-0007.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Steven Kvortek, Security and Public Safety Division Acting Chief, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, DHS, 5900 Capital Gateway Drive, Camp Springs, MD 20746; telephone 240-721-3000 (this is not a toll-free number). Individuals with hearing or speech impairments may access the telephone numbers above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627 (TTY/TDD).</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On September 11, 2020, DHS published a notice of proposed rulemaking (NPRM or proposed rule) titled “Collection and Use of Biometrics by U.S. Citizenship and Immigration Services” in the 
                    <E T="04">Federal Register</E>
                     (85 FR 56338). This rule proposed to amend DHS regulations concerning the use and collection of biometrics in the enforcement and administration of immigration laws by U.S. Citizenship and Immigration Services (USCIS), U.S. Customs and Border Protection (CBP), and U.S. Immigration and Customs Enforcement (ICE). DHS is withdrawing the September 11, 2020, NPRM for a number of reasons.
                </P>
                <P>In response to the NPRM, DHS received 5,147 comments during the 30-day public comment period, and 192 comments on the rule's information collection requirements before the comment period ended. Commenters consisted of individuals, advocacy groups, legal service providers, professional associations, State or local governments, and social organizations. The majority of commenters expressed general opposition to the rule, mentioning immigration policy concerns, general privacy concerns, and economic concerns (both to individuals and communities). Many commenters wrote that the rule was unnecessary, offensive, an invasion of privacy, would infringe on freedoms, and violate the respect, privacy rights, and civil liberties of U.S. citizens, legal immigrants, noncitizens, victims of domestic violence, other vulnerable parties, and children. Many commenters stated that the rule was overly broad, highly invasive, and would impose excessive monetary costs on applicants and result in administrative delays in adjudicating immigration benefit requests that are already subjected to backlogs and long waits.</P>
                <P>
                    Executive Order 14012, “Restoring Faith in Our Legal Immigration Systems and Strengthening Integration and Inclusion Efforts for New Americans,” in section 3(a)(i), instructs the Secretary of Homeland Security to identify barriers that impede access to immigration benefits. 86 FR 8277, (Feb. 5, 2021) (“E.O. 14012”). Having reviewed the public comments received in response to the NPRM in light of Executive Order 14012, DHS has decided to withdraw the NPRM. The proposed rule was intended to provide DHS with the flexibility to change its biometrics collection practices and policies to ensure that necessary adjustments can be made to meet emerging needs, enhance the use of biometrics beyond background checks and document production to include identity verification and management in the immigration lifecycle, enhance vetting to lessen the dependence on paper documents to prove identity and familial relationships, preclude imposters, and improve the consistency in biometrics terminology within DHS. DHS still supports the goals of the NPRM to have flexibility in its immigration benefit administration biometrics collection practices and policies and enhance the use of biometrics for identity verification and management but not in a way that conflicts with Executive Order 14012. DHS, USCIS, CBP, and ICE remain committed to national security, identity management, fraud prevention and program integrity, and will continue to require the submission of biometrics where appropriate. 
                    <E T="03">See, e.g.,</E>
                     INA section 333 and 335 (requiring submission of photographs and a personal investigation before an application for naturalization may be approved); INA section 264(a) (directing the collection of fingerprints for the purpose of registering aliens); 8 U.S.C. 1732(b)(1) (requiring that alien visas and other travel and entry documents use biometric identifiers); 8 U.S.C. 1365a-1365b (requiring creation of a biometric data system for national security purposes). DHS may engage in a future rulemaking to enhance our biometrics requirements while not hindering access to the immigration system and protecting privacy and civil liberties.
                </P>
                <P>
                    However, commenters suggested that the breadth of the biometrics submission requirements that were proposed in the proposed rule are more than what is necessary to meet the requirements of the adjudication of immigration and naturalization benefits. DHS has considered the commenters concerns, and believe some of them may be justified and require additional deliberation. Accordingly, DHS is withdrawing the NPRM and will analyze the entirety of the NPRM in the context of the directive in E.O. 14012 and what changes may be appropriate and consistent with DHS's needs, 
                    <PRTPAGE P="24751"/>
                    policies, and applicable law. In the meantime, DHS' current biometrics collection practices and policies are sufficient to meet the statutory and regulatory requirements for document production and the vetting of any applicant, petitioner, sponsor, beneficiary, or individual filing or associated with an immigration benefit or request, including United States citizens.
                </P>
                <HD SOURCE="HD1">Authority</HD>
                <P>As stated in the NPRM, DHS has general and specific statutory authority to collect or require submission of biometrics from applicants, co-applicants, petitioners requestors, derivatives, beneficiaries and others directly associated with a request for immigration benefits; and for purposes incident to apprehending, arresting, processing, and care and custody of aliens. 85 FR 56347. DHS is withdrawing the NPRM using those same authorities.</P>
                <SIG>
                    <NAME>Alejandro N. Mayorkas,</NAME>
                    <TITLE>Secretary, U.S. Department of Homeland Security.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09671 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9111-97-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>U.S. Citizenship and Immigration Services</SUBAGY>
                <CFR>8 CFR Parts 106, 241, and 274a</CFR>
                <DEPDOC>[CIS No. 2653-19; DHS Docket No. USCIS-2019-0024]</DEPDOC>
                <RIN>RIN 1615-AC40</RIN>
                <SUBJECT>Employment Authorization for Certain Classes of Aliens With Final Orders of Removal; Withdrawal</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Citizenship and Immigration Services, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule; withdrawal.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of Homeland Security (DHS) is withdrawing a notice of proposed rulemaking (NPRM) that published on November 19, 2020. The NPRM proposed to revise DHS regulations governing employment authorization for individuals who have a final order of removal and are released from DHS custody on an order of supervision. The NPRM also proposed to amend DHS regulations to clearly indicate the employment eligibility of individuals who have been granted deferral of removal based on the United States' obligations under the Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (CAT).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>DHS withdraws the NPRM as of May 10, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The docket for this withdrawn proposed rule is available at 
                        <E T="03">http://www.regulations.gov.</E>
                         Please search for docket number USCIS-2019-0024.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Steven P. Kvortek, Acting Chief, Security and Public Safety Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, DHS, 5900 Capital Gateway Drive, Camp Springs, MD 20746; telephone 240-721-3000 (this is not a toll-free number). Individuals with hearing or speech impairments may access the telephone numbers above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627 (TTY/TDD).</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>On November 19, 2020, DHS published an NPRM titled “Employment Authorization for Certain Classes of Aliens With Final Orders of Removal.” (85 FR 74196). This NPRM proposed to eliminate employment authorization under 8 CFR 274a.12(c)(18) for individuals who have a final order of removal and are released on an order of supervision with a narrow exception. DHS also proposed to amend its regulations to clearly indicate that individuals who have been granted CAT deferral of removal would be employment authorized based on their grant of CAT deferral of removal.</P>
                <P>
                    In response to the NPRM, DHS received more than 302 comments during the 30-day public comment period. Nearly 98 percent of commenters opposed the proposed rule with several commenters specifically requesting that DHS withdraw the NPRM.
                    <SU>1</SU>
                    <FTREF/>
                     Less than 2 percent expressed support for the rule with such commenters generally supporting the rule because they believed it would deter illegal immigration and protect U.S. workers. The commenters who opposed the NPRM argued that it would significantly limit the ability of individuals who have a final order of removal and are released on an order of supervision to legally work, be self-sufficient, and support their families, which may include U.S. citizen children and lawful permanent resident spouses or partners. Several commenters also noted the proposed rule would impose exorbitant costs and burdens on U.S. employers related to labor turnover and the proposed E-Verify requirement. Various state and local agencies, including Attorneys General from 15 states, also opposed the rule on the basis it would decrease tax revenue, deny states various revenue streams, and increase costs related to state-funded public benefit programs. Many commenters also disagreed with the NPRM's assertion that the proposed changes would incentivize individuals with final orders of removal to leave the United States. They argued that the majority of individuals who have a final order of removal and are released on an order of supervision are in the United States with DHS's acknowledgment, as reflected by their release on an order of supervision, and that DHS's inability to remove them primarily stems not from inaction on the individual's part but due to the unwillingness of foreign governments to issue them travel documents and cooperate in their repatriation.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Comments may be viewed at the Federal Docket Management System (FDMS) at 
                        <E T="03">http://www.regulations.gov,</E>
                         docket number USCIS-2019-0024.
                    </P>
                </FTNT>
                <P>The NPRM stemmed from two executive orders issued by President Trump, which have been revoked since the publication of the NPRM. DHS initiated the regulatory action pursuant to Executive Order 13768, “Enhancing Public Safety in the Interior of the United States” (Jan. 24, 2017) and Executive Order 13788, “Buy American and Hire American” (Apr. 18, 2017). These executive orders directed DHS to revise or rescind any regulations inconsistent with these orders. DHS issued the NPRM after determining that the current regulations at 8 CFR 274a.12(c)(18) could be inconsistent with the above-mentioned executive orders.</P>
                <P>On January 20, 2021, President Biden issued Executive Order 13993, “Revision of Civil Immigration Enforcement Policies and Priorities,” which revoked Executive Order 13768. Further, on January 25, 2021, President Biden issued Executive Order 14005, “Ensuring the Future Is Made in All of America by All of America's Workers,” which revoked Executive Order 13788. Executive Orders 13993 and 14005 directed agencies to review, revise, or rescind any agency actions or guidance inconsistent with the executive orders.</P>
                <P>
                    Having reviewed the NPRM and the public comments in light of Executive Orders 13993 and 14005, DHS has decided to withdraw the NPRM. The original bases and rationale for promulgating the NPRM no longer align with the current Administration's immigration enforcement priorities. This Administration is focused on protecting the interests of American workers by ensuring the “[Federal 
                    <PRTPAGE P="24752"/>
                    Government] . . . procure[s] goods, products, materials, and services from sources that will help American businesses compete in strategic industries and help America's workers thrive.” By withdrawing the proposed rule, the Administration will allow individuals with final orders of removal who are released from DHS custody on an order of supervision, and are in a position to work, to continue to work for American businesses that provide services in key industries and to supplement the existing U.S. workforce.
                </P>
                <P>
                    As noted in Executive Order 13933, which articulates the Administration's overarching values and priorities on civil immigration enforcement, “the task of enforcing the immigration laws is complex and requires setting priorities to best serve the national interest.” 
                    <SU>2</SU>
                    <FTREF/>
                     DHS has been directed to focus its limited resources on national and border security, addressing the humanitarian challenges at the southern border, and ensuring public health and safety.
                    <SU>3</SU>
                    <FTREF/>
                     In doing so, DHS must develop enforcement priorities and use its limited resources to pursue those priorities. Additionally, the limited resources of the agency and the significant operational challenges caused by the COVID-19 pandemic do not allow DHS to respond to all immigration violations or remove all individuals with a final order of removal.
                    <SU>4</SU>
                    <FTREF/>
                     DHS's enforcement priorities, including removals, are to be focused on national security, public safety, and border security.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         Exec. Order No. 13993, 86 FR 7051, Sec. 1 (Jan. 25, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Acting ICE Director Tae Johnson, “Interim Guidance: Civil Immigration Enforcement and Removal Priorities,” Feb. 18, 2021, available at: 
                        <E T="03">https://www.ice.gov/doclib/news/releases/2021/021821_civil-immigration-enforcement_interim-guidance.pdf</E>
                         (last visited March 3, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>DHS believes that continuing to provide employment authorization to individuals who have a final order of removal and are released from DHS custody on an order of supervision is consistent with this Administration's values and priorities on immigration enforcement. It will allow individuals who do not fall within the Administration's enforcement priorities and who are still in the United States to continue to qualify for employment authorization, to legally work, remain self-sufficient, and support their families, which in many instances include U.S. citizen children.</P>
                <P>This withdrawal notice does not affect the continued employment eligibility of individuals who have been granted CAT deferral of removal. Such individuals currently qualify for employment authorization under 8 CFR 274a.12(c)(18) and will continue to do so. The primary purpose behind the proposed regulatory amendments related to individuals with CAT deferral of removal was to clearly indicate in the regulations that individuals with CAT deferral of removal are eligible for employment authorization. Even though DHS is not pursuing the proposed regulatory amendments at this time, individuals who are granted CAT deferral of removal will continue to qualify for employment authorization under 8 CFR 274a.12(c)(18). DHS plans to consider similar regulatory amendments clarifying eligibility for employment authorization for individuals with CAT deferral of removal as part of future rulemaking efforts consistent with DHS's priorities, policies, and applicable law.</P>
                <P>For all the reasons discussed above, DHS is withdrawing the NPRM.</P>
                <HD SOURCE="HD1">Authority</HD>
                <P>As stated in the NPRM, DHS has general and specific statutory authority to detain individuals with final orders of removal, release such individuals from custody on an order of supervision, and grant them employment authorization. 85 FR 74211. DHS is withdrawing the NPRM using those same authorities. Executive Order 13993, “Revision of Civil Immigration Enforcement Policies and Priorities;” Executive Order 14005, “Ensuring the Future Is Made in All of America by All of America's Workers;” 8 U.S.C. 1324a(h)(3); and 8 U.S.C. 1231(a)(7).</P>
                <SIG>
                    <NAME>Alejandro N. Mayorkas,</NAME>
                    <TITLE>Secretary, U.S. Department of Homeland Security.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09670 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9111-97-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF ENERGY</AGENCY>
                <CFR>10 CFR Part 431</CFR>
                <DEPDOC>[EERE-2011-BT-DET-0045]</DEPDOC>
                <RIN>RIN 1904-AC55</RIN>
                <SUBJECT>Energy Conservation Program: Coverage Determination for Commercial and Industrial Fans</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Energy Efficiency and Renewable Energy, Department of Energy.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for information.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of Energy (“DOE”) requests comment on a potential definition of “commercial and industrial fan” for consideration in determining whether such equipment should be classified as covered equipment under Part C of Title III of the Energy Policy and Conservation Act, as amended. DOE welcomes written comments from the public on any subject within the scope of this document (including topics not raised in this RFI), as well as the submission of data and other relevant information.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written comments and information are requested and will be accepted on or before May 25, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments. Alternatively, interested persons may submit comments, identified by docket number EERE-2011-BT-DET-0045, by any of the following methods:
                    </P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        2. 
                        <E T="03">Email:</E>
                         to 
                        <E T="03">commercialindustrialfansDET0045@ee.doe.gov.</E>
                         Include docket number EERE-2011-BT-DET-0045 in the subject line of the message.
                    </P>
                    <P>No telefacsimiles (“faxes”) will be accepted. For detailed instructions on submitting comments and additional information on this process, see section III of this document.</P>
                    <P>
                        <E T="03">Although DOE has routinely accepted public comment submissions through a variety of mechanisms, including postal mail and hand delivery/courier, the Department has found it necessary to make temporary modifications to the comment submission process in light of the ongoing Covid-19 pandemic. DOE is currently suspending receipt of public comments via postal mail and hand delivery/courier. If a commenter finds that this change poses an undue hardship, please contact Appliance Standards Program staff at (202) 586-1445 to discuss the need for alternative arrangements. Once the Covid-19 pandemic health emergency is resolved, DOE anticipates resuming all of its regular options for public comment submission, including postal mail and hand delivery/courier.</E>
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         The docket for this activity, which includes 
                        <E T="04">Federal Register</E>
                         notices, comments, and other supporting documents/materials, is available for review at 
                        <E T="03">http://www.regulations.gov.</E>
                         All documents in the docket are listed in the 
                        <E T="03">http://www.regulations.gov</E>
                         index. However, some documents listed in the index, such as those containing information 
                        <PRTPAGE P="24753"/>
                        that is exempt from public disclosure, may not be publicly available.
                    </P>
                    <P>
                        The docket web page can be found at 
                        <E T="03">http://www.regulations.gov/docket/EERE-2011-BT-DET-0045.</E>
                         The docket web page contains instructions on how to access all documents, including public comments, in the docket. See section III for information on how to submit comments through 
                        <E T="03">http://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        Mr. Jeremy Dommu, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 586-9870. Email: 
                        <E T="03">ApplianceStandardsQuestions@ee.doe.gov.</E>
                    </P>
                    <P>
                        Mr. Pete Cochran, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW, Washington, DC, 20585-0121. Telephone: (202) 586-9496. Email: 
                        <E T="03">peter.cochran@hq.doe.gov.</E>
                    </P>
                    <P>
                        For further information on how to submit a comment or review other public comments and the docket, contact the Appliance and Equipment Standards Program staff at (202) 287-1445 or by email: 
                        <E T="03">ApplianceStandardsQuestions@ee.doe.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Introduction</FP>
                    <FP SOURCE="FP1-2">A. Authority</FP>
                    <FP SOURCE="FP1-2">B. Background</FP>
                    <FP SOURCE="FP-2">II. Request for Information</FP>
                    <FP SOURCE="FP-2">III. Submission of Comments</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>
                    The following section briefly discusses the statutory authority underlying this request for information, as well as some of the historical background relevant to the potential inclusion of commercial and industrial fans as covered equipment under the Energy Policy and Conservation Act, as amended (“EPCA”).
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         All references to EPCA in this document refer to the statute as amended through the Energy Act of 2020, Public Law 116-260 (Dec. 27, 2020).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">A. Authority</HD>
                <P>
                    EPCA authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. (42 U.S.C. 6291-6317) Title III, Part C 
                    <SU>2</SU>
                    <FTREF/>
                     of EPCA established the Energy Conservation Program for Certain Industrial Equipment, which sets forth a variety of provisions designed to improve energy efficiency of certain commercial and industrial equipment (hereafter referred to as “covered equipment”).
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         For editorial reasons, upon codification in the U.S. Code, Part C was redesignated Part A-1.
                    </P>
                </FTNT>
                <P>EPCA specifies a list of equipment that constitutes covered equipment. (42 U.S.C. 6311(1)) EPCA also provides that “covered equipment” includes any other type of industrial equipment for which the Secretary of Energy (“Secretary”) determines inclusion is necessary to carry out the purpose of this part. (42 U.S.C. 6311(1)(L); 42 U.S.C. 6312(b)) EPCA specifies the types of industrial equipment that can be classified as covered equipment. This industrial equipment includes fans and blowers. (42 U.S.C. 6311(2)(B)(ii) and (iii)) Additionally, in order to be classified as covered equipment, the industrial equipment must be of a type that: (1) Consumes, or is designed to consume, energy in operation; (2) is distributed in commerce for industrial or commercial use; and (3) is not a covered product as defined in 42 U.S.C. 6291(a)(2). (42 U.S.C. 6311(2)(A))</P>
                <HD SOURCE="HD2">B. Background</HD>
                <P>On June 28, 2011, DOE published a notice of proposed determination of coverage that fans, blowers, and fume hoods qualify as covered equipment. 76 FR 37678 (“June 2011 NOPD”). DOE also proposed definitions for the terms “fan,” “blower,” and “fume hood.”</P>
                <P>
                    In the June 2011 NOPD, DOE preliminarily determined that coverage of fans, blowers, and fume hoods is necessary to carry out the purposes of Part A-1 because coverage will promote the conservation of energy supplies. 76 FR 37678, 37680. DOE estimated that technologies exist which can reduce the electricity consumption of fans and blowers by as much as 20 percent and that there are technologies and design strategies for fume hoods that could reduce energy by 50 percent. 
                    <E T="03">Id.</E>
                     DOE requested comment on the proposed definitions and its preliminary determination that coverage of fans, blower, and fume hoods is necessary to carry out the purposes of Part A-1. 76 FR 37678, 37682.
                </P>
                <P>
                    In parallel with the proposed determination rulemaking process, DOE published notice of a framework document that detailed an analytical approach for developing potential energy conservation standards for commercial and industrial fans and blowers should the Secretary classify such industrial equipment as covered equipment.
                    <SU>3</SU>
                    <FTREF/>
                     78 FR 7306 (February 1, 2013). The January 2013 Framework Document included revised definitions for “fan” and “blower.”
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The framework document is available at 
                        <E T="03">https://www.regulations.gov/document?D=EERE-2013-BT-STD-0006-0001</E>
                         (“January 2013 Framework Document”).
                    </P>
                </FTNT>
                <P>
                    DOE also established a negotiated rulemaking working group under the Appliance Standards and Rulemaking Federal Advisory Committee to negotiate proposed definitions, test procedures and energy conservation standards for commercial and industrial fans and blowers. The Working Group held 16 meetings and three webinars and concluded its negotiations on September 3, 2015, with the approval of a term sheet containing recommendations for DOE.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         All Working Group documents, including the term sheet, are available at: 
                        <E T="03">https://www.regulations.gov/docket/EERE-2013-BT-STD-0006.</E>
                    </P>
                </FTNT>
                <P>On January 10, 2020, DOE received a petition from the Air Movement and Control Association (AMCA), International, Air Conditioning Contractors of America, and Sheet Metal &amp; Air Conditioning Contractors of America requesting that DOE establish a Federal test procedure for certain categories of fans based on an upcoming industry test method, AMCA 214, Test Procedure for Calculating Fan Energy Index (FEI) for Commercial and Industrial Fans and Blowers. DOE published a notice of petition and request for public comment. 85 FR 22677 (April 23, 2020) (“April 2020 Notice of Petition”).</P>
                <P>To date DOE has not classified commercial and industrial fans as covered equipment and has not proposed test procedures or energy conservation standards for this equipment.</P>
                <HD SOURCE="HD1">II. Request for Information</HD>
                <P>Although EPCA lists fans and blowers as types of industrial equipment, these terms are not defined. As noted, DOE proposed definitions for “fan” and “blower” in the June 2011 NOPD. Specifically, DOE proposed the following definitions: </P>
                <EXTRACT>
                    <P>
                        A 
                        <E T="03">fan</E>
                         is an electrically powered device used in commercial or industrial systems to provide a continuous flow of a gas, typically air, for ventilation, circulation, or other industrial process requirements. Fans are classified as axial or centrifugal. Axial fans move an airstream along the axis of the fan. Centrifugal fans generate airflow by accelerating the airstream radially. A fan may include some or all of the following components: motor and motor controls, rotor or fan blades, and transmission and housing.
                    </P>
                    <P>
                        A 
                        <E T="03">blower</E>
                         is a type of centrifugal fan. 
                    </P>
                </EXTRACT>
                <P>
                    June 2011 NOPD, 76 FR 37678, 37679. Taking into consideration the comments 
                    <PRTPAGE P="24754"/>
                    received to the June 2011 NOPD, DOE considered the following definitions for “fan” and “blower” in the January 2013 Framework Document:
                </P>
                <EXTRACT>
                    <P>
                        <E T="03">Commercial/Industrial Fan:</E>
                         A device used in commercial or industrial systems to provide a continuous flow of a gas, typically air, by an impeller fit to a shaft and bearing(s). A fan may be manufactured with or without a housing component.
                    </P>
                    <P>
                        <E T="03">Blower:</E>
                         An axial or centrifugal fan with a specific ratio between 1.11 and 1.20.
                    </P>
                </EXTRACT>
                <FP>
                    (January 2013 Framework Document at pp. 7 and 9) DOE also acknowledged that the terms “fan” and “blower” are used interchangeably by the industry. 
                    <E T="03">Id.</E>
                     at p. 7.
                </FP>
                <P>
                    The industry test procedure referenced in AMCA's petition for a federal test procedure has since been finalized as ANSI/AMCA Standard 214-21, Test Procedure for Calculating Fan Energy Index (FEI) for Commercial and Industrial Fans and Blowers (“ANSI/AMCA Standard 214-21”).
                    <SU>5</SU>
                    <FTREF/>
                     The newly finalized industry test procedure contains the following definition for a fan: “a rotary-bladed machine used to convert electrical or mechanical power to air power, with an energy output limited to 25 kJ/kg of air. It consists of an impeller, shaft and bearings and/or driver to support the impeller as well as a structure or housing. A fan may include a transmission, driver and/or motor controller.” 
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         ANSI/AMCA Standard 214-21 is available at: 
                        <E T="03">https://www.amca.org/assets/resources/public/pdf/Publications/AMCA-214-21.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         ANSI/AMCA Standard 214-21 at p. 3.
                    </P>
                </FTNT>
                <P>DOE is considering establishing a definition of “commercial and industrial fan” that is identical to the definition of “fan” in ANSI/AMCA Standard 214-21. As discussed, DOE has initially determined that the terms “fan” and “blower” are used interchangeably. DOE is considering including the descriptor “commercial and industrial” with the term to clarify that the subject fans are industrial equipment and that the term excludes ceiling fans and furnace fans, both covered products defined at 10 CFR 430.2.</P>
                <P>
                    DOE notes that the maximum energy limit of 25 kJ/kg of air is equivalent to a pressure ratio of 1.3.
                    <SU>7</SU>
                    <FTREF/>
                     The current definition of a compressor at 10 CFR 431.342 states that, among other things, a compressor has a pressure ratio at full-load operating pressure greater than 1.3. As a result, DOE initially concludes that the maximum fan energy limit of 25 kJ/kg is appropriate to distinguish commercial and industrial fans from compressors.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         For an air density of 1.2 kg/m3, the fan pressure is 1.2 kg/m3 × 25 kJ/kg, 
                        <E T="03">i.e.,</E>
                         30 kPa, and the pressure ratio is calculated as (100+30)/100 = 1.30 (where atmospheric pressure = 100 kPa).
                    </P>
                </FTNT>
                <P>With regard to the criterion that a commercial and industrial fan must convert “electrical and mechanical power into air power,” fans that are powered by an engine or any other driver would meet this criterion as the engine or other driver would be providing mechanical power that is converted into air power.</P>
                <P>DOE requests comment on the definition of commercial and industrial fans as considered in this RFI. The definition being considered is identical to the definition of “fan” in ANSI/AMCA Standard 214-21. Specifically, DOE is requesting comment on whether this definition would accurately describe equipment generally understood as commercial and industrial fans.</P>
                <HD SOURCE="HD1">III. Submission of Comments</HD>
                <P>
                    DOE invites all interested parties to submit in writing by the date specified under the 
                    <E T="02">DATES</E>
                     heading, comments and information on matters addressed in this RFI for commercial and industrial fans. These comments and information will aid in the development of a final determination for commercial and industrial fans if DOE determines that a final determination is appropriate for this equipment.
                </P>
                <P>
                    <E T="03">Submitting comments via http://www.regulations.gov.</E>
                     The 
                    <E T="03">http://www.regulations.gov</E>
                     web page will require you to provide your name and contact information. Your contact information will be viewable to DOE Building Technologies staff only. Your contact information will not be publicly viewable except for your first and last names, organization name (if any), and submitter representative name (if any). If your comment is not processed properly because of technical difficulties, DOE will use this information to contact you. If DOE cannot read your comment due to technical difficulties and cannot contact you for clarification, DOE may not be able to consider your comment.
                </P>
                <P>However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Following this instruction, persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.</P>
                <P>
                    Do not submit to 
                    <E T="03">http://www.regulations.gov</E>
                     information for which disclosure is restricted by statute, such as trade secrets and commercial or financial information (hereinafter referred to as Confidential Business Information (“CBI”)). Comments submitted through 
                    <E T="03">http://www.regulations.gov</E>
                     cannot be claimed as CBI. Comments received through the website will waive any CBI claims for the information submitted. For information on submitting CBI, see the Confidential Business Information section.
                </P>
                <P>
                    DOE processes submissions made through 
                    <E T="03">http://www.regulations.gov</E>
                     before posting. Normally, comments will be posted within a few days of being submitted. However, if large volumes of comments are being processed simultaneously, your comment may not be viewable for up to several weeks. Please keep the comment tracking number that 
                    <E T="03">http://www.regulations.gov</E>
                     provides after you have successfully uploaded your comment.
                </P>
                <P>
                    <E T="03">Submitting comments via email.</E>
                     Comments and documents submitted via email also will be posted to 
                    <E T="03">http://www.regulations.gov.</E>
                     If you do not want your personal contact information to be publicly viewable, do not include it in your comment or any accompanying documents. Instead, provide your contact information on a cover letter. Include your first and last names, email address, telephone number, and optional mailing address. The cover letter will not be publicly viewable as long as it does not include any comments.
                </P>
                <P>Include contact information each time you submit comments, data, documents, and other information to DOE. Faxes will not be accepted.</P>
                <P>Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.</P>
                <P>
                    <E T="03">Campaign form letters.</E>
                     Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This reduces comment processing and posting time.
                </P>
                <P>
                    <E T="03">Confidential Business Information.</E>
                     According to 10 CFR 1004.11, any 
                    <PRTPAGE P="24755"/>
                    person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email two well-marked copies: one copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. DOE will make its own determination about the confidential status of the information and treat it according to its determination.
                </P>
                <P>It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).</P>
                <P>
                    DOE considers public participation to be a very important part of the process for developing test procedures and energy conservation standards. DOE actively encourages the participation and interaction of the public during the comment period in each stage of this process. Interactions with and between members of the public provide a balanced discussion of the issues and assist DOE in the process. Anyone who wishes to be added to the DOE mailing list to receive future notices and information about this process should contact Appliance and Equipment Standards Program staff at (202) 287-1445 or via email at 
                    <E T="03">ApplianceStandardsQuestions@ee.doe.gov.</E>
                </P>
                <HD SOURCE="HD1">Signing Authority</HD>
                <P>
                    This document of the Department of Energy was signed on April 25, 2021 by Kelly Speakes-Backman, Principal Deputy Assistant Secretary and Acting Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <DATED>Signed in Washington, DC, on May 4, 2021.</DATED>
                    <NAME>Treena V. Garrett,</NAME>
                    <TITLE>Federal Register Liaison Officer, U.S. Department of Energy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09723 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6450-01-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TREASURY</AGENCY>
                <SUBAGY>Office of the Comptroller of the Currency</SUBAGY>
                <CFR>12 CFR Part 30</CFR>
                <DEPDOC>[Docket ID OCC-2020-0043]</DEPDOC>
                <RIN>RIN 1557-AF03</RIN>
                <AGENCY TYPE="O">FEDERAL RESERVE SYSTEM</AGENCY>
                <CFR>12 CFR Part 208</CFR>
                <DEPDOC>[Docket No. R-1746]</DEPDOC>
                <RIN>RIN 7100-AG 14</RIN>
                <AGENCY TYPE="O">FEDERAL DEPOSIT INSURANCE CORPORATION</AGENCY>
                <CFR>12 CFR Part 364</CFR>
                <RIN>RIN 3064-AF62</RIN>
                <SUBJECT>Tax Allocation Agreements</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Comptroller of the Currency, Treasury; Board of Governors of the Federal Reserve System; and Federal Deposit Insurance Corporation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking and comment request.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Office of the Comptroller of the Currency, the Board of Governors of the Federal Reserve System, and the Federal Deposit Insurance Corporation (collectively, the agencies) are inviting comment on a proposed rule (proposal) under section 39 of the Federal Deposit Insurance Act that would establish requirements for tax allocation agreements between institutions and their holding companies in a consolidated tax filing group. The proposal would promote safety and soundness by preserving depository institutions' ownership rights in tax refunds and ensuring equitable allocation of tax liabilities among entities in a holding company structure. Under the proposal, national banks, state banks, and savings associations that file tax returns as part of a consolidated tax filing group would be required to enter into tax allocation agreements with their holding companies and other members of the consolidated group that join in the filing of a consolidated group tax return. The proposal also would describe specific mandatory provisions in these tax allocation agreements, including provisions addressing the ownership of tax refunds received. If the agencies were to adopt the proposal as a final rule, the agencies would rescind the interagency policy statement on tax allocation agreements that was issued in 1998 and supplemented in 2014.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received by July 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Comments should be directed to:</P>
                    <P>
                        <E T="03">OCC:</E>
                         Commenters are encouraged to submit comments through the Federal eRulemaking Portal. Please use the title “Tax Allocation Agreements” to facilitate the organization and distribution of the comments. You may submit comments by any of the following methods:
                    </P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal—Regulations.gov:</E>
                         Go to 
                        <E T="03">https://regulations.gov/.</E>
                         Enter “Docket ID OCC-2020-0043” in the Search Box and click “Search.” Public comments can be submitted via the “Comment” box below the displayed document information or by clicking on the document title and then clicking the “Comment” box on the top-left side of the screen. For help with submitting effective comments please click on “Commenter's Checklist.” For assistance with the 
                        <E T="03">Regulations.gov</E>
                         site, please call (877) 378-5457 (toll free) or (703) 454-9859 Monday-Friday, 9 a.m.-5 p.m. ET or email 
                        <E T="03">regulations@erulemakinghelpdesk.com.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Chief Counsel's Office, Attention: Comment Processing, Office of the Comptroller of the Currency, 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">Instructions:</E>
                         You must include “OCC” as the agency name and “Docket ID OCC-2020-0043” in your comment. In general, the OCC will enter all comments received into the docket and publish the comments on the 
                        <E T="03">Regulations.gov</E>
                         website 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>
                        You may review comments and other related materials that pertain to this action by the following method:
                        <PRTPAGE P="24756"/>
                    </P>
                    <P>
                        • 
                        <E T="03">Viewing Comments Electronically—Regulations.gov:</E>
                         Go to 
                        <E T="03">https://regulations.gov/.</E>
                         Enter “Docket ID OCC-2020-0043” in the Search Box and click “Search.” Click on the “Documents” tab and then the document's title. After clicking the document's title, click the “Browse Comments” tab. Comments can be viewed and filtered by clicking on the “Sort By” drop-down on the right side of the screen or the “Refine Results” options on the left side of the screen. Supporting materials can be viewed by clicking on the “Documents” tab and filtered by clicking on the “Sort By” drop-down on the right side of the screen or the “Refine Documents Results” options on the left side of the screen.” For assistance with the 
                        <E T="03">Regulations.gov</E>
                         site, please call (877) 378-5457 (toll free) or (703) 454-9859 Monday-Friday, 9 a.m.-5 p.m. ET or email 
                        <E T="03">regulations@erulemakinghelpdesk.com.</E>
                    </P>
                    <P>The docket may be viewed after the close of the comment period in the same manner as during the comment period.</P>
                    <P>
                        <E T="03">Board:</E>
                         When submitting comments, please consider submitting your comments by email or fax because paper mail in the Washington, DC, area and at the Board may be subject to delay.
                    </P>
                    <P>You may submit comments, identified by Docket No. R-1746; RIN 7100-AG 14, by any of the following method:</P>
                    <P>
                        • 
                        <E T="03">Agency Website: http://www.federalreserve.gov.</E>
                         Follow the instructions for submitting comments at 
                        <E T="03">http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Email:</E>
                          
                        <E T="03">regs.comments@federalreserve.gov.</E>
                         Include docket and RIN numbers in the subject line of the message.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 452-3819 or (202) 452-3102.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Ann E. Misback, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue NW, Washington, DC 20551.
                    </P>
                    <P>
                        All public comments will be made available on the Board's website at 
                        <E T="03">http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm</E>
                         as submitted, unless modified for technical reasons. Accordingly, comments will not be edited to remove any identifying or contact information unless specifically requested by the commenter. Public comments may also be viewed in paper in Room 146, 1709 New York Avenue NW, Washington, DC 20006, between 9:00 a.m. and 5:00 p.m. on weekdays. For security reasons, the Board requires that visitors make an appointment to inspect comments. You may do so by calling (202) 452-3684.
                    </P>
                    <P>
                        <E T="03">FDIC:</E>
                         You may submit comments, identified by FDIC RIN 3064-AF62, by any of the following methods:
                    </P>
                    <P>
                        • 
                        <E T="03">Agency Website: https://www.fdic.gov/regulations/laws/federal/.</E>
                         Follow instructions for submitting comments on the Agency website.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         James P. Sheesley, Assistant Executive Secretary, Attention: Comments—RIN 3064-AF62/Legal ESS, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery/Courier:</E>
                         Comments may be hand-delivered to the guard station at the rear of the 550 17th Street NW building (located on F Street) on business days between 7:00 a.m. and 5:00 p.m.
                    </P>
                    <P>
                        • 
                        <E T="03">Email:</E>
                          
                        <E T="03">comments@FDIC.gov.</E>
                         Comments submitted must include “FDIC RIN 3064-AF62” on the subject line of the message.
                    </P>
                    <P>
                        • 
                        <E T="03">Public Inspection:</E>
                         All comments received must include “FDIC RIN 3064-AF62” for this rulemaking. All comments received will be posted without change to 
                        <E T="03">https://www.fdic.gov/regulations/laws/federal/,</E>
                         including any personal information provided. Paper copies of public comments may be requested from the FDIC Public Information Center, or by telephone at (877) 275-3342 or (703) 562-2200.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        <E T="03">OCC:</E>
                         Carol Raskin, Senior Policy Accountant, or Mary Katherine Kearney, Professional Accounting Fellow, Office of the Chief Accountant, 202-649-6280; Kevin Korzeniewski, Counsel, or Joanne Phillips, Counsel, Chief Counsel's Office, (202) 649-5490.
                    </P>
                    <P>
                        <E T="03">Board:</E>
                         Lara Lylozian, Chief Accountant, (202) 475-6656; Juan Climent, Assistant Director, (202) 872-7526; Kathryn Ballintine, Manager, (202) 452-2555; Michael Ofori-Kuragu, Senior Financial Institution Policy Analyst II, (202) 475-6623, Sasha Pechenik, Senior Accounting Policy Analyst, (202) 452-3608, Division of Supervision and Regulation; Benjamin W. McDonough, Associate General Counsel, (202) 452-2036; Asad Kudiya, Senior Counsel, (202) 475-6358; Lucy Chang, Senior Counsel, (202) 475-6331; Joshua Strazanac, Senior Attorney, (202) 452-2457; David Imhoff, Attorney, (202) 452-2249, Legal Division, Board of Governors of the Federal Reserve System, 20th and C Streets NW, Washington, DC 20551. For the hearing impaired only, Telecommunication Device for the Deaf (TDD), (202) 263-4869.
                    </P>
                    <P>
                        <E T="03">FDIC:</E>
                         John Rieger, Chief Accountant, (202) 898-3602, 
                        <E T="03">jrieger@fdic.gov</E>
                        ; Andrew Overton, Senior Examination Specialist, (202) 898-8922, 
                        <E T="03">aoverton@fdic.gov,</E>
                         Accounting and Securities Disclosure Section, Division of Risk Management Supervision; Jeffrey Schmitt, Counsel, (703) 562-2429, 
                        <E T="03">jschmitt@fdic.gov</E>
                        ; Joyce M. Raidle, Counsel, (202) 898-6763, 
                        <E T="03">jraidle@fdic.gov</E>
                        ; Francis Kuo, Counsel, (202) 898-6654, 
                        <E T="03">fkuo@fdic.gov,</E>
                         Legal Division.
                    </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="FP1-2">A. Summary of Proposal</FP>
                    <FP SOURCE="FP1-2">B. Background</FP>
                    <FP SOURCE="FP-2">II. Description of the Proposal</FP>
                    <FP SOURCE="FP1-2">A. Scope of Application</FP>
                    <FP SOURCE="FP1-2">B. Tax Allocation in a Holding Company Structure</FP>
                    <FP SOURCE="FP1-2">C. Tax Allocation Agreements and Key Terms</FP>
                    <FP SOURCE="FP1-2">D. Regulatory Reporting</FP>
                    <FP SOURCE="FP-2">III. Incorporation of the Proposal as an Appendix to the Agencies' Safety and Soundness Rules</FP>
                    <FP SOURCE="FP-2">IV. Impact Analysis</FP>
                    <FP SOURCE="FP-2">V. Administrative Law Matters</FP>
                    <FP SOURCE="FP1-2">A. Paperwork Reduction Act</FP>
                    <FP SOURCE="FP1-2">B. Regulatory Flexibility Act</FP>
                    <FP SOURCE="FP1-2">C. Plain Language</FP>
                    <FP SOURCE="FP1-2">D. Riegle Community Development and Regulatory Improvement Act of 1994</FP>
                    <FP SOURCE="FP1-2">E. OCC Unfunded Mandates Reform Act of 1995</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Introduction</HD>
                <HD SOURCE="HD2">A. Summary of Proposal</HD>
                <P>
                    The Office of the Comptroller of the Currency (OCC), the Board of Governors of the Federal Reserve System (Board), and the Federal Deposit Insurance Corporation (FDIC) (collectively, the agencies) are inviting comment on a proposed rule (proposal) that would prescribe requirements for tax allocation agreements that involve insured depository institutions and OCC chartered uninsured institutions supervised by the agencies (collectively, institutions).
                    <SU>1</SU>
                    <FTREF/>
                     Under the proposal, institutions in a consolidated tax filing group (consolidated group 
                    <SU>2</SU>
                    <FTREF/>
                    ) would be required to enter into tax allocation agreements with their holding companies and other members of the consolidated group that join in the filing of a consolidated group tax return. The proposal would establish a methodology for tax payment obligations between an institution and its parent holding company within a consolidated group 
                    <PRTPAGE P="24757"/>
                    and would address how the institution should be compensated for the use of its tax assets (such as net operating losses and tax credits). The proposal would be adopted primarily under Section 39 of the Federal Deposit Insurance Act (FDI Act) 
                    <SU>3</SU>
                    <FTREF/>
                     and codified within the agencies' safety and soundness regulations.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         National banks and Federal savings associations, (OCC); state member banks (Board); and state nonmember banks and state savings associations (FDIC).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         A consolidated group refers to an institution, its parent, and any affiliates of the institution that join in the filing of a tax return as a single consolidated, combined, or unitary group.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         12 U.S.C. 1831p-1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         12 CFR part 30 (OCC); 12 CFR part 208 (Board); 12 CFR part 364 (FDIC).
                    </P>
                </FTNT>
                <P>The proposal would require institutions to include certain provisions in all tax allocation agreements, such as: The timing and amounts of any payments for taxes due to taxing authorities; the acknowledgment of an agency relationship between institutions and their holding companies in a consolidated group with respect to tax refunds received; and a provision stating that documents, including returns, relating to consolidated or combined federal, state, or local income tax filings must be made available to an institution or any successor during regular business hours. The proposal further addresses the regulatory reporting treatment of an institution's deferred tax assets (DTAs).</P>
                <HD SOURCE="HD2">B. Background</HD>
                <P>
                    In 1998, the agencies and the Office of Thrift Supervision 
                    <SU>5</SU>
                    <FTREF/>
                     adopted the Interagency Policy Statement on Income Tax Allocation in a Holding Company Structure 
                    <SU>6</SU>
                    <FTREF/>
                     (Interagency Policy Statement) to provide guidance to insured depository institutions, their holding companies, and other affiliates regarding the allocation and payment of taxes when these entities file income tax returns on a consolidated basis. One of the principal goals of the Interagency Policy Statement is to clarify insured depository institutions' ownership rights in tax refunds when the consolidated group elects to file a consolidated tax return. The Interagency Policy Statement states that tax settlements between an insured depository institution and its holding company should be conducted in a manner that is no less favorable to the insured depository institution than if it were a separate taxpayer, and that whenever a holding company receives a tax refund from any taxing authority, and the refund is one that is attributable to its subsidiary insured depository institution, the holding company is acting purely as an agent for the insured depository institution.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         The functions of the Office of Thrift Supervision were transferred to the OCC and FDIC in accordance with Title III of the Dodd-Frank Wall Street Reform and Consumer Protection Act, Public Law 111-203, enacted July 21, 2010.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         63 FR 64757 (Nov. 23, 1998).
                    </P>
                </FTNT>
                <P>
                    In 2014, the agencies issued an addendum to the Interagency Policy Statement to emphasize that tax allocation agreements should expressly acknowledge an agency relationship between a holding company and its subsidiary insured depository institution to protect the insured depository institution's ownership rights in tax refunds (2014 Addendum).
                    <SU>7</SU>
                    <FTREF/>
                     The 2014 Addendum also clarifies that all tax allocation agreements are subject to section 23B of the Federal Reserve Act (section 23B).
                    <SU>8</SU>
                    <FTREF/>
                     In addition, the 2014 Addendum provides that tax allocation agreements that do not clearly acknowledge the presence of an agency relationship between the holding company and the subsidiary insured depository institution may be subject to requirements under section 23A of the Federal Reserve Act (section 23A).
                    <SU>9</SU>
                    <FTREF/>
                     Moreover, the 2014 Addendum clarifies that section 23B requires a holding company to transmit promptly to its subsidiary insured depository institution any tax refunds received from a taxing authority that are attributable to the insured depository institution. Sections 23A and 23B apply to institutions supervised by the agencies.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         79 FR 35228 (June 19, 2014).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         12 U.S.C. 371c-1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         12 U.S.C. 371c. Section 23A requires, among other things, that loans and other extensions of credit from an insured depository institution to its affiliate be collateralized properly by a specified amount and subject to certain quantitative limits. Issues concerning compliance with section 23A could arise from instances whereby a tax allocation agreement does not (i) acknowledge that a holding company in a consolidated group serves as agent for its subsidiary insured depository institution with respect to tax refunds generated by the subsidiary insured depository institution, or (ii) require a holding company in a consolidated group to transmit promptly the appropriate portion of a consolidated group's tax refund to the subsidiary insured depository institution. In such circumstances, the failure of a holding company to acknowledge an agency relationship with respect to tax refunds or to pay promptly the subsidiary insured depository institution its appropriate portion of tax refunds could result in an extension of credit from the insured depository institution to its affiliated holding company in the consolidated group that would be subject to the requirements of section 23A.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Sections 23A and 23B and 12 CFR part 223 apply by their terms to “member banks”, that is, any national bank, State bank, trust company, or other institution that is a member of the Federal Reserve System. In addition, the Federal Deposit Insurance Act (12 U.S.C. 1828(j)) applies sections 23A and 23B to insured State nonmember banks in the same manner and to the same extent as if they were member banks. The Home Owners' Loan Act (12 U.S.C. 1468(a)) also applies sections 23A and 23B to insured savings associations in the same manner and to the same extent as if they were member banks.
                    </P>
                </FTNT>
                <P>In their supervision of institutions, the agencies have observed that some institutions in consolidated groups either lack tax allocation agreements with their holding companies or have agreements that do not have language conforming with section 23A or 23B. In particular, the agencies have reviewed tax allocation agreements that do not require a holding company in a consolidated group to transmit promptly the appropriate portion of a consolidated group's tax refund to its subsidiary institution, resulting in the holding company failing to do so in some instances. Such inaction could adversely affect the safety and soundness of the subsidiary institutions because delayed access to funds could weaken an institution's liquidity profile. Further, in its capacity as receiver for failed insured depository institutions, the FDIC has engaged in legal disputes regarding the ownership of tax refunds claimed by holding companies based on losses incurred by insured depository institutions in a consolidated group because the tax allocation agreements did not clearly acknowledge an agency relationship between an insured depository institution and its holding company. These disputes can reduce or prevent recoveries by the FDIC on behalf of failed insured depository institutions, consequently increase costs to the Deposit Insurance Fund, and thus could lead to higher FDIC deposit insurance premiums charged to solvent insured depository institutions.</P>
                <HD SOURCE="HD1">II. Description of the Proposal</HD>
                <HD SOURCE="HD2">A. Scope of Application</HD>
                <P>The proposal would apply to all institutions that file federal and state income taxes in a consolidated group in which one or more of the institutions in the consolidated group is supervised by any of the agencies. A consolidated group refers to an institution, its parent, and any affiliates of the institution that join in the filing of a tax return as a single consolidated, combined, or unitary group. While the Interagency Policy Statement and 2014 Addendum only apply to insured depository institutions, the OCC has observed similar problematic tax practices at uninsured institutions it supervises. Therefore, the OCC proposes to apply relevant provisions of the proposal to uninsured institutions as well.</P>
                <P>
                    In contrast, institutions that do not file federal and state income taxes as members of a consolidated group file separately and account for taxes on a separate entity basis. Therefore, an institution that files on a separate entity basis or in a group consisting solely of the institution and its subsidiaries would not be subject to the proposal. 
                    <PRTPAGE P="24758"/>
                    The proposal also would not apply to an institution if the institution or its holding company is not subject to corporate income taxes at either the federal or state level, such as those that have elected S-Corporation status and do not have an obligation to pay corporate income taxes.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         S-corporations are corporations that elect to pass corporate income, losses, deductions, and credits through to their shareholders for federal tax purposes under Subchapter S of the Internal Revenue Code. 
                        <E T="03">See</E>
                         26 U.S.C. 1361 
                        <E T="03">et seq.</E>
                    </P>
                </FTNT>
                <P>
                    <E T="03">Question [1]: Is the scope of application of the proposal appropriate, and what are the advantages and disadvantages of this scope?</E>
                </P>
                <HD SOURCE="HD2">B. Tax Allocation in a Holding Company Structure</HD>
                <P>As noted, a holding company and its bank subsidiaries have the ability to file a consolidated group income tax return. However, each depository institution is viewed as, and reports as, a separate legal and accounting entity for certain regulatory purposes, including for regulatory capital requirements. When a depository institution has subsidiaries of its own, the institution's applicable income taxes on a separate entity basis include the taxes of the subsidiaries of the institution itself that are included with the institution in the consolidated group return. Accordingly, each depository institution's applicable income taxes, reflecting either an expense or benefit, should be recorded in its books and records and reflected in the institution's regulatory reports as if the institution had filed on a separate entity basis. Throughout this notice, the terms “separate entity” and “separate taxpayer” are used synonymously. Furthermore, the amount and timing of payments or refunds should not be in any case less favorable to the institution than if the institution were a separate taxpayer. Any practice that is not consistent with this principle may be viewed as an unsafe or unsound practice.</P>
                <HD SOURCE="HD2">C. Tax Allocation Agreements and Key Terms</HD>
                <P>The proposal would require that all institutions that are subject to Federal or State tax and file tax returns as part of a consolidated group execute a tax allocation agreement that applies to and binds each member of the consolidated group. The proposal also would require that the tax allocation agreement be approved by the boards of directors of an institution subject to that tax allocation agreement and its holding company to ensure the agreement's enforceability by and among the institutions in the consolidated group.</P>
                <P>Section 23A and 23B generally govern extensions of credit and certain other transactions between institutions and their affiliates, which include their holding companies. Section 23A places quantitative limits on covered transactions between an institution and its affiliates and imposes collateral requirements on certain covered transactions. Section 23B requires that transactions between an institution and its affiliates be made on terms and under circumstances that are substantially the same, or at least as favorable to the institution, as comparable transactions involving nonaffiliated companies or, in the absence of the comparable transactions, on terms and circumstances that would in good faith be offered to nonaffiliated companies. The tax allocation agreement requirements in the proposal are intended to be consistent with sections 23A and 23B.</P>
                <P>As mentioned above, one of the principles of the Interagency Policy Statement is that a tax allocation agreement cannot result in terms less favorable to an institution than if the institution filed its income tax return on a separate entity basis (that is, not as part of a consolidated group). To achieve this result, tax allocation agreements subject to the proposal would be required to establish certain rights and obligations among institutions in the consolidated group. Adjustments for statutory tax considerations that may arise on a consolidated tax return are permitted as long as the adjustments are made on a basis that is equitable and consistently applied among the holding company and other affiliates. Certain proposed key terms that would be required under the proposal for tax allocation agreements are explained below.</P>
                <P>
                    The proposal clarifies that, in terms of timing, an institution must be compensated for the use of its tax assets by the parent or other members of the consolidated group at the time the relevant tax asset is absorbed by the consolidated group. The proposal also clarifies that an institution must be promptly remitted any tax refund received (by the holding company) from a taxing authority that is based on the institution's tax attributes.
                    <SU>12</SU>
                    <FTREF/>
                     This is a common approach taken in tax sharing agreements, would promote safety and soundness by ensuring that an institution receives the benefit of its tax attributes, and is the approach least likely to create an extension of credit under section 23A.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         If an overpayment of tax is applied as a credit toward estimated tax or other payments due, the tax refund would be considered received by the holding company when it files the return electing to apply the refund as a credit.
                    </P>
                </FTNT>
                <P>
                    <E T="03">Question [2]: While the agencies expect refunds would be transmitted to the institution as soon as possible, what are the advantages and disadvantages of the agencies requiring that an institution receive any tax refund based on its tax attributes within a specific timeframe from the date received? What would be an appropriate timeframe, and why?</E>
                </P>
                <P>
                    <E T="03">Question [3]: What are the advantages and disadvantages of requiring that a parent or other members of a consolidated group compensate an institution for the use of its tax assets if and when the relevant tax asset is absorbed or used? How do these advantages and disadvantages compare to the advantages and disadvantages of other approaches including, for example, requiring that a parent or other members of the consolidated group compensate an institution for use of its tax assets if and when the institution would have been able to use the tax asset on a stand-alone basis?</E>
                </P>
                <HD SOURCE="HD3">Agency Relationship</HD>
                <P>
                    As discussed in the preamble to the 2014 Addendum, there have been many legal disputes between holding companies and the FDIC, as receiver for failed insured depository institutions, regarding the ownership of tax refunds generated by the insured depository institutions. In reported decisions, some courts have found that tax refunds generated by an insured depository institution were the property of its holding company based on certain language contained in their tax allocation agreements that the courts have interpreted as creating a debtor-creditor relationship.
                    <SU>13</SU>
                    <FTREF/>
                     As a result, the FDIC's Deposit Insurance Fund has a material stake in the outcome of these legal disputes because they may lead to significant losses to creditors of the receiverships and, ultimately, the Deposit Insurance Fund.
                    <SU>14</SU>
                    <FTREF/>
                     Therefore, the agencies are proposing that holding companies receive refunds due to institutions (if attributable to the tax attributes of an institution) in trust and promptly remit them to the institutions for two reasons. First, an institution's prompt receipt of refunds that are based on the tax attributes created by that institution would allow management to 
                    <PRTPAGE P="24759"/>
                    direct those funds for the immediate benefit of the institution that owns them, rather than allowing them to be retained for the benefit of the holding company. Second, receipt of the refund by the institution strengthens the institution's liquidity profile as compared to a receivable from the holding company, and reduces the risk that a refund paid by the taxing authority to the holding company based on use of the institution's tax attributes would be diverted to the holding company's creditors or other affiliates.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See, e.g., In re IndyMac Bancorp, Inc.,</E>
                         2012 WL 1037481 (Bankr. C.D. Cal. Mar. 29, 2012); 
                        <E T="03">In re Downey Financial Corp.,</E>
                         593 F. App'x 123 (3d Cir. 2015).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         The Deposit Insurance Fund is funded primarily from deposit insurance assessments collected by the FDIC from insured depository institutions.
                    </P>
                </FTNT>
                <P>
                    Under the proposal, a group's tax allocation agreement must specify that an agency relationship exists between the institution and its holding company, including an affiliate of the institution that submits tax returns for the consolidated group with respect to tax refunds. The proposal would clarify that the subsidiary institution must enter into a tax allocation agreement that specifies that the institution owns any tax refund that is created from or results from its tax attributes. A group tax allocation agreement must state that the holding company receives any portion of the tax refund related to the subsidiary institution's tax attributes in trust for the benefit of the subsidiary institution, including, for example, when a holding company receives a tax refund for a consolidated group, and some or all of the tax refund is due to tax attributes 
                    <SU>15</SU>
                    <FTREF/>
                     of a subsidiary institution. Further, under the proposal, the tax allocation agreement must provide that the holding company will remit the refund promptly to the subsidiary institution. Finally, to avoid any transactions that would prevent institutions from receiving tax refunds attributable to their tax attributes, the tax allocation agreement must provide that, notwithstanding any other transactions or agreements to the contrary, the institution must receive any tax refund attributable to its tax attributes.
                    <SU>16</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         For example, if a refund is based on losses generated by or tax credits due to activities occurring at the subsidiary insured depository institution.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For example, this would preclude an institution entering into any side agreements purporting to allocate a tax refund attributable to its tax attributes to an affiliate.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Tax Payments to a Holding Company</HD>
                <P>
                    The proposal also would address the timing and amount of tax payments 
                    <SU>17</SU>
                    <FTREF/>
                     made to a holding company by an institution in a consolidated group. Specifically, the proposal would require an institution to be a party to a tax allocation agreement that prohibits tax payments by the institution to its affiliates in excess of the current period tax obligation of the institution calculated on a separate entity basis. This requirement would reduce the risk that the holding company would use the institution's funds to pay expenses or offset tax liabilities owed by the holding company or its other affiliates (other than the institution).
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         Tax payments include both annual statutory tax payments and interim estimated payments required within an annual period.
                    </P>
                </FTNT>
                <P>Remitting a current period tax expense payment to a holding company significantly in advance of when the payment would be due to the taxing authority if the institution filed on a stand-alone basis may treat the institution less favorably than if it were a separate taxpayer and, further, may be subject to section 23B. As a result, under the proposal, an institution must not remit its current period tax expense (or reasonably calculated estimated tax payment) earlier than when the institution would have been obligated to pay the taxing authority had it filed as a separate entity, based on the timeframes established by the taxing authority. Furthermore, the tax allocation agreement may permit the holding company to collect less than what the institution's current period income tax obligation would have been, calculated on a separate entity basis. Provided the parent will not later require the institution to pay the remainder of the current tax liability, the amount of this unremitted liability should be accounted for as having been paid with a simultaneous capital contribution by the parent to the subsidiary. With respect to deferred tax liabilities (DTLs), however, a parent cannot forgive some or all of the institution's DTL because the parent cannot legally relieve the subsidiary of a potential future obligation to the taxing authorities, especially if the subsidiary were to become a stand-alone entity. Furthermore, taxing authorities can collect some or all of a group's liability from any of the group members if tax payments are not made when due.</P>
                <HD SOURCE="HD3">Payments and Hypothetical Tax Refunds From a Holding Company to an Institution</HD>
                <P>
                    The proposal would address the timing and amount of tax payments and hypothetical refunds to be received by an institution in a consolidated group from its holding company. For example, in a situation whereby the institution, as a separate entity, has a net operating loss (NOL) and other members of the group have taxable income, the consolidated group must utilize the institution's tax loss to reduce the consolidated group's current tax liability because consolidated tax return rules require the holding company to utilize the NOLs of members of the group to reduce the group's taxable income and thus its current tax liability.
                    <SU>18</SU>
                    <FTREF/>
                     As a result, in this situation, the holding company must reimburse the institution for the current use of its tax losses at the time the NOL is used. The institution must reflect the tax benefit of the loss in the current portion of its applicable income taxes in the period the loss is incurred.
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         26 CFR 1.1502-11 and 1.1502-12.
                    </P>
                </FTNT>
                <P>
                    Separately, the proposal would require that an institution must receive from its holding company no less than the tax refund amount it would have received had it filed tax returns on a separate entity basis. For example, this would apply if the institution has a tax loss and would have been able to carry back that loss to a previous year and obtain a tax refund from a taxing authority had it filed income tax returns on a separate entity basis, but there is no ability to obtain an actual refund because other members in the consolidated group had losses that offset the institution's separate tax liability for the previous year(s). Similarly, if the institution makes quarterly tax payments, on an aggregate basis, in excess of its annual tax liability at year end and would obtain a tax refund had it filed on a separate entity basis, the proposal would require that the institution receive from the holding company no less than the tax refund amount the institution would have received as a separate entity from the taxing authority. Consistent with the principle that the amount and timing of tax payments within the consolidated group should be no less favorable to the institution than if it were a separate taxpayer, this proposed requirement would ensure that an institution receives the full benefit of its tax assets, such as any tax losses or tax credits it generates as a separate entity, instead of allowing those benefits to subsidize the activities of other affiliates, even if other affiliates in the consolidated group generate offsetting tax liabilities that reduce or eliminate a refund to the consolidated group. In this situation, the holding company would be required to remit the amount due to the institution within a reasonable period following the date the institution would have filed its own return on a separate entity basis. The prompt transmittal of funds from the holding company to the institution would permit management to use those funds for the benefit of the institution rather than of the holding company.
                    <PRTPAGE P="24760"/>
                </P>
                <P>
                    If a holding company were to fail to remit amounts or refunds owed to its subsidiary institution promptly, that inaction may be considered an extension of credit under section 23A. A holding company's failure to remit amounts or refunds owed to its subsidiary institution also could be viewed as a constructive dividend from the institution to the holding company, which would be subject to other requirements under applicable regulations of the agencies.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See</E>
                         12 CFR part 5, subpart E, and 5.55 (OCC); 12 CFR 303.241 (FDIC).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Consolidated Tax Group Filings</HD>
                <P>
                    Under the proposal, a tax allocation agreement must require that all materials including, but not limited to, returns, supporting schedules, workpapers, correspondence, and other documents relating to the consolidated federal income tax return and any consolidated, combined, or unitary group state or local return, which return includes the institution, be made available on demand to the institution or any successor during regular business hours and that this requirement must survive any termination of the tax allocation agreement. Access to this information would permit the institution, as well as agency examiners, to evaluate compliance with the proposal, including whether the institution and holding company are appropriately calculating the institution's share of any tax liability and the institution's refund for use of its tax attributes. This proposed approach also is consistent with how the Internal Revenue Service views the relationship of members in a consolidated group with respect to tax documentation.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Internal Revenue Manual 11.3.2.4.4 (09-17-2020).
                    </P>
                </FTNT>
                <P>
                    With respect to insured depository institutions that enter receivership, the FDIC as receiver would be successor to any rights or interests of the insured depository institution with respect to various agreements, including any tax allocation agreement and the ability to obtain tax return information for the consolidated group of which the insured depository institution is a member.
                    <SU>21</SU>
                    <FTREF/>
                     Requiring the holding company to provide access to tax returns to the consolidated group, including the insured depository institution, would benefit the FDIC as receiver by improving its ability to meet its tax obligations and obtain tax refunds that are due and owed to the failed insured depository institution in a timely manner.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         26 U.S.C. 6103(e).
                    </P>
                </FTNT>
                <P>
                    <E T="03">Question [4]: What are the advantages and disadvantages of the proposed requirements for a tax allocation agreement between an institution and its affiliates? Are there other requirements that the agencies should consider prescribing?</E>
                </P>
                <P>
                    <E T="03">Question [5]: To what extent is the proposal consistent with current industry practices? To the extent that the proposal differs from current practice, what are the advantages and disadvantages of the proposal, relative to current industry practices?</E>
                </P>
                <HD SOURCE="HD2">D. Regulatory Reporting</HD>
                <P>
                    Regardless of whether an institution files as part of a consolidated group or as a separate entity, the institution must prepare its regulatory reports 
                    <SU>22</SU>
                    <FTREF/>
                     on a separate entity basis, as specified in the current instructions for those reports.
                    <SU>23</SU>
                    <FTREF/>
                     The current instructions for the Consolidated Reports of Condition and Income (Call Reports) issued by the Federal Financial Institutions Examination Council require an institution that is a subsidiary of a holding company to calculate and report its current and deferred taxes on a separate entity basis. This existing reporting requirement would be unaffected by the proposal, which would establish a similar principle. The proposal would address transactions involving the purported purchase or sale of, or advancement of funds with respect to, an institution's DTAs and DTLs (collectively, “deferred tax items”). A DTA or DTL is an estimate of an expected future tax benefit more likely than not to be realized or an expected future tax obligation to be paid, respectively. Deferred tax items are generated by and are intrinsically, and often legally, tied to the activities, assets, and liabilities of the institution. DTAs and DTLs represent the future effects on income taxes that result from temporary differences and carryforwards that exist at the end of a period.
                    <SU>24</SU>
                    <FTREF/>
                     The agencies would propose to revise the Call Report instructions to incorporate the treatment for deferred tax items under the proposal, as described in the 
                    <E T="03">Paperwork Reduction Act</E>
                     section of the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                    .
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         The Consolidated Reports of Condition and Income (Call Reports) (FFIEC 031, FFIEC 041, and FFIEC 051; OMB No. 1557-0081 (OCC), 7100-0036 (Board), and 3064-0052 (FDIC)).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         The separate entity method of accounting for income taxes of depository institution subsidiaries of holding companies is discussed in the glossary entry for “Income Taxes” in the Call Report instructions, available at: 
                        <E T="03">www.ffiec.gov/ffiec_report_forms.htm.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">See</E>
                         Acct. Standards Codification (ASC) Topic 740 ¶ 740-10-05-7 (Fin. Acct. Standards Bd. 2019).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Temporary Difference Deferred Tax Items</HD>
                <P>
                    Consistent with the separate entity basis reporting requirement, separating DTAs and DTLs from the associated assets or liabilities that gave rise to the deferred tax items would depart from one of the primary objectives related to accounting for income taxes, which is to recognize deferred tax items for the future tax consequences of events that have been recognized in an entity's financial statements or tax returns.
                    <SU>25</SU>
                    <FTREF/>
                     The relevant accounting standards specifically state that a temporary difference refers to a difference between the tax basis of an asset or liability and its reported amount in the financial statements that will result in taxable or deductible amounts in future years when the reported amount of the asset or liability is recovered or settled, respectively.
                    <SU>26</SU>
                    <FTREF/>
                     More specifically, DTAs are the deferred tax consequences attributable to deductible temporary differences and carryforwards, while DTLs are the deferred tax consequences attributable to taxable temporary differences.
                    <SU>27</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         
                        <E T="03">Id.</E>
                         ¶ 740-10-10-1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">Id.</E>
                         ¶ 740-10-05-7.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">Id.</E>
                         ¶ 740-10-20.
                    </P>
                </FTNT>
                <P>
                    Based on the description of deferred tax items in ASC paragraph 740-10-05-7 and the uncertainty over the actual amounts at which deferred tax items will be settled or realized in future periods, temporary difference deferred tax items should remain on the balance sheet as long as the associated assets or liabilities that give rise to those deferred tax items remain on the balance sheet. Accordingly, an institution's purchase, sale, or other transfer of deferred tax items arising from temporary differences is not acceptable under U.S. generally accepted accounting principles (GAAP) unless these items are transferred in connection with the transfer of the associated assets or liabilities. In the case of timing differences, it may be appropriate to transfer DTAs or DTLs resulting from a timing difference when the underlying asset or liability that created the future tax benefit or obligation is being purchased, sold, or transferred within the consolidated group.
                    <SU>28</SU>
                    <FTREF/>
                     In addition, when the DTA or DTL can be realized or is absorbed by the consolidated group in the current 
                    <PRTPAGE P="24761"/>
                    period tax return, it would be appropriate to settle or recover the DTA or DTL, respectively.
                    <SU>29</SU>
                    <FTREF/>
                     Therefore, as described in the 
                    <E T="03">Paperwork Reduction Act</E>
                     section of the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                    , the agencies plan to revise the Call Report instructions to clarify that transfers of temporary difference deferred tax items as described above are not consistent with GAAP.
                </P>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         When an asset or liability is transferred outside the consolidated group, the institution would no longer recognize the associated DTA or DTL. The institution would include the tax consequences of the transaction in the calculation of its current period tax expense or benefit.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Under GAAP, a deferred tax item generally becomes a current tax item when it is expected to be used to calculate estimated taxes payable or receivable on tax returns for current and prior years. ASC Topic 740 ¶ 740-10-25-2(a) (Fin. Acct. Standards Bd. 2019).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Operating Loss and Tax Credit Carryforward DTAs</HD>
                <P>
                    Carryforwards are deductions or credits that cannot be utilized on the tax return during a year that may be carried forward to reduce taxable income or taxes payable in a future year.
                    <SU>30</SU>
                    <FTREF/>
                     Thus, in contrast to temporary differences, carryforwards do not arise directly from book-tax basis differences associated with particular assets or liabilities.
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         
                        <E T="03">Id.</E>
                         ¶ 740-10-20.
                    </P>
                </FTNT>
                <P>
                    GAAP does not require a single allocation method for income taxes when members of a consolidated group issue separate financial statements.
                    <SU>31</SU>
                    <FTREF/>
                     The commonly applied “separate-return” method, which would reflect DTAs for NOLs and tax credit carryforwards on a separate return basis, would meet the relevant criteria.
                    <SU>32</SU>
                    <FTREF/>
                     Other systematic and rational methods that are consistent with the broad principles established by ASC 740 are also acceptable.
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         
                        <E T="03">See id.</E>
                         ¶ 740-10-30-27 (referring to ASC subtopic 740-10).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    The FDI Act provides that the accounting principles applicable to reports or statements required to be filed with the agencies by insured depository institutions should result in reports of condition that accurately reflect the capital of such institutions, facilitate effective supervision of the institutions, and facilitate prompt corrective action to resolve the institutions at the least cost to the Deposit Insurance Fund.
                    <SU>33</SU>
                    <FTREF/>
                     The FDI Act also provides that, in general, the accounting principles applicable to Call Reports must be uniform and consistent with GAAP.
                    <SU>34</SU>
                    <FTREF/>
                     However, this section permits the agencies to adopt alternate accounting principles for regulatory reporting that are no less stringent than GAAP, if the agencies find that application of GAAP fails to meet any of the objectives stated above.
                    <SU>35</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         12 U.S.C. 1831n(a)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         12 U.S.C. 1831n(a)(2)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         12 U.S.C. 1831n(a)(2)(B).
                    </P>
                </FTNT>
                <P>
                    The agencies are aware of instances in which institutions have engaged in transactions with affiliates in a consolidated group to purchase, sell, or otherwise transfer deferred tax items, specifically DTAs, other than current period tax losses useable in the consolidated group's tax return for the current period, which would otherwise be NOL carryforward DTAs for the institution. The agencies' regulatory capital rule requires the deduction from common equity tier 1 capital of NOLs and tax credit carryforward DTAs, net of any related valuation allowances and net of DTLs.
                    <SU>36</SU>
                    <FTREF/>
                     Because of this treatment, an institution may attempt to derecognize its DTAs for NOLs or tax credit carryforwards on its separate-entity regulatory reports prior to the time when the carryforward benefits are absorbed by the consolidated group by selling or otherwise transferring these DTAs to affiliates, particularly affiliates not subject to the agencies' regulatory capital rule, potentially overstating capital. While an institution may receive cash from affiliates in exchange for these transfers, the transfer may be reversible and not provide the same quality of regulatory capital as cash in the form of a capital contribution from a holding company.
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">See</E>
                         12 CFR 3.22(a)(3) (OCC); 12 CFR 217.22(a)(3) (Board); 12 CFR 324.22(a)(3) (FDIC).
                    </P>
                </FTNT>
                <P>
                    Second, there are significant valuation uncertainties associated with deferred tax items, particularly DTAs for NOLs or tax credit carryforwards, when the underlying tax attributes cannot be used or absorbed by the group in the current period. Even though deferred tax items are measured in accordance with the enacted tax rates expected to apply when these items are settled or realized, the actual amounts at which these items will be settled or realized will be determined using the tax rates in effect in the future periods when settlement or realization occurs. In cases where such transactions have been observed, the cash settlement for the deferred tax assets is based on tax rates at the time of the settlement between the entities. However, the actual tax benefit realized by the consolidated group may ultimately differ from that amount, depending upon tax rates at the time the relevant deferred tax asset is absorbed by the consolidated group. As a result, an institution that sells or purchases DTAs for NOLs or tax credit carryforwards may receive significantly less than, or overpay for, these DTAs in relation to the amounts at which these DTAs ultimately would have been realized had they not been transferred, which also raises concerns under section 23B to the extent that the insured depository institution is placed in a position less favorable than if it filed its income tax return on a separate entity basis.
                    <SU>37</SU>
                    <FTREF/>
                     For example, changes in federal tax laws, such as a change in the corporate income tax rate or provisions related to NOL carryback periods, can significantly affect the value of associated DTAs.
                    <SU>38</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         This circumstance also may raise concerns under section 23A, to the extent that monies owed to the insured depository institution from an affiliate as a result of these changed amounts are not paid promptly to the insured depository institution and may be viewed as extensions of credit subject to the requirements of section 23A.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See, e.g.,</E>
                         NOL carryback provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) and the Worker, Homeownership, and Business Assistance Act of 2009, and NOL and corporate tax rate changes in the Tax Cuts and Jobs Act. Public Law 116-136, 134 Stat. 281 (2020); Public Law 111-92, 123 Stat. 2984 (2009); Public Law 115-97, 131 Stat. 2054 (2017).
                    </P>
                </FTNT>
                <P>
                    For these reasons, the agencies have concluded that the derecognition by insured depository institutions of DTAs for NOL or tax credit carryforwards on their separate-entity regulatory reports before the period in which they are absorbed by the consolidated group raises significant concerns and would not meet the objectives described in 12 U.S.C. 1831n(a)(1).
                    <SU>39</SU>
                    <FTREF/>
                     Specifically, the agencies find that derecognizing DTAs for NOLs or tax credit carryforwards in the Call Report in such circumstances may not accurately reflect an institution's capital and may increase the cost to the Deposit Insurance Fund if insured depository institutions that have engaged in these transactions subsequently fail after the DTAs were sold for less than their value, and the FDIC as receiver is unable to fully recover the value of these DTAs under applicable tax laws.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         The establishment of valuation allowances for DTAs for NOL and tax credit carryforwards when required in accordance with U.S. GAAP is not a derecognition event.
                    </P>
                </FTNT>
                <P>
                    Consistent with this finding, as described in the 
                    <E T="03">Paperwork Reduction Act</E>
                     section of the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                    , the agencies expect to propose to revise the Call Report instructions to clarify that an institution must not derecognize DTAs for NOLs or tax credit carryforwards on its separate-entity regulatory reports prior to the time when such carryforwards are absorbed by the consolidated group.
                </P>
                <HD SOURCE="HD1">III. Incorporation of the Proposal as an Appendix to the Agencies' Safety and Soundness Rules</HD>
                <P>
                    The agencies would adopt the proposal under the procedures described in section 39 of the FDI Act.
                    <FTREF/>
                    <SU>40</SU>
                      
                    <PRTPAGE P="24762"/>
                    The OCC would also adopt the proposal for uninsured institutions under its general rulemaking authority.
                    <SU>41</SU>
                    <FTREF/>
                     Guidelines or standards adopted under section 39 through a rulemaking are accorded special enforcement treatment under that statute. The agencies each have procedural rules that implement the enforcement remedies for guidelines prescribed by section 39. Under procedural provisions in these rules, each agency would be authorized to require an institution that intends to participate in a consolidated tax filing group and does not have an acceptable tax allocation agreement to develop a plan to implement an acceptable agreement consistent with the proposal or to be subject to enforcement actions.
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         12 U.S.C. 1831p-1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         12 U.S.C. 93a.
                    </P>
                </FTNT>
                <P>Each agency proposes to incorporate the proposal as an appendix to its relevant safety and soundness rule (located in 12 CFR part 30 (OCC), 12 CFR part 208 (Board) and part 364 (FDIC)).</P>
                <HD SOURCE="HD1">IV. Impact Analysis</HD>
                <HD SOURCE="HD2">Scope of Application</HD>
                <P>
                    As of the most recent data, the agencies estimate that 2,604 supervised institutions (including 2,581 insured institutions and 23 uninsured OCC-chartered institutions) would be subject to the proposal.
                    <SU>42</SU>
                    <FTREF/>
                     Covered institutions must be part of a consolidated group and obligated to pay federal and state income taxes. These covered institutions represent 51 percent of all institutions supervised by the agencies, and they hold over 93 percent of total assets of all institutions supervised by the agencies.
                    <SU>43</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         Call Report data, September 30, 2020. The agencies estimate the covered institutions by subtracting the 1,537 insured institutions and 3 uninsured OCC-chartered institutions supervised by the agencies that are subsidiaries of bank or thrift holding companies supervised by the Board, are registered as Subchapter S corporations, and would not be affected by the adoption of the proposal; from the 4,118 insured institutions and 26 uninsured OCC-chartered institutions supervised by the agencies that are subsidiaries of bank or thrift holding companies supervised by the Board, respectively.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         Id.
                    </P>
                </FTNT>
                <P>The agencies do not have, nor are they aware of, data that indicates whether any particular institution files taxes as part of a consolidated group, whether the institutions have tax allocation agreements with their holding companies, or whether the institutions have agreements that would conform with the proposal. Therefore, it is difficult to accurately estimate the number of institutions that would be potentially affected by the proposal. However, in their supervision of institutions, the agencies have observed that only a small number of institutions in consolidated groups lack tax allocation agreements with their holding companies, have agreements that do not have language conforming with section 23A or 23B, or engage in transfers of DTAs or DTLs that are inconsistent with the separate entity basis reporting requirement. Overall, due to the fact that the agencies expect most covered institutions to already be in compliance with the proposal, the expected costs of the proposal are likely to be small.</P>
                <P>The potential benefits and costs discussed below generally apply to the supervised institutions, their affiliates, and holding companies that are not already implementing principles from the existing non-codified guidance.</P>
                <HD SOURCE="HD2">Benefits</HD>
                <P>There are three key benefits of the proposal. First, in some situations, the proposal would strengthen the safety and soundness of covered insured and uninsured institutions by ensuring that consolidated tax filing arrangements and practices are not adverse to their interests. Second, in some circumstances, the proposal would reduce the FDIC's resolution-related costs for covered insured institutions. Third, under some circumstances, the proposal would result in institutions more accurately reflecting their common equity tier 1 capital. These issues are discussed in more detail below.</P>
                <P>The proposal could strengthen the safety and soundness of covered institutions. In particular, to the extent that covered institutions, their affiliates, and holding companies are not already implementing principles from the existing non-codified guidance, it may be possible to transfer tax credits out of the institution to a parent or affiliate. In this situation, the transfer weakens the safety and soundness of the institution. The proposal would limit such transfers, increasing the safety and soundness of the covered institution.</P>
                <P>The effect of the proposal on safety and soundness of all members of a consolidated group can be more nuanced. For example, when the parent or affiliate entity retains the transfers of tax credits out of the covered institution, the potential reduction of the safety and soundness of the covered institution may be accompanied by a corresponding increase in safety and soundness at the holding company or other affiliates.</P>
                <P>To the extent there are covered institutions that currently engage in transactions involving NOL and tax credit carryforward DTAs within a consolidated group, the proposal could result in fewer transfers of such deferred tax items and the covered institutions may be more likely to receive equitable treatment. Furthermore, if the proposal were adopted, the covered institutions would retain access to the appropriate share of funds as they avoid being underpaid, or overpaying, in the course of the transactions related to deferred tax items.</P>
                <P>By requiring a tax allocation agreement, and clear language in such agreements about an agency relationship, the proposal could reduce the cost of resolving failed insured depository institutions. In particular, to the extent that covered institutions, their affiliates, and holding companies are not already implementing principles from the existing non-codified guidance, it is possible to transfer tax credits out of the insured depository institution and into a parent or affiliate thereby reducing the value of the assets of the insured depository institution and raising the cost of resolving failed banks. Prompt receipt of tax refunds and appropriate timing and payment of tax obligations based on terms and provisions in a tax allocation agreement would, in some situations, result in the insured depository institution being better capitalized when entering receivership, and allow the FDIC to avoid litigation over the consolidated group's tax refunds and reduce uncertainties over any tax liabilities. By reducing the insured depository institution's failure resolution costs, including the related litigation and other procedural costs of resolution, the proposal would allow the FDIC to more efficiently resolve failed insured depository institutions, carry out its mission in a more cost-effective manner, and reduce future costs to the Deposit Insurance Fund.</P>
                <P>
                    As described in the 
                    <E T="03">Operating Loss and Tax Credit Carryforward DTAs</E>
                     section of the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                    , the agencies are aware of instances in which institutions have engaged in transactions with affiliates in a consolidated group to purchase, sell, or otherwise transfer deferred tax items, specifically DTAs, other than current period tax losses useable in the consolidated group's tax return for the current period, which would otherwise be NOL and tax credit carryforward DTAs for the covered institution. The proposal clarifies regulatory reporting requirements to help ensure that an institution recognizes all its individual deferred tax items, including those arising from temporary timing 
                    <PRTPAGE P="24763"/>
                    differences, in its regulatory reports.
                    <SU>44</SU>
                    <FTREF/>
                     An institution cannot report such items on its Call Reports separately from the asset or liability that gave rise to it, except under certain circumstances that are appropriate under GAAP.
                    <SU>45</SU>
                    <FTREF/>
                     The proposal also addresses accounting principles for regulatory reporting for institutions' transactions involving the purported purchase or sale of, or advancement of funds with respect to its NOLs and tax credit carryforward DTAs 
                    <SU>46</SU>
                    <FTREF/>
                     to other affiliates in the consolidated group or the holding company. The agencies' regulatory capital rule requires the deduction from common equity tier 1 capital of NOL and tax credit carryforward DTAs, net of any related valuation allowances and net of DTLs.
                    <SU>47</SU>
                    <FTREF/>
                     Thus, by clarifying the regulatory reporting requirements, the proposal would more accurately reflect institutions' common equity tier 1 capital.
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         For banks, savings associations, and non-deposit trust companies, the Consolidated Reports of Condition and Income (Call Reports) (FFIEC 031, FFIEC 041, and FFIEC 051; OMB No. 1557-0081 (OCC), 7100-0036 (Board), and 3064-0052 (FDIC)).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         GAAP does not prohibit the purchase, sale, or transfer of deferred tax items of the institutions within the consolidated group if the institution would not be entitled to a current refund on a separate entity basis, or if the purchase, sale, or transfer of deferred tax items occurs in conjunction with the purchase, sale, or transfer of the assets or the liabilities giving rise to those items.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         In contrast to temporary differences, carryforwards do not arise directly from book-tax basis differences associated with particular assets or liabilities.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         
                        <E T="03">See</E>
                         12 CFR 3.22(a)(3) (OCC); 12 CFR 217.22(a)(3) (Board); 12 CFR 324.22(a)(3) (FDIC).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Costs</HD>
                <P>To the extent the supervised institutions, their affiliates, and holding companies are not already implementing principles from the existing non-codified guidance, there are two primary costs of the proposal. First, parent companies and affiliates of covered institutions could lose some discretion over the timing, magnitude, and direction of cash flows between members of the group. Second, there would be regulatory costs associated with preparing agreements as well as ongoing compliance or reporting expenses. These issues are discussed in more detail below.</P>
                <P>Under the proposal, holding companies would be required to remit tax refunds to their subsidiary institutions, if the relevant subsidiary's tax assets such as net operating losses or tax credits generate the refund. Similarly, if the institution's tax assets allow the group to make smaller payments to a tax authority, the institution must be compensated at such time as when the consolidated group has benefitted from the use of its assets. The proposal would also enable institutions to avoid scenarios whereby they are required to submit tax payments to their holding company either materially before the holding company must remit taxes to the tax authority or greater than their actual obligations. The proposal could also result in certain holding companies ceasing to retain tax refunds and transmitting refunds to their subsidiary institutions, or no longer receiving funds well in advance of the obligated payment date.</P>
                <P>Mandatory tax allocation agreements with terms outlined in the proposal would reduce discretion over the timing, magnitude, or direction of certain cash flows between members of the group. This may reduce the flexibility of the holding company to allocate funds between members of the consolidated group, potentially resulting in reduced growth or profitability.</P>
                <P>
                    To the extent the supervised institutions, their affiliates, and holding companies are not already implementing principles from the existing non-codified guidance, they could incur regulatory costs in order to enter into tax allocation agreements that comply with the requirements in the proposal. While these costs are uncertain, they are likely to be relatively small given that in the agencies' experience only a small number of institutions do not have a tax allocation agreement or, have a tax allocation agreement that does not conform with the proposal. Further, the 
                    <E T="03">Paperwork Reduction Act</E>
                     section of the 
                    <E T="02">Supplementary Information</E>
                     describes relatively small recordkeeping, reporting and disclosure costs associated with the proposal for covered entities.
                </P>
                <P>Overall, due to the fact that the agencies expect most covered institutions to already be in compliance with the proposal, the expected costs are likely to be small. The proposal would increase the safety and soundness of institutions not implementing the principles in the Interagency Policy Statement and the 2014 Addendum and reduce litigation costs to the Deposit Insurance Fund.</P>
                <HD SOURCE="HD1">V. Administrative Law Matters</HD>
                <HD SOURCE="HD2">A. Paperwork Reduction Act</HD>
                <P>Certain provisions of the proposal contain “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) (PRA). In accordance with the requirements of the PRA, the agencies may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The agencies will request new control numbers for this information collection. The information collection requirements contained in this proposal have been submitted to OMB for review and approval by the OCC and FDIC under section 3507(d) of the PRA (44 U.S.C. 3507(d)) and § 1320.11 of the OMB's implementing regulations (5 CFR part 1320). The Board reviewed the proposal under the authority delegated to the Board by OMB.</P>
                <P>Comments are invited on:</P>
                <P>a. Whether the collections of information are necessary for the proper performance of the agencies' functions, including whether the information has practical utility;</P>
                <P>b. The accuracy or the estimate 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;</P>
                <P>d. Ways to minimize the burden of the information collections on respondents, including through the use of automated collection techniques or other forms of information technology; and</P>
                <P>e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.</P>
                <P>
                    All comments will become a matter of public record. Comments on aspects of this notice that may affect reporting, recordkeeping, or disclosure requirements and burden estimates should be sent to the addresses listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. A copy of the comments may also be submitted to the OMB desk officer for the agencies by mail to U.S. Office of Management and Budget, 725 17th Street NW, #10235, Washington, DC 20503; facsimile to (202) 395-6974; or email to 
                    <E T="03">oira_submission@omb.eop.gov,</E>
                     Attention, Federal Banking Agency Desk Officer.
                </P>
                <HD SOURCE="HD3">(1) New Information Collection</HD>
                <HD SOURCE="HD3">OCC</HD>
                <P>
                    <E T="03">OMB control number:</E>
                     1557-NEW.
                </P>
                <P>
                    <E T="03">Title of Information Collection:</E>
                     Recordkeeping Provisions Associated with the Interagency Guidelines on Safety and Soundness Standards for Tax Allocation Agreements.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Event generated, annually.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     National banks and federal savings associations.
                    <PRTPAGE P="24764"/>
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     579.
                </P>
                <P>
                    <E T="03">Estimated average hours per response:</E>
                </P>
                <P>Recordkeeping Section 30 Appendix F Initial setup—20.</P>
                <P>Recordkeeping Section 30 Appendix F Ongoing—1.</P>
                <P>
                    <E T="03">Estimated annual burden hours:</E>
                </P>
                <P>Recordkeeping Section 30 Appendix F Initial setup—11,580.</P>
                <P>Recordkeeping Section 30 Appendix F Ongoing—579.</P>
                <P>Total—12,159.</P>
                <HD SOURCE="HD3">Board</HD>
                <P>
                    <E T="03">OMB control number:</E>
                     7100-NEW.
                </P>
                <P>
                    <E T="03">Title of Information Collection:</E>
                     Recordkeeping Provisions Associated with the Interagency Guidelines on Safety and Soundness Standards for Tax Allocation Agreements.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Event generated, annual.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     State member banks.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     435.
                </P>
                <P>
                    <E T="03">Estimated average hours per response:</E>
                </P>
                <P>Recordkeeping Section 208 Appendix D-3 Initial setup—20.</P>
                <P>Recordkeeping Section 208 Appendix D-3 Ongoing—1.</P>
                <P>
                    <E T="03">Estimated annual burden hours:</E>
                </P>
                <P>Recordkeeping Section 208 Appendix D-3 Initial setup—8,700.</P>
                <P>Recordkeeping Section 208 Appendix D-3 Ongoing—435.</P>
                <HD SOURCE="HD3">FDIC</HD>
                <P>
                    <E T="03">OMB control number:</E>
                     3064-NEW.
                </P>
                <P>
                    <E T="03">Title of Information Collection:</E>
                     Recordkeeping Provisions Associated with the Interagency Guidelines on Safety and Soundness Standards for Tax Allocation Agreements.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     Event generated, annual.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     State nonmember banks and state savings associations.
                </P>
                <P>
                    <E T="03">Estimated average hours per response:</E>
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     1,590.
                </P>
                <P>
                    <E T="03">Estimated average hours per response:</E>
                </P>
                <P>Recordkeeping Section 364 Appendix C Initial setup—20.</P>
                <P>Recordkeeping Section 364 Appendix C Ongoing—1.</P>
                <P>
                    <E T="03">Estimated annual burden hours:</E>
                </P>
                <P>Recordkeeping Section 364 Appendix C Initial setup—31,800.</P>
                <P>Recordkeeping Section 364 Appendix C Ongoing—1,590.</P>
                <P>
                    <E T="03">Current Actions:</E>
                     The proposal prescribes PRA recordkeeping requirements for tax allocation agreements that involve institutions supervised by the agencies. Each institution that is part of a consolidated group must enter into a written tax allocation agreement with its holding company. The respective boards of directors of each institution and its parent holding company must approve the tax allocation agreement.
                </P>
                <HD SOURCE="HD3">(2) FFIEC 031, FFIEC 041, and FFIEC 051</HD>
                <HD SOURCE="HD3">Current Actions</HD>
                <P>
                    In addition, the proposal would require changes to the instructions for the Call Reports (OMB No. 1557-0081 (OCC), 7100-0036 (Board), and 3064-0052 (FDIC)), which will be addressed in a separate 
                    <E T="04">Federal Register</E>
                     notice.
                </P>
                <HD SOURCE="HD2">B. Regulatory Flexibility Act Analysis</HD>
                <P>
                    <E T="03">OCC:</E>
                     In general, the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 
                    <E T="03">et seq.,</E>
                     requires an agency, in connection with a proposed rule, to prepare and make available for public comment an Initial Regulatory Flexibility Analysis describing the impact of the rule on small entities (defined by the Small Business Administration (SBA) for purposes of the RFA to include commercial banks and savings institutions with total assets of $600 million or less and trust companies with total assets of $41.5 million of less) or to certify that the proposed rule would not have a significant economic impact on a substantial number of small entities. The OCC currently supervises approximately 745 small entities, of which 281 may be within the scope of the proposed rule. The OCC classifies the economic impact on an individual small entity as significant if the total estimated impact in one year is greater than 5 percent of the small entity's total annual salaries and benefits or greater than 2.5 percent of the small entity's total non-interest expense. The OCC estimates the cost of implementing or revising the tax allocation agreements under the proposal would be less than $1,000 per institution and not result in a significant economic impact to these entities. Therefore, the OCC certifies that the proposal, if adopted as final, would not have a significant economic impact on a substantial number of small entities.
                </P>
                <P>
                    <E T="03">Board:</E>
                     The Board is providing an initial regulatory flexibility analysis with respect to this proposal. The Regulatory Flexibility Act, 5 U.S.C. 601 
                    <E T="03">et seq.</E>
                     (RFA), requires an agency to consider whether the rules it proposes will have a significant economic impact on a substantial number of small entities. In connection with a proposed rule, the RFA requires an agency to prepare an Initial Regulatory Flexibility Analysis describing the impact of the rule on small entities or to certify that the proposed rule would not have a significant economic impact on a substantial number of small entities. An initial regulatory flexibility analysis must contain (1) a description of the reasons why action by the agency is being considered; (2) a succinct statement of the objectives of, and legal basis for, the proposed rule; (3) a description of, and, where feasible, an estimate of the number of small entities to which the proposed rule will apply; (4) a description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities that will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; (5) an identification, to the extent practicable, of all relevant Federal rules which may duplicate, overlap with, or conflict with the proposed rule; and (6) a description of any significant alternatives to the proposed rule which accomplish its stated objectives.
                </P>
                <P>The Board has considered the potential impact of the proposal on small entities in accordance with the RFA. Based on its analysis and for the reasons stated below, the proposal is not expected to have a significant economic impact on a substantial number of small entities. Nevertheless, the Board is publishing and inviting comment on this initial regulatory flexibility analysis. The Board will consider whether to conduct a final regulatory flexibility analysis after any comments received during the public comment period have been considered.</P>
                <HD SOURCE="HD3">Reasons Why Action Is Being Considered by the Board</HD>
                <P>In their supervision of institutions, the agencies have observed that certain institutions in consolidated groups either lack tax allocation agreements with their holding companies or have agreements that fail to ensure that the institutions receive the benefit of their tax attributes, which could negatively impact the safety and soundness of these institutions. Although there is existing interagency guidance relating to tax allocation agreements, this guidance is nonbinding.</P>
                <HD SOURCE="HD3">The Objectives of, and Legal Basis for, the Proposal</HD>
                <P>
                    The proposal would codify and make enforceable (with certain modifications) earlier guidance documents relating to tax allocation agreements. The proposal is intended to (1) ensure that state member banks that file taxes as part of a consolidated group have tax allocation agreements in place, and (2) specify certain mandatory terms for such agreements. The proposal would also clarify that an institution must not derecognize DTAs for NOLs or tax credit carryforwards on its separate-entity regulatory reports prior to the time 
                    <PRTPAGE P="24765"/>
                    when such carryforwards are absorbed by the consolidated group.
                </P>
                <P>
                    The Board proposes to adopt the proposal pursuant to sections 39 and 37 of the FDI Act.
                    <SU>48</SU>
                    <FTREF/>
                     Section 39 of the FDI Act authorizes the Board to prescribe standards for safety and soundness by regulation or guideline. Section 37 of the FDI Act permits the Board to prescribe an accounting principle applicable to insured depository institutions that is no less stringent than generally accepted accounting principles. The guidelines promulgated under the proposal would be incorporated as an appendix to the Interagency Guidelines Establishing Standards for Safety and Soundness contained in 12 CFR part 208.
                </P>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         12 U.S.C. 1831p-1 and 12 U.S.C. 1831(a)(2).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Estimate of the Number of Small Entities</HD>
                <P>
                    The proposal would apply to state member banks. According to Call Reports, there are approximately 455 state member banks that are small entities for purposes of the RFA.
                    <SU>49</SU>
                    <FTREF/>
                     213 of these entities are registered as Subchapter S corporations, would pay no tax at the business level, and therefore would not be impacted by the proposal. Additionally, the majority of potentially impacted small entities are likely already party to a tax allocation agreement, as discussed in existing guidance, and thus the number of small entities impacted by the proposal's requirements is likely to be considerably smaller.
                </P>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         Under regulations issued by the Small Business Administration, a small entity includes a depository institution, bank holding company, or savings and loan holding company with total assets of $600 million or less. 
                        <E T="03">See</E>
                         84 FR 34261 (July 18, 2019). Consistent with the General Principles of Affiliation in 13 CFR 121.103, the Board counts the assets of all domestic and foreign affiliates when determining if the Board should classify a Board-supervised institution as a small entity. The small entity information is based on Call Report data as of September 30, 2020.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Description of the Compliance Requirements of the Proposal</HD>
                <P>
                    The proposal would require state member banks to enter into tax allocation agreements containing certain specified terms. To the extent that institutions are not already party to compliant tax allocation agreements, they could incur administrative costs to enter into tax allocation agreements that comply with this proposal, or to modify existing tax allocation agreements to be compliant, which would require legal and accounting skills. It is likely that the majority of potentially impacted small entities are already party to a tax allocation agreement, as discussed in existing guidance. The majority of these agreements are likely either compliant with the proposal or could be made compliant with relatively minor modifications. Board staff estimates that impacted Board-supervised small entities will spend 20 hours establishing or modifying a tax allocation agreement, at an hourly cost of $115.00.
                    <SU>50</SU>
                    <FTREF/>
                     The estimated aggregate initial administrative costs of the proposal to Board-supervised small entities amount to $556,600.00,
                    <SU>51</SU>
                    <FTREF/>
                     and ongoing costs are expected to be small when measured by small banks' annual expenses. In addition, the proposal may also reduce existing flexibility around the timing of compensation from holding companies to state member banks for the use of their tax attributes. The Board does not anticipate any material impact on the overall tax liability of consolidated groups as a result of the proposal.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         To estimate average hourly wages, we review data from September 2020 for wages (by industry and occupation) from the U.S. Bureau of Labor Statistics (BLS) for depository credit intermediation (NAICS 522100). To estimate compensation costs associated with the rule, we use $115 per hour, which is based on the weighted average of the 75th percentile for four occupations adjusted for inflation, plus an additional 33.9 percent to cover private sector benefits.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         This estimate is based on the assumption that all 242 Board-supervised small entities that are not Subchapter S corporations would need to spend 20 hours establishing or modifying a tax allocation agreement, at a cost of $115.00 per hour. As discussed above, because the proposal largely codifies existing guidance and likely reflects existing industry practice, the number of small entities impacted by the rule's requirements and the initial aggregate administrative cost of the proposal is likely to be considerably smaller.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Consideration of Duplicative, Overlapping, or Conflicting Rules and Significant Alternatives to the Proposal</HD>
                <P>The Board has not identified any federal statutes or regulations that would duplicate, overlap, or conflict with the proposal. The Board has considered the alternative of maintaining or amending existing interagency guidance but considers the proposal to be a more appropriate alternative.</P>
                <P>
                    <E T="03">FDIC:</E>
                </P>
                <P>
                    The RFA generally requires that, in connection with a proposed rulemaking, an agency prepare and make available for public comment an initial regulatory flexibility analysis describing the impact of the proposed rule on small entities.
                    <SU>52</SU>
                    <FTREF/>
                     However, a regulatory flexibility analysis is not required if the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The SBA has defined “small entities” to include banking organizations with total assets of less than or equal to $600 million that are independently owned and operated or owned by a holding company with less than or equal to $600 million in total assets.
                    <SU>53</SU>
                    <FTREF/>
                     Generally, the FDIC considers a significant effect to be a quantified effect in excess of 5 percent of total annual salaries and benefits per institution, or 2.5 percent of total non-interest expenses. The FDIC believes that effects in excess of these thresholds typically represent significant effects for FDIC-supervised institutions. The FDIC does not believe that the proposed rule, if adopted, will have a significant economic effect on a substantial number of small entities. However, some expected effects of the proposed rule are difficult to assess or accurately quantify given current information, therefore the FDIC has included an Initial Regulatory Flexibility Act Analysis in this section.
                </P>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         5 U.S.C. 601 
                        <E T="03">et seq.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         The SBA defines a small banking organization as having $600 million or less in assets, where “a financial institution's assets are determined by averaging the assets reported on its four quarterly financial statements for the preceding year.” 
                        <E T="03">See</E>
                         13 CFR 121.201 (as amended, effective August 19, 2019). In its determination, the “SBA counts the receipts, employees, or other measure of size of the concern whose size is at issue and all of its domestic and foreign affiliates.” 
                        <E T="03">See</E>
                         13 CFR 121.103. Following these regulations, the FDIC uses a covered entity's affiliated and acquired assets, averaged over the preceding four quarters, to determine whether the covered entity is “small” for the purposes of RFA.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Reasons Why This Action Is Being Considered</HD>
                <P>
                    As previously discussed, in its supervision of institutions, the FDIC has observed that some institutions and affiliated entities in consolidated groups lack tax allocation agreements with their holding companies, have agreements that do not have language conforming with section 23A or 23B, or engage in the sale or transfer of DTAs or DTLs with other entities in a consolidated tax filing group that is inconsistent with the separate entity basis reporting requirement. In particular, the FDIC has reviewed tax allocation agreements that do not require holding companies in a consolidated group to promptly transmit the appropriate portion of a consolidated group's tax refund to their subsidiary institutions, resulting in some holding companies failing to do so in some instances. The FDIC believes that such inaction could adversely affect the safety and soundness of the subsidiary institutions. Further, in its capacity as receiver for failed insured depository institutions, the FDIC has engaged in legal disputes regarding the ownership of tax refunds claimed by the holding company based on losses incurred by insured depository institutions in a consolidated group due 
                    <PRTPAGE P="24766"/>
                    to tax allocation agreements that did not clearly acknowledge an agency relationship between the insured depository institution and its holding company. These disputes can reduce or prevent recoveries by the FDIC on behalf of failed insured depository institutions, which increases the cost to the Deposit Insurance Fund and thus leads to higher FDIC deposit insurance premiums charged to solvent insured depository institutions.
                </P>
                <HD SOURCE="HD3">Policy Objectives</HD>
                <P>The primary objective of the proposal is to further clarify the relationship between institutions supervised by the agencies (including insured depository institutions and uninsured institutions) and affiliates or parent holding companies who are in a consolidated tax filing group with respect to the treatment of tax obligations, tax refunds and related intra-group transactions. Tax allocation agreements between institutions and their holding companies and other affiliates are important safeguards to ensure compliance by institutions with sections 23A and 23B and certain other agency regulations that ensure that holding companies in a consolidated group promptly transmit the appropriate portion of a consolidated group's tax refund to their subsidiary institutions.</P>
                <HD SOURCE="HD3">Legal Basis</HD>
                <P>
                    The FDIC proposes to adopt the guidelines pursuant to sections 39 and 37 of the FDI Act.
                    <SU>54</SU>
                    <FTREF/>
                     Section 39 prescribes different consequences depending on whether the agency issues regulations or guidelines. Under these provisions, an agency may require an institution that intends to participate in a consolidated tax filing group and does not have an acceptable tax allocation agreement to develop a plan to implement an acceptable agreement consistent with the proposal or to be subject to enforcement actions. Section 37(a) of the FDI Act states that the accounting principles applicable to reports or statements required to be filed with the agencies by institutions should result in reports of condition that accurately reflect the capital of such institutions, facilitate effective supervision of the institutions, and facilitate prompt corrective action to resolve the institutions at the least cost to the Deposit Insurance Fund.
                    <SU>55</SU>
                    <FTREF/>
                     For a more detailed discussion of the proposal's legal basis please refer to Section III entitled “Incorporation of the Guidelines as an Appendix to the Agencies' Safety and Soundness Rules”.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         12 U.S.C. 1831p-1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         
                        <E T="03">See</E>
                         12 U.S.C. 1831n(a)(1).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">The Proposed Rule</HD>
                <P>
                    The FDIC proposes to incorporate the guidelines as an appendix to its safety and soundness rule in part 364. The FDIC has procedural rules in part 364 that implement the enforcement remedies prescribed by section 39. Under these provisions, the FDIC may require an institution that does not have an acceptable tax allocation agreement to develop a plan to implement an acceptable agreement consistent with the proposal or be subject to enforcement actions.
                    <SU>56</SU>
                    <FTREF/>
                     For a more detailed discussion of the proposal please refer to Section II entitled “Description of the Proposal” and Section III entitled “Incorporation of the Guidelines as an Appendix to the Agencies' Safety and Soundness Rules”.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         
                        <E T="03">See</E>
                         12 U.S.C. 1831n(a)(1).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Small Entities Affected</HD>
                <P>
                    As of the most recent data, the FDIC supervises 3,245 depository institutions of which 2,434 are “small” entities according to the terms of the RFA. Covered institutions must be part of a consolidated group, and subject to and obligated to pay federal and state income tax. The FDIC estimates that 1,008 small, FDIC-supervised institutions will be subject to the proposal.
                    <SU>57</SU>
                    <FTREF/>
                     These covered institutions represent 41 percent of all small institutions supervised by the FDIC, and they hold over 47 percent of total assets of all small institutions supervised by the FDIC.
                    <SU>58</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         Call Report data, September 30, 2020. The FDIC estimates small covered institutions by subtracting the 906 small insured institutions supervised by the FDIC that are subsidiaries of bank or thrift holding companies supervised by the Board, are registered as Subchapter S corporations, and would not be affected by the adoption of the proposed rule; from the 1,914 small insured institutions supervised by the FDIC that are subsidiaries of bank or thrift holding companies supervised by the Board, respectively.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         Id.
                    </P>
                </FTNT>
                <P>
                    As described in the 
                    <E T="03">Impact Analysis</E>
                     section of the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                    , it is difficult to accurately estimate the number of small FDIC-supervised institutions that would be potentially affected by the proposal. Specifically, the FDIC does not have data that indicates whether or not any particular small FDIC-supervised institution files taxes as a consolidated group, whether the small FDIC-supervised institutions have tax allocation agreements with their holding companies, or whether the institutions have agreements that do not have language conforming with section 23A or 23B. However, the FDIC believes that the number of small, FDIC-supervised depository institutions that will be directly affected by the proposal is likely to be small, given that in the agencies' supervisory experience only a small number of institutions do not currently have tax allocation agreements, have existing tax allocation agreements that do not have language conforming with section 23A or 23B, or engage in the sale or transfer of DTAs or DTLs with other entities in a consolidated tax filing group that is not consistent with the separate entity basis reporting requirement, notwithstanding the existing non-codified guidance.
                </P>
                <HD SOURCE="HD3">Expected Effects</HD>
                <P>The potential benefits and costs summarized below generally apply to the small FDIC-supervised institutions, their affiliates, and holding companies that are not already implementing principles from the existing non-codified guidance.</P>
                <HD SOURCE="HD3">Benefits</HD>
                <P>
                    There are three key benefits of the proposal. First, in some situations, the proposal would strengthen the safety-and-soundness of covered small FDIC-supervised institutions by ensuring that consolidated tax filing arrangements and practices are not adverse to their interests. Second, in some circumstances, the proposal would reduce the FDIC's resolution-related costs. Third, under some circumstances, the proposal would result in small FDIC-supervised institutions more accurately reflecting their common equity tier 1 capital. These benefits are discussed in more detail in the 
                    <E T="03">Impact Analysis</E>
                     section of the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                    .
                </P>
                <HD SOURCE="HD3">Costs</HD>
                <PRTPAGE P="24767"/>
                <P>
                    To the extent the small, FDIC-supervised institutions, their affiliates, and holding companies are not already implementing principles from the existing non-codified guidance, there are two primary costs of the proposal. First, covered small FDIC-supervised institutions, their parent companies, and affiliates could lose some discretion over the timing, magnitude, and direction of cash flows between members of the group. Second, there would be regulatory costs associated with preparing agreements as well as ongoing compliance or reporting expenses. These costs are discussed in more detail in the 
                    <E T="03">Impact Analysis</E>
                     section of the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                    .
                </P>
                <P>Overall, due to the fact that the FDIC expects most small FDIC-supervised institutions to already be in compliance with the proposal, the expected effects are likely to be small.</P>
                <HD SOURCE="HD3">Alternatives Considered</HD>
                <P>
                    The FDIC considered the status quo alternative to maintain or amend the existing guidance and not include the guidance as a new codified appendix to the agencies' safety and soundness rules. However, for reasons previously stated in the 
                    <E T="03">Background</E>
                     section of the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                    , the FDIC considers the proposal to be a more appropriate alternative.
                </P>
                <HD SOURCE="HD3">Other Statutes and Federal Rules</HD>
                <P>The FDIC has not identified any likely duplication, overlap, and/or potential conflict between this proposal and any other federal rule.</P>
                <P>The FDIC invites comments on all aspects of the supporting information provided in this RFA section. In particular, would the proposal have any significant effects on small entities that the FDIC has not identified?</P>
                <HD SOURCE="HD2">C. Plain Language</HD>
                <P>
                    Section 722 of the Gramm-Leach-Bliley Act requires the Federal banking agencies to use plain language in all proposed and final rules published after January 1, 2000.
                    <SU>59</SU>
                    <FTREF/>
                     The agencies have sought to present the proposal as a new appendix to certain codified safety and soundness rules in a simple and straightforward manner and invite comment on the use of plain language. For example:
                </P>
                <FTNT>
                    <P>
                        <SU>59</SU>
                         Public Law 106-102, sec. 722, 113 Stat. 1338 (codified at 12 U.S.C. 4809).
                    </P>
                </FTNT>
                <P>• Have the agencies organized the material to suit your needs? If not, how could they present the proposal more clearly?</P>
                <P>• Are the requirements in the proposal clearly stated? If not, how could the proposal be more clearly stated?</P>
                <P>• Does the proposal contain technical language or jargon that is not clear? If so, which language requires clarification?</P>
                <P>• Would a different format (grouping and order of sections, use of headings, paragraphing) make the proposal easier to understand? If so, what changes would achieve that?</P>
                <P>• Is the section format adequate? If not, which of the sections should be changed and how?</P>
                <P>• What other changes can the agencies incorporate to make the proposal easier to understand?</P>
                <HD SOURCE="HD2">D. Riegle Community Development and Regulatory Improvement Act of 1994</HD>
                <P>
                    Pursuant to section 302(a) of the Riegle Community Development and Regulatory Improvement Act of 1994 (RCDRIA),
                    <SU>60</SU>
                    <FTREF/>
                     in determining the effective date and administrative compliance requirements for new regulations that impose additional reporting, disclosure, or other requirements on insured depository institutions, each Federal banking agency must consider, consistent with principles of safety and soundness and the public interest, any administrative burdens that such regulations would place on depository institutions, including small depository institutions, and customers of depository institutions, as well as the benefits of such regulations. In addition, section 302(b) of RCDRIA requires new regulations and amendments to regulations that impose additional reporting, disclosures, or other new requirements on insured depository institutions generally to take effect on the first day of a calendar quarter that begins on or after the date on which the regulations are published in final form.
                    <SU>61</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>60</SU>
                         12 U.S.C. 4802(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>61</SU>
                         12 U.S.C. 4802.
                    </P>
                </FTNT>
                <P>The agencies invite comments that will further inform their consideration of RCDRIA.</P>
                <HD SOURCE="HD2">E. OCC Unfunded Mandates Reform Act of 1995</HD>
                <P>
                    The OCC analyzed the proposal under the factors set forth in the Unfunded Mandates Reform Act of 1995 (UMRA).
                    <SU>62</SU>
                    <FTREF/>
                     Under this analysis, the OCC considered whether the proposal includes a Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $157 million or more in any one year (as adjusted for inflation). The OCC has determined that the proposal, if implemented, could result in total costs of approximately $1 million for OCC institutions. Therefore, the OCC believes the proposal, if adopted as final, will not result in a Federal mandate imposing costs of $157 million or more.
                </P>
                <FTNT>
                    <P>
                        <SU>62</SU>
                         2 U.S.C. 1532.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Text of Common Proposed Guidelines on Tax Allocation Agreements (All Agencies)</HD>
                <HD SOURCE="HD1">Appendix [ ]</HD>
                <HD SOURCE="HD1">Interagency Guidelines on Safety and Soundness Standards for Tax Allocation Agreements</HD>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>The Guidelines establish standards under section 39 of the Federal Deposit Insurance Act (12 U.S.C. 1831p-1) for intercorporate tax allocation agreements between a [BANK] and its parent holding company and other affiliates.</P>
                <HD SOURCE="HD2">A. Scope</HD>
                <P>These Guidelines apply to a [BANK] that is part of a consolidated or combined group for federal or state income tax purposes. These Guidelines apply only if the [BANK] is subject to corporate income tax obligations at the federal or state level and files income taxes as part of a consolidated group.</P>
                <HD SOURCE="HD2">B. Preservation of Existing Authority</HD>
                <P>Neither section 39 of the Federal Deposit Insurance Act (12 U.S.C. 1831p-1) nor these Guidelines in any way limits the authority of the [AGENCY] to address unsafe or unsound practices or conditions or other violations of law or regulation. The [AGENCY] may take action under section 39 of the FDI Act and these Guidelines independently of or in addition to any other supervisory or enforcement authority available to the [AGENCY].</P>
                <HD SOURCE="HD2">C. Definitions</HD>
                <P>
                    <E T="03">Consolidated group</E>
                     means one or more [BANKS], any parent holding company, and any other affiliate that file federal or state income tax returns on a consolidated basis.
                </P>
                <P>
                    <E T="03">Deferred tax items</E>
                     mean deferred tax assets and deferred tax liabilities.
                </P>
                <P>
                    <E T="03">Separate entity basis</E>
                     refers to a situation where each [BANK] is viewed, and reports its applicable income taxes and its deferred tax items, as if it were a stand-alone legal and accounting entity for regulatory reporting purposes, notwithstanding its membership in a consolidated group. For purposes of this definition, when a [BANK] has subsidiaries that are included with the [BANK] in the consolidated group return, the [BANK's] applicable income 
                    <PRTPAGE P="24768"/>
                    taxes and deferred tax items on a 
                    <E T="03">separate entity basis</E>
                     include the applicable income taxes and deferred tax items of its subsidiaries, unless eliminated in consolidation for regulatory reporting purposes.
                </P>
                <HD SOURCE="HD1">II. General Provisions</HD>
                <P>
                    A. 
                    <E T="03">Purpose.</E>
                     A [BANK] must ensure that its inclusion in a consolidated or combined group tax return does not prejudice the interests of any [BANK] that is a member of the consolidated group. For purposes of this standard, intercorporate tax settlements between a [BANK] and its parent company do not prejudice the interests of a [BANK] provided that the settlements are conducted in a manner that is no less favorable to the [BANK] than if it were a separate taxpayer.
                </P>
                <P>
                    B. 
                    <E T="03">Measurement of Current and Deferred Income Taxes.</E>
                     U.S. generally accepted accounting principles and instructions for the preparation of Reports of Condition and Income require [BANKS] to provide for their current tax liability or benefit as well as for deferred income taxes resulting from any temporary differences and tax carryforwards.
                </P>
                <P>1. When the [BANKS] in a consolidated group prepare separate regulatory reports, each [BANK] must record current and deferred taxes as if it filed its tax returns on a separate entity basis, regardless of the consolidated group's tax paying or refund status. Adjustments for statutory tax considerations that arise in a consolidated return may be made to the [BANK's] liability as calculated on a separate entity basis, as long as they are made on a consistent and equitable basis among all members of the consolidated group.</P>
                <P>2. A [BANK] must recognize all of its deferred tax items, including those based on or attributable to temporary differences or net operating loss or tax credit carryforwards on its separate-entity regulatory reports, and these items cannot be presented separate from the entity that reports the asset or liability that gave rise to them. A [BANK] is prohibited from derecognizing any of its deferred tax items unless those items are reversed, are settled through payment to the [BANK] because the items are absorbed in a current tax period by the consolidated tax group, or are transferred in connection with the transfer of the associated assets or liabilities that gave rise to the deferred tax items.</P>
                <P>
                    C. 
                    <E T="03">Tax Refunds.</E>
                </P>
                <P>1. A [BANK] that files tax returns as part of a consolidated group must enter into a tax allocation agreement that specifies that a parent company that receives a tax refund from a taxing authority obtains these funds as agent for the [BANK] member whose tax attributes created the tax refund. This refund could be the result of a current year tax loss carried back to years with taxable income or quarterly payments made in excess of the current tax liability owed by the [BANK]. The agreement must specify that the parent hold such funds in trust for the exclusive benefit of the member [BANK] that owns the funds and must promptly remit the funds held in trust to such member [BANK]. The agreement must also specify that the parent company does not obtain any ownership interest in any tax refund because it receives a tax refund from a taxing authority.</P>
                <P>2. If a [BANK's] loss or credit is used to reduce the consolidated group's overall tax liability, the [BANK] must reflect the tax benefit of the loss or credit in the current portion of its applicable income taxes in the period the loss or credit is incurred, and the [BANK] must obtain compensation for the use of its loss or credit at the time that it is used. If a [BANK's] loss or credit is not absorbed in the current period by the consolidated group, the [BANK] must not recognize the tax benefit in the current portion of its applicable income taxes in the loss year. Rather, the tax loss or credit represents a loss carryforward, the benefit of which is recognized as a deferred tax asset, net of any valuation allowance.</P>
                <P>3. If a [BANK] would have received a refund from the taxing authority if it had filed on a separate entity basis, but there is no ability to obtain an actual refund because other members in the consolidated group had losses that offset the [BANK's] separate tax liability for the previous year, the [BANK] must obtain no less than its stand-alone refund amount from the parent company on or before the date the [BANK] would have filed its own return if it had filed on a separate entity basis. To the extent the group has previously made a payment to the [BANK] for the use of its loss by the group, such amount can offset the amount due.</P>
                <P>
                    D. 
                    <E T="03">Income Tax Forgiveness Transaction.</E>
                     A tax allocation agreement may allow a subsidiary [BANK] to pay a parent company less than the full amount of the current income tax liability that the [BANK] would have owed if calculated on a separate entity basis. Provided the parent will not later require the [BANK] to pay the remainder of such stand-alone current tax liability, the [BANK] must account for this unremitted liability as having been paid with a simultaneous capital contribution by the parent to the [BANK]. In contrast, because a parent cannot relieve a [BANK] of future tax liability to a taxing authority, a [BANK] may not enter into a transaction in which a parent purports to forgive some or all of the [BANK's] deferred tax liability, through a capital contribution or otherwise.
                </P>
                <HD SOURCE="HD1">III. Intercompany Tax Allocation Agreements</HD>
                <P>
                    <E T="03">A. Intercompany Tax Allocation Agreement.</E>
                     Each [BANK] that is part of a consolidated group must enter into a written tax allocation agreement with its holding company that protects the tax position of the [BANK] and is consistent with the principles in Section II and the terms described below, as well as the requirements of sections 23A and 23B of the Federal Reserve Act (12 U.S.C. 371c and 371c-1). The board of directors, or a duly authorized committee thereof, of each [BANK] and each holding company must approve the tax allocation agreement.
                </P>
                <P>
                    B. 
                    <E T="03">Terms.</E>
                     The tax allocation agreement must:
                </P>
                <P>1. Expressly state and not contain language to suggest a contrary intent:</P>
                <P>a. That an agency relationship exists between the [BANK] and its holding company with respect to tax refunds and that the [BANK] owns the tax assets that were created from its tax attributes;</P>
                <P>b. That any refund received from the taxing authority and due to the [BANK] is held in trust by the holding company; and</P>
                <P>c. That, notwithstanding any other transactions to the contrary, the [BANK] must receive promptly any tax refund attributable to the [BANK's] tax attributes.</P>
                <P>2. Include the following paragraph or substantially similar language:</P>
                <P>
                    “The [name of holding company] is an agent for the [name of institution] (the “Institution”) with respect to all matters related to consolidated tax returns and refund claims, and nothing in this agreement shall be construed to alter or modify this agency relationship. If the [name of holding company] receives a tax refund [attributable to income earned, taxes paid, or losses incurred by the Institution] from a taxing authority, these funds are obtained as agent for the Institution. Any tax refund attributable to income earned, taxes paid, or losses incurred by the Institution is the property of and owned by the Institution, and must be held in trust by the [name of holding company] for the benefit of the Institution. The [name of holding company] must forward promptly the 
                    <PRTPAGE P="24769"/>
                    amounts held in trust to the Institution. Nothing in this agreement is intended to be or should be construed to provide the [name of holding company] with an ownership interest in a tax refund that is attributable to income earned, taxes paid, or losses incurred by the Institution. The [name of holding company] hereby agrees that this tax sharing agreement does not give it an ownership interest in a tax refund generated by the tax attributes of the Institution.”
                </P>
                <P>3. With respect to tax payments from the [BANK] to its affiliates:</P>
                <P>a. Prohibit payments in excess of the current period tax expense or reasonably calculated estimated tax expense of the [BANK] on a separate entity basis;</P>
                <P>b. Prohibit payment for the settlement of any deferred tax liabilities of the [BANK]; and</P>
                <P>c. Prohibit payment from occurring earlier than when the [BANK] would have been obligated to pay the taxing authority had it filed as a separate entity.</P>
                <P>d. Provide that if, on the basis of payments previously made during the year for estimated tax owed, the [BANK] would have been entitled to a refund if it had filed on a separate entity basis, the affiliate must repay such excess in an amount equal to the refund the institution would have been entitled to.</P>
                <P>4. State that if a [BANK's] loss or credit is used to reduce the consolidated group's overall tax liability, the [BANK] must reflect the tax benefit of the loss or credit in the current portion of its applicable income taxes in the period the loss or credit is incurred, and the parent company must compensate the [BANK] for the use of its loss or credit at the time that it is used.</P>
                <P>5. State that all materials, including, but not limited to, returns, supporting schedules, workpapers, correspondence, and other documents relating to the consolidated federal income tax return and any consolidated, combined, or unitary group state or local returns must be made available on demand to the [BANK] or any successor during regular business hours. The tax allocation agreement must provide that this obligation will survive any termination of the tax allocation agreement.</P>
                <HD SOURCE="HD3">End of Common Proposed Guidelines on Tax Allocation Agreements</HD>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>12 CFR Part 30</CFR>
                    <P>Safety and soundness standards.</P>
                    <CFR>12 CFR Part 208</CFR>
                    <P>Accounting, Agriculture, Banks, banking, Confidential business information, Consumer protection, Crime, Currency, Federal Reserve System, Flood insurance, Insurance, Investments, Mortgages, Reporting and recordkeeping requirements, Securities.</P>
                    <CFR>12 CFR Part 364</CFR>
                    <P>Banks, banking, Information.</P>
                </LSTSUB>
                <HD SOURCE="HD3">Adoption of Proposed Common Guidelines</HD>
                <P>The adoption of the proposed common guidelines by the agencies, as modified by the agency-specific text, is set forth below:</P>
                <HD SOURCE="HD1">DEPARTMENT OF THE TREASURY</HD>
                <HD SOURCE="HD1">Office of the Comptroller of the Currency</HD>
                <HD SOURCE="HD2">12 CFR Chapter I</HD>
                <HD SOURCE="HD3">Authority and Issuance</HD>
                <P>
                    For the reasons stated in the 
                    <E T="02">Supplementary Information</E>
                    , the Office of the Comptroller of the Currency proposes to amend part 30 of chapter I of Title 12, Code of Federal Regulations as follows:
                </P>
                <PART>
                    <HD SOURCE="HED">PART 30—SAFETY AND SOUNDNESS STANDARDS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 30 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 12 U.S.C. 1, 93a, 371, 1462a, 1463, 1464, 1467a, 1818, 1828, 1831p-1, 1881-1884, 3102(b) and 5412(b)(2)(B); 15 U.S.C. 1681s, 1681w, 6801, and 6805(b)(1).</P>
                </AUTH>
                <HD SOURCE="HD1">Appendix F [Added]</HD>
                <AMDPAR>2. Amend part 30 by adding Appendix F as set forth at the end of the common preamble.</AMDPAR>
                <HD SOURCE="HD1">Appendix F [Amended]</HD>
                <AMDPAR>3. Amend Appendix F of part 30 by:</AMDPAR>
                <AMDPAR>a. Removing “[BANK]” and adding in its place “national bank or Federal savings association”, removing “[BANKS]” and adding in its place “national banks and Federal savings associations”, and removing “[BANK's]” and adding in its place “national bank's or Federal savings association's” whenever they appear.</AMDPAR>
                <AMDPAR>b. Removing “[AGENCY]” and adding in its place “OCC”, whenever it appears.</AMDPAR>
                <HD SOURCE="HD1">BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM</HD>
                <HD SOURCE="HD2">12 CFR Chapter II</HD>
                <HD SOURCE="HD3">Authority and Issuance</HD>
                <P>
                    For the reasons stated in the 
                    <E T="02">Supplementary Information</E>
                    , the Board proposes to amend chapter II of Title 12, Code of Federal Regulations as follows:
                </P>
                <PART>
                    <HD SOURCE="HED">PART 208—MEMBERSHIP OF STATE BANKING INSTITUTIONS IN THE FEDERAL RESERVE SYSTEM (REGULATION H)</HD>
                </PART>
                <AMDPAR>4. The authority citation for part 208 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>12 U.S.C. 24, 36, 92a, 93a, 248(a), 248(c), 321-338a, 371d, 461, 481-486, 601, 611, 1814, 1816, 1817(a)(3), 1817(a)(12), 1818, 1820(d)(9), 1833(j), 1828(o), 1831, 1831o, 1831p-1, 1831r-1, 1831w, 1831x, 1835a, 1882, 2901-2907, 3105, 3310, 3331-3351, 3905-3909, 5371, and 5371 note; 15 U.S.C. 78b, 78I(b), 78l(i), 780-4(c)(5), 78q, 78q-1, 78w, 1681s, 1681w, 6801, and 6805; 31 U.S.C. 5318; 42 U.S.C. 4012a, 4104a, 4104b, 4106, and 4128.</P>
                </AUTH>
                <HD SOURCE="HD1">Appendix D-3 [Added]</HD>
                <AMDPAR>5. Amend part 208 by adding Appendix D-3 as set forth at the end of the common preamble:</AMDPAR>
                <HD SOURCE="HD1">Appendix D-3 [Amended]</HD>
                <AMDPAR>6. Amend Appendix D-3 of part 208 by:</AMDPAR>
                <AMDPAR>a. Removing “[BANK]” and adding in its place “state member bank”, removing “[BANK]” and adding in its place “state member banks”, and removing “[BANK's]” and adding in its place “state member bank's”, whenever it appears.</AMDPAR>
                <AMDPAR>b. Removing “[AGENCY]” and adding in its place “Board” whenever it appears.</AMDPAR>
                <HD SOURCE="HD1">FEDERAL DEPOSIT INSURANCE CORPORATION</HD>
                <HD SOURCE="HD2">12 CFR Chapter III</HD>
                <HD SOURCE="HD3">Authority and Issuance</HD>
                <P>For the reasons set forth in the common preamble, the Federal Deposit Insurance Corporation proposes to amend part 364 of chapter III of title 12 of the Code of Federal Regulations as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 364—STANDARDS FOR SAFETY AND SOUNDNESS</HD>
                </PART>
                <AMDPAR>7. The authority citation for part 364 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>12 U.S.C. 1818 and 1819 (Tenth), 1831p-1; 15 U.S.C. 1681b, 1681s, 1681w, 6801(b), 6805(b)(1).</P>
                </AUTH>
                <HD SOURCE="HD1">Appendix C [Added]</HD>
                <AMDPAR>8. Amend part 364 by adding Appendix C as set forth at the end of the common preamble.</AMDPAR>
                <HD SOURCE="HD1">Appendix C [Amended]</HD>
                <AMDPAR>9. Amend Appendix C of part 364 by:</AMDPAR>
                <AMDPAR>
                    a. Removing “[BANK]” and adding in its place “FDIC-supervised institution”, 
                    <PRTPAGE P="24770"/>
                    removing “[BANKS]” and adding in its place “FDIC-supervised institutions”, and removing “[BANK's]” and adding in its place “FDIC-supervised institution's”, whenever it appears.
                </AMDPAR>
                <AMDPAR>b. Removing “[AGENCY]” and adding in its place “FDIC” whenever it appears.</AMDPAR>
                <SIG>
                    <NAME>Blake J. Paulson,</NAME>
                    <TITLE>Acting Comptroller of the Currency.</TITLE>
                    <P>By order of the Board of Governors of the Federal Reserve System.</P>
                    <NAME>Ann E. Misback,</NAME>
                    <TITLE>Secretary of the Board.</TITLE>
                    <FP>Federal Deposit Insurance Corporation.</FP>
                    <P>By order of the Board of Directors.</P>
                    <DATED>Dated at Washington, DC, on April 21, 2021.</DATED>
                    <NAME>James P. Sheesley,</NAME>
                    <TITLE>Assistant Executive Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09047 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-33-P; 6210-01-P; 6714-01-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL DEPOSIT INSURANCE CORPORATION</AGENCY>
                <CFR>12 CFR Part 328</CFR>
                <RIN>RIN 3064-AF71</RIN>
                <SUBJECT>False Advertising, Misrepresentation of Insured Status, and Misuse of the FDIC's Name or Logo</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Deposit Insurance Corporation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking and request for information.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Deposit Insurance Corporation is seeking comment on a proposed rule to implement section 18(a)(4) of the Federal Deposit Insurance Act. Section 18(a)(4) of the Federal Deposit Insurance Act prohibits any person from making false or misleading representations about deposit insurance or from using the Federal Deposit Insurance Corporation's name or logo in a manner that would imply that an uninsured financial product is insured or guaranteed by the Federal Deposit Insurance Corporation. The proposed rule would describe: The process by which the Federal Deposit Insurance Corporation will identify and investigate conduct that may violate section 18(a)(4) of the Federal Deposit Insurance Act; the standards under which such conduct will be evaluated; and the procedures which the Federal Deposit Insurance Corporation will follow when formally and informally enforcing the provisions of section 18(a)(4) of the Federal Deposit Insurance Corporation Act.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments are due on or before July 9, 2021. Comments on the Paperwork Reduction Act burden estimates are due on or before July 9, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by RIN 3064-AF71, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">FDIC website: https://www.fdic.gov/regulations/laws/federal/.</E>
                         Follow instructions for submitting comments on the agency website.
                    </P>
                    <P>
                        • 
                        <E T="03">FDIC Email: Comments@fdic.gov.</E>
                         Include RIN 3064-AF71 on the subject line of the message.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         James P. Sheesley, Assistant Executive Secretary, Legal-ESS, Attention: Comments—RIN 3064-AF71, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery/Courier:</E>
                         Comments may be hand-delivered to the guard station at the rear of the 550 17th Street NW building (located on F Street) on business days between 7 a.m. and 5 p.m.
                    </P>
                    <P>Please include your name, affiliation, address, email address, and telephone number(s) in your comment. All statements received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. You should submit only information that you wish to make publicly available.</P>
                </ADD>
                <NOTE>
                    <HD SOURCE="HED">Please note: </HD>
                    <P>
                        All comments received will be posted generally without change to 
                        <E T="03">https://www.fdic.gov/regulations/laws/federal/,</E>
                         including any personal information provided. 
                    </P>
                </NOTE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Richard M. Schwartz, Counsel, Legal Division, (202) 898-7424; Michael P. Farrell, Counsel, Legal Division, (202) 898-3853, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Policy Objectives</HD>
                <P>Section 18(a)(4) of the Federal Deposit Insurance Act, 12 U.S.C. 1828(a)(4), (Section 18(a)(4)) prohibits any person from misusing the name or logo of the Federal Deposit Insurance Corporation (FDIC) or from engaging in false advertising or making knowing misrepresentations about deposit insurance. The FDIC has observed an increasing number of instances where financial services providers or other entities or individuals have misused the FDIC's name or logo or have made false or misleading representations that would suggest to the public that these providers' products are FDIC-insured. To provide transparency into how the FDIC will address these and similar concerns, the FDIC is proposing to adopt regulations to further clarify its procedures for identifying, investigating, and where necessary taking formal and informal action to address potential violations of Section 18(a)(4). The regulations would also establish a point-of-contact for receiving complaints about potentially false or misleading representations regarding deposit insurance and would direct depositors and prospective depositors to where they could obtain information or verification about deposit insurance claims. Although the FDIC is not required to promulgate regulations to implement section 18(a)(4), the FDIC nonetheless believes that the proposed rule, if adopted, would establish a more transparent process that will benefit all parties and would promote stability and confidence in FDIC deposit insurance and the nation's financial system.</P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>
                    The FDIC has steadfastly and proactively sought to protect depositors and prospective depositors by limiting use of the FDIC's name, seal, and logo to insured depository institutions (IDIs) and preventing false and misleading representations about the manner and extent of FDIC deposit insurance (deposit insurance). Under Federal law, it is a criminal offense to misuse the FDIC name or make false representations regarding deposit insurance.
                    <SU>1</SU>
                    <FTREF/>
                     Moreover, the FDIC has independent authority to investigate and take administrative enforcement actions, including the power to issue cease and desist orders and impose civil money penalties, against any person who: (1) Falsely represents or implies that any deposit liability, obligation, certificate, or share is insured by the FDIC; or (2) otherwise knowingly misrepresents: (a) That any deposit liability, obligation, certificate, or share is insured, or (b) the extent or manner 
                    <PRTPAGE P="24771"/>
                    in which any deposit liability, obligation, certificate, or share is insured.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See</E>
                         18 U.S.C. 709 (“Whoever, except as expressly authorized by Federal law, uses the words `Federal Deposit', Federal Deposit Insurance', or `Federal Deposit Insurance Corporation' or a combination of any three of these words, as the name or a part thereof under which he or it does business, or advertises or otherwise represents falsely by any device whatsoever that his or its deposit liabilities, obligations, certificates, or shares are insured or guaranteed by the Federal Deposit Insurance Corporation, or by the United States or by any instrumentality thereof, or whoever advertises that his or its deposits, shares, or accounts are federally insured, or falsely advertises or otherwise represents by any device whatsoever the extent to which or the manner in which the deposit liabilities of an insured bank or banks are insured by the Federal Deposit Insurance Corporation . . . Shall be punished . . . by a fine under this title or imprisonment for not more than one year . . .”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         12 U.S.C. 1828(a)(4)(C)-(D). With regard to an insured depository institution under the supervision of another Federal banking agency, the FDIC shall first write to that agency to take enforcement action under section 18(a)(4) against any entity for which the agency is the appropriate Federal banking agency or any institution-affiliated party of such entity; if that agency takes no action within 30 days, the FDIC may take action.
                    </P>
                </FTNT>
                <P>Although the FDIC has broad statutory authority in this area, the FDIC has never issued specific regulations regarding false representations related to FDIC insurance or the misuse of the FDIC's name or logo.</P>
                <P>
                    On February 26, 2020, the FDIC published in the 
                    <E T="04">Federal Register</E>
                     a Request for Information (RFI) related to potential modernization of its signage and advertising rules set out in part 328 of the FDIC regulations.
                    <SU>3</SU>
                    <FTREF/>
                     This RFI included the questions tied to the deposit insurance misrepresentation issues discussed in this Notice of Proposed Rulemaking.
                    <SU>4</SU>
                    <FTREF/>
                     On March 13, 2020, the FDIC published an extension of the comment period in the 
                    <E T="04">Federal Register</E>
                    .
                    <SU>5</SU>
                    <FTREF/>
                     However, on April 16, 2020, in light of COVID-19, the FDIC announced that it was temporarily postponing its efforts to modify the rules under part 328 of the FDIC regulations.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         85 FR 10997 (Feb. 26, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Id, at 10999-11000.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         85 FR 14678 (Mar. 13, 2020).
                    </P>
                </FTNT>
                <P>In light of the increasing number of instances where financial services providers or other entities or individuals have misused the FDIC's name or logo, the FDIC has elected to address false or misleading representation and misuse issues through this Notice of Proposed Rulemaking. Because the FDIC is committed to obtaining input on these issues from the industry and the public, we have included relevant questions in this document.</P>
                <P>
                    Separately, on April 9, 2021, the FDIC re-issued its RFI regarding the FDIC Sign and Official Advertising Requirements.
                    <SU>6</SU>
                    <FTREF/>
                     The 2021 RFI focuses on soliciting information on the modernization of the FDIC's advertising requirements applicable to IDIs, and related topics. While questions related to misrepresentation and misuse have been removed from that document, there remains a degree of overlap between the RFI and the proposed rule and responses to the RFI may provide information that is relevant to consideration of the proposed rule. For example, the RFI asks about how to deal with parties that may be fraudulently impersonating insured depository institutions, which necessarily overlaps with the proposed rule. Therefore, the FDIC will consider relevant comments submitted in response to the RFI, together with comments submitted in response to the proposed rule, in adopting the final rule.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         86 FR 18528 (Apr. 9, 2021).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Summary of Proposed Regulation</HD>
                <P>The proposed regulation establishes a new subpart B to part 328, entitled “False Advertising, Misrepresentation of Insured Status, and Misuse of the FDIC's Name or Logo.” The proposed subpart sets forth the process by which the FDIC will identify and investigate conduct that may violate Section 18(a)(4), the standards under which such conduct will be evaluated, and the procedures which the FDIC will follow when formally and informally enforcing the provisions of Section 18(a)(4).</P>
                <HD SOURCE="HD2">Section 328.100—Scope</HD>
                <P>Section 328.100 notes that, unlike many FDIC regulations, which are binding upon IDIs and institution-affiliated parties (IAPs), this regulation, consistent with the authority set forth in Section 18(a)(4), will apply to any person who violates Section 18(a)(4) or who aids another in such a violation.</P>
                <HD SOURCE="HD2">Section 328.101—Definitions</HD>
                <P>Section 328.101 sets forth certain definitions that will be used throughout the subpart. Such definitions include, but are not limited to the terms or phrases “non-deposit product,” “uninsured financial product,” “FDIC-associated images,” and “FDIC-associated terms.”</P>
                <HD SOURCE="HD2">Section 328.102—Prohibition</HD>
                <P>
                    Section 328.102 sets forth the conduct that is prohibited by Section 18(a)(4). It further provides transparency by setting forth the FDIC's interpretation of the scope of prohibited conduct, including specific examples of conduct that the FDIC deems to violate Section 18(a)(4). The identified practices include instances where false statements are made regarding the existence or extent of deposit insurance associated with a product, as well as instances where material information is omitted from a representation (
                    <E T="03">e.g.,</E>
                     where a non-bank third party represents that its products are FDIC-insured without identifying the name or the names of the IDIs where customer deposits will be placed and through whom such insurance is derived.) These examples are not meant to be an exhaustive list, but rather specific examples of the type of conduct that the FDIC has observed that violate the prohibitions in Section 18(a)(4). This list is not intended to be an exhaustive list, and the FDIC may modify the list based on responses to this notice or the RFI.
                </P>
                <P>
                    The section further sets forth certain standards that the FDIC will use to determine if a statement violates Section 18(a)(4). The standards laid out in § 328.102 are adapted from the standards that Federal Trade Commission developed decades ago to determine if acts or practices are deceptive in violation of Section 5 of the Federal Trade Commission Act, 15 U.S.C. 45 (Section 5).
                    <SU>7</SU>
                    <FTREF/>
                     While Section 18(a)(4) is separate from Section 5, it prohibits similar conduct—deception in connection with commerce. The standards governing deception under Section 5 have been consistently accepted by courts,
                    <SU>8</SU>
                    <FTREF/>
                     and used by the FTC and other agencies, including the FDIC, which enforces prohibitions of Section 5 against the institutions it supervises and IAPs of those institutions.
                    <SU>9</SU>
                    <FTREF/>
                     In light of the long-term use and acceptance of these standards, the FDIC believes it is appropriate to use similar standards to determine if a representation about deposit insurance violates Section 18(a)(4).
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See generally,</E>
                         FTC Policy Statement on Deception, October 14, 1983.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See,e.g., FTC</E>
                         v. 
                        <E T="03">Stefanchik,</E>
                         559 F.3d 924 (9th Cir. 2009).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See,</E>
                         FIL-57-2002 Unfair or Deceptive Acts—Applicability of the Federal Trade Commission Act (May 30, 2002) and FIL-26-2004, Unfair or Deceptive Acts or Practices under Section 5 of the Federal Trade Commission Act (March 11, 2004).
                    </P>
                </FTNT>
                <P>
                    Section 328.102 also sets forth a bright-line rule for when the FDIC will presume a misrepresentation to have been knowingly made (
                    <E T="03">i.e.,</E>
                     when a respondent continues to make representations about deposit insurance after having been advised by a governmental or regulatory authority that such representations are false or misleading). This bright-line rule is not, however, intended to be the exclusive manner in which the FDIC can establish that any misrepresentation was knowingly made, and the agency reserves the right to establish this statutory element by introducing other evidence.
                </P>
                <HD SOURCE="HD2">Section 328.103—Inquiries and Complaints</HD>
                <P>
                    Section 328.103 provides a process by which members of the public may submit complaints to the FDIC regarding suspected false or misleading representations about deposit insurance. It also directs members of the public to the agency's existing resources to submit inquiries about representations 
                    <PRTPAGE P="24772"/>
                    regarding deposit insurance to the FDIC's Information and Support Center.
                </P>
                <P>The FDIC believes that having a specified point-of-contact for depositors and prospective depositors who may have questions about deposit insurance coverage will be of particular value to the public given the increasing volume of communication and advertising relating to financial products that members of the public receive over various media, including social media and electronic communication. This process represents a continuation of the Information and Support Center's role of aiding the FDIC's mission of ensuring and promoting the stability and confidence of the banking system by responding to inquiries from the public.</P>
                <HD SOURCE="HD2">Section 328.104—Investigation</HD>
                <P>
                    Section 328.104 sets forth procedures for formal investigations into potential violations of Section 18(a)(4). Among other things, the section delegates authority to the FDIC's General Counsel to investigate potential violations and provides that such investigations will be conducted in accordance with section 10(c) of the Federal Deposit Insurance Act 
                    <SU>10</SU>
                    <FTREF/>
                     and the FDIC's rules governing investigations, which are found in subpart K of the FDIC's Rules of Practice and Procedure.
                    <SU>11</SU>
                    <FTREF/>
                     Section 328.104 further provides that, notwithstanding the longstanding confidentiality provisions found in 12 CFR 308.147, in those limited circumstances where there is risk of imminent harm to consumers or depositors, the FDIC may disclose the existence of an investigation under this part that does not involve a bank or a known IAP of a bank. This disclosure authorization, which is a departure from the general practice of maintaining the confidentiality of investigations, is intended to further the FDIC's mission of promoting confidence and stability in the banking system by allowing it to disclose investigations into potentially false or misleading representations about deposit insurance where there is a risk of imminent harm to consumers or depositors.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         12 U.S.C. 1820(c).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         12 CFR 308.144-150.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Section 328.105—Referral to Appropriate Authority</HD>
                <P>Section 328.105 sets forth circumstances under which the FDIC may notify other authorities of potential violations of law that it becomes aware of in connection with a complaint, inquiry, investigation or action under this subpart.</P>
                <P>Section 328.105 provides that the FDIC may recommend that another appropriate Federal banking agency take action to enforce Section 18(a)(4) against an IDI that is subject to the authority of that appropriate Federal banking agency or an IAP of such an institution. Such recommendations are authorized by Section 18(a)(4), which also provides that if the appropriate Federal banking agency fails to take action within 30 days, the FDIC may take enforcement action.</P>
                <P>Section 328.105 further provides that, in the event the FDIC becomes aware of conduct that potentially violates laws or regulations within the jurisdiction of another regulatory authority, the FDIC may take steps to notify the appropriate authority.</P>
                <P>Section 328.105 also provides that, in the event the FDIC becomes aware of conduct that potentially constitutes a criminal violation of 18 U.S.C. 709, the FDIC may, in appropriate circumstances, notify the FDIC Office of the Inspector General or the appropriate criminal law authority.</P>
                <P>Finally, § 328.105 contains provisions governing the provision of any records to other regulatory or criminal authorities in connection with notice under the section.</P>
                <HD SOURCE="HD2">Section 328.106—Informal Resolution</HD>
                <P>Historically, the FDIC has generally resolved apparent violations of Section 18(a)(4) informally by notifying the party responsible and requesting that the apparent false or misleading representation be withdrawn and corrected. Section 328.106 sets forth the process the FDIC will follow when pursuing an informal resolution. Under this process, the FDIC will generally send any person that appears to be making a false or misleading representation, or any person aiding or abetting such a representation, an advisory letter notifying the person of the basis for the FDIC's concerns and requesting corrective action. Such letters will also provide the recipient the opportunity to provide the FDIC with supplemental information if the recipient contends that the representations made are true and not misleading and/or that any use of the FDIC's name or logo is authorized.</P>
                <P>
                    Examples of the general form such advisory letters may take may be found on the FDIC's public website at 
                    <E T="03">https://www.fdic.gov/regulations/laws/federal/2021/template-advisory-letters.pdf.</E>
                     Form A-1 provides a template advisory letter for communicating directly with a person that is believed to be misusing the FDIC's name or logo or making false or misleading representations about deposit insurance. Form A-2 provides a template advisory letter for communications directed to a third-party publisher that may be disseminating potentially false or misleading representations regarding deposit insurance. Form A-3 provides a template for communications with internet service providers (ISPs), alerting them that a website hosted by the ISP may be making false representations in violation of Section 18(a)(4).
                </P>
                <P>
                    Generally, the FDIC will only send such advisory letters to an ISP if the website in question contains one or more indicia of fraud. Such indicia would include, among other things, evidence that: (1) The website purports to belong to or be associated with an IDI when the IDI disclaims any ownership or association with the website; (2) the website appears to mirror or look like a valid website maintained by an IDI by spoofing or copying photos or pages from the IDI's website in an attempt to deceive depositors into believing that the website belongs to or is associated with the IDI; (3) the website purports to belong to an IDI, when no such IDI exists; or (4) there are geographic or other inconsistencies on the site (
                    <E T="03">e.g.,</E>
                     the website is hosted abroad or the contact information reflected on the site does not match those on file with the FDIC).
                </P>
                <P>Section 328.106 further provides that if the recipient of such a letter takes the requested corrective action within the time requested, the FDIC will generally take no further action. However, if the recipient fails to timely take corrective action, the FDIC may pursue all remedies available to it. Additionally, pursuant to § 328.106, the FDIC may commence formal enforcement action at any time if the FDIC has reason to believe that depositors or IDIs may suffer harm as a result of continued conduct or if the person making the false or misleading representation has been previously advised of the agency's concerns.</P>
                <HD SOURCE="HD2">Section 328.107—Formal Enforcement Action</HD>
                <P>
                    Section 328.107 sets forth the procedures that will govern any formal enforcement action brought by the FDIC to enforce the provisions of Section 18(a)(4). Under § 328.107, and as authorized by Section 18(a)(4), the FDIC may bring formal actions to enforce Section 18(a)(4) under section 8 of the Federal Deposit Insurance Act (Section 8) 
                    <SU>12</SU>
                    <FTREF/>
                     against any person in the same 
                    <PRTPAGE P="24773"/>
                    manner and to the same extent that it can bring such actions against insured state nonmember banks and their IAPs.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         12 U.S.C. 1818. Specifically, the FDIC is authorized to pursue actions under Section 8(b), (c), (d), or (i) to enforce the provisions of Section 18(a)(4).
                    </P>
                </FTNT>
                <P>Section 328.107 authorizes the FDIC General Counsel to bring an action against any person to enforce the provisions of Section 18(a)(4); however, it provides that in the case of an IDI for which another Federal banking agency is the appropriate Federal banking agency, the General Counsel can only commence an action if the appropriate Federal banking agency fails to take action after receiving a recommendation pursuant to § 328.105. It further provides that administrative proceedings brought to enforce Section 18(a)(4) will be governed by the FDIC's Rules of Practice and Procedure set forth in Part 308 of the FDIC's Regulations.</P>
                <P>Section 328.107 also sets forth the venue for formal enforcement actions. In the case of actions against IDIs or IAPs, venue will be in the federal judicial district where the home office of the IDI is located. This is consistent with the venue provisions of Section 8. In actions that do not involve IDIs or IAPs, venue will be based on the residence of the respondent, similar to the manner in which venue is determined for general civil actions under 29 U.S.C 1391. The FDIC believes these venue provisions are consistent with existing law and due process.</P>
                <HD SOURCE="HD2">Section 328.108—Appeals Process</HD>
                <P>Section 328.108 clarifies that any order issued after hearings conducted pursuant to this subpart is subject to judicial review to the same extent as any other order issued under Section 8. While Section 18(a)(4) does not expressly provide for judicial review, it does authorize enforcement actions under Section 8, which provides for such review. The FDIC believes that this grant of authority includes the right to seek judicial review and further believes such right is necessary and appropriate. Section 328.108 also provides that any petitions for judicial review may be filed in the court of appeals for the federal circuit where the hearing was held or the United States Court of Appeals for the District of Columbia Circuit. This venue provision is consistent with the venue provisions of Section 8 and provides respondents with the same choice of venue provided after any other FDIC enforcement hearing.</P>
                <HD SOURCE="HD1">IV. Expected Effects</HD>
                <P>
                    The proposed rule, if adopted, would primarily affect non-bank entities and individuals who are potentially misusing the FDIC's name or logo or are making false or misleading representations about deposit insurance. The FDIC currently insures 5,042 depository institutions 
                    <SU>13</SU>
                    <FTREF/>
                     that could also be affected; however in practice, the proposed rule would primarily affect non-bank entities and private individuals. Since the adoption of Section 18(a)(4) in 2008, the FDIC has issued only one formal enforcement order against a non-bank entity for misuse of the FDIC's name or logo or for misrepresentations or false advertising in relation to deposit insurance. However, as previously noted the FDIC has observed a recent increase in the number of instances where financial services providers or other entities or individuals have misused the FDIC's name or logo or have made misrepresentations that would falsely suggest to the public that these providers' products are FDIC-insured and been subject to an informal resolution. Between January 1, 2019, and December 31, 2020, the FDIC has worked with non-bank entities to reach informal resolutions regarding the potential misuse of the FDIC's name or logo and/or misrepresentations relation to deposit insurance in at least 165 instances.
                    <SU>14</SU>
                    <FTREF/>
                     Based on this experience, the FDIC estimates that the proposed rule, if adopted, would apply to relatively few formal enforcement actions and conservatively estimates that it would affect fewer than 165 informal resolutions with non-bank entities and individuals each year.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         FDIC Call Report data, September 30, 2020.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See FDIC 2019 Annual Report,</E>
                         p. 38; 
                        <E T="03">FDIC 2020 Annual Report,</E>
                         p. 47.
                    </P>
                </FTNT>
                <P>As discussed previously, the proposed rule, if adopted, would clarify the FDIC's procedures for evaluating potential violations of Section 18(a)(4). The proposed rule would generally be consistent with existing practices used by the FDIC with respect to these matters. Further the proposed rule, if adopted, would not affect the application of related criminal prohibitions under 18 U.S.C. 709. Therefore, the FDIC believes that the proposed rule, if adopted, would be unlikely to have any significant effect on formal and informal enforcement of the Section 18(a)(4) prohibitions.</P>
                <P>The FDIC believes that the proposed rule, if adopted, would benefit FDIC-insured institutions and members of the public by further clarifying what constitutes a violation of Section 18(a)(4), by creating a process by which institutions and members of the public can report suspected instances of false advertising, misuse, or misrepresentation regarding deposit insurance, and by establishing clear procedures by which the FDIC will investigate and, where necessary, formally and informally resolve potential violations of Section 18(a)(4). Specifically, the added transparency on the FDIC's processes for investigating potential instances of misuse or misrepresentation and, if needed, resolution are expected to benefit the parties involved by establishing a common understanding of those processes.</P>
                <HD SOURCE="HD1">V. Alternatives</HD>
                <P>The FDIC has considered alternatives to the rule but believes that adopting subpart B to part 328 represents the most appropriate option. As discussed previously, Section 18(a)(4) establishes prohibitions against the misuse of the FDIC's name or logo and prohibits misrepresentations and false advertising in relation to deposit insurance. The FDIC considered the status quo alternative of not adopting a regulation that further clarifies what constitutes misuse of FDIC name or logo or false or misleading representation with respect to FDIC insurance, how the FDIC will identify and investigate suspected instances of misuse or misrepresentation, and the process by which the FDIC will pursue formal or informal resolution of instances of misuse or misrepresentation. However, based on the FDIC's recent experience addressing instances of potential and actual misuse, misrepresentation, and false advertising in relation to the FDIC name and logo, the FDIC believes that the proposed rule is the most appropriate action.</P>
                <HD SOURCE="HD1">VI. Request for Comments</HD>
                <P>The FDIC invites comments on all aspects of this proposed rulemaking. In particular, the FDIC seeks feedback on the scope of the proposed rule and the procedures described therein, including the following specific questions:</P>
                <HD SOURCE="HD2">False Advertising, Misuse of Logo, and Misrepresentations</HD>
                <P>1. Please describe the extent to which the proposed rule sufficiently identifies situations that present potential risks related to false or misleading representations regarding deposit insurance coverage and the misuse of the FDIC's name or logo, including those related to specific products and advertising channels. If there are additional types of false or misleading representations about deposit insurance coverage that may not be effectively captured by the rule, please describe them.</P>
                <P>
                    2. Please describe the extent to which the proposed rule sufficiently addresses 
                    <PRTPAGE P="24774"/>
                    false or misleading representations regarding deposit insurance and the misuse of the FDIC's name and logo. If there are additional or alternative ways to more effectively or efficiently address such misrepresentations and/or misuse, please describe them.
                </P>
                <P>3. Please describe any suggested additions to the proposed rule for preventing and addressing the risks of false or misleading representations regarding deposit insurance and/or the misuse of the FDIC's name and logo.</P>
                <HD SOURCE="HD2">Procedures for Investigations, Informal Resolution, and Formal Enforcement Actions</HD>
                <P>4. Are the proposed complaint and inquiry procedures sufficiently clear about how business entities and members of the public may contact the FDIC if they have questions or concerns relating to potentially false or misleading representations regarding deposit insurance or misuse of the FDIC's name and logo? Are there other types of procedures the FDIC should consider? If so, please describe them.</P>
                <P>5. Are there other alternative, effective, and efficient methods by which a customer can ensure that a third-party's representations regarding deposit insurance are true and accurate? If so, please describe them.</P>
                <P>6. Is the proposed informal resolution process an adequate means of addressing, in the first instance in most circumstances, potentially false or misleading representations regarding deposit insurance or misuse of the FDIC's name and logo? Should the FDIC consider other or additional procedures? If so, please describe them.</P>
                <P>7. The proposed rule contains a provision that would permit the FDIC, in those limited circumstances where there is risk of imminent harm to consumers or depositors, to confirm the existence of a formal investigation, so long as the target of the investigation was not an IDI or a known IAP thereof. This provision would be an exception to the longstanding confidentiality provisions found in 12 CFR 308.147. Is such an exception appropriate? Does the proposed rule strike an appropriate balance between the need to maintain the confidentiality of investigations involving IDIs and known IAPs, versus the potential value in identifying the existence of investigations into non-bank persons and entities whose conduct may result in risk of imminent harm to consumers and depositors? Are there alternatives the FDIC should consider? If so, please describe them.</P>
                <P>8. Is the formal enforcement action process sufficiently clear, given that Section 18(a)(4) expressly references the use of established enforcement mechanisms set forth in Section 8 of the FDI Act? Should other provisions be added? If so, please describe them.</P>
                <P>9. Do the investigation, informal resolution, and formal enforcement action processes described in the proposed rule strike the appropriate balance between addressing in a timely manner potentially false or misleading representations regarding deposit insurance and allowing the parties identified as potentially participating in the false or misleading representations an opportunity to present additional facts or provide a legal defense?</P>
                <HD SOURCE="HD2">Other Areas of Concern</HD>
                <P>10. Upon entering into a relationship or arrangement with a third-party non-bank entity, as part of FDIC-insured institutions' due diligence, do such institutions currently take steps to ensure: (a) That the non-bank is aware of existing laws and regulations related to the use of the FDIC's name and logo, and (b) that representations made by the non-bank regarding the insured status of bank products are accurate and comply with existing laws and regulations? If not, are there practices that FDIC-insured institutions could adopt to spread awareness of and compliance with these laws and regulations by non-banks?</P>
                <P>11. Are there other topics or issues relating to false or misleading representations regarding deposit insurance or the misuse of the FDIC's name and logo that the FDIC should consider? If so, please describe them and how you think the FDIC should address those topics and issues.</P>
                <P>Written comments must be received by the FDIC no later than July 9, 2021.</P>
                <HD SOURCE="HD1">VII. Administrative Law Matters</HD>
                <HD SOURCE="HD2">A. The Regulatory Flexibility Act</HD>
                <P>
                    The Regulatory Flexibility Act (RFA), requires that, in connection with a notice of proposed rulemaking, an agency prepare and make available for public comment an initial regulatory flexibility analysis that describes the impact of the proposed rule on small entities.
                    <SU>15</SU>
                    <FTREF/>
                     However, a regulatory flexibility analysis is not required if the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities, and publishes its certification and a short explanatory statement in the 
                    <E T="04">Federal Register</E>
                     together with the rule. The Small Business Administration (SBA) has defined “small entities” to include banking organizations with total assets of less than or equal to $600 million.
                    <SU>16</SU>
                    <FTREF/>
                     Generally, the FDIC considers a significant effect to be a quantified effect in excess of 5 percent of total annual salaries and benefits per institution, or 2.5 percent of total noninterest expenses. The FDIC believes that effects in excess of these thresholds typically represent significant effects for FDIC-supervised institutions. For the reasons provided below, the FDIC certifies that the proposed rule, if adopted in final form, would not have a significant economic impact on a substantial number of small banking organizations. Accordingly, a regulatory flexibility analysis is not required.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         5 U.S.C. 601, 
                        <E T="03">et seq.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         The SBA defines a small banking organization as having $600 million or less in assets, where an organization's “assets are determined by averaging the assets reported on its four quarterly financial statements for the preceding year.” 
                        <E T="03">See</E>
                         13 CFR 121.201 (as amended, by 84 FR 34261, effective August 19, 2019). “SBA counts the receipts, employees, or other measure of size of the concern whose size is at issue and all of its domestic and foreign affiliates.” 
                        <E T="03">See</E>
                         13 CFR 121.103. Following these regulations, the FDIC uses a covered entity's affiliated and acquired assets, averaged over the preceding four quarters, to determine whether the covered entity is “small” for the purposes of RFA.
                    </P>
                </FTNT>
                <P>
                    As of September 30, 2020, the FDIC insured 5,042 depository institutions, of which 3,585 are considered small banking organizations for the purposes of RFA.
                    <SU>17</SU>
                    <FTREF/>
                     Potential instances of misuse or misrepresentation of the FDIC name or logo by IDIs are usually addressed under the normal supervisory authority of the appropriate federal financial regulator, therefore although the proposed rule could affect IDIs, in practice the proposed rule would primarily affect non-bank entities and private individuals. Private individuals are not considered “small entities” by the terms of the RFA.
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         FDIC Call Report data, September 30, 2020.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         How to Comply with the Regulatory Flexibility Act, August 2017, The U.S. Small Business Administration, Office of Advocacy, 
                        <E T="03">https://cdn.advocacy.sba.gov/wp-content/uploads/2019/06/21110349/How-to-Comply-with-the-RFA.pdf.</E>
                    </P>
                </FTNT>
                <P>Based on the information above, the FDIC certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities.</P>
                <P>The FDIC invites comments on all aspects of the supporting information provided in this RFA section. In particular, would this rule have any significant effects on small entities that the FDIC has not identified?</P>
                <HD SOURCE="HD2">B. Plain Language</HD>
                <P>
                    Section 722 of the Gramm-Leach-Bliley Act 
                    <SU>19</SU>
                    <FTREF/>
                     requires the federal banking agencies to use plain language in all proposed and final rules 
                    <PRTPAGE P="24775"/>
                    published after January 1, 2000. The FDIC has sought to present the proposed rule in a simple and straightforward manner. The FDIC invites comments on whether the proposal is clearly stated and effectively organized, and how the FDIC might make the proposal easier to understand.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Public Law 106-102, section 722, 113 Stat. 1338, 1471 (1999).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. The Economic Growth and Regulatory Paperwork Reduction Act</HD>
                <P>
                    Under section 2222 of the Economic Growth and Regulatory Paperwork Reduction Act of 1996 (EGRPRA), the FDIC is required to review all of its regulations, at least once every 10 years, in order to identify any outdated or otherwise unnecessary regulations imposed on insured institutions.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         Public Law 104-208, 110 Stat. 3009 (1996).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">D. Riegle Community Development and Regulatory Improvement Act of 1994</HD>
                <P>
                    Pursuant to section 302(a) of the Riegle Community Development and Regulatory Improvement Act (RCDRIA),
                    <SU>21</SU>
                    <FTREF/>
                     in determining the effective date and administrative compliance requirements for new regulations that impose additional reporting, disclosure, or other requirements on IDIs, each Federal banking agency must consider, consistent with principles of safety and soundness and the public interest, any administrative burdens that the regulations would place on depository institutions, including small depository institutions, and customers of depository institutions, as well as the benefits of the regulations. In addition, section 302(b) of RCDRIA requires new regulations and amendments to regulations that impose additional reporting, disclosures, or other new requirements on IDIs generally to take effect on the first day of a calendar quarter that begins on or after the date on which the regulations are published in final form.
                    <SU>22</SU>
                    <FTREF/>
                     The FDIC invites comments that further will inform its consideration of RCDRIA.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         12 U.S.C. 4802(a).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 12 CFR Part 328</HD>
                    <P>Advertising, Bank deposit insurance, Savings associations, Signs and symbols.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Authority and Issuance</HD>
                <P>For the reasons stated in the preamble, the Federal Deposit Insurance Corporation proposes to amend 12 CFR part 328 as follows:</P>
                <AMDPAR>1. Revise the heading for part 328 to read as follows:</AMDPAR>
                <PART>
                    <HD SOURCE="HED">PART 328—ADVERTISEMENT OF MEMBERSHIP, FALSE ADVERTISING, MISREPRESENTATION OF INSURED STATUS, AND MISUSE OF THE FDIC'S NAME OR LOGO</HD>
                </PART>
                <AMDPAR>2. Revise the authority citation for part 328 to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>12 U.S.C. 1818, 1819 (Tenth), 1820(c), 1828(a).</P>
                </AUTH>
                <AMDPAR>3. Add new subpart A of part 328 entitled “Subpart A—Advertisement of Membership.”</AMDPAR>
                <AMDPAR>4. Redesignate §§ 328.0 through 328.4 as subpart A of part 328.</AMDPAR>
                <AMDPAR>5. Reserve §§ 328.5 through 328.99.</AMDPAR>
                <AMDPAR>6. Add a new part 328, subpart B to read as follows:</AMDPAR>
                <SUBPART>
                    <HD SOURCE="HED">Subpart B—False Advertising, Misrepresentation of Insured Status, and Misuse of the FDIC's Name or Logo.</HD>
                </SUBPART>
                <CONTENTS>
                    <SECHD>Sec.</SECHD>
                    <SECTNO>328.100 </SECTNO>
                    <SUBJECT>Scope</SUBJECT>
                    <SECTNO>328.101 </SECTNO>
                    <SUBJECT>Definitions</SUBJECT>
                    <SECTNO>328.102 </SECTNO>
                    <SUBJECT>Prohibition</SUBJECT>
                    <SECTNO>328.103 </SECTNO>
                    <SUBJECT>Inquiries and Complaints</SUBJECT>
                    <SECTNO>328.104 </SECTNO>
                    <SUBJECT>Investigations of Potential Violations</SUBJECT>
                    <SECTNO>328.105 </SECTNO>
                    <SUBJECT>Referral to Appropriate Authority</SUBJECT>
                    <SECTNO>328.106 </SECTNO>
                    <SUBJECT>Informal Resolution</SUBJECT>
                    <SECTNO>328.107 </SECTNO>
                    <SUBJECT>Formal Enforcement Actions</SUBJECT>
                    <SECTNO>328.108 </SECTNO>
                    <SUBJECT>Appeals Process</SUBJECT>
                </CONTENTS>
                <SUBPART>
                    <HD SOURCE="HED">Subpart B—False Advertising, Misrepresentation of Insured Status, and Misuse of the FDIC's Name or Logo</HD>
                    <SECTION>
                        <SECTNO>§ 328.100 </SECTNO>
                        <SUBJECT>Scope.</SUBJECT>
                        <P>This Subpart applies to any person who: (1) Falsely represents, expressly or by implication, that any deposit liability, obligation, certificate, or share is FDIC-insured by using the FDIC's name or logo; (2) knowingly misrepresents, expressly or by implication, that any deposit liability, obligation, certificate, or share is insured by the FDIC if such an item is not so insured; (3) knowingly misrepresents, expressly or by implication, the extent to which or the manner in which any deposit liability, obligation, certificate, or share is insured by the FDIC, if such an item is not insured to the extent or manner represented; or (4) aid or abets another in any of the foregoing.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 328.101 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <P>For purposes of this subpart:</P>
                        <P>
                            (a) 
                            <E T="03">Advertisement</E>
                             means a commercial message, in any medium, that is designed to attract public attention or patronage to a product, business, or service.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Appropriate Federal Banking Agency</E>
                             has the meaning set forth in section 3(q) of the FDIC (12 U.S.C. 1813(q)).
                        </P>
                        <P>
                            (c) 
                            <E T="03">FDIA</E>
                             means the Federal Deposit Insurance Act, 12 U.S.C. 1811 
                            <E T="03">et seq.</E>
                        </P>
                        <P>
                            (d) 
                            <E T="03">FDIC</E>
                             means the Federal Deposit Insurance Corporation.
                        </P>
                        <P>
                            (e) 
                            <E T="03">FDIC-Associated Images</E>
                             means the Seal of the FDIC, alone or within the letter C of the term FDIC; the Official Sign and Symbol of the FDIC, as set forth in 12 CFR 328.1; the Official Advertising Statement, as set forth in 12 CFR 328.3(b); any similar images; and any other signs and symbols that may represent or imply that any deposit, liability, obligation certificate, or share is insured or guaranteed by the FDIC.
                        </P>
                        <P>
                            (f) 
                            <E T="03">FDIC-Associated Terms</E>
                             means the abbreviation, “FDIC,” and the following words or phrases: “Federal Deposit Insurance Corporation,” “Federal Deposit,” “Federal Deposit Insurance,” “FDIC-insured,” “FDIC insurance,” “insured by FDIC,” “member FDIC;” any similar words or phrases; or any other terms that may represent or imply that any deposit, liability, obligation certificate, or share is insured or guaranteed by the FDIC.
                        </P>
                        <P>
                            (g) 
                            <E T="03">Federal Banking Agency</E>
                             has the meaning set forth in section 3(z) of the FDIC (12 U.S.C. 1813(z)).
                        </P>
                        <P>
                            (h) 
                            <E T="03">General Counsel</E>
                             means the General Counsel of the FDIC or his or her designee.
                        </P>
                        <P>
                            (i) 
                            <E T="03">Hybrid Product</E>
                             has the same meaning as set forth under 12 CFR 328.3(e)(1)(ii).
                        </P>
                        <P>
                            (j) 
                            <E T="03">Institution-Affiliated Party (</E>
                            <E T="03">IAP</E>
                            ) has the same meaning as set forth under section 3(u) of the FDIA, 12 U.S.C. 1813(u).
                        </P>
                        <P>
                            (k) 
                            <E T="03">Insured Deposit</E>
                             has the same meaning as set forth under section 3(m) of the FDIA, 12 U.S.C. 1813(m).
                        </P>
                        <P>
                            (l) 
                            <E T="03">Insured Depository Institution</E>
                             has the same meaning as set forth under section 3(c)(2) of the FDIA, 12 U.S.C. 1813(c)(2).
                        </P>
                        <P>
                            (m) 
                            <E T="03">Non-Deposit Product</E>
                             has the same meaning as set forth under 12 CFR 328.3(e)(1)(i).
                        </P>
                        <P>
                            (n) 
                            <E T="03">Person</E>
                             means a natural person, sole proprietor, partnership, corporation, unincorporated association, trust, joint venture, pool, syndicate, agency or other entity, association, or organization, including a Regulated Institution as defined in paragraph (o) of this section.
                        </P>
                        <P>
                            (o) 
                            <E T="03">Regulated Institution</E>
                             means any institution for which the FDIC, the Office of the Comptroller of the Currency, or the Board of Governors of the Federal Reserve System is the “appropriate Federal banking agency” under section 3(q) of the FDIA, 12 U.S.C. 1813(q).
                            <PRTPAGE P="24776"/>
                        </P>
                        <P>
                            (p) 
                            <E T="03">Third-Party Publisher</E>
                             means any party that publishes, places, distributes, or circulates advertising or marketing materials, regardless of the platform or media used for distribution, containing FDIC-Associated Images, FDIC-Associated Terms, or other claims regarding FDIC insurance or guarantees. Third-Party Publishers shall include, but not be limited to: Publishers and distributors of written, visual, or print advertising; broadcasters of video or audio advertisements; telemarketers; internet or web-based distributors, including internet service providers, and email marketers; and direct mail marketers and distributors.
                        </P>
                        <P>
                            (q) 
                            <E T="03">Uninsured Financial Product</E>
                             means any Non-Deposit Product, Hybrid-Product, investment, security, obligation, certificate, share, or financial product other than an “Insured Deposit” as defined in paragraph (k) of this section.
                        </P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 328.102 </SECTNO>
                        <SUBJECT>Prohibition.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Use of the FDIC Name or Logo.</E>
                        </P>
                        <P>(1) No person may represent or imply that any Uninsured Financial Product is insured or guaranteed by the FDIC by using FDIC-Associated Terms as part of any business name or firm name of any person;</P>
                        <P>(2) No person may represent or imply that any Uninsured Financial Product is insured or guaranteed by the FDIC by using FDIC-Associated Terms or by using FDIC-Associated Images as part of an Advertisement, solicitation, or other publication or dissemination.</P>
                        <P>(3) This subsection applies, but is not limited, to:</P>
                        <P>(i) An Advertisement for any Uninsured Financial Product which feature or include one or more FDIC-Associated Terms or FDIC-Associated Images, without a clear, conspicuous, and prominent disclaimer that the products being offered are not FDIC insured or guaranteed;</P>
                        <P>(ii) An Advertisement for any Uninsured Financial Product which may be backed or guaranteed by an entity other that the FDIC, but which feature or include one or more FDIC-Associated Terms or FDIC-Associated Images, without a clear, conspicuous, prominent, and accurate explanation as to the actual nature and source of the guarantee;</P>
                        <P>(iii) An Advertisement for any Non-Deposit Product or Hybrid Product by a Regulated Institution which include any statement or symbol which implies or suggests the existence of Federal deposit insurance relating to the Non-Deposit product or Hybrid Product;</P>
                        <P>(iv) Publication or dissemination of information, regardless of the media or platform, that suggests or implies that the party making the representation is an FDIC-insured institution if this is not in fact true.</P>
                        <P>(v) Publication or dissemination of information, regardless of the media or platform, that suggests or implies that the party making the representation is associated with an FDIC-insured institution if the nature of the association is not clearly, conspicuously, prominently, and accurately described.</P>
                        <P>(vi) Publication or dissemination of information, regardless of the media or platform, that suggests or implies that the party making the representation is the FDIC or any office, division, or subdivision thereof, if this is not in fact true.</P>
                        <P>(vii) Publication or dissemination of information, regardless of the media or platform, that suggests or implies that the party making the representation is associated with the FDIC or any office, division, or subdivision thereof, if the nature of the association is not clearly, conspicuously, prominently, and accurately described.</P>
                        <P>
                            (b) 
                            <E T="03">False or Misleading Representations regarding FDIC Insurance.</E>
                        </P>
                        <P>(1) No person may knowingly make false or misleading representations about deposit insurance, including:</P>
                        <P>(i) That any deposit liability, obligation, certificate, or share is insured, under this subpart, if such a deposit is not so insured;</P>
                        <P>(ii) the extent to which any deposit liability, obligation, certificate, or share is insured under this subpart, if such item is not insured to the extent represented; or</P>
                        <P>(iii) the manner in which any deposit liability, obligation, certificate, or share is insured under this subpart, if such item is not insured in the manner represented.</P>
                        <P>(2) For the purposes of this subsection, a statement is deemed to be a statement regarding deposit insurance, if it:</P>
                        <P>(i) Includes any FDIC-Associated Images or FDIC-Associated Terms;</P>
                        <P>(ii) makes any representation, suggestion, or implication about the existence of FDIC insurance or the extent or manner of coverage; or</P>
                        <P>(iii) makes any representation, suggestion, or implication about the existence, extent, or effectiveness of any guarantee by FDIC in the event of financial distress by Insured Depository Institutions, whether a specific Insured Depository Institution or Insured Depository Institutions generally, including but not limited to bank failure, insolvency, or receivership of such institutions.</P>
                        <P>(3) For the purposes of this subsection, a statement regarding deposit insurance violates this section, if:</P>
                        <P>(i) The statement contains any material representations which would have the tendency or capacity to mislead a reasonable consumer, regardless of whether any such consumer was actually misled; or</P>
                        <P>(ii) the statement omits material information which would be necessary to prevent a reasonable consumer from being misled, regardless of whether any such consumer was actually misled. Where such a statement is made by a person other than an Insured Depository Institution, failure to identify the name(s) of the Insured Depository Institution(s) that will be receiving the deposits is deemed a material omission.</P>
                        <P>(4) Without limitation, a false or misleading representation is deemed to be material if it states, suggests or implies that:</P>
                        <P>(i) Uninsured Financial Products are insured or guaranteed by the FDIC;</P>
                        <P>(ii) Insured Deposits (whether generally or at a particular Regulated Institution) are not insured or guaranteed by the FDIC;</P>
                        <P>(iii) the amount of deposit insurance coverage is different (whether greater or less) than actually provided under the FDIA;</P>
                        <P>(iv) the circumstances under which deposit insurance may be paid are different than actually provided under the FDIA;</P>
                        <P>(v) the requirements to qualify for deposit insurance, or the process by which deposit insurance would be paid, are different from what is provided under the FDIA and its implementing regulations, including false or misleading claims related to actions required of depositors to qualify for or obtain such insurance; or</P>
                        <P>(vi) Regulated Institutions may convert Insured Deposits into another form of liability that is not insured, such as unsecured debt or equity.</P>
                        <P>(5) Without limitation, a representation is deemed to have been knowingly made if the person making the representation:</P>
                        <P>(i) Has made false or misleading representations regarding deposit insurance;</P>
                        <P>
                            (ii) has been advised by the FDIC in an advisory letter, as provided in § 328.106(a) or has been advised by another governmental or regulatory authority, including, but not limited to, another Federal banking agency, the Federal Trade Commission, the U.S. Department of Justice, or a state bank 
                            <PRTPAGE P="24777"/>
                            <E T="03">supervisor,</E>
                             that such representations are false or misleading; and
                        </P>
                        <P>(iii) thereafter, continues to make these, or substantially-similar, representations.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 328.103 </SECTNO>
                        <SUBJECT>Inquiries and Complaints.</SUBJECT>
                        <P>
                            Should any person have reason to believe that anyone is or may be acting in violation of section 18(a) of the FDIA (12 U.S.C. 1828(a)) or this subpart, or have questions regarding the accuracy of deposit-related representations, such individuals may contact the FDIC at the FDIC Information and Support Center, 
                            <E T="03">https://ask.fdic.gov/fdicinformationandsupportcenter/s/,</E>
                             or by telephone at: 1-877-275-3342 (1-877-ASK-FDIC).
                        </P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 328.104 </SECTNO>
                        <SUBJECT>Investigations of Potential Violations.</SUBJECT>
                        <P>(a) The General Counsel shall have delegated authority to investigate potential violations of section 18(a) of the FDIA (12 U.S.C. 1828(a)) and this subpart.</P>
                        <P>(b) Such investigations will be conducted as prescribed under section 10(c) of the FDIA (12 U.S.C. 1820(c)) and subpart K of part 308 of the FDIC's Rules of Practice and Procedure (12 CFR 308.144-150). Notwithstanding the general confidentiality provisions of 12 CFR 308.147, in cases which may pose a risk of imminent harm to consumers or depositors, the FDIC may disclose or confirm the existence of an investigation that does not involve an Insured Depository Institution or a known IAP thereof. Such disclosure shall not disclose any information obtained or uncovered during the course of the investigation.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 328.105 </SECTNO>
                        <SUBJECT>Referral to Appropriate Authority.</SUBJECT>
                        <P>(a) If, in connection with the receipt of an inquiry or complaint, or during the course of an investigation, informal resolution, or formal enforcement under this subpart:</P>
                        <P>(1) The FDIC becomes aware of conduct by a Regulated Institution for which another Federal banking agency is the appropriate Federal banking agency or an Institution-Affiliated Party of such an institution, that appears to violate section 18(a) of the FDIA (12 U.S.C. 1828(a)), the FDIC may recommend that the appropriate Federal banking agency take appropriate enforcement action. If the appropriate Federal banking agency does not take the recommended action within 30 days, the FDIC may pursue any and all remedies available under section 18(a) or the FDIA (12 U.S.C. 1828(a)) and this subpart;</P>
                        <P>(2) the FDIC becomes aware of conduct that the FDIC has reason to believe violates a civil law or regulations within the jurisdiction of another regulatory authority, the FDIC may take steps to notify the appropriate authority; and</P>
                        <P>(3) the FDIC becomes aware of conduct that the FDIC has reason to believe violates 18 U.S.C. 709, the FDIC may notify FDIC's Office of Inspector General for referral to the appropriate criminal law enforcement authority.</P>
                        <P>(b) To the extent that any records are provided to a regulatory or criminal law enforcement authority, as set forth in paragraph (a), of this section, the provision of such records will be made in accordance with the requirements of part 309. Where such records were obtained during the course of an investigation, informal resolution, or formal enforcement action, the General Counsel shall be considered the Director of the Corporation's Division having primary authority over records so obtained.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 328.106 </SECTNO>
                        <SUBJECT>Informal Resolution.</SUBJECT>
                        <P>(a) If the FDIC has reason to believe that any person may be misusing an FDIC-associated image or FDIC-associated term or otherwise violating § 328.102(a), or may be making false or misleading representations regarding deposit insurance in violation of § 328.102(b), the FDIC may issue an advisory letter to such a person and/or any person who aids or abets another in such conduct, including any Third-Party Publisher. Generally, such an advisory letter will:</P>
                        <P>(1) Alert the recipient of advisory letter of the basis for the FDIC's concerns;</P>
                        <P>(2) Request that the person and/or Third-Party Publisher:</P>
                        <P>(i) Take reasonable steps to prevent any violations of section 18(a) of the FDIA (12 U.S.C. 1828(a)) and this subpart;</P>
                        <P>(ii) commit in writing to refrain from such violations in the future; and</P>
                        <P>(iii) notify the FDIC in writing that the identified concerns have been fully addressed and remediated; and</P>
                        <P>(3) Offer the person or Third-Party Publisher the opportunity to provide additional information, documentation, or justifications to substantiate the representations made or otherwise refute the FDIC's expressed concerns.</P>
                        <P>(b) Except in cases where the FDIC has reason to believe that consumers or Insured Depository Institutions may suffer harm arising from continued violations, recipients of advisory letters described in paragraph (a) of this section, shall be provided not less than fifteen (15) days to provide the requested commitment, explanation, or justification.</P>
                        <P>(c) Where a recipient of an advisory letter described in paragraph (a) of this section, provides the FDIC with the requested written commitments within the timeframe specified in the letter, and where any required remediation has been verified by FDIC staff, the FDIC will generally take no further administrative enforcement against such a party under § 328.107.</P>
                        <P>(d) Where a recipient of an advisory letter described in paragraph (a) of this section, fails to respond to the letter; fails to make the requested commitments; or fails to provide additional information, documentation, or justifications that the FDIC, in its discretion, finds adequate to substantiate the representations made or otherwise refute the concerns set forth in the advisory letter, the FDIC may pursue all remedies set forth in this subpart.</P>
                        <P>(e) Nothing in this section shall prevent the FDIC from commencing a formal enforcement action under § 328.107 at any time before or after the issuance of an advisory letter under this section if:</P>
                        <P>(1) The FDIC has reason to believe that consumers or Insured Depository Institutions may suffer harm arising from continued violations; or</P>
                        <P>(2) the person to whom such an advisory letter would be sent has previously received a similar advisory letter from the FDIC under § 328.106(a).</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 328.107 </SECTNO>
                        <SUBJECT>Formal Enforcement Actions.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Enforcement Authority</E>
                            —For the purpose of enforcing the requirements of Section 18(a)(4) of the FDIA (12 U.S.C. 1818(a)(4)), the General Counsel is authorized to bring administrative enforcement actions against any person under sections 8(b), (c), (d), and (i) of the FDIA (12 U.S.C. 1818(b), 1818(c), 1818(d), and 1818(i)), in the same manner and to the same extent as with respect to a state nonmember insured bank. In the case of conduct by a Regulated Institution for which another Federal banking agency is the appropriate Federal banking agency or an institution-affiliated party of such an institution, the General Counsel may not bring an enforcement action under this subpart unless the FDIC has provided the appropriate Federal banking agency with notice as set forth in section 105(a)(1) of this subpart and the appropriate Federal banking agency failed to take the recommended action.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Venue</E>
                            —Unless the person who is the subject of the enforcement action consents to a different location, the venue for an administrative action 
                            <PRTPAGE P="24778"/>
                            commenced under Section 18(a)(4) of the FDIA (12 U.S.C. 1818(a)(4)), shall be as follows:
                        </P>
                        <P>(1) In a case where the person who is the subject of the action is an Insured Depository Institution or an IAP of an Insured Depository Institution, in the federal judicial district or territory in which the home office of the Insured Depository Institution is located;</P>
                        <P>(2) In a case where the person who is the subject of the action is not an Insured Depository Institution or an IAP of an Insured Depository Institution, the federal judicial district or territory where the person who is the subject of the action resides, if the subject resides in the United States. If the subject of the action does not reside in the United States, the venue shall be where the subject of the action conducts business or the federal judicial district for the District of Columbia.</P>
                        <P>(3) For the purposes of paragraph (1) of this section, a natural person is deemed to reside in the federal judicial district where the natural person is domiciled. A person other than a natural person is deemed to reside in the federal judicial district where it is headquartered or has its principal place of business.</P>
                        <P>
                            (c) 
                            <E T="03">Rules of Practice and Procedure.</E>
                             All actions brought and maintained under this section will be subject to the FDIC's Rules of Practice and Procedure, Subparts A-C of Part 308 (12 CFR 308.1-308.109).
                        </P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 328.108 </SECTNO>
                        <SUBJECT>Appeals Process.</SUBJECT>
                        <P>(a) A person who is the subject of a final order issued after an administrative action commenced pursuant to this subpart may obtain judicial review of such order in accordance with the procedures set forth in section 8(h)(2) of the FDIA (12 U.S.C. 1818(h)(2)).</P>
                        <P>(b) Petitions for review under this section may be filed in the court of appeals for the circuit where the hearing was held or the United States Court of Appeals for the District of Columbia Circuit.</P>
                    </SECTION>
                </SUBPART>
                <SIG>
                    <FP>Federal Deposit Insurance Corporation.</FP>
                    <P>By order of the Board of Directors.</P>
                    <DATED>Dated at Washington, DC, on April 21, 2021.</DATED>
                    <NAME>James P. Sheesley,</NAME>
                    <TITLE>Assistant Executive Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-08690 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6714-01-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2021-0338; Project Identifier AD-2020-01423-T]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; The Boeing Company Airplanes</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA proposes to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 and 787-9 airplanes. This proposed AD was prompted by reports that shimming requirements were not met during the assembly of certain structural joints, which can result in reduced fatigue thresholds and cracking of the affected structural joints. This proposed AD would require repetitive inspections for cracking of certain areas of the aft wheel well bulkhead (AWWB) body chord and AWWB side fitting and failsafe straps, and repair of any cracking found. 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 June 24, 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 Boeing Commercial Airplanes, Attention: Contractual &amp; Data Services (C&amp;DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet 
                        <E T="03">https://www.myboeingfleet.com.</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. It is also available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for and locating Docket No. FAA-2021-0338.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2021-0338; 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>
                        Greg Rutar, Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3529; email: 
                        <E T="03">Greg.Rutar@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under 
                    <E T="02">ADDRESSES</E>
                    . Include “Docket No. FAA-2021-0338; Project Identifier AD-2020-01423-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 the proposal because of those comments.
                </P>
                <P>
                    Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments we receive, 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 we receive about this proposed AD.
                </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 
                    <PRTPAGE P="24779"/>
                    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 Greg Rutar, Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206 231 3529; email: 
                    <E T="03">Greg.Rutar@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 has received reports indicating that shimming requirements were not met during the assembly of certain AWWB structural joints, which can result in reduced fatigue thresholds and cracking of the affected structural joints. The existing inspection program does not adequately detect this fatigue cracking. The affected locations are the forward edge of the AWWB side fitting and failsafe strap at STA 1209 on the left and right side, and the AWWB side fitting outer chord surface and failsafe strap; and the forward edge of the horizontal flange of the AWWB body chord and around all the fastener heads and vertical beam clips common to the AWWB body chord horizontal flange. Not meeting the shimming requirements during assembly of the STA 1209 AWWB side fitting and body chord structural joints results in excessive pull-up forces, fastener shanking, excessive burr heights in metallic members, and metallic chips (foreign object debris) in fastened interfaces, which all degrade fatigue performance of any affected structural joints.</P>
                <P>Undetected fatigue cracking could weaken primary structure so it cannot sustain limit load, which could result in reduced structural integrity of the airplane.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>The FAA reviewed Boeing Alert Requirements Bulletin B787-81205-SB530077-00 RB, Issue 001, dated September 8, 2020. The service information describes procedures for repetitive high frequency eddy current (HFEC) inspections for cracking of the forward edge of the AWWB side fitting and failsafe strap at station (STA) 1209 on the left and right side, and the AWWB side fitting outer chord surface and failsafe strap, and repair of any cracking found.</P>
                <P>The FAA reviewed Boeing Alert Requirement Bulletin B787-81205-SB530078-00 RB, Issue 001, dated September 8, 2020. The service information describes procedures for repetitive HFEC inspections for cracking of the forward edge of the horizontal flange of the AWWB body chord and around all the fastener heads and vertical beam clips common to the AWWB body chord horizontal flange.</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">FAA's Determination</HD>
                <P>The FAA is proposing this AD because the agency evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.</P>
                <HD SOURCE="HD1">Proposed AD Requirements</HD>
                <P>This proposed AD would require accomplishment of the actions identified in Boeing Alert Requirements Bulletins B787-81205-SB530077-00 RB and B787-81205-SB530078-00 RB, both Issue 001, both dated September 8, 2020, except for any differences identified as exceptions in the regulatory text of this proposed AD.</P>
                <P>
                    For information on the procedures and compliance times, see this service information at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2021-0338.
                </P>
                <HD SOURCE="HD1">Explanation of Requirements Bulletin</HD>
                <P>The FAA worked in conjunction with industry, under the Airworthiness Directive Implementation Aviation Rulemaking Committee (AD ARC), to enhance the AD system. One enhancement is a process for annotating which steps in the service information are “required for compliance” (RC) with an AD. Boeing has implemented this RC concept into Boeing service bulletins.</P>
                <P>
                    In an effort to further improve the quality of ADs and AD-related Boeing service information, a joint process improvement initiative was worked between the FAA and Boeing. The initiative resulted in the development of a new process in which the service information more clearly identifies the actions needed to address the unsafe condition in the “Accomplishment Instructions.” The new process results in a Boeing Requirements Bulletin, which contains only the actions needed to address the unsafe condition (
                    <E T="03">i.e.,</E>
                     only the RC actions).
                </P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this proposed AD affects 79 airplanes 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,r75,10,r40,r50">
                    <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 product</CHED>
                        <CHED H="1">Cost on U.S. operators</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Repetitive inspections</ENT>
                        <ENT>16 work-hours × $85 per hour = $1,360 per inspection cycle</ENT>
                        <ENT>$0</ENT>
                        <ENT>$1,360 per inspection cycle</ENT>
                        <ENT>$107,440 per inspection cycle.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The FAA has received no definitive data on which to base the cost estimates for the on-condition repairs specified in this proposed AD.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>
                    The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the 
                    <PRTPAGE P="24780"/>
                    States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
                </P>
                <P>For the reasons discussed above, I certify this proposed regulation:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Would not affect intrastate aviation in Alaska, and</P>
                <P>(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39</HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 39 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(g), 40113, 44701.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 39.13 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">The Boeing Company:</E>
                         Docket No. FAA-2021-0338; Project Identifier AD-2020-01423-T.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) by June 24, 2021.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>None.</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to The Boeing Company Model 787-8 and 787-9 airplanes, certificated in any category, as identified in Boeing Alert Requirements Bulletin B787-81205-SB530077-00 RB, Issue 001, dated September 8, 2020.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Air Transport Association (ATA) of America Code 53, Fuselage.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD was prompted by reports that shimming requirements were not met during the assembly of certain aft wheel well bulkhead (AWWB) structural joints, which can result in reduced fatigue thresholds and cracking of the affected structural joints. The FAA is issuing this AD to address undetected fatigue cracking, which could weaken primary structure so it cannot sustain limit load, and could result in reduced structural integrity of the airplane.</P>
                    <HD SOURCE="HD1">(f) Compliance</HD>
                    <P>Comply with this AD within the compliance times specified, unless already done.</P>
                    <HD SOURCE="HD1">(g) Required Actions</HD>
                    <P>Except as specified by paragraph (h) of this AD: At the applicable times specified in the “Compliance” paragraph of Boeing Alert Requirements Bulletins B787-81205-SB530077-00 RB and B787-81205-SB530078-00 RB, both Issue 001, both dated September 8, 2020, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Alert Requirements Bulletins B787-81205-SB530077-00 RB and B787-81205-SB530078-00 RB, both Issue 001, both dated September 8, 2020.</P>
                    <NOTE>
                        <HD SOURCE="HED">Note 1 to paragraph (g):</HD>
                        <P> Guidance for accomplishing the actions required by this AD can be found in Boeing Alert Service Bulletins B787-81205-SB530077-00 and B787-81205-SB530078-00, both Issue 001, both dated September 8, 2020, which are referred to in Boeing Alert Requirements Bulletins B787-81205-SB530077-00 RB and B787-81205-SB530078-00 RB, both Issue 001, both dated September 8, 2020.</P>
                    </NOTE>
                    <HD SOURCE="HD1">(h) Exceptions to Service Information Specifications</HD>
                    <P>(1) Where Boeing Alert Requirements Bulletin B787-81205-SB530077-00 RB, Issue 001, dated September 8, 2020, uses the phrase “the issue 001 date of the Requirements Bulletin B787-81205-SB530077-00 RB” this AD requires using “the effective date of this AD.”</P>
                    <P>(2) Where Boeing Alert Requirements Bulletin B787-81205-SB530078-00 RB, Issue 001, dated September 8, 2020, uses the phrase “the issue 001 date of the Requirements Bulletin B787-81205-SB530078-00 RB,” this AD requires using “the effective date of this AD.”</P>
                    <P>(3) Where Boeing Alert Requirements Bulletins B787-81205-SB530077-00 RB and B787-81205-SB530078-00 RB, both Issue 001, both dated September 8, 2020, specify contacting Boeing for repair instructions: This AD requires doing the repair using a method approved in accordance with the procedures specified in paragraph (i) of this AD.</P>
                    <HD SOURCE="HD1">(i) Alternative Methods of Compliance (AMOCs)</HD>
                    <P>
                        (1) The Manager, Seattle ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j)(1) of this AD. Information may be emailed to: 
                        <E T="03">9-ANM-Seattle-ACO-AMOC-Requests@faa.gov.</E>
                    </P>
                    <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.</P>
                    <P>(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO Branch, FAA, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.</P>
                    <HD SOURCE="HD1">(j) Related Information</HD>
                    <P>
                        (1) For more information about this AD, contact Greg Rutar, Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3529; email: 
                        <E T="03">Greg.Rutar@faa.gov.</E>
                    </P>
                    <P>
                        (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual &amp; Data Services (C&amp;DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet 
                        <E T="03">https://www.myboeingfleet.com.</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 April 20, 2021.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09345 Filed 5-7-21; 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-2021-0348; Project Identifier 2018-SW-076-AD]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Leonardo S.p.a. (Type Certificate Previously Held by Agusta S.p.A.) 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) 2011-18-52 for certain Agusta S.p.A. (now Leonardo S.p.a.) Model AB139 and AW139 helicopters. AD 2011-18-52 requires revising the life limit for certain part-numbered tail rotor (T/R) blades, updating the helicopter's historical records, repetitively inspecting each T/R blade for a crack or damage, and depending on the results, replacing the T/R blade. Since the FAA 
                        <PRTPAGE P="24781"/>
                        issued AD 2011-18-52, the manufacturer developed improved T/R blades using different materials and established life limits for each improved blade. This proposed AD would retain certain requirements from AD 2011-18-52, revise certain requirements from AD 2011-18-52, and expand the applicability to include the newly-designed T/R blades. The actions of this proposed AD are intended to address an unsafe condition on these products.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The FAA must receive comments on this proposed AD by June 24, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Docket:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the online instructions for sending your comments electronically.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Send comments to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         Deliver to the “Mail” address between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        For service information identified in this NPRM, contact Leonardo S.p.a. Helicopters, Emanuele Bufano, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone +39-0331-225074; fax +39-0331-229046; or at 
                        <E T="03">https://www.leonardocompany.com/en/home.</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 on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2021-0348; 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 proposed AD, the European Aviation Safety Agency (now 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>
                        Matt Fuller, AD Program Manager, Operational Safety Branch, Airworthiness Products Section, General Aviation &amp; Rotorcraft Unit, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email 
                        <E T="03">Matthew.Fuller@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under 
                    <E T="02">ADDRESSES</E>
                    . Include “Docket No. FAA-2021-0348; Project Identifier 2018-SW-076-AD” 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 proposal.
                </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, Matt Fuller, AD Program Manager, Operational Safety Branch, Airworthiness Products Section, General Aviation &amp; Rotorcraft Unit, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email 
                    <E T="03">Matthew.Fuller@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 Emergency AD 2011-18-52 on August 25, 2011, which was published as a Final rule; request for comments, on April 18, 2012 (77 FR 23109) (AD 2011-18-52). AD 2011-18-52 applies to Agusta S.p.A. (now Leonardo S.p.a.) Model AB139 and AW139 helicopters with a T/R blade part number (P/N) 3G6410A00131 or P/N 4G6410A00131 installed. AD 2011-18-52 requires, within 5 hours time-in-service (TIS), establishing a life limit of 600 hours TIS or 1,500 takeoff and landing cycles (cycles), whichever occurs first, on the affected T/R blades and updating the helicopter's historical records. If a T/R blade's total number of cycles is unknown, determining the T/R blade cycles by multiplying the T/R blade's hours TIS by 4 is required. For a T/R blade that, on the effective date of the AD, has already exceeded 600 hours TIS or 1,500 cycles, the AD requires replacing the T/R blade with an airworthy T/R blade within 5 hours TIS.</P>
                <P>AD 2011-18-52 also requires, within 25 hours TIS, and thereafter at intervals not to exceed 25 hours TIS, inspecting the T/R blade for a crack or damage that exceeds the limits of the applicable maintenance manual. The inspection must be accomplished using a mirror, magnifying glass (5X or greater), and light source; or borescope. If there is a crack, or if there is damage that exceeds the limits of the applicable maintenance manual, AD 2011-18-52 requires, before further flight, replacing the T/R blade with an airworthy T/R blade.</P>
                <P>AD 2011-18-52 was prompted by a fatal accident involving an Agusta Model AW139 helicopter, which may have been caused by cracks in a T/R blade. EASA, which is the Technical Agent for the Member States of the European Union, issued EASA Emergency AD 2011-0156-E, dated August 25, 2011 (EASA AD 2011-0156-E) to require repetitive inspections and reducing the life limit of the T/R blades. According to EASA, this condition, if not detected and corrected, could result in failure of a T/R blade and subsequent loss of control of the helicopter.</P>
                <HD SOURCE="HD1">Actions Since AD 2011-18-52 Was Issued</HD>
                <P>Since the FAA issued AD 2011-18-52, EASA issued a series of ADs as follows:</P>
                <P>
                    • EASA AD 2012-0030, dated February 17, 2012 (EASA AD 2012-0030), which superseded Emergency AD 2011-0156-E, advised that the manufacturer developed improved, newly-designed T/R blades P/N 3G6410A00132 and P/N 4G6410A00132, established life limits for each improved T/R blade, added repetitive inspections for the improved T/R blades, and advised that each T/R 
                    <PRTPAGE P="24782"/>
                    blade P/N had its own individual life limit.
                </P>
                <P>• EASA AD 2012-0076, dated May 2, 2012 (EASA AD 2012-0076), which superseded EASA AD 2012-0030 and was issued after the manufacturer developed another version of improved T/R blades P/N 3G6410A00133 and P/N 4G6410A00133 with different materials. AD 2012-0076 required interim life limits for the new improved version of the T/R blades while also retaining the inspection requirements of EASA AD 2012-0030.</P>
                <P>• EASA AD 2012-0076R1, dated July 13, 2012 (EASA AD 2012-0076R1), which revised EASA AD 2012-0076 after a modification was developed to allow installation of certain part-numbered T/R blades under certain conditions.</P>
                <P>• EASA AD 2012-0076R2, dated February 20, 2014 (EASA AD 2012-0076R2), which revised EASA AD 2012-0076R1, was issued after another modification was developed. EASA AD 2012-0076R2 requires removing the 25 hours TIS inspection of certain part-numbered T/R blades, extending the life limit of certain part-numbered T/R blades, retaining the repetitive inspections of certain part-numbered T/R blades and depending on the inspection results, performing certain applicable corrections.</P>
                <P>
                    Also, after AD 2011-18-52 was issued, the FAA issued an NPRM (78 FR 54596), which published in the 
                    <E T="04">Federal Register</E>
                     on September 5, 2013. The NPRM proposed to require retaining the inspection requirements for certain part-numbered blades and expand the applicability to include the newly designed blades and establish life limits for those blades. The NPRM also proposed to require replacing any cracked blade or any blade that has reached its life limit. That NPRM was prompted by improved modifications of the T/R blades. However, because the FAA determined that the NPRM does not adequately address the identified unsafe condition, the NPRM was withdrawn on February 25, 2021 (86 FR 11477).
                </P>
                <P>Additional review also revealed necessary changes to address the unsafe condition. This proposed AD clarifies the repetitive inspection for T/R blade P/Ns 3G6410A00131 and P/N 4G6410A00131 from, “visually inspect the T/R blade for a crack or damage” to “visually inspect the T/R blade for a crack and damage.” This proposed AD further revises that repetitive inspection from “damage that exceeds the limits of the applicable maintenance manual” to “damage that exceeds allowable limits” to meet current publishing requirements. This proposed AD clarifies the inspection area for that repetitive inspection by proposing to require using a figure in the related service information instead of using a figure in the body of this AD action. This proposed AD also revises the requirements by removing unnecessary information, including the special flight permits paragraph.</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 of the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining that an unsafe condition is likely to exist or develop on other helicopters of the same type design.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>The FAA reviewed AgustaWestland S.p.A Mandatory Bollettino Tecnico No. 139-265, Revision B, dated February 18, 2014. This service information specifies a precautionary inspection for a crack, a life limit for the affected T/R blades, and a quarantine of T/R blades that have exceeded their life limit. This service information also provides instructions for mixed usage of the affected T/R blades and sending certain data to the manufacturer.</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">Proposed AD Requirements</HD>
                <P>This proposed AD would retain the inspection requirements of AD 2011-18-52 for certain part-numbered T/R blades, expand the applicability to include the improved T/R blades, require determining each T/R blade's total hours TIS or landing cycles, and establish life limits for certain T/R blades. This proposed AD would require removing from service any T/R blade that has a crack or damage beyond allowable limits or any T/R blade that has reached its life limit.</P>
                <HD SOURCE="HD1">Differences Between This Proposed AD and EASA AD</HD>
                <P>The EASA AD does not list the T/R blade life limits and instead references the Airworthiness Limitations Section of 139 AMPI Chapter 4, while this proposed AD would include the life limits in the AD. The EASA AD requires reporting information to Product Support Engineering, whereas this proposed AD would not. The EASA AD requires contacting AgustaWestland if a crack or damage is found during the inspection, whereas this proposed AD would require removing the T/R blade from service.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this proposed AD would affect 130 helicopters of U.S. Registry. The FAA estimates that operators may incur the following costs in order to comply with this proposed AD. Labor costs are estimated at $85 per work-hour.</P>
                <P>Inspecting one T/R blade for a crack would take about 1 work-hour for an estimated cost of $85 per T/R blade per inspection cycle and up to $44,200 for the U.S. fleet per inspection cycle.</P>
                <P>Replacing one T/R blade would take about 8 work-hours and parts would cost about $40,560 for an estimated cost of $41,240 per replacement.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.</P>
                <P>For the reasons discussed, 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
                    <PRTPAGE P="24783"/>
                </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 2011-18-52, Amendment 39-17020 (77 FR 23109, April 18, 2012); and</AMDPAR>
                <AMDPAR>b. Adding the following new airworthiness directive:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">Leonardo S.p.a. (Type Certificate Previously Held by Agusta S.p.A.):</E>
                         Docket No. FAA-2021-0348; Project Identifier 2018-SW-076-AD.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) action by June 24, 2021.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>This AD replaces AD 2011-18-52, Amendment 39-17020 (77 FR 23109, April 18, 2012) (AD 2011-18-52).</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to Leonardo S.p.a. (type certificate previously held by Agusta S.p.A.) Model AB139 and AW139 helicopters, certificated in any category, with tail rotor (T/R) blade, part number (P/N) 3G6410A00131, 3G6410A00132, 3G6410A00133, 4G6410A00131, 4G6410A00132, or 4G6410A00133, installed.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Joint Aircraft Service Component (JASC) Code: 6410, Tail Rotor Blades.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD defines the unsafe condition as a crack in a T/R blade. This condition could result in failure of a T/R blade 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) Required Actions</HD>
                    <P>(1) For T/R blade P/Ns 3G6410A00131 and 4G6410A00131, within 5 hours time-in-service (TIS) after May 3, 2012 (the effective date of AD 2011-18-52), establish a life limit of 600 hours TIS or 1,500 takeoff and landing cycles (cycles), whichever occurs first, on the affected T/R blades and update the helicopter's historical records. If a T/R blade's total number of cycles is unknown, determine the T/R blade cycles by multiplying the T/R blade's hours TIS by 4.</P>
                    <P>(2) For T/R blade P/Ns 3G6410A00131 and 4G6410A00131, thereafter following paragraph (g)(1) of this AD, remove any T/R blade from service before accumulating 600 total hours TIS or 1,500 total cycles, whichever occurs first.</P>
                    <P>(3) For T/R blade P/Ns 3G6410A00132, 3G6410A00133, 4G6410A00132, and 4G6410A00133, within 5 hours TIS after the effective date of this AD, determine the total number of cycles. If a T/R blade's total number of cycles is unknown, determine the T/R blade cycles by multiplying the blade's hours TIS by 4. Before further flight, remove any T/R blade from service that has accumulated or exceeded its life limit as follows. Thereafter, remove any T/R blade from service before accumulating its life limit as follows:</P>
                    <P>(i) T/R blade P/Ns 3G6410A00132 and 4G6410A00132: 1,200 total hours TIS or 3,200 total cycles, whichever occurs first.</P>
                    <P>(ii) T/R blade P/N 3G6410A00133: 40,000 total cycles.</P>
                    <P>(iii) T/R blade P/N 4G6410A00133: 4,033 total hours TIS or 40,000 cycles, whichever occurs first.</P>
                    <NOTE>
                        <HD SOURCE="HED">Note 1 to paragraph (g)(3): </HD>
                        <P>A combination of T/R blades having different P/Ns can be installed on the same helicopter. The eligible combinations of T/R blades P/N are listed in AgustaWestland S.p.A. Mandatory Bollettino Tecnico No. 139-265, Revision B, dated February 18, 2014 (BT No. 139-265).</P>
                    </NOTE>
                    <P>(4) For T/R blade P/Ns 3G6410A00131 and P/N 4G6410A00131, within 25 hours TIS after the effective date of this AD, and thereafter at intervals not to exceed 25 hours TIS, visually inspect the T/R blade for a crack and damage that exceeds allowable limits. Inspect in the area depicted in Figure 1 of BT No. 139-265 using a mirror, a 5X or higher power magnifying glass, and a flashlight, or borescope. If there is a crack or damage that exceeds allowable limits, before further flight, remove the T/R blade from service.</P>
                    <P>(5) As of the effective date of this AD, do not install on any helicopter any T/R blade P/N 3G6410A00131 or P/N 4G6410A00131, unless the actions required by paragraphs (g)(1), (2), and (4) of this AD have been accomplished.</P>
                    <HD SOURCE="HD1">(h) 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 (i)(1) of this AD. Information may be emailed to: email 
                        <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">(i) Related Information</HD>
                    <P>
                        (1) For more information about this AD, contact Matt Fuller, AD Program Manager, Operational Safety Branch, Airworthiness Products Section, General Aviation &amp; Rotorcraft Unit, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email 
                        <E T="03">matthew.fuller@faa.gov.</E>
                    </P>
                    <P>
                        (2) For service information identified in this AD, contact Leonardo S.p.a. Helicopters, Emanuele Bufano, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone +39-0331-225074; fax +39-0331-229046; or at 
                        <E T="03">https://www.leonardocompany.com/en/home.</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.
                    </P>
                    <P>
                        (3) The subject of this AD is addressed in European Aviation Safety Agency (now European Union Aviation Safety Agency) (EASA) AD 2012-0076R2, dated February 20, 2014. You may view the EASA AD on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         in the AD Docket.
                    </P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued on April 30, 2021.</DATED>
                    <NAME>Lance T. Gant, </NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09759 Filed 5-7-21; 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-2020-0904; Product Identifier 2019-SW-041-AD]</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>Supplemental notice of proposed rulemaking (SNPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA is revising a notice of proposed rulemaking (NPRM) that applied to certain Airbus Helicopters Model EC225LP helicopters. This action revises the NPRM by revising the required actions paragraph such that the required actions apply to all helicopter models specified in the applicability. The FAA is proposing this airworthiness directive (AD) to address the unsafe condition on these products. Since these actions would impose an additional burden over those in the NPRM, the agency is requesting comments on this SNPRM.</P>
                </SUM>
                <DATES>
                    <PRTPAGE P="24784"/>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The FAA must receive comments on this SNPRM by June 24, 2021.</P>
                </DATES>
                <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 between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        For service information identified in this SNPRM, contact Airbus Helicopters, 2701 N 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-2020-0904; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, this SNPRM, 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>
                        James Blyn, Aviation Safety Engineer, Strategic Policy Emerging Aircraft Section, Policy and Innovation Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email 
                        <E T="03">james.blyn@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-2020-0904; Product Identifier 2019-SW-041-AD” 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 again revise 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 proposed AD.
                </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 SNPRM 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 SNPRM, 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 SNPRM. Submissions containing CBI should be sent to James Blyn, Aviation Safety Engineer, Strategic Policy Emerging Aircraft Section, Policy and Innovation Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email 
                    <E T="03">james.blyn@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 an NPRM to amend 14 CFR part 39 by adding an AD that would apply to Airbus Helicopters Model EC225LP helicopters, with left-hand side (LH) engine fuel supply (fuel supply) hose part number (P/N) 704A34416087 installed. The NPRM published in the 
                    <E T="04">Federal Register</E>
                     on October 7, 2020, (85 FR 63235). For helicopters delivered to the first operator before November 30, 2018, and for helicopters delivered to the first operator on or after November 30, 2018, that have had the LH fuel supply hose replaced or reinstalled before May 10, 2019, the NPRM proposed to require visually inspecting the LH fuel supply hose for twisting, and if needed, borescope inspecting the entire length of the inside of the fuel supply hose for twisting. Depending on the inspection results, the NPRM proposed to require reinstalling or removing the fuel supply hose from service. Additionally, the NPRM proposed to prohibit installing a certain part-numbered LH fuel supply hose on any helicopter unless that LH fuel supply hose is installed by following certain procedures specified in the manufacturer's service bulletin. The proposed requirements were intended to prevent a decrease of the LH engine power when accelerating to a power setting corresponding to One Engine Inoperative (OEI) power and subsequent reduced control of the helicopter. The NPRM was prompted by EASA AD 2019-0092, dated April 26, 2019 (EASA AD 2019-0092), issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for Airbus Helicopters (formerly Eurocopter) Model EC 225 LP helicopters, all serial numbers. EASA advises that an occurrence was reported where during an in-flight single engine power check, the LH side engine experienced a power loss. EASA states that a subsequent investigation determined that the fuel flow to the affected engine was restricted by a twisted fuel supply hose. EASA states that this condition, if not detected and corrected, could lead to a decrease of the LH engine power when accelerating to the power setting corresponding to OEI power, and subsequent reduced control of the helicopter. Accordingly, the EASA AD requires a one-time visual inspection of the fuel supply hose and depending on the inspection results, removing from service or replacing the affected part. EASA also introduces re-installation requirements for a fuel supply hose that is being replaced or reinstalled.
                </P>
                <HD SOURCE="HD1">Actions Since the NPRM Was Issued</HD>
                <P>
                    Since the NPRM was issued, the FAA determined that operators may not have the information required to comply with the required actions proposed in the NPRM. Operators may not know the date the helicopter was delivered to the first operator. Additionally, operators may not know whether the LH fuel supply hose has been previously removed or reinstalled since the maintenance regulations do not require certain operators to maintain these records after one year. Accordingly, the FAA has determined the proposed paragraph (e)(1) of the NPRM must be revised by deleting the language referring to delivery dates and dates of LH fuel supply hose replacement or 
                    <PRTPAGE P="24785"/>
                    reinstallation. As a result of these changes, all helicopters specified in the applicability paragraph would be required to comply with the required actions in this proposed AD. Also, since the NPRM was issued, the FAA has determined that a limit on special flight permits is required. This SNPRM reflects this change that special flight permits may be permitted provided that there are no passengers on board.
                </P>
                <HD SOURCE="HD1">Comments</HD>
                <P>The FAA received no comments on the NPRM or on the determination of the cost.</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 determining the unsafe condition described previously is likely to exist or develop in other helicopters of these same type designs. Certain changes described above expand the scope of the NPRM. As a result, it is necessary to reopen the comment period to provide additional opportunity for the public to comment on this SNPRM.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>The FAA reviewed Airbus Helicopters Alert Service Bulletin No. EC225-71A019, Revision 1, dated February 28, 2019, which specifies procedures for removing the fuel supply hose from the LH power plant, visually inspecting the fuel supply hose for twisting, and depending on inspection results, performing an endoscope inspection on the inside of the hose. This service information also specifies procedures required to install a serviceable fuel supply hose.</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">Proposed AD Requirements in This SNPRM</HD>
                <P>For helicopters with a certain part-numbered LH fuel supply hose installed, this proposed AD would require visually inspecting the LH fuel supply hose for twisting, and if needed, borescope inspecting the entire length of the inside of the fuel supply hose for twisting. Depending on the inspection results, this proposed AD would require reinstalling or removing the fuel supply hose from service. Additionally, this proposed AD would prohibit installing a certain part-numbered LH fuel supply hose on any helicopter unless that LH fuel supply hose is installed by following certain procedures described in the manufacturer's service bulletin.</P>
                <HD SOURCE="HD1">Differences Between This SNPRM and the EASA AD</HD>
                <P>The EASA AD requires compliance within 110 flight hours or 6 months, whichever occurs first, while this proposed AD would require compliance within 110 hours time-in-service after the effective date of this AD. The EASA AD requires reporting information to Airbus Helicopters if the LH fuel supply hose is twisted on the inside, while this proposed AD would not. Additionally, the EASA AD is applicable to certain aircraft delivered to the first operator prior to 30 Nov 2018, and also to certain aircraft in which the affected part or LH engine were not replaced or reinstalled before the effective date of the EASA AD, whereas this proposed AD would apply to EC225LP helicopters with a certain LH fuel supply hose installed, because operators might not know when the helicopter was first delivered or what maintenance was previously performed.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD, if adopted as proposed, would affect 28 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD.</P>
                <P>Visually inspecting the LH fuel supply hose for twisting would take about 1 work-hour for an estimated cost of $85 per helicopter and $2,380 for the U.S. fleet.</P>
                <P>Replacing a LH fuel supply hose would take about 8 work-hours and parts would cost about $2,278 for an estimated replacement cost of $2,958 per replacement.</P>
                <P>Borescope inspecting the LH fuel supply hose would take about 8 work-hours for an estimated cost of $680 per helicopter.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.</P>
                <P>For the reasons discussed, I certify this proposed regulation:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Would not affect intrastate aviation in Alaska, and</P>
                <P>(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39</HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 39 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(g), 40113, 44701.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 39.13 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">Airbus Helicopters:</E>
                         Docket No. FAA-2020-0904; Product Identifier 2019-SW-041-AD.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) action by June 24, 2021.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>
                        None.
                        <PRTPAGE P="24786"/>
                    </P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to Airbus Helicopters Model EC225LP helicopters, certificated in any category, with a left-hand side (LH) engine fuel supply (fuel supply) hose part number (P/N) 704A34416087 installed.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Joint Aircraft Service Component (JASC) Code: 2820, Aircraft Fuel Distribution System.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD was prompted by a report of an incorrect installation of the LH fuel supply hose P/N 704A34416087. The FAA is issuing this AD to prevent restricted fuel flow to the LH engine. The unsafe condition, if not addressed, could result in a decrease of the LH engine power when accelerating to a power setting corresponding to One Engine Inoperative power and subsequent reduced 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) Required Actions</HD>
                    <P>(1) Within 110 hours time-in-service (TIS) after the effective date of this AD, visually inspect the LH fuel supply hose for twisting as shown in Figures 1 and 2 of Airbus Helicopters Alert Service Bulletin No. EC225-71A019, Revision 1, dated February 28, 2019 (ASB EC225-71A019). If the LH fuel supply hose has any twisting, before further flight, borescope inspect the entire length of the inside of the fuel supply hose for twisting as shown in Figures 3 through 5 of ASB EC225-71A019.</P>
                    <P>(i) If the inside of the LH fuel supply hose has any twisting, before further flight, remove the LH fuel supply hose from service and install an airworthy LH fuel supply hose by following the Accomplishment Instructions, paragraph 3.B.3.b, of ASB EC225-71A019.</P>
                    <P>(ii) If the LH fuel supply hose does not have any twisting, reinstall the LH fuel supply hose by following the Accomplishment Instructions, paragraph 3.B.3.b, of ASB EC225-71A019.</P>
                    <P>(2) As of the effective date of this AD, do not install an LH fuel supply hose P/N 704A34416087 on any helicopter unless it is installed by following the Accomplishment Instructions, paragraph 3.B.3.b, of ASB EC225-71A019.</P>
                    <HD SOURCE="HD1">(h) Special Flight Permits</HD>
                    <P>Special flight permits may be permitted provided that there are no passengers on board.</P>
                    <HD SOURCE="HD1">(i) 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 (j)(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">(j) Related Information</HD>
                    <P>
                        (1) For more information about this AD, contact James Blyn, Aviation Safety Engineer, Strategic Policy Emerging Aircraft Section, Policy and Innovation Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email 
                        <E T="03">9-ASW-FTW-AMOC-Requests@faa.gov.</E>
                    </P>
                    <P>
                        (2) For service information identified in this AD, contact Airbus Helicopters, 2701 N 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 the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 7617 N-321. 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 2019-0092, dated April 26, 2019. You may view the EASA AD on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         in the AD Docket. You may view the EASA AD on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         in Docket No. FAA-2020-0904.
                    </P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued on May 3, 2021.</DATED>
                    <NAME>Lance T. Gant, </NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09760 Filed 5-7-21; 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-2021-0331; Project Identifier AD-2020-01703-T]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; The Boeing Company Airplanes</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA proposes to adopt a new airworthiness directive (AD) for all The Boeing Company Model 757 airplanes. This proposed AD was prompted by significant changes, including new or more restrictive requirements, made to the airworthiness limitations (AWLs) related to fuel tank ignition prevention and the nitrogen generation system. This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA is proposing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The FAA must receive comments on this proposed AD by June 24, 2021.</P>
                </DATES>
                <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 Boeing Commercial Airplanes, Attention: Contractual &amp; Data Services (C&amp;DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet 
                        <E T="03">https://www.myboeingfleet.com.</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-2021-0331; 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>
                        Tak Kobayashi, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3553; email: 
                        <E T="03">takahisa.kobayashi@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. 
                    <PRTPAGE P="24787"/>
                    FAA-2021-0331; Project Identifier AD-2020-01703-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 Tak Kobayashi, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3553; email: 
                    <E T="03">takahisa.kobayashi@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 has examined the underlying safety issues involved in fuel tank explosions on several large transport airplanes, including the adequacy of existing regulations, the service history of airplanes subject to those regulations, and existing maintenance practices for fuel tank systems. As a result of those findings, the FAA issued a final rule titled “Transport Airplane Fuel Tank System Design Review, Flammability Reduction, and Maintenance and Inspection Requirements” (66 FR 23086, May 7, 2001). In addition to new airworthiness standards for transport airplanes and new maintenance requirements that rule included Amendment 21-78, which established Special Federal Aviation Regulation No. 88 (“SFAR 88”) to 14 CFR part 21. Subsequently, SFAR 88 was amended by: Amendment 21-82 (67 FR 57490, September 10, 2002; corrected at 67 FR 70809, November 26, 2002), Amendment 21-83 (67 FR 72830, December 9, 2002; corrected at 68 FR 37735, June 25, 2003, to change “21-82” to “21-83”), and Amendment 21-101 (83 FR 9162, March 5, 2018).</P>
                <P>
                    Among other actions, SFAR 88 requires certain type design (
                    <E T="03">i.e.,</E>
                     type certificate (TC) and supplemental type certificate (STC)) holders to substantiate that their fuel tank systems can prevent ignition sources in the fuel tanks. This requirement applies to type design holders for large turbine-powered transport airplanes and for subsequent modifications to those airplanes. It requires them to perform design reviews and to develop design changes and maintenance procedures if their designs do not meet the new fuel tank safety standards. As explained in the preamble to the final rule published on May 7, 2001, the FAA intended to adopt airworthiness directives to mandate any changes found necessary to address unsafe conditions identified as a result of these reviews.
                </P>
                <P>In evaluating these design reviews, the FAA has established four criteria intended to define the unsafe conditions associated with fuel tank systems that require corrective actions. The percentage of operating time during which fuel tanks are exposed to flammable conditions is one of these criteria. The other three criteria address the failure types under evaluation: Single failures, single failures in combination with another latent condition(s), and in-service failure experience. For all four criteria, the evaluations included consideration of previous actions taken that may mitigate the need for further action.</P>
                <P>The FAA issued AD 2012-12-15, Amendment 39-17095 (77 FR 42964, July 23, 2012) (AD 2012-12-15), which applies to all The Boeing Company Model 757 airplanes. AD 2012-12-15 requires revising the maintenance or inspection program to incorporate new limitations for fuel tank systems. AD 2012-12-15 also requires the initial inspection of certain repetitive AWL inspections to phase-in those inspections, and repair if necessary. Since the FAA issued AD 2012-12-15, the Airworthiness Limitations Section (ALS) of the Instructions for Continued Airworthiness (Boeing document D622N001-9) has been significantly revised by the manufacturer to correct technical and editorial errors and also to add new or more restrictive requirements. Many of those changes are related to fuel tank ignition prevention and the nitrogen generation system. Incorporating the revision required by this proposed AD would terminate all the requirements of AD 2012-12-15.</P>
                <P>The FAA also issued AD 2018-20-13, Amendment 39-19447 (83 FR 52305, October 17, 2018) (2018-20-13), which applies to all The Boeing Company Model 757 airplanes; Model 737 airplanes, excluding Model 737-100, -200, -200C, -300, -400, and -500 series airplanes; and Model 767-200, -300, -300F, and -400ER series airplanes. For Model 757 airplanes, AD 2018-20-13 requires, among other things, revising the maintenance or inspection program to incorporate AWLs No. 28-AWL-23, 28-AWL-24, and 28-AWL-25. Since the FAA issued 2018-20-13, those AWLs have been revised, therefore, this proposed AD would require the incorporation of those revised AWLs. Incorporating the revision required by this proposed AD would terminate the requirements in paragraph (i)(2) of AD 2018-20-13.</P>
                <P>The FAA has assessed the changes, including new or more restrictive requirements, that were made to the AWLs related to fuel tank ignition prevention and the nitrogen generation system. The FAA is issuing this AD to address ignition sources inside the fuel tanks and the increased flammability exposure of the center fuel tank caused by latent failures, alterations, repairs, or maintenance actions, which could result in a fuel tank explosion and consequent loss of an airplane.</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 Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), of Boeing 757 Maintenance Planning Data (MPD) Document, D622N001-9, dated March 2020. This service information specifies airworthiness limitation instruction (ALI) and critical design configuration control limitation (CDCCL) tasks related to fuel tank ignition prevention and the nitrogen generation system.
                    <PRTPAGE P="24788"/>
                </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 require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations.</P>
                <P>
                    This proposed AD would require revisions to certain operator maintenance documents to include new actions (
                    <E T="03">e.g.,</E>
                     inspections) and CDCCLs. Compliance with these actions and CDCCLs is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by this proposed AD, the operator may not be able to accomplish the actions described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph (k) of this proposed AD.
                </P>
                <HD SOURCE="HD1">Differences Between This Proposed AD and the Service Information</HD>
                <P>Paragraph (g) of this proposed AD would require operators to revise their existing maintenance or inspection program by incorporating, in part, AWL No. 28-AWL-05, “Wire Separation Requirements for New Wiring Installed in Proximity to Wiring that Goes into the Fuel Tanks,” of Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), of Boeing 757 Maintenance Planning Data (MPD) Document, D622N001-9, dated March 2020.</P>
                <P>Paragraph (h) of this proposed AD would allow certain changes to be made to the requirements specified in AWL No. 28-AWL-05 as an option. Where AWL No. 28-AWL-05 identifies certain wire types for routing and installation of any new wiring under certain conditions, paragraph (h) of this proposed AD provides acceptable alternative wire types. Where AWL No. 28-AWL-05 identifies certain wiring sleeve material for new wiring installed under certain conditions, paragraph (h) of this proposed AD provides acceptable alternative wire sleeve materials.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD, if adopted as proposed, would affect 493 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:</P>
                <P>The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the FAA estimates the average total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.</P>
                <P>For the reasons discussed above, I certify this proposed regulation:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Would not affect intrastate aviation in Alaska, and</P>
                <P>(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39</HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 39 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(g), 40113, 44701.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 39.13 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">The Boeing Company:</E>
                         Docket No. FAA-2021-0331; Project Identifier AD-2020-01703-T.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) by June 24, 2021.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>This AD affects the ADs specified in paragraphs (b)(1) and (2) of this AD.</P>
                    <P>(1) AD 2012-12-15, Amendment 39-17095 (77 FR 42964, July 23, 2012) (AD 2012-12-15).</P>
                    <P>(2) AD 2018-20-13, Amendment 39-19447 (83 FR 52305, October 17, 2018).</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to all The Boeing Company Model 757-200, -200PF, -200CB, and -300 series airplanes, certificated in any category.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Air Transport Association (ATA) of America Code 28, Fuel.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD was prompted by significant changes, including new or more restrictive requirements, made to the airworthiness limitations (AWLs) related to fuel tank ignition prevention and the nitrogen generation system. The FAA is issuing this AD to address ignition sources inside the fuel tanks and the increased flammability exposure of the center fuel tank caused by latent failures, alterations, repairs, or maintenance actions, which could result in a fuel tank explosion and consequent loss of an airplane.</P>
                    <HD SOURCE="HD1">(f) Compliance</HD>
                    <P>Comply with this AD within the compliance times specified, unless already done.</P>
                    <HD SOURCE="HD1">(g) Maintenance or Inspection Program Revision</HD>
                    <P>
                        Within 60 days after the effective date of this AD, revise the existing maintenance or inspection program, as applicable, to incorporate the information specified in Section E. “Airworthiness Limitations—Systems,” including Subsections E.1 and E.3, of Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance 
                        <PRTPAGE P="24789"/>
                        Requirements (CMRs), of Boeing 757 Maintenance Planning Data (MPD) Document, D622N001-9, dated March 2020; except as provided by paragraph (h) of this AD. The initial compliance time for doing the airworthiness limitation instruction (ALI) tasks is at the times specified in paragraphs (g)(1) through (12) of this AD.
                    </P>
                    <P>(1) For AWL No. 28-AWL-01, “External Wires Over Center Fuel Tank”: Within 120 months after the most recent inspection was performed as specified in AWL No. 28-AWL-01.</P>
                    <P>(2) For AWL No. 28-AWL-03, “Fuel Quantity Indicating System (FQIS)—Out Tank Wiring Lightning Shield to Ground Termination”: Within 120 months after the most recent inspection was performed as specified in AWL No. 28-AWL-03.</P>
                    <P>(3) For AWL No. 28-AWL-14, “Main and Center Wing Tank Fueling Shutoff Valve Body and Actuator—Fault Current Bond”: Within 120 months after the most recent inspection was performed as specified in AWL No. 28-AWL-14.</P>
                    <P>(4) For AWL No. 28-AWL-20, “Center Tank Fuel Override Boost Pump Automatic Shutoff System”: Within 12 months after accomplishment of the actions specified in Boeing Service Bulletin 757-28A0081 or Boeing Service Bulletin 757-28A0082, as applicable; or within 12 months after the most recent inspection was performed as specified in AWL No. 28-AWL-20; whichever occurs later.</P>
                    <P>(5) For AWL No. 28-AWL-21, “Over-Current and Arcing Protection Electrical Design Features Operation—Boost Pump Ground Fault Interrupter (GFI)”: Within 12 months after accomplishment of the actions specified in Boeing Service Bulletin 757-28A0078 or Boeing Service Bulletin 757-28A0079, as applicable; or within 12 months after the most recent inspection was performed as specified in AWL No. 28-AWL-21; whichever occurs later.</P>
                    <P>(6) For AWL No. 28-AWL-25, “Motor Operated Valve (MOV) Actuator—Lightning and Fault Current Protection Electrical Bond”: Within 72 months after accomplishment of the actions specified in Boeing Service Bulletin 757-28A0088, or within 72 months after the most recent inspection was performed as specified in AWL No. 28-AWL-25, whichever occurs later.</P>
                    <P>(7) For AWL No. 28-AWL-26, “Center Tank Fuel Boost Pump Power Failed On Protection System”: Within 12 months after accomplishment of the actions specified in Boeing Service Bulletin 757-28A0105, or within 12 months after the most recent inspection was performed as specified in AWL No. 28-AWL-26, whichever occurs later.</P>
                    <P>(8) For AWL No. 28-AWL-30, “AC Fuel Pump Fault Current Bonding Jumper Installation, Main and Center Tank”: Within 24 months after the effective date of this AD, or within 72 months after the most recent inspection was performed as specified in AWL No. 28-AWL-30, whichever occurs later.</P>
                    <P>(9) For AWL No. 28-AWL-33, “Full Cushion Clamps and Teflon Sleeving Installed on Out-of-Tank Wire Bundles Installed on Brackets that are Mounted Directly on the Fuel Tanks”: Within 24 months after the effective date of this AD; or within 144 months after accomplishment of the actions specified in Boeing Service Bulletin 757-57A0064 (Part 2 through Part 10 of the Work Instructions); or within 144 months since the most recent inspection was performed as specified in AWL No. 28-AWL-33; whichever occurs later.</P>
                    <P>(10) For AWL No. 47-AWL-04, “NGS—NEA Distribution Ducting”: Within 17,300 flight hours after accomplishment of the actions specified in Boeing Service Bulletin 757-47-0001 or Boeing Service Bulletin757-47-0005, as applicable; or within 17,300 flight hours after the most recent inspection was performed as specified in AWL No. 47-AWL-04; whichever occurs later.</P>
                    <P>(11) For AWL No. 47-AWL-05, “NGS—Cross Vent Check Valve”: Within 17,300 flight hours after accomplishment of the actions specified in Boeing Service Bulletin 757-47-0001 or Boeing Service Bulletin 757-47-0005, as applicable; or within 17,300 flight hours after the most recent inspection was performed as specified in AWL No. 47-AWL-05; whichever occurs later.</P>
                    <P>(12) For AWL No. 47-AWL-07, “NGS—Thermal Switch”: Within 48,000 flight hours after accomplishment of the actions specified in Boeing Service Bulletin 757-47-0001 or Boeing Service Bulletin 757-47-0005, as applicable; or within 48,000 flight hours after the most recent inspection was performed as specified in AWL No. 47-AWL-07; whichever occurs later.</P>
                    <HD SOURCE="HD1">(h) Additional Acceptable Wire Types and Sleeving</HD>
                    <P>As an option, when accomplishing the actions required by paragraph (g) of this AD, the alternatives specified in paragraphs (h)(1) and (2) of this AD are acceptable.</P>
                    <P>(1) Where AWL No. 28-AWL-05 identifies wire types BMS 13-48, BMS 13-58, and BMS 13-60, the following wire types are acceptable: MIL-W-22759/16, SAE AS22759/16 (M22759/16), MIL-W-22759/32, SAE AS22759/32 (M22759/32), MIL-W-22759/34, SAE AS22759/34 (M22759/34), MIL-W-22759/41, SAE AS22759/41 (M22759/41), MIL-W-22759/86, SAE AS22759/86 (M22759/86), MIL-W-22759/87, SAE AS22759/87 (M22759/87), MIL-W-22759/92, and SAE AS22759/92 (M22759/92); and MIL-C-27500 and NEMA WC 27500 cables constructed from these military or SAE specification wire types, as applicable.</P>
                    <P>(2) Where AWL No. 28-AWL-05 identifies TFE-2X Standard wall for wire sleeving, the following sleeving materials are acceptable: Roundit 2000NX and Varglas Type HO, HP, or HM.</P>
                    <HD SOURCE="HD1">(i) No Alternative Actions, Intervals, or CDCCLs</HD>
                    <P>
                        After the existing maintenance or inspection program has been revised as required by paragraph (g) of this AD, no alternative actions (
                        <E T="03">e.g.,</E>
                         inspections), intervals, or CDCCLs may be used unless the actions, intervals, and CDCCLs are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (k) of this AD.
                    </P>
                    <HD SOURCE="HD1">(j) Terminating Actions for Certain AD Requirements</HD>
                    <P>Accomplishment of the revision required by paragraph (g) of this AD terminates the requirements specified in paragraphs (j)(1) and (2) of this AD for that airplane.</P>
                    <P>(1) All requirements of AD 2012-12-15.</P>
                    <P>(2) The requirements in paragraph (i)(2) of AD 2018-20-13.</P>
                    <HD SOURCE="HD1">(k) Alternative Methods of Compliance (AMOCs)</HD>
                    <P>
                        (1) The Manager, Seattle ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in Related Information. Information may be emailed to: 
                        <E T="03">9-ANM-Seattle-ACO-AMOC-Requests@faa.gov.</E>
                    </P>
                    <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.</P>
                    <P>(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO Branch, FAA, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.</P>
                    <HD SOURCE="HD1">(l) Related Information</HD>
                    <P>
                        (1) For more information about this AD, contact Tak Kobayashi, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3553; email: 
                        <E T="03">takahisa.kobayashi@faa.gov.</E>
                    </P>
                    <P>
                        (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual &amp; Data Services (C&amp;DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet 
                        <E T="03">https://www.myboeingfleet.com.</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 April 15, 2021.</DATED>
                    <NAME>Lance T. Gant, </NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09761 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="24790"/>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2021-0349; Project Identifier MCAI-2021-00103-T]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Airbus SAS Airplanes</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA proposes to adopt a new airworthiness directive (AD) for all Airbus SAS Model A330-841 and -941 airplanes. This proposed AD was prompted by reports of missing or disbonded pressure seals on two thrust reverser (TR) translating cowls. This proposed AD would require a one-time inspection of each thrust reverser for damage, seal bonding rework, and replacement of translating cowl pressure seals if necessary, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference. The FAA is proposing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The FAA must receive comments on this proposed AD by June 24, 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 material that will be incorporated by reference (IBR) 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 IBR material on the EASA website at 
                        <E T="03">https://ad.easa.europa.eu.</E>
                         You may view this IBR material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available in the AD docket on the internet at 
                        <E T="03">https://www.regulations .gov</E>
                         by searching for and locating Docket No. FAA-2021-0349.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2021-0349; 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>
                        Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, International Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3229; email 
                        <E T="03">vladimir.ulyanov@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under 
                    <E T="02">ADDRESSES</E>
                    . Include “Docket No. FAA-2021-0349; Project Identifier MCAI-2021-00103-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 the proposal because of those comments.
                </P>
                <P>
                    Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to 
                    <E T="03">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 proposed AD.
                </P>
                <HD SOURCE="HD1">Confidential Business Information</HD>
                <P>
                    CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, International Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3229; email 
                    <E T="03">vladimir.ulyanov@faa.gov.</E>
                     Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0035, dated January 25, 2021 (EASA AD 2021-0035) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for all Airbus SAS Model A330-841 and -941 airplanes.</P>
                <P>This proposed AD was prompted by reports of missing or disbonded pressure seals on two TR translating cowls. An investigation determined that the issue is due to surface preparation not being properly performed during seal installation. The FAA is proposing this AD to address missing or disbonded TR translating cowl seal segments. In a case where all seal segments were missing, this condition, if not addressed, could lead to loss of thrust at maximum continuous thrust or at takeoff/go-around, possibly resulting in substantially reduced performance of the airplane. See the MCAI for additional background information.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>EASA AD 2021-0035 describes procedures for inspecting the each thrust reverser for damage (including tears, cracks, unwanted sealant on the contact surface, missing pieces, worn-out seals, or glass or ceramic ply that is not impacted), reworking the pressure seal bonding, and replacing damaged translating cowl pressure seals.</P>
                <P>
                    This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">FAA's Determination and Requirements of This Proposed AD</HD>
                <P>
                    This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the 
                    <PRTPAGE P="24791"/>
                    FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI referenced above. The FAA is proposing this AD because the FAA evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
                </P>
                <HD SOURCE="HD1">Proposed AD Requirements</HD>
                <P>This proposed AD would require accomplishing the actions specified in EASA AD 2021-0035 described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD.</P>
                <HD SOURCE="HD1">Explanation of Required Compliance Information</HD>
                <P>
                    In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA initially worked with Airbus and EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has since coordinated with other manufacturers and civil aviation authorities (CAAs) to use this process. As a result, EASA AD 2021-0035 will be incorporated by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2021-0035 in its entirety, through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in the EASA AD does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in the EASA AD. Service information specified in EASA AD 2021-0035 that is required for compliance with EASA AD 2021-0035 will be available on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2021-0349 after the FAA final rule is published.
                </P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this proposed AD affects 8 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s100,12C,12C,12C">
                    <TTITLE>Estimated Costs for Required Actions</TTITLE>
                    <BOXHD>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                        <CHED H="1">
                            Cost on U.S.
                            <LI>operators</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">7 work-hours × $85 per hour = $595 (per thrust reverser)</ENT>
                        <ENT>$0</ENT>
                        <ENT>$595</ENT>
                        <ENT>$4,760</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The FAA estimates the following costs to do any necessary on-condition action that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need these on-condition actions:</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12C,12C">
                    <TTITLE>Estimated Costs of On-Condition Action</TTITLE>
                    <BOXHD>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">22 work-hours × $85 per hour = $1,870 (per thrust reverser)</ENT>
                        <ENT>$42,268</ENT>
                        <ENT>$44,138</ENT>
                    </ROW>
                </GPOTABLE>
                <P>According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators. The FAA does not control warranty coverage for affected operators. As a result, the FAA has included all known costs in the cost estimate.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.</P>
                <P>For the reasons discussed above, I certify 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>
                    <PRTPAGE P="24792"/>
                    <SECTNO>§ 39.13 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">Airbus SAS:</E>
                         Docket No. FAA-2021-0349; Project Identifier MCAI-2021-00103-T.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) by June 24, 2021.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>None.</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to all Airbus SAS Model A330-841 and -941 airplanes, certificated in any category.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Air Transport Association (ATA) of America Code 78, Engine exhaust.</P>
                    <HD SOURCE="HD1">(e) Reason</HD>
                    <P>This AD was prompted by reports of missing or disbonded pressure seals on two thrust reverser (TR) translating cowls. The FAA is issuing this AD to address missing or disbonded TR translating cowl seal segments. In a case where all seal segments were missing, this condition, if not addressed, could lead to loss of thrust at maximum continuous thrust or at takeoff/go-around, possibly resulting in substantially reduced performance of the airplane.</P>
                    <HD SOURCE="HD1">(f) Compliance</HD>
                    <P>Comply with this AD within the compliance times specified, unless already done.</P>
                    <HD SOURCE="HD1">(g) Requirements</HD>
                    <P>Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency (EASA) AD 2021-0035, dated January 25, 2021 (EASA AD 2021-0035).</P>
                    <HD SOURCE="HD1">(h) Exceptions to EASA AD 2021-0035</HD>
                    <P>(1) Where EASA AD 2021-0035 refers to its effective date, this AD requires using the effective date of this AD.</P>
                    <P>(2) The “Remarks” section of EASA AD 2021-0035 does not apply to this AD.</P>
                    <HD SOURCE="HD1">(i) No Reporting Requirement</HD>
                    <P>Although the service information referenced in EASA AD 2021-0035 specifies to submit certain information to the manufacturer, this AD does not include that requirement.</P>
                    <HD SOURCE="HD1">(j) Other FAA AD Provisions</HD>
                    <P>The following provisions also apply to this AD:</P>
                    <P>
                        (1) 
                        <E T="03">Alternative Methods of Compliance (AMOCs):</E>
                         The Manager, Large Aircraft Section, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the Large Aircraft Section, International Validation Branch, send it to the attention of the person identified in paragraph (k)(2) of this AD. Information may be emailed to: 
                        <E T="03">9-AVS-AIR-730-AMOC@faa.gov.</E>
                         Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Contacting the Manufacturer:</E>
                         For any requirement in this AD to obtain instructions from a manufacturer, the instructions must be accomplished using a method approved by the Manager, Large Aircraft Section, International Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
                    </P>
                    <P>
                        (3) 
                        <E T="03">Required for Compliance (RC):</E>
                         Except as required by paragraph (j)(2) of this AD, if any service information contains procedures or tests that are identified as RC, those procedures and tests must be done to comply with this AD; any procedures or tests that are not identified as RC are recommended. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition. Any substitutions or changes to procedures or tests identified as RC require approval of an AMOC.
                    </P>
                    <HD SOURCE="HD1">(k) Related Information</HD>
                    <P>
                        (1) For information about EASA AD 2021-0035 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 EASA AD on the EASA website at 
                        <E T="03">https://ad.easa.europa.eu.</E>
                         You may view this material 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. This material may be found in the AD docket on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for and locating Docket No. FAA-2021-0349.
                    </P>
                    <P>
                        (2) For more information about this AD, contact Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section, International Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3229; email 
                        <E T="03">vladimir.ulyanov@faa.gov.</E>
                    </P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued on May 4, 2021.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09789 Filed 5-7-21; 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-2021-0277; Airspace Docket No. 21-AGL-19]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Revocation of Class E Airspace; Standish, MI</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 the Class E airspace extending upward from 700 feet above the surface at Standish Industrial Airport, Standish, MI. The FAA is proposing this action as the result of an airspace review caused by the closing of the Standish Industrial Airport and associated instrument procedures no longer required.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 24, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2021-0277/Airspace Docket No. 21-AGL-19, at the beginning of your comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                         You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays.
                    </P>
                    <P>
                        FAA Order 7400.11E, 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 Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11E at NARA, email 
                        <E T="03">fedreg.legal@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>
                        Rebecca Shelby, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 
                        <PRTPAGE P="24793"/>
                        Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5857.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would revoke the Class E airspace extending upward from 700 feet above the surface at Standish Industrial Airport, Standish, MI, due to the closure of the airport and cancellation of the instrument procedures at this airport.</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. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2021-0277/Airspace Docket No. 21-AGL-19.” The postcard will be date/time stamped and returned to the commenter.</P>
                <P>All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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 the 
                    <E T="02">ADDRESSES</E>
                     section for the 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 Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 by revoking the Class E airspace extending upward from 700 feet above the surface to at Standish Industrial Airport, Standish, MI.</P>
                <P>This action is the result of an airspace review due to the closing of the Standish Industrial Airport, Standish, MI, and cancellation of the instrument procedures at this airport.</P>
                <P>Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.</P>
                <P>FAA Order 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 regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would 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>Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS </HD>
                </PART>
                <AMDPAR>1. The authority citation for 14 CFR part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth.</HD>
                    <STARS/>
                    <PRTPAGE P="24794"/>
                    <HD SOURCE="HD1">AGL MI E5 Standish, MI [Removed]</HD>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Fort Worth, Texas, on April 29, 2021.</DATED>
                    <NAME>Martin A. Skinner,</NAME>
                    <TITLE>Manager, Operations Support Group, ATO Central Service Center.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09477 Filed 5-7-21; 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-2021-0324; Airspace Docket No. 21-AGL-9]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Amendment of V-37 and V-270; Removal of V-43 in the Vicinity of Erie, PA</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 two VHF Omnidirectional Range (VOR) Federal airways and remove one VOR Federal airway in the vicinity of Erie, Pennsylvania. The FAA proposes this action due to the planned decommissioning of the VOR portion of the Erie, PA, VOR/Tactical Air Navigation (VORTAC) that these airways utilize for navigation guidance. The Erie VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 24, 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: (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2021-0324; Airspace Docket No. 21-AGL-9 at the beginning of your comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                         FAA Order 7400.11E, 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. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11E at NARA, email: 
                        <E T="03">fedreg.legal@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>Jesse Acevedo, 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>
                <P/>
                <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-2021-0324; Airspace Docket No. 21-AGL-9) 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-2021-0324; Airspace Docket No. 21-AGL-9.” 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 Operations Support Group, Central Service Center, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX, 76177.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The FAA is planning to decommission the VOR portion of the Erie, PA, VORTAC. This VOR was one of the candidate VORs identified for discontinuance by the FAA's VOR MON program and listed in the final policy statement notice, “Provision of Navigation Services for the Next Generation Air Transportation System (NextGen) Transition to Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum Operational Network),” published in the 
                    <PRTPAGE P="24795"/>
                    <E T="04">Federal Register</E>
                     of July 26, 2016 (81 FR 48694), Docket No. FAA-2011-1082.
                </P>
                <P>Although the VOR portion of the Eric VORTAC is planned for decommissioning, the co-located DME portion of the navigational aid is being retained in support of current and future Area Navigation (RNAV) procedures. The tactical air navigation (TACAN) system is also being retained to support the Department of Defense mission requirements.</P>
                <P>The VOR Federal airways affected by the Erie VOR are V-37, V-270, and V-43. With the planned decommissioning of the VOR portion of the Erie VORTAC, the remaining navigational aids in the area are insufficient to enable the continuity of the affected airways. As such, the proposal would result in the shortening of V-37 and V-270, and would result in the revocation of V-43. To overcome the shortening and removal of the proposed airways, pilots using RNAV could navigate point to point utilizing the fixes that would be retained or request air traffic control radar vectors through the area. Additionally, visual flight rules (VFR) pilots who elect to navigate via the affected airways could also take advantage of the air traffic control (ATC) services previously listed.</P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 to amend V-37 and V-270, and revoke V-43, in the vicinity of Erie, PA. This is required due to the planned decommissioning of the VOR portion of the Erie, PA, VORTAC. The proposed airway changes are described below.</P>
                <P>
                    <E T="03">V-37:</E>
                     V-37 currently extends between the Craig, FL, VORTAC and the Erie, PA VORTAC. The FAA proposes to remove the airway segment between the Ellwood City, PA, VOR/DME and the Erie VORTAC. As a result, the amended airway would extend between the Craig VORTAC and the Ellwood City VOR/DME.
                </P>
                <P>
                    <E T="03">V-270:</E>
                     V-270 currently extends between the Erie, PA, VORTAC and the Jamestown, NY, VOR/DME; and between the Elmira, NY, VOR/DME and the Boston, MA, VOR/DME. The FAA proposes to remove the airway segment between the Erie VORTAC and the Jamestown VOR/DME. As a result, the amended airway would extend between the Elmira VOR/DME and the Boston VOR/DME.
                </P>
                <P>
                    <E T="03">V-43:</E>
                     V-43 currently extends between the Youngstown, OH, VORTAC and the Erie, PA, VORTAC. The FAA proposes to remove V-43 in its entirety.
                </P>
                <P>All radials in the VOR Federal airway descriptions below are unchanged and stated in True degrees.</P>
                <P>Domestic VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document would be subsequently published in the Order.</P>
                <P>FAA Order 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 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6010(a) Domestic VOR Federal Airways.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">V-37 [Amended]</HD>
                    <P>From Craig, FL; Brunswick, GA; INT Brunswick 014° and Savannah, GA, 177° radials; Savannah; Allendale, SC; Columbia, SC; Charlotte, NC; Pulaski, VA; Elkins, WV; Clarksburg, WV; INT Clarksburg 359° and Ellwood City, PA, 185° radials; to Ellwood City.</P>
                    <STARS/>
                    <HD SOURCE="HD1">V-43 [Removed]</HD>
                    <STARS/>
                    <HD SOURCE="HD1">V-270 [Amended]</HD>
                    <P>From Elmira, NY; Binghamton, NY; DeLancey, NY; Chester, MA; INT Chester 091° and Boston, MA, 262° radials; to Boston.</P>
                    <STARS/>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Washington, DC, on April 30, 2021.</DATED>
                    <NAME>George Gonzalez,</NAME>
                    <TITLE>Acting Manager, Rules and Regulations Group.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09668 Filed 5-7-21; 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-2021-0119; Airspace Docket No. 21-AEA-3]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Amendment and Establishment of Class E Airspace; York, PA</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 Class E surface airspace at York Airport, York, PA. An airspace evaluation of the area determined the additional airspace is necessary to accommodate operations at the airport. This action would also update the name of York Airport (formerly York County Airport), York, PA. This action also establishes Class E airspace extending upward from 700 feet above the surface at York Airport, and Class E airspace extending upward from 700 feet above 
                        <PRTPAGE P="24796"/>
                        the surface for Wellstone York Hospital Heliport, York, PA, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures serving the heliport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 24, 2021.</P>
                </DATES>
                <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 20590-0001; Telephone: (800) 647-5527, or (202) 366-9826. You must identify the Docket No. FAA-2021-0119; Airspace Docket No. 21-AEA-3, 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 7400.11E 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 Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; Telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11E at NARA, email 
                        <E T="03">fedreg.legal@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>John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Avenue, College Park, GA 30337; Telephone (404) 305-6364.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would amend and establish Class E airspace in York, PA, to support IFR operations in the area.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>Interested persons are invited to comment on 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 (Docket No. FAA-2021-0119 and Airspace Docket No. 21-AEA-3) and be submitted in triplicate to DOT Docket Operations (see 
                    <E T="02">ADDRESSES</E>
                     section for the address and phone number). You may also submit comments through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>Persons 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-2021-0119; Airspace Docket No. 21-AEA-3.” The postcard will be date/time stamped and returned to the commenter.</P>
                <P>All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this document may be changed in light of the 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 the 
                    <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 between 8:00 a.m. and 4:30 p.m., Monday through Friday, except federal holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, GA 30337.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA proposes an amendment to 14 14 CFR part 71 to amend Class E surface airspace by increasing the radius to 6.8 miles (previously 6.5 miles) at York Airport, York, PA. This action would also would update the airports name. This action would also establish Class E airspace upward from 700 feet above the surface at York Airport, York, PA, and establish Class E airspace upward from 700 feet above the surface at Wellstone York Hospital Heliport, York, PA, providing the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for IFR operations serving them respectively.</P>
                <P>Class E airspace designations are published in Paragraph 6005, of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.</P>
                <P>FAA Order 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 DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation 
                    <PRTPAGE P="24797"/>
                    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">Lists 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 Federal Aviation Administration Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6002 Class E Surface Airspace.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">AEA PA E2 York, PA [Amend]</HD>
                    <FP SOURCE="FP-2">York Airport, PA</FP>
                    <FP SOURCE="FP1-2">(Lat. 39°55′01″ N, long. 76°52′23″ W)</FP>
                    <P>That airspace extending upward from the surface within a 6.8-mile radius of the York Airport.</P>
                    <HD SOURCE="HD2">Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet Or More Above the Surface of the Earth.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">AEA PA E5 York, PA [New]</HD>
                    <FP SOURCE="FP-2">York Airport, PA</FP>
                    <FP SOURCE="FP1-2">(Lat. 39°55′01″ N, long. 76°52′23″ W)</FP>
                    <FP SOURCE="FP-2">Wellstone York Hospital Heliport, PA</FP>
                    <FP SOURCE="FP1-2">(Lat. 39°56′41″ N, long. 76°43′06″ W)</FP>
                    <P>That airspace extending upward from 700 feet above the surface within a 9.3-mile radius of York Airport, and within 4.0 miles each side of the 339° bearing from the airport, extending from the 9.3-mile radius to 11.9 miles northwest of the airport, and that airspace extending upward from 700 feet above the surface within a 6-mile radius of Wellstone York Hospital Heliport.</P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in College Park, Georgia, on May 3, 2021.</DATED>
                    <NAME>Andreese C. Davis,</NAME>
                    <TITLE>Manager, Airspace &amp; Procedures Team South, Eastern Service Center, Air Traffic Organization.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09815 Filed 5-7-21; 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-2021-0235; Airspace Docket No. 21-AGL-18]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Revocation of Class E Airspace; Port Huron, MI</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 the Class E surface airspace at St. Clair County International Airport, Port Huron, MI. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Remote Communications Outlet (RCO) frequency at St. Clair County International Airport.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 24, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2021-0235/Airspace Docket No. 21-AGL-18 at the beginning of your comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                         You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays.
                    </P>
                    <P>
                        FAA Order 7400.11E, 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 Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11E at NARA, email: 
                        <E T="03">fedreg.legal@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>Rebecca Shelby, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5857.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would revoke the Class E surface airspace at St. Clair County International Airport.</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. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2021-0235/Airspace Docket No. 21-AGL-18.” The postcard will be date/time stamped and returned to the commenter.</P>
                <P>
                    All communications received before the specified closing date for comments 
                    <PRTPAGE P="24798"/>
                    will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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 https://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at https://
                    <E T="03">www.faa.gov/air_traffic/publications/airspace_amendments/.</E>
                </P>
                <P>
                    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the 
                    <E T="02">ADDRESSES</E>
                     section for the 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 Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 by removing the Class E surface area at St. Clair County International Airport as it is no longer required.</P>
                <P>This action is necessary due to an airspace review caused by the decommissioning of the RCO, which provided navigation information for the instrument procedures this airport.</P>
                <P>Class E airspace designations are published in paragraph 6002 respectively, of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.</P>
                <P>FAA Order 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 regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would 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>Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for 14 CFR part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6002 Class E Surface Airspace.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">AGL MI E2 Port Huron, MI [Revoked]</HD>
                    <FP SOURCE="FP-2">St. Clair County International Airport, MI</FP>
                    <FP SOURCE="FP1-2">(Lat. 42°54′39″ N, long. 82°31′44″ W)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Fort Worth, Texas, on April 29. 2021.</DATED>
                    <NAME>Martin A. Skinner,</NAME>
                    <TITLE>Manager, Operations Support Group, ATO Central Service Center.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09476 Filed 5-7-21; 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-2021-0288; Airspace Docket No. 21-AGL-6]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Amendment of Area Navigation (RNAV) T-348 and Establishment of T-409; Northcentral United States</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 one RNAV route and establish one new RNAV route, in the northcentral United States. The proposal would expand the availability of RNAV routing in support of transitioning the National Airspace System (NAS) from ground-based to satellite-based navigation.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 24, 2021.</P>
                </DATES>
                <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: (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2021-0288; Airspace Docket No. 21-AGL-6 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 7400.11E, 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. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA 
                        <PRTPAGE P="24799"/>
                        Order 7400.11E at NARA, email: 
                        <E T="03">fedreg.legal@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>Jesse Acevedo, 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-2021-0288; Airspace Docket No. 21-AGL-6) 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-2021-0288; Airspace Docket No. 21-AGL-6.” 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 Operations Support Group, Central Service Center, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order 7400.11E 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 support of FAA-led modernization efforts to improve the safety, efficiency, and predictability of the national airspace, as well as transition the NAS from a ground-based to a satellite-based Performance Based Navigation (PBN) system, the FAA is proposing to amend RNAV route T-348 by extending it to provide additional PBN enroute structure, and establish RNAV route T-409. This action would reduce air traffic control (ATC) sector workload and complexity, reduce pilot-to-controller communication, and assist ATC when non-radar procedures are required. These RNAV routes would be available for use by any aircraft equipped with Global Positioning Satellite (GPS) and/or RNAV navigation capabilities.</P>
                <P>Additionally, both RNAV route proposals have transiting legs that pass through the Lake Andes Military Operations Areas (MOA). This would provide cost, fuel, and time saving benefits for aircraft transiting the MOA when the MOA is not in use.</P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 to amend RNAV route T-348 and establish RNAV route T-409. The proposed route changes are described below.</P>
                <P>
                    <E T="03">T-348:</E>
                     T-348 currently extends between the BRAIN, MN, waypoint (WP) and the LUNGS, WI, WP. The FAA proposes to extend the route westward between the LESNR, SD, WP and the BRAIN, MN, WP. As a result of the addition of the proposed segment, the BRAIN WP would remain in place but would no longer be referenced in the legal description. The new proposed route would flow from the LESNR WP, through the TECUD, SD, fix and Sioux Falls, SD, VOR/Tactical Air Navigation (VORTAC), to the GRSIS, MN, WP onward. The resulting RNAV route would extend between the LESNR WP and the LUNGS WP.
                </P>
                <P>
                    <E T="03">T-409:</E>
                     T-409 is a proposed new route that would extend between the LLUKY, NE, WP and the Pierre, SD, VORTAC. This route would mitigate the loss of the V-71 airway segments removed on September 10, 2020 due to the decommissioning of the Winner, SD, VOR.
                </P>
                <P>All radials in the RNAV T-route descriptions below are unchanged and stated in True degrees.</P>
                <P>United States Area Navigation routes are published in paragraph 6011 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The RNAV routes listed in this document would be subsequently published in the Order.</P>
                <P>FAA Order 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 
                    <PRTPAGE P="24800"/>
                    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 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">
                        <E T="03">Paragraph 6011 United States Area Navigation Routes.</E>
                    </HD>
                    <STARS/>
                    <HD SOURCE="HD1">T-348 LESNR, SD to LUNGS, WI [Amended]</HD>
                    <FP SOURCE="FP-2">LESNR, SD WP </FP>
                    <FP SOURCE="FP1-2">(Lat. 43°29′16.49″ N, long. 099°45′41.00″ W)</FP>
                    <FP SOURCE="FP-2">TECUD, SD FIX </FP>
                    <FP SOURCE="FP1-2">(Lat. 43°32′54.48″ N, long. 097°51′42.23″ W)</FP>
                    <FP SOURCE="FP-2">Sioux Falls, SD (FSD) VORTAC </FP>
                    <FP SOURCE="FP1-2">(Lat. 43°38′58.14″ N, long. 096°46′52.02″ W)</FP>
                    <FP SOURCE="FP-2">GRSIS, MN WP </FP>
                    <FP SOURCE="FP1-2">(Lat. 43°38′45.54″ N, long. 094°25′21.17″ W)</FP>
                    <FP SOURCE="FP-2">FOOLS, MN WP </FP>
                    <FP SOURCE="FP1-2">(Lat. 43°46′58.20″ N, long. 092°35′44.93″ W)</FP>
                    <FP SOURCE="FP-2">GABDE, MN WP </FP>
                    <FP SOURCE="FP1-2">(Lat. 43°38′50.04″ N, long. 092°18′26.46″ W)</FP>
                    <FP SOURCE="FP-2">KRRTR, IA WP </FP>
                    <FP SOURCE="FP1-2">(Lat. 43°16′18.12″ N, long. 091°22′30.62″ W)</FP>
                    <FP SOURCE="FP-2">Madison, WI (MSN) VORTAC </FP>
                    <FP SOURCE="FP1-2">(Lat. 43°08′41.41″ N, long. 089°20′22.91″ W)</FP>
                    <FP SOURCE="FP-2">LUNGS, WI WP </FP>
                    <FP SOURCE="FP1-2">(Lat. 43°02′43.66″ N, long. 088°56′54.86″ W)</FP>
                    <STARS/>
                    <HD SOURCE="HD1">T-409 LLUKY, NE to Pierre, SD (PIR) [New]</HD>
                    <FP SOURCE="FP-2">LLUKY, NE WP </FP>
                    <FP SOURCE="FP1-2">(Lat. 42°29′20.26″ N, long. 098°38′11.44″ W)</FP>
                    <FP SOURCE="FP-2">ADEDY, SD FIX </FP>
                    <FP SOURCE="FP1-2">(Lat. 43°03′05.06″ N, long. 099°17′41.35″ W)</FP>
                    <FP SOURCE="FP-2">LESNR, SD WP </FP>
                    <FP SOURCE="FP1-2">(Lat. 43°29′16.49″ N, long. 099°45′41.00″ W)</FP>
                    <FP SOURCE="FP-2">Pierre, SD (PIR) VORTAC </FP>
                    <FP SOURCE="FP1-2">(Lat. 44°23′40.40″ N, long. 100°09′46.11″ W)</FP>
                    <STARS/>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Washington, DC, on May 4, 2021.</DATED>
                    <NAME>George Gonzalez,</NAME>
                    <TITLE>Acting Manager, Rules and Regulations Group.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09757 Filed 5-7-21; 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-2021-0278; Airspace Docket No. 21-ACE-10]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Amendment of Class E Airspace; Pocahontas, IA</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 the Class E airspace extending upward from 700 feet above the surface at Pocahontas Municipal Airport, Pocahontas, IA. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Pocahontas non-directional beacon (NDB).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 24, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2021-0278/Airspace Docket No. 21-ACE-10, at the beginning of your comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                         You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays.
                    </P>
                    <P>
                        FAA Order 7400.11E, 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 Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11E at NARA, email 
                        <E T="03">fedreg.legal@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>Rebecca Shelby, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5857.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend the Class E airspace extending upward from 700 feet above the surface at Pocahontas Municipal Airport, IA, to support instrument flight rule operations at this airport.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    Interested parties are invited to participate in this proposed rulemaking 
                    <PRTPAGE P="24801"/>
                    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. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2021-0278/Airspace Docket No. 21-ACE-10.” The postcard will be date/time stamped and returned to the commenter.
                </P>
                <P>All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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 the 
                    <E T="02">ADDRESSES</E>
                     section for the 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 Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 by amending the Class E airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Pocahontas Municipal Airport, Pocahontas, IA; and removes the Pocahontas NDB and the associated extensions from the airspace legal description.</P>
                <P>This action is the result of an airspace review due to the decommissioning of the Pocahontas NDB which provided navigation information for the instrument procedures at this airport.</P>
                <P>Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.</P>
                <P>FAA Order 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 regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would 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>Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for 14 CFR part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">ACE IA E5 Pocahontas, IA [Amended]</HD>
                    <FP SOURCE="FP-2">Pocahontas Municipal Airport, IA</FP>
                    <FP SOURCE="FP1-2">(Lat. 42°44′34″ N, long. 94°38′50″ W)</FP>
                    <P>That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of Pocahontas Municipal Airport.</P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Fort Worth, Texas, on April 29, 2021.</DATED>
                    <NAME>Martin A. Skinner,</NAME>
                    <TITLE>Manager, Operations Support Group, ATO Central Service Center.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09480 Filed 5-7-21; 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-2021-0294; Airspace Docket No. 20-ASO-31]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Amendment and Removal of Air Traffic Service (ATS) Routes; Eastern United States</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 three jet routes, and remove four jet routes, in the eastern United States. 
                        <PRTPAGE P="24802"/>
                        This action is in support of the Northeast Corridor Atlantic Coast Route Project to improve the efficiency of the National Airspace System (NAS) and reduce dependency on ground-based navigational systems.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 24, 2021.</P>
                </DATES>
                <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: (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2021-0294; Airspace Docket No. 20-ASO-31 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 7400.11E, 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. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11E at NARA, email: 
                        <E T="03">fedreg.legal@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>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">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 NAS.</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. Communications should identify both docket numbers (FAA Docket No. FAA-2021-0294; Airspace Docket No. 20-ASO-31) 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-2021-0294; Airspace Docket No. 20-ASO-31.” 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.
                </P>
                <P>An informal docket may also be examined during normal business hours at the office of the Eastern Service Center, Federal Aviation Administration, Room 210, 1701 Columbia Ave., College Park, GA 30337.</P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 to amend three jet routes, and remove four jet routes, in the eastern United States. This action would support the Northeast Corridor Atlantic Coast Route Project by amending and removing certain jet route segments that are being replaced by RNAV routing. Additionally, the proposed jet route changes would reduce aeronautical chart clutter by removing unneeded route segments.</P>
                <P>The proposed route changes are as follows:</P>
                <P>
                    <E T="03">J-42:</E>
                     J-42 currently extends between the Delicias, Mexico, VOR/DME, and the Boston, MA, VOR/DME. This action would remove the segments between Texarkana, AR, and Boston, MA. The amended route would extend between Delicias, Mexico and Texarkana, AR. The portion within Mexico is excluded.
                </P>
                <P>
                    <E T="03">J-55:</E>
                     J-55 currently extends in, two parts, between the intersection of the Flat Rock, VA 212° and the Raleigh-Durham, NC, 224° radials, and the intersection of the Hopewell, VA, 030° and the Nottingham, MD 174° radials; and between the Sea Isle, NJ and Presque Isle, ME. The FAA proposes to remove the segments between Sea Isle, NJ and Presque Isle ME. The amended route would extend from the intersection of the Flat Rock, VA 212° and the Raleigh-Durham, NC, 224° radials, and the intersection of the Hopewell, VA, 030° and the Nottingham, MD 174° radials.
                </P>
                <P>
                    <E T="03">J-150:</E>
                     J-150 extends between the Gordonsville, VA, VORTAC and the Marconi, MA, 082° and the Boston, MA, 097° radials (STOOL intersection). The FAA proposes to remove the entire route.
                </P>
                <P>
                    <E T="03">J-191:</E>
                     J-191 currently extends between the Robbinsville, NJ, VORTAC, and the Wilmington, NC, VORTAC. The FAA proposes to remove the segments between Robbinsville, NJ, and Patuxent, 
                    <PRTPAGE P="24803"/>
                    MD. The amended route would extend between Hopewell, VA and Wilmington, NC.
                </P>
                <P>
                    <E T="03">J-193:</E>
                     J-193 currently extends between the Wilmington, NC, VORTAC, and the intersection of the Harcum, VA, VORTAC 006° and Hopewell, VA, VORTAC 030° radials (HUBBS intersection). The FAA proposes to remove the entire route.
                </P>
                <P>
                    <E T="03">J-222:</E>
                     J-222 currently extends between the Robbinsville, NJ, VORTAC, and the Cambridge, NY, VOR/DME. The FAA proposes to remove the entire route.
                </P>
                <P>
                    <E T="03">J-225:</E>
                     J-225 currently extends between the Cedar Lake, NJ, VOR/DME, and the Providence, RI, VOR/DME. The FAA proposes to remove the entire route.
                </P>
                <P>Jet routes are published in paragraph 2004, of FAA Order 7400.11E dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The jet routes listed in this document would be subsequently amended in, or removed, respectively, from the Order.</P>
                <P>FAA Order 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 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020 is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 2004 Jet Routes.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">J-42 [Amended]</HD>
                    <P>From Delicias, Mexico, via Fort Stockton, TX; Abilene, TX; Ranger, TX; Texarkana, AR; excluding the portion in Mexico.</P>
                    <STARS/>
                    <HD SOURCE="HD1">J-55 [Amended]</HD>
                    <P>From INT Flat Rock, VA, 212° and Raleigh-Durham, NC, 224° radials; Raleigh-Durham; INT Raleigh-Durham 035° and Hopewell, VA, 234° radials; Hopewell; INT Hopewell 030° and Nottingham, MD, 174° radials.</P>
                    <STARS/>
                    <HD SOURCE="HD1">J-150 [Remove]</HD>
                    <STARS/>
                    <HD SOURCE="HD1">J-191 [Amended]</HD>
                    <P>From Hopewell, VA; to Wilmington, NC</P>
                    <STARS/>
                    <HD SOURCE="HD1">J-193 [Remove]</HD>
                    <STARS/>
                    <HD SOURCE="HD1">J-222 [Remove]</HD>
                    <STARS/>
                    <HD SOURCE="HD1">J-225 [Remove]</HD>
                    <STARS/>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Washington, DC, April 28, 2021.</DATED>
                    <NAME>George Gonzalez,</NAME>
                    <TITLE>Acting Manager, Rules and Regulations Group.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09311 Filed 5-7-21; 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-2021-0279; Airspace Docket No. 21-AGL-13]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Amendment of V-36 and V-316, and Revocation of V-180 Due to Planned Decommissioning of the Elliot Lake and Dryden Non-Directional Beacons (NDBs) Ontario, Canada</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 2 VHF Omnidirectional Range (VOR) Federal airways and remove one VOR Federal airway in the northeastern United States. The airway amendments are necessary due to the planned decommissioning of the Elliot Lake, Ontario, NDB and the Dryden, Ontario, Canada, NDB. Both NDBs are being decommissioned as part of NAV CANADA's navigational aid (NAVAID) Modernization Program.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 24, 2021.</P>
                </DATES>
                <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: (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2021-0279; Airspace Docket No. 21-AGL-13 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 7400.11E, 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. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11E at NARA, email: 
                        <E T="03">fedreg.legal@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>
                        Jesse Acevedo, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 
                        <PRTPAGE P="24804"/>
                        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-2021-0279; Airspace Docket No. 21-AGL-13) 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-2021-0279; Airspace Docket No. 21-AGL-13.” 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 Operations Support Group, Central Service Center, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>NAV CANADA, which operates Canada's civil air navigation service, is implementing changes to Canada's instrument flight rules (IFR) navigation infrastructure as part of their NAVAID Modernization Program. This program is designed to enhance the efficiency of Canada's flying operations by taking advantage of performance-based navigation and modern avionic capabilities. As such, changes implemented by NAV CANADA occasionally affect VOR Federal airways that extend across the United States/Canada border into the United States.</P>
                <P>NAV CANADA is planning to decommission the Elliot Lake and Dryden NDBs as part of their NAVAID Modernization Program. As a result, amendments of V-36 and V-316, and the removal of V-180, are required to mirror changes that are planned to be made by NAV CANADA within Canadian airspace. To mitigate the deletion of V-36 and V-316 airway segments affected by the NDBs being decommissioned, IFR traffic may use adjacent VOR Federal airways, V-300 and V-348, or request air traffic control (ATC) radar vectors to fly around or through the affected area. To mitigate the deletion of V-180, IFR traffic may use adjacent VOR Federal airways, V-133 and V-367, or request ATC radar vectors to fly through or circumnavigate the affected area also. Aircraft with Area Navigation (RNAV) equipment may also navigate point to point using airspace fixes that will remain in place. Visual flight rules (VFR) pilots who elect to navigate via the airways through the affected area could also take advantage of the adjacent VOR Federal airways or ATC services listed previously.</P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 to amend V-36 and V-316, and remove V-180 due to the planned decommissioning of the Elliot Lake and Dryden NDBs, ON, Canada to mirror changes that are planned to be made by NAV CANADA within Canadian airspace. The proposed Federal airway amendments and removal are described below.</P>
                <P>
                    <E T="03">V-36:</E>
                     V-36 currently extends between the Thunder Bay, ON, Canada, VOR/DME and the intersection of the Wiarton, ON, Canada, VOR/DME 150° radial and Toronto, ON, Canada, VOR/DME 304° radial; and between the Buffalo, NY, VOR/DME and the intersection of the La Guardia, NY, VOR/DME 310° and Stillwater, NJ, VOR/DME 043° radials. The airspace within Canada is excluded. The FAA proposes to remove the airway segment between the Thunder Bay, ON, Canada, VOR/DME and Wawa, ON, Canada, VOR/DME. The FAA also proposes to remove the airway segment between the Sault Ste Marie, MI, VOR/DME and the intersection of the La Guardia, NY, VOR/DME 310° and Stillwater, NJ, VOR/DME 043° radials (NEION fix). The resulting airway would extend between the Wawa, ON, Canada, VOR/DME and the Sault Ste Marie, MI, VOR/DME; and between the Buffalo, NY, VOR/DME and the intersection of the La Guardia, NY, VOR/DME 310° and Stillwater, NJ, VOR/DME 043° radials (NEION fix). Concurrent changes to other segments of V-36 have been proposed in a separate rulemaking proposal.
                </P>
                <P>
                    <E T="03">V-316:</E>
                     V-316 currently extends between the Ironwood, MI, VOR/DME and the Sawyer, MI, VOR/DME; and between the Sault Ste Marie, MI, VOR/DME and the Sudbury, ON, Canada, VOR/DME. The airspace in Canada is 
                    <PRTPAGE P="24805"/>
                    excluded. The FAA proposes to delete the airway segment between the Sault Ste Marie, MI, VOR/DME and the Sudbury, ON, Canada, VOR/DME, and the exclusionary language. The resulting airway would extend between the Ironwood, MI, VOR/DME and the Sawyer, MI, VOR/DME.
                </P>
                <P>
                    <E T="03">V-180:</E>
                     V-180 currently extends between the International Falls, MN, VOR/DME and the Dryden, ON, Canada, NDB. The airspace within Canada is excluded. The FAA proposes to remove the airway in its entirety.
                </P>
                <P>All radials in the VOR Federal airway descriptions below are unchanged and stated in True degrees.</P>
                <P>VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document would be subsequently updated in the next edition of this Order.</P>
                <P>FAA Order 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 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020, is amended as follows: </AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">
                        <E T="03">Paragraph 6010(a) Domestic VOR Federal Airways.</E>
                    </HD>
                    <STARS/>
                    <HD SOURCE="HD1">V-36 [Amended]</HD>
                    <P>From Wawa, ON, Canada; to Sault Ste Marie, MI. From Buffalo, NY; Elmira, NY; INT Elmira 110° and LaGuardia, NY, 310° radials; to INT LaGuardia 310° and Stillwater, NJ, 043° radials. The airspace within Canada is excluded.</P>
                    <STARS/>
                    <HD SOURCE="HD1">V-180 [Removed]</HD>
                    <STARS/>
                    <HD SOURCE="HD1">V-316 [Amended] From Ironwood, MI; to Sawyer, MI.</HD>
                    <STARS/>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Washington, DC, on May 4, 2021.</DATED>
                    <NAME>George Gonzalez,</NAME>
                    <TITLE>Acting Manager, Rules and Regulations Group.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09756 Filed 5-7-21; 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-2021-0274; Airspace Docket No. 20-ANM-58]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Modification of Class E Airspace; Saratoga, WY</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action proposes to modify the Class E airspace extending upward from 700 feet above the surface at Shively Field Airport, Saratoga, WY. This action also proposes to remove the Class E airspace extending upward from 1,200 feet above the surface, and the Saratoga NDB and the Cherokee VOR/DME from the airspace's text header and description. Lastly, this action proposes administrative updates to the airspace's legal description. This action would ensure the safety and management of instrument flight rules (IFR) operations at the airport.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 24, 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-2021-0274; Airspace Docket No. 20-ANM-58, 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 7400.11E, 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 Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11E at NARA, email 
                        <E T="03">fedreg.legal@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>Matthew Van Der Wal, Federal Aviation Administration, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-3695.</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 
                    <PRTPAGE P="24806"/>
                    of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would modify the Class E airspace at Shively Field Airport, Saratoga, WY, to support IFR operations at the airport.
                </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. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2021-0274; Airspace Docket No. 20-ANM-58”. The postcard will be date/time stamped and returned to the commenter.</P>
                <P>All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. 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 the 
                    <E T="02">ADDRESSES</E>
                     section for the 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 Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to 14 CFR part 71 by modifying the Class E airspace, extending upward from 700 feet above the surface, at Shively Field Airport, Saratoga, WY. This airspace is designed to contain IFR departures to 1,200 feet above the surface and IFR arrivals descending below 1,500 feet above the surface. To properly contain arriving and departing IFR aircraft, the radius south of the airport should be reduced from 6.9 miles to 5 miles. The radius north of the airport should increase from 6.9 miles to 7.3 miles. Also, the area extending north of the airport should be increased to properly contain IFR aircraft performing a procedure turn maneuver for the NDB-A Approach.</P>
                <P>This action also proposes to remove the Class E airspace extending upward from 1,200 feet above the surface. This airspace area is wholly contained within the Denver en route airspace and duplication is not necessary.</P>
                <P>Further, this action proposes to remove the Saratoga NDB and the Cherokee VOR/DME from the Class E's text header and airspace description. The navigational aids (NAVAIDs) are not needed to define the airspace and removal of the NAVAIDs simplifies the airspace's description.</P>
                <P>Lastly, the action proposes administrative updates to the airspace's text header. The city name should be removed from the second line of the text header, and the airport's geographic coordinates on the third line of the text header should be updated to “lat. 41°26′37″ N, long. 106°49′39″ W” to match the FAA database.</P>
                <P>Class E5 airspace designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.</P>
                <P>FAA Order 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 regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial, and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would 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>Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS </HD>
                </PART>
                <AMDPAR>1. The authority citation for 14 CFR part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <PRTPAGE P="24807"/>
                    <HD SOURCE="HD2">Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">ANM WY E5 Saratoga, WY</HD>
                    <FP SOURCE="FP-2">Shively Field Airport, WY</FP>
                    <FP SOURCE="FP1-2">(Lat. 41°26′37″ N, long. 106°49′39″ W)</FP>
                    <P>That airspace extending upward from 700 feet above the surface within a 5-mile radius of the airport beginning at the 075° bearing from the airport clockwise to the 234° bearing from the airport, and within a 7.3-mile radius of the airport from the 234° bearing from the airport clockwise to the 075° bearing from the airport, and within 4 miles east and 8 miles west of the 341° bearing from the airport, extending from the 7.3-miles radius to 16.1 miles north of the airport.</P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Des Moines, Washington, on April 28, 2021.</DATED>
                    <NAME>B.G. Chew,</NAME>
                    <TITLE>Acting Group Manager,  Operations Support Group, Western Service Center.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09339 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <CFR>33 CFR Part 165</CFR>
                <DEPDOC>[Docket Number USCG-2021-0199]</DEPDOC>
                <RIN>RIN 1625-AA00</RIN>
                <SUBJECT>Safety Zones; July 4th Holiday Fireworks in the Coast Guard Captain of the Port Maryland-National Capital Region Zone</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Coast Guard is proposing to establish three temporary safety zones for navigable waters within the Captain of the Port Maryland-National Capital Region Zone. This action is necessary to provide for the safety of life on these navigable waters of the Severn River in Anne Arundel County, MD, on July 3, 2021, (with alternate date of July 5, 2021), Kent Island Narrows (North Approach) in Queen Anne's County, MD, on July 4, 2021, (with alternate date of July 5, 2021), and Susquehanna River in Harford County, MD, on July 4, 2021, (with alternate date of July 5, 2021), during fireworks displays to commemorate the July 4th holiday. This proposed rulemaking would prohibit persons and vessels from being in these safety zones unless authorized by the Captain of the Port Maryland-National Capital Region or a designated representative. We invite your comments on this proposed rulemaking.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments and related material must be received by the Coast Guard on or before May 25, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments identified by docket number USCG-2021-0199 using the Federal eRulemaking Portal at 
                        <E T="03">https://www.regulations.gov.</E>
                         See the “Public Participation and Request for Comments” portion of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section for further instructions on submitting comments.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you have questions about this proposed rulemaking, call or email Mr. Ron Houck, Sector Maryland-National Capital Region Waterways Management Division, U.S. Coast Guard; telephone 410-576-2674, email 
                        <E T="03">Ronald.L.Houck@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">COTP Captain of the Port</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, Purpose, and Legal Basis</HD>
                <P>The Fifth Coast Guard District has been been notified of three fireworks displays planned throughout the Maryland-National Capital Region to commemorate the July 4th holiday. Hazards from these fireworks displays include accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. To respond to these hazards, the Coast Guard plans to establish temporary safety zones to protect the nearby public.</P>
                <P>1. The Sherwood Forest Club, Inc., of Sherwood Forest, MD, plans to conduct a fireworks display from 9:20 p.m. to 9:50 p.m. on July 3, 2021. The fireworks are to be launched from the end of the Sherwood Forest Club main pier, located adjacent to the Severn River, approximately 200 yards east of Brewer Pond in Sherwood Forest, MD. In the event of inclement weather, the fireworks display will be scheduled for July 5, 2021. The COTP Maryland-National Capital Region has determined that potential hazards associated with the fireworks to be used in this display would be a safety concern for anyone within 150 yards of the fireworks discharge site.</P>
                <P>2. Queen Anne's County Government, of Centreville, MD, plans to conduct a fireworks display from 10 p.m. to 10:20 p.m. on July 4, 2021. The fireworks are to be launched from Kent Island along the Kent Island Narrows (North Approach) in Chester, MD. In the event of inclement weather, the fireworks display will be scheduled for July 5, 2021. The COTP Maryland-National Capital Region has determined that potential hazards associated with the fireworks to be used in this display would be a safety concern for anyone within 800 feet of the fireworks discharge site.</P>
                <P>3. The Independence Day Commission of Havre de Grace, MD, plans to conduct a fireworks display from 9:30 p.m. to 10 p.m. on July 4, 2021. The fireworks are to be launched from a fireworks barge located in the Susquehanna River, approximately 300 yards southeast of Concord Point in Havre de Grace, MD. In the event of inclement weather, the fireworks display will be scheduled for July 5, 2021. The COTP Maryland-National Capital Region has determined that potential hazards associated with the fireworks to be used in this display would be a safety concern for anyone within 200 yards of the fireworks barge.</P>
                <P>The Coast Guard is requesting that interested parties provide comments within a shortened comment period of 15 days instead of the typical 30 days for this notice of proposed rulemaking. The Coast Guard believes a shortened comment period is necessary and reasonable to ensure the Coast Guard has time to review and respond to any significant comments submitted by the public in response to this NPRM and has a final rule in effect in time for the first scheduled event.</P>
                <P>The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231).</P>
                <HD SOURCE="HD1">III. Discussion of Proposed Rule</HD>
                <P>The COTP is proposing to establish three temporary safety zones for certain navigable waters within the COTP Maryland-National Capital Region Zone, as described in 33 CFR 3.25-15, and would be enforced during the times described below for each zone.</P>
                <P>
                    The first safety zone would be enforced from 8:30 p.m. to 10:30 p.m. on July 3, 2021, or if necessary due to inclement weather, from 8:30 p.m. to 10:30 p.m. on July 5, 2021. The safety zone would cover all navigable waters of the Severn River, within 150 yards of a fireworks discharge site located at the end of Sherwood Forest Club main pier in approximate position latitude 39°01′54.0″ N, longitude 076°32′41.8″ W, Sherwood Forest, MD. The duration of the zone is intended to ensure the safety of vessels and these navigable 
                    <PRTPAGE P="24808"/>
                    waters before, during, and after the scheduled 9:20 p.m. to 9:50 p.m. on July 3, 2021 fireworks display.
                </P>
                <P>The second safety zone would be enforced from 9 p.m. to 11 p.m. on July 4, 2021, or if necessary due to inclement weather, from 9 p.m. to 11 p.m. on July 5, 2021. The safety zone would cover all navigable waters of the Kent Island Narrows (North Approach), within 800 feet of the fireworks launch site at Kent Island in approximate position latitude 38°58′44.8″ N, longitude 076°14′52.9″ W, in Queen Anne's County, MD. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 10 p.m. to 10:20 p.m. on July 4, 2021 fireworks display.</P>
                <P>The third safety zone would be enforced from 8:30 p.m. to 10:30 p.m. on July 4, 2021, or if necessary due to inclement weather, from 8:30 p.m. to 10:30 p.m. on July 5, 2021. The safety zone would cover all navigable waters of the Susquehanna River within 200 yards of a barge in approximate position latitude 39°32′19″ N, longitude 076°04′58.3″ W, located at Havre de Grace, MD. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 9:30 to 10 p.m. on July 4, 2021 fireworks display.</P>
                <P>No vessel or person would be permitted to enter these safety zones without obtaining permission from the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.</P>
                <HD SOURCE="HD1">IV. Regulatory Analyses</HD>
                <P>We developed this proposed 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 NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).</P>
                <P>This regulatory action determination is based on the size, duration, and time-of-day of the safety zones, which would impact small designated areas of the Severn River, Kent Island Narrows (North Approach), and Susquehanna River for a total no more than six total enforcement-hours, during the evening when vessel traffic is normally low. Moreover, the Coast Guard will issue Local Notices to Mariners and a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zones.</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 proposed rule would not have a significant economic impact on a substantial number of small entities.</P>
                <P>While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.</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 proposed 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. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.
                </P>
                <HD SOURCE="HD2">C. Collection of Information</HD>
                <P>This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please call or email 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 proposed rule would 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 proposed 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 made a preliminary 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. This proposed rule involves five safety zones lasting six total enforcement hours that would prohibit entry within portions of the Severn River, Kent Island Narrows (North Approach), and Susquehanna River. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A 
                    <PRTPAGE P="24809"/>
                    preliminary 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. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
                </P>
                <HD SOURCE="HD2">G. Protest Activities</HD>
                <P>
                    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.
                </P>
                <HD SOURCE="HD1">V. Public Participation and Request for Comments</HD>
                <P>We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.</P>
                <P>
                    We encourage you to submit comments through the Federal eRulemaking Portal at 
                    <E T="03">https://www.regulations.gov.</E>
                     If your material cannot be submitted using 
                    <E T="03">https://www.regulations.gov,</E>
                     call or email the person in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this document for alternate instructions.
                </P>
                <P>
                    We accept anonymous comments. Comments we post to 
                    <E T="03">https://www.regulations.gov</E>
                     will include any personal information you have provided. For more about privacy and submissions in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).
                </P>
                <P>
                    Documents mentioned in this NPRM as being available in the docket, and public comments, will be in our online docket at 
                    <E T="03">https://www.regulations.gov</E>
                     and can be viewed by following that website's instructions. We review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive. If you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 33 CFR Part 165</HD>
                    <P>Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 165 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 165 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.</P>
                </AUTH>
                <AMDPAR>2. Add § 165.T05-0199 to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 165.T05-0199 </SECTNO>
                    <SUBJECT>Safety Zones; July 4th Holiday Fireworks in the Coast Guard Captain of the Port Maryland-National Capital Region Zone.</SUBJECT>
                    <P>
                        (a) 
                        <E T="03">Locations.</E>
                         The following areas are a safety zone: These coordinates are based on datum NAD 83.
                    </P>
                    <P>(1) Safety Zone 1. All waters of the Severn River, within 150 yards of a fireworks discharge site located at the end of Sherwood Forest Club main pier in approximate position latitude 39°01′54.0″ N, longitude 076°32′41.8″ W, Sherwood Forest, MD.</P>
                    <P>(2) Safety Zone 2. All navigable waters of the Kent Island Narrows (North Approach), within 800 feet of the fireworks launch site at Kent Island in approximate position latitude 38°58′44.8″ N, longitude 076°14′52.9″ W, in Queen Anne's County, MD.</P>
                    <P>(3) Safety Zone 3. All navigable waters of the Susquehanna River within 200 yards of a barge in approximate position latitude 39°32′19″ N, longitude 076°04′58.3″ W, located at Havre de Grace, MD.</P>
                    <P>
                        (b) 
                        <E T="03">Definitions.</E>
                         As used in this section—
                    </P>
                    <P>
                        <E T="03">Captain of the Port (COTP)</E>
                         means the Commander, U.S. Coast Guard Sector Maryland-National Capital Region.
                    </P>
                    <P>
                        <E T="03">Designated representative</E>
                         means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port Maryland-National Capital Region (COTP) in the enforcement of the safety zone.
                    </P>
                    <P>
                        (c) 
                        <E T="03">Regulations.</E>
                         (1) Under the general safety zone regulations in subpart C of this part, you may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative.
                    </P>
                    <P>(2) To seek permission to enter, contact the COTP or the COTP's representative by telephone at 410-576-2693 or on Marine Band Radio VHF-FM channel 16 (156.8 MHz). Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.</P>
                    <P>
                        (d) 
                        <E T="03">Enforcement officials.</E>
                         The U.S. Coast Guard may be assisted in the patrol and enforcement of the safety zone by Federal, State, and local agencies.
                    </P>
                    <P>
                        (e) 
                        <E T="03">Enforcement periods.</E>
                         (1) Paragraph (a)(1) of this section will be enforced from 8:30 p.m. to 10:30 p.m. on July 3, 2021. If necessary due to inclement weather on July 3, 2021, it will be enforced from 8:30 p.m. to 10:30 p.m. on July 5, 2021.
                    </P>
                    <P>(2) Paragraph (a)(2) of this section will be enforced from 9 p.m. to 11 p.m. on July 4, 2021. If necessary due to inclement weather on July 4, 2021, it will be enforced from 9 p.m. to 11 p.m. on July 5, 2021.</P>
                    <P>(3) Paragraph (a)(3) of this section will be enforced from 8:30 p.m. to 10:30 p.m. on July 4, 2021. If necessary due to inclement weather on July 4, 2021, it will be enforced from 8:30 p.m. to 10:30 p.m. on July 5, 2021.</P>
                </SECTION>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <NAME>David E. O'Connell,</NAME>
                    <TITLE>Captain, U.S. Coast Guard, Captain of the Port Maryland-National Capital Region.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09947 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R09-OAR-2020-0254; FRL-10023-52-Region 9]</DEPDOC>
                <SUBJECT>Clean Air Plans; 2008 8-Hour Ozone Nonattainment Area Requirements; West Mojave Desert, California</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, or conditionally approve, all or portions of the state implementation plan (SIP) revision submitted by the State of California to meet Clean Air Act requirements for the 2008 8-hour ozone national ambient air quality standards (NAAQS or “standards”) in the West Mojave Desert ozone nonattainment area. The SIP revision addresses the nonattainment area requirements for the 
                        <PRTPAGE P="24810"/>
                        2008 8-hour ozone NAAQS, including the requirements for an emissions inventory, emissions statements, attainment demonstration, reasonable further progress, reasonably available control measures, contingency measures, and motor vehicle emissions budgets. The EPA is proposing to approve the SIP revision as meeting all the applicable ozone nonattainment area requirements, except for contingency measures, for which we are proposing conditional approval.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written comments must arrive on or before June 9, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by Docket ID No. EPA-R09-OAR-2020-0254 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">http://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>
                        Tom Kelly, EPA Region IX, (415) 972-3856, 
                        <E T="03">kelly.thomasp@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. Regulatory Context</FP>
                    <FP SOURCE="FP1-2">A. Ozone Standards, Area Designations, and SIPs</FP>
                    <FP SOURCE="FP1-2">B. The West Mojave Desert Ozone Nonattainment Area</FP>
                    <FP SOURCE="FP1-2">C. CAA and Regulatory Requirements for 2008 Ozone Nonattainment Area SIPs</FP>
                    <FP SOURCE="FP-2">II. Submissions From the State of California To Address 2008 Ozone Standards Requirements in the West Mojave Desert</FP>
                    <FP SOURCE="FP1-2">A. Summary of Submissions</FP>
                    <FP SOURCE="FP1-2">B. Clean Air Act Procedural Requirements for Adoption and Submission of SIP Revisions</FP>
                    <FP SOURCE="FP-2">III. Evaluation of the 2016 WMD Attainment Plan and the 2018 SIP Update</FP>
                    <FP SOURCE="FP1-2">A. Emissions Inventories</FP>
                    <FP SOURCE="FP1-2">B. Emissions Statements</FP>
                    <FP SOURCE="FP1-2">C. Reasonably Available Control Measures Demonstration</FP>
                    <FP SOURCE="FP1-2">D. Attainment Demonstration</FP>
                    <FP SOURCE="FP1-2">E. Rate of Progress Plan and Reasonable Further Progress Demonstration</FP>
                    <FP SOURCE="FP1-2">F. Transportation Control Strategies and Measures To Offset Emissions Increases From Vehicle Miles Traveled</FP>
                    <FP SOURCE="FP1-2">G. Contingency Measures</FP>
                    <FP SOURCE="FP1-2">H. Motor Vehicle Emissions Budgets for Transportation Conformity</FP>
                    <FP SOURCE="FP1-2">I. Other Clean Air Act Requirements Applicable to Severe Ozone Nonattainment Areas</FP>
                    <FP SOURCE="FP-2">IV. Proposed Action</FP>
                    <FP SOURCE="FP-2">V. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Regulatory Context</HD>
                <HD SOURCE="HD2">A. Ozone Standards, Area Designations, and SIPs</HD>
                <P>
                    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.
                    <SU>1</SU>
                    <FTREF/>
                     These two pollutants, referred to as ozone precursors, are emitted by many types of sources, including on-and off-road motor vehicles and engines, power plants and industrial facilities, and smaller area sources such as lawn and garden equipment and paints.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The State of California typically refers to reactive organic gases (ROG) in its ozone-related submissions since VOC in general can include both reactive and unreactive gases. However, since ROG and VOC inventories pertain to common chemical species (
                        <E T="03">e.g.,</E>
                         benzene, xylene, etc.), we refer to this set of gases as VOC in this proposed rule.
                    </P>
                </FTNT>
                <P>
                    Scientific evidence indicates that adverse public health effects occur following exposure to ozone, particularly in children and adults with lung disease. Breathing air containing ozone can reduce lung function and inflame airways, which can increase respiratory symptoms and aggravate asthma or other lung diseases.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         See “Fact Sheet—2008 Final Revisions to the National Ambient Air Quality Standards for Ozone” dated March 2008.
                    </P>
                </FTNT>
                <P>
                    Under section 109 of the Clean Air Act (CAA or “Act”), the EPA promulgates NAAQS for pervasive air pollutants, such as ozone. The EPA has previously promulgated NAAQS for ozone in 1979 and 1997.
                    <SU>3</SU>
                    <FTREF/>
                     In 2008, the EPA revised and further strengthened the ozone NAAQS by setting the acceptable level of ozone in the ambient air at 0.075 parts per million (ppm) averaged over an 8-hour period.
                    <SU>4</SU>
                    <FTREF/>
                     Although the EPA further tightened the 8-hour ozone NAAQS to 0.070 ppm in 2015, this action relates to the requirements for the 2008 ozone NAAQS.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The ozone NAAQS promulgated in 1979 was 0.12 parts per million (ppm) averaged over a 1-hour period. See 44 FR 8202 (February 8, 1979). The ozone NAAQS promulgated in 1997 was 0.08 ppm averaged over an 8-hour period. See 62 FR 38856 (July 18, 1997).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         73 FR 16436 (March 27, 2008).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Information on the 2015 ozone NAAQS is available at 80 FR 65292 (October 26, 2015).
                    </P>
                </FTNT>
                <P>
                    Following promulgation of a new or revised NAAQS, the EPA is required under CAA section 107(d) to designate areas throughout the country as attaining or not attaining the NAAQS. The “Los Angeles-San Bernardino Counties (West Mojave Desert), CA” area (“West Mojave Desert” or WMD) was designated as nonattainment for the 2008 ozone standards on May 21, 2012 and classified as “Severe-15.” 
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         77 FR 30088 (May 21, 2012).
                    </P>
                </FTNT>
                <P>
                    Under the CAA, after the EPA designates areas as nonattainment for a NAAQS, states with nonattainment areas are required to submit SIP revisions that provide for, among other things, attainment of the NAAQS within certain prescribed periods that vary depending on the severity of nonattainment. Areas classified as Severe-15 must attain the NAAQS within 15 years of the effective date of the nonattainment designation.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         CAA section 181(a)(1), 40 CFR 51.1102 and 51.1103(a).
                    </P>
                </FTNT>
                <P>
                    In California, the California Air Resources Board (CARB) is the agency responsible for the adoption and submission to the EPA of California SIPs and SIP revisions, and it has broad authority to establish emissions standards and other requirements for mobile sources. Local and regional air pollution control districts in California are responsible for the regulation of stationary sources and are generally responsible for the development of regional air quality plans. In the West Mojave Desert, two agencies develop and adopt air quality management plans to address CAA planning requirements applicable to that region, the Antelope Valley Air Quality Management District (AVAQMD) and the Mojave Desert Air Quality Management District (MDAQMD) (collectively, “Districts”). Such plans are then submitted to CARB for adoption and submittal to the EPA as revisions to the California SIP.
                    <PRTPAGE P="24811"/>
                </P>
                <HD SOURCE="HD2">B. The West Mojave Desert Ozone Nonattainment Area</HD>
                <P>The West Mojave Desert is located in northeast Los Angeles County and southwest San Bernardino County. For a precise description of the geographic boundaries of the area, see 40 CFR 81.305. The Los Angeles County portion of the WMD area is under the jurisdiction of the AVAQMD, and the San Bernardino County portion of the area is under the jurisdiction of the MDAQMD.</P>
                <P>
                    The population of the West Mojave Desert is approximately 868,380.
                    <SU>8</SU>
                    <FTREF/>
                     Ambient 8-hour ozone concentrations in the WMD are above the level of the 2008 8-hour ozone NAAQS. The area's maximum design value for the 2017-2019 period, based on certified data at the Phalen monitor (Air Quality System ID: 06-071-0012), is 0.096 ppm.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         8-Hour Ozone (2008) Designated Area/State Information, Green Book, EPA, accessed on November 19, 2020, Population Data from 2010, 
                        <E T="03">https://www3.epa.gov/airquality/greenbook/hbtc.html.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Air Quality System (AQS) Design Value Report, O3_designvalues_2017_2019_final_5_26_20.pdf, in the docket for this proposed action. The AQS is a database containing ambient air pollution data collected by the EPA and state, local, and tribal air pollution control agencies from over thousands of monitors. Design values, defined to be consistent with the individual NAAQS as described in 40 CFR part 50, are typically used to designate and classify nonattainment areas, as well as to assess progress towards meeting the NAAQS.
                    </P>
                </FTNT>
                <P>
                    The West Mojave Desert receives significant transport of ozone and ozone precursors from the South Coast Air Basin, and to a lesser extent, the San Joaquin Valley. To attain the 2008 ozone NAAQS, the WMD will depend on continued emissions reductions in those areas.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         See CARB, Staff Report, “CARB Review of the Mojave Desert AQMD and Antelope Valley AQMD Federal 75 ppb Ozone Attainment Plans for the Western Mojave Desert Nonattainment Area,” April 21, 2017 (“CARB Staff Report”), Appendix B, “Weight of Evidence Analysis,” B-28.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. CAA and Regulatory Requirements for 2008 8-Hour Ozone Nonattainment Area SIPs</HD>
                <P>
                    States must implement the 2008 ozone standards under title I, part D of the CAA, which includes sections 171-179B of subpart 1, “Nonattainment Areas in General,” and sections 181-185 of subpart 2, “Additional Provisions for Ozone Nonattainment Areas.” To assist states in developing effective plans to address ozone nonattainment problems, in 2015 the EPA issued a SIP Requirements Rule (SRR) for the 2008 ozone standards (“2008 Ozone SRR”) that addresses requirements for nonattainment areas, such as attainment dates, emissions inventories, attainment and reasonable further progress (RFP) demonstrations, and the transition from the 1997 8-hour ozone standards to the 2008 8-hour ozone standards and associated anti-backsliding requirements.
                    <SU>11</SU>
                    <FTREF/>
                     The 2008 Ozone SRR is codified at 40 CFR part 51, subpart AA. We discuss each of the CAA statutory and regulatory requirements for 2008 8-hour ozone plans in more detail in Section III of this document.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         80 FR 12264 (March 6, 2015).
                    </P>
                </FTNT>
                <P>
                    The EPA's 2008 Ozone SRR was challenged, and on February 16, 2018, the U.S. Court of Appeals for the D.C. Circuit (“D.C. Circuit”) published its decision in 
                    <E T="03">South Coast Air Quality Management District</E>
                     v. 
                    <E T="03">EPA</E>
                     (“
                    <E T="03">South Coast II</E>
                    ”) 
                    <SU>12</SU>
                    <FTREF/>
                     vacating portions of the 2008 Ozone SRR. The only aspect of the 
                    <E T="03">South Coast II</E>
                     decision that affects this proposed action is the vacatur of the alternative baseline year for RFP plans. More specifically, the 2008 Ozone SRR required states to develop the baseline emissions inventory for RFP plans using the emissions inventory for the most recent calendar year for which states submit a triennial inventory to the EPA under subpart A of 40 CFR part 51, “Air Emissions Reporting Requirements,” which was 2011. The 2008 Ozone SRR, however, allowed states to use an alternative year, between 2008 and 2012, for the baseline emissions inventory, provided the state demonstrated why the alternative baseline year was appropriate. In the 
                    <E T="03">South Coast II</E>
                     decision, the D.C. Circuit vacated the provisions of the 2008 Ozone SRR that allowed states to use an alternative baseline year for demonstrating RFP.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">South Coast Air Quality Management District</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>
                <HD SOURCE="HD1">II. Submissions From the State of California To Address 2008 Ozone Standards Requirements in the West Mojave Desert</HD>
                <HD SOURCE="HD2">A. Summary of Submissions</HD>
                <HD SOURCE="HD3">1. 2016 WMD Attainment Plan</HD>
                <P>
                    On June 2, 2017, CARB submitted a SIP revision to address the WMD's planning obligations as a Severe-15 nonattainment area for the 2008 ozone NAAQS.
                    <SU>13</SU>
                    <FTREF/>
                     The June 2, 2017 submittal includes attainment plans prepared by the AVAQMD (“AVAQMD Attainment Plan”) 
                    <SU>14</SU>
                    <FTREF/>
                     and the MDAQMD (“MDAQMD Attainment Plan”),
                    <SU>15</SU>
                    <FTREF/>
                     an accompanying staff report prepared by CARB (“CARB Staff Report”),
                    <SU>16</SU>
                    <FTREF/>
                     and other supporting documents. We refer to the AVAQMD Attainment Plan and the MDAQMD Attainment Plan collectively as the Districts' “Attainment Plans,” and we refer to all the documents submitted to the EPA on June 2, 2017 as the “2016 WMD Attainment Plan.” The 2016 WMD Attainment Plan addresses the requirements for base year and projected future year emissions inventories, air quality modeling demonstrating attainment of the 2008 ozone NAAQS by the applicable attainment year, provisions demonstrating implementation of reasonably available control measures (RACM), provisions for transportation control strategies and measures, a demonstration of RFP, and contingency measures for failure to make RFP or to attain, among other requirements.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Letter dated June 2, 2017, from Richard Corey, CARB, to Alexis Strauss, EPA Region IX.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         AVAQMD, “AVAQMD Federal 75 ppb Ozone Attainment Plan (Western Mojave Desert Nonattainment Area),” adopted on March 21, 2017.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         MDAQMD, “MDAQMD Federal 75 ppb Ozone Attainment Plan (Western Mojave Desert Nonattainment Area),” adopted on February 27, 2017.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         CARB, Staff Report, “CARB Review of the Mojave Desert AQMD and Antelope Valley AQMD Federal 75 ppb Ozone Attainment Plans for the Western Mojave Desert Nonattainment Area,” released April 21, 2017.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. CARB's 2018 Updates to the California State Implementation Plan</HD>
                <P>
                    On December 11, 2018, CARB submitted the “2018 Updates to the California State Implementation Plan” (“2018 SIP Update”) to the EPA as a revision to the California SIP.
                    <SU>17</SU>
                    <FTREF/>
                     CARB adopted the 2018 SIP Update on October 25, 2018. CARB developed the 2018 SIP Update in response to the court's decision in 
                    <E T="03">South Coast II</E>
                     vacating the 2008 Ozone SRR with respect to the use of an alternate baseline year for demonstrating RFP, and to address contingency measure requirements in the wake of the court decision in 
                    <E T="03">Bahr</E>
                     v. 
                    <E T="03">EPA.</E>
                    <SU>18</SU>
                    <FTREF/>
                     The 2018 SIP Update includes updates for 8 different California ozone nonattainment areas. We have previously approved portions of the 2018 SIP Update related to other 
                    <PRTPAGE P="24812"/>
                    nonattainment areas.
                    <SU>19</SU>
                    <FTREF/>
                     For the West Mojave Desert, the 2018 SIP Update includes an RFP demonstration using the required 2011 baseline year and revised motor vehicle emission budgets for the 2008 ozone NAAQS.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         Letter dated December 5, 2018, from Richard Corey, CARB, to Mike Stoker, EPA Region IX.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">Bahr</E>
                         v. 
                        <E T="03">EPA,</E>
                         836 F.3d 1218 (9th Cir. 2016). In this case, the court rejected the EPA's longstanding interpretation of CAA section 172(c)(9) as allowing for early implementation of contingency measures. The court concluded that a contingency measure must take effect at the time the area fails to make RFP or attain by the applicable attainment date, not before. See also 
                        <E T="03">Sierra Club</E>
                         v. 
                        <E T="03">EPA,</E>
                         985 F.3d 1055 (D.C. Cir. 2021), reaching a similar decision. These cases are addressed below in Section III.G of this document.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         See, 
                        <E T="03">e.g.,</E>
                         84 FR 11198 (March 25, 2019) (final approval of the San Joaquin Valley portion of the 2018 SIP Update) and 84 FR 52005 (October 1, 2019) (final approval of the South Coast portion of the 2018 SIP Update).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         CARB withdrew the 2016 WMD Attainment Plan RFP demonstration in a letter dated December 18, 2019, from Richard Corey, CARB, to Michael Stoker, EPA Region IX.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Clean Air Act Procedural Requirements for Adoption and Submission of SIP Revisions</HD>
                <HD SOURCE="HD3">1. Requirements</HD>
                <P>CAA sections 110(a)(1) and (2) and 110(l) require a state to provide reasonable public notice and opportunity for public hearing prior to the adoption and submission of a SIP or SIP revision. To meet this requirement, every SIP submittal should include evidence that adequate public notice was given and an opportunity for a public hearing was provided consistent with the EPA's implementing regulations in 40 CFR 51.102.</P>
                <HD SOURCE="HD3">2. Summary of the State's Documentation</HD>
                <HD SOURCE="HD3">a. 2016 WMD Attainment Plan</HD>
                <P>
                    On February 17, 2017, the AVAQMD published notice in a local newspaper of a public hearing to be held on March 21, 2017, for adoption of the AVAQMD Attainment Plan.
                    <SU>21</SU>
                    <FTREF/>
                     The District held the public hearing on March 21, 2017,
                    <SU>22</SU>
                    <FTREF/>
                     and signed a Board resolution adopting the plan that same day.
                    <SU>23</SU>
                    <FTREF/>
                     The District sent the plan to CARB on April 18, 2017.
                    <SU>24</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         Appendix B of Final Staff Report, Adoption of AVAQMD Attainment Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         Minutes of the Governing Board of the Antelope Valley Air Quality Management District, Lancaster, California, March 21, 2017.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         Resolution 17-01, March 21, 2017.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Letter dated April 18, 2017, from Alan J. De Salvio, AVAQMD, to Richard Corey, CARB.
                    </P>
                </FTNT>
                <P>
                    On January 27, 2017, the MDAQMD published notice in a local newspaper of a public hearing to be held on February 27, 2017, for adoption of the MDAQMD Attainment Plan.
                    <SU>25</SU>
                    <FTREF/>
                     The District held the public hearing on February 27, 2017,
                    <SU>26</SU>
                    <FTREF/>
                     and signed a Board resolution adopting the plan the same day.
                    <SU>27</SU>
                    <FTREF/>
                     The District sent the plan to CARB on April 3, 2017.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Appendix B of Final Staff Report, MDAQMD Attainment Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         Minutes of the Governing Board of the Mojave Desert Air Quality Management District, Victorville, California, February 27, 2017.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         Resolution 17-05, dated February 27, 2017.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Letter dated April 3, 2017, from Alan J. De Salvio, MDAQMD, to Richard Corey, CARB.
                    </P>
                </FTNT>
                <P>
                    On April 20, 2017, CARB provided notice of a public comment period and public hearing to be held on May 25, 2017, for the 2016 WMD Attainment Plan.
                    <SU>29</SU>
                    <FTREF/>
                     CARB adopted the 2016 WMD Attainment Plan by resolution at the May 25, 2017 hearing,
                    <SU>30</SU>
                    <FTREF/>
                     and submitted it to the EPA on June 2, 2017.
                    <SU>31</SU>
                    <FTREF/>
                     The EPA notified CARB the submittal was complete on November 22, 2017.
                    <SU>32</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Notice of Public Meeting to Consider the 2016 Ozone State Implementation Plan for the Western Mojave Desert Nonattainment Area, California Air Resources Board, April 20, 2017.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         Board Resolution 17-12, May 25, 2017.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Letter dated June 2, 2017, from Richard Corey, CARB, to Alexis Strauss, EPA Region IX.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         Letter dated November 22, 2017, from Matt Lakin, EPA Region IX, to Richard Corey, CARB.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">b. 2018 SIP Update</HD>
                <P>
                    On September 21, 2018, CARB provided notice of a public comment period and public hearing to be held on October 25, 2018, for the 2018 SIP Update.
                    <SU>33</SU>
                    <FTREF/>
                     CARB adopted the 2018 SIP Update by resolution at the October 25, 2018 hearing,
                    <SU>34</SU>
                    <FTREF/>
                     and submitted it the to the EPA in a letter dated December 5, 2018, which was electronically transmitted to the EPA's State Planning Electronic Collaboration System on December 11, 2018.
                    <SU>35</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         Notice of Public Meeting to Consider the 2018 Updates to the California State Implementation Plan, September 21, 2018.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         Board Resolution 18-50, October 25, 2018.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         Letter dated December 5, 2018, from Richard Corey, CARB, to Mike Stoker, EPA Region IX.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">c. The EPA's Conclusions on the Submission Requirements for the WMD 2016 Attainment Plan</HD>
                <P>CARB has satisfied the applicable statutory and regulatory requirements for reasonable public notice and hearing prior to the adoption and submittal of the elements of the 2016 WMD Attainment Plan. Based on information provided in each SIP revision and summarized above, the EPA has determined that all hearings were properly noticed. Therefore, we find that the submittals of the 2016 WMD Attainment Plan meet the procedural requirements for public notice and hearing in CAA sections 110(a) and 110(l) and 40 CFR 51.102.</P>
                <HD SOURCE="HD1">III. Evaluation of the 2016 WMD Attainment Plan and 2018 SIP Update</HD>
                <HD SOURCE="HD2">A. Emission Inventories</HD>
                <HD SOURCE="HD3">1. Statutory and Regulatory Requirements</HD>
                <P>
                    Sections 172(c)(3) and 182(a)(1) of the CAA require states to submit for each ozone nonattainment area a “base year inventory” that is a comprehensive, accurate, current inventory of actual emissions from all sources of the relevant pollutant or pollutants in the area. In addition, the 2008 Ozone SRR requires that the inventory year be selected consistent with the baseline year for the RFP demonstration, which is usually the most recent calendar year for which a complete triennial inventory is required to be submitted to the EPA under the Air Emissions Reporting Requirements.
                    <SU>36</SU>
                    <FTREF/>
                     The EPA has issued guidance on the development of base year and future year emissions inventories for 8-hour ozone and other pollutants.
                    <SU>37</SU>
                    <FTREF/>
                     Emissions inventories for ozone must include emissions of VOC and NO
                    <E T="52">X</E>
                     and represent emissions for a typical ozone season weekday.
                    <SU>38</SU>
                    <FTREF/>
                     States should include documentation explaining how the emissions data were calculated. In estimating mobile source emissions, states should use the latest emissions models and planning assumptions available at the time the SIP is developed.
                    <SU>39</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         2008 Ozone SRR at 40 CFR 51.1115(a) and the Air Emissions Reporting Requirements at 40 CFR part 51 subpart A.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         “Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter National Ambient Air Quality Standards (NAAQS) and Regional Haze Regulations,” EPA-454/B-17-002, May 2017. At the time the 2016 WMD Attainment Plan was developed, the following EPA emissions inventory guidance applied: “Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter National Ambient Air Quality Standards (NAAQS) and Regional Haze Regulations,” EPA-454/R-05-001, August 2005.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         40 CFR 51.1115(a) and (c), and 40 CFR 51.1100(bb) and (cc).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         80 FR 12264, 12290 (March 6, 2015).
                    </P>
                </FTNT>
                <P>Future year baseline emissions inventories must reflect the most recent population, employment, travel, and congestion estimates for the area. In this context, “baseline” emissions inventories refer to emissions estimates for a given year and area that reflect rules and regulations and other measures that are already adopted. Future year baseline emissions inventories are necessary to show the projected effectiveness of SIP control measures. Both the base year and future year inventories are necessary for photochemical modeling to demonstrate attainment.</P>
                <HD SOURCE="HD3">2. Summary of State's Submission</HD>
                <P>
                    The 2016 WMD Attainment Plan includes base year (2012) and future year baseline inventories for NO
                    <E T="52">X</E>
                     and VOC for the West Mojave Desert.
                    <FTREF/>
                    <SU>40</SU>
                      
                    <PRTPAGE P="24813"/>
                    Documentation for the inventories is found in Appendix A-2 of the CARB Staff Report.
                    <SU>41</SU>
                    <FTREF/>
                     The emissions inventories represent average summer day emissions, consistent with the observation that ozone levels in West Mojave Desert are typically higher from May through October.
                    <SU>42</SU>
                    <FTREF/>
                     For stationary and area sources, the 2012 base year and future year inventories considered several of the Districts' rules, specifically including MDAQMD Rule 1461, “Portland Cement Kilns” (covering mineral processing), and rules from both Districts based on CARB's rules for consumer products, aerosol coatings,
                    <SU>43</SU>
                    <FTREF/>
                     and architectural coatings.
                    <SU>44</SU>
                    <FTREF/>
                     The inventory also specifically notes the incorporation of CARB's performance standards for gasoline dispensing hose permeation,
                    <SU>45</SU>
                    <FTREF/>
                     and revised vehicle refueling emission factors.
                    <SU>46</SU>
                    <FTREF/>
                     These District and CARB rules are noted in Table 5, “Stationary Source Control Rules and Regulations Included in the Inventory,” of Appendix A-1 of the CARB Staff Report. The mobile source portions of both base year and projected future year inventories were developed using California's EPA-approved mobile source emissions model, EMFAC2014, for estimating on-road motor vehicle emissions.
                    <SU>47</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         The 2012 base year and future year baseline emissions inventories in the CARB Staff Report exclude non-anthropogenic “natural sources” emissions such as biogenics and geogenics. However, emissions from such natural sources are included in the emissions inventories used for the attainment demonstration because they affect ozone formation.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         The 2012 base year emissions inventory included in the CARB Staff Report supersedes and replaces a previous submittal of the 2012 base year emissions inventory for the West Mojave Desert in the “8-Hour Ozone State Implementation Plan Emission Inventory Submittal” (the “Multi-Area Emission Inventory”). The Multi-Area Emission Inventory was submitted by CARB on July 17, 2014 and later withdrawn on December 18, 2019. The Multi-Area Inventory included 2012 base year emissions inventories for 16 nonattainment areas, including the West Mojave Desert. Relative to the corresponding inventory for the West Mojave Desert in the Multi-Area Emission Inventory, the 2012 base year emissions inventory in the 2016 WMD Attainment Plan reflects updated stationary, area, and nonroad source calculations as well as an updated version of the EMFAC model for on-road motor vehicle estimates.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         Appendix A-2 of the CARB Staff Report. In contrast, the emissions inventory and projections in Appendix A and B of the Districts' Attainment Plans contain average daily emissions, not average summer day emissions.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         See California Code of Regulations 94522, “Limits and Requirements for Aerosol Coating Products,” incorporated into the SIP on November 4, 2009 (74 FR 57074).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         As stated on the CARB website (
                        <E T="03">https://ww2.arb.ca.gov/our-work/programs/coatings/architectural-coatings/scm-district-rulemaking-schedule,</E>
                         accessed on August 25, 2020), AVAQMD Rule 1113, adopted locally on June 18, 2013 and MDAQMD Rule 1113, adopted locally on April 23, 2012, implement California's 2007 suggested control measures for architectural coatings. These rules were incorporated into the SIP on December 8, 2015 (80 FR 76222) and December 8, 2015 (80 FR 76222), respectively.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         See 
                        <E T="03">https://ww3.arb.ca.gov/vapor/gdf-emisfactor/attachment5.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         See 
                        <E T="03">https://ww2.arb.ca.gov/gasoline-dispensing-facility-emission-factors.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         EMFAC is short for EMission FACtor.
                    </P>
                </FTNT>
                <P>
                    The 2016 WMD Attainment Plan includes emissions inventories for stationary sources, area sources, and on-road and off-road mobile sources.
                    <SU>48</SU>
                    <FTREF/>
                     Stationary sources refer to larger “point” sources that have a fixed geographic location. The 2018 SIP Update explains that 2012 “stationary source emissions reflect actual emissions reported from industrial point sources” and include stationary aggregate sources, such as gasoline dispensing facilities.
                    <SU>49</SU>
                    <FTREF/>
                     AVAQMD Rule 107, “Certification of Submissions and Emission Statements,” and MDAQMD Rule 107, “Certification and Emission Statements,” require all stationary sources within the nonattainment area that emit more than 25 tons per year (tpy) or more of VOC or NO
                    <E T="52">X</E>
                     to report and certify annual emissions. For the 2012 base year, CARB developed a list of stationary sources in Los Angeles and San Bernardino counties and their associated emissions. AVAQMD and MDAQMD separated the stationary sources within the WMD from those within their respective counties but outside the WMD.
                </P>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         CARB Staff Report, Appendix A-2.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         2018 SIP Update, Appendix A, A-1.
                    </P>
                </FTNT>
                <P>
                    Area sources include smaller emissions sources distributed across the nonattainment area, such as consumer products, architectural coatings, pesticides and herbicides, farming operations, and cooking. CARB and the District estimate emissions for area sources using surveys and information from other state and federal agencies. These estimates are updated with relevant factors such as population changes, demographic factors, and agency specific growth factors (
                    <E T="03">e.g.,</E>
                     for farming operations and use of herbicides and pesticides).
                    <SU>50</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         CARB Staff Report, see the discussion of areawide sources beginning on page A1-8.
                    </P>
                </FTNT>
                <P>
                    On-road emissions inventories in the CARB Staff Report are calculated using CARB's EMFAC2014 model 
                    <SU>51</SU>
                    <FTREF/>
                     and the travel activity data provided by the area's metropolitan planning organization, the Southern California Association of Governments (SCAG), in the “2016-2040 Regional Transportation Plan/Sustainable Communities Strategy.” 
                    <SU>52</SU>
                    <FTREF/>
                     CARB consulted with MDAQMD staff to estimate emissions from off-road equipment and area sources occurring in the nonattainment area, most often using human population as default surrogate for the quantity of emissions occurring in the WMD.
                    <SU>53</SU>
                    <FTREF/>
                     Future emissions forecasts are primarily based on population and economic growth projections provided by SCAG; growth estimates from government agencies such as the U.S. Bureau of Labor Statistics, the U.S. Department of Agriculture, and CARB; forecasts from the Districts; and research studies. The growth factors for each emissions category are discussed in Appendix A-1 of the CARB Staff Report.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         In December 2015, the EPA approved EMFAC2014 for SIP development and transportation conformity purposes in California. 80 FR 77337 (December 14, 2015). EMFAC2014 was the most recently approved version of the EMFAC model that was available at the time of preparation of the 2016 Attainment Plan. The EPA approved an updated version of the EMFAC model, EMFAC2017, for future SIP development and transportation purposes in California. 84 FR 41717 (August 15, 2019).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         CARB Staff Report, Appendix A-1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Id. at A1-3.
                    </P>
                </FTNT>
                <P>
                    Table 1 below provides a summary of the CARB Staff Report's 2012 base year and future attainment year VOC and NO
                    <E T="52">X</E>
                     emissions estimates within the West Mojave Desert (average summer day). These inventories provide the basis for the control measure analysis and the attainment demonstration in the 2016 WMD Attainment Plan. Based on the inventory for 2012, stationary and area sources of VOC emissions are roughly equivalent to the combined on-road and off-road mobile source emissions. For NO
                    <E T="52">X</E>
                     emissions in 2012, on-road mobile sources contribute the highest fraction of emissions (37.11 tons per day (tpd) or 37.5 percent) followed by off-road (32.53 tpd or 32.9 percent), stationary (28.27 tpd or 28.6 percent), and area sources (1.05 tpd or 1.1 percent).
                    <PRTPAGE P="24814"/>
                </P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,12">
                    <TTITLE>Table 1—West Mojave Desert Nonattainment Area Base Year and Attainment Year Emissions Inventory Summary </TTITLE>
                    <TDESC>[Summer season average tpd]</TDESC>
                    <BOXHD>
                        <CHED H="1">Category</CHED>
                        <CHED H="1">
                            NO
                            <E T="0732">X</E>
                              
                            <LI>(2012)</LI>
                        </CHED>
                        <CHED H="1">
                            NO
                            <E T="0732">X</E>
                              
                            <LI>(2026)</LI>
                        </CHED>
                        <CHED H="1">
                            VOC 
                            <LI>(2012)</LI>
                        </CHED>
                        <CHED H="1">
                            VOC 
                            <LI>(2026)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Stationary Sources</ENT>
                        <ENT>28.27</ENT>
                        <ENT>42.08</ENT>
                        <ENT>13.16</ENT>
                        <ENT>17.35</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Area Sources</ENT>
                        <ENT>1.05</ENT>
                        <ENT>0.92</ENT>
                        <ENT>11.32</ENT>
                        <ENT>12.15</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">On-road Mobile</ENT>
                        <ENT>37.11</ENT>
                        <ENT>9.84</ENT>
                        <ENT>15.21</ENT>
                        <ENT>5.98</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">Off-road Mobile</ENT>
                        <ENT>32.53</ENT>
                        <ENT>25.53</ENT>
                        <ENT>7.09</ENT>
                        <ENT>4.99</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT>98.95</ENT>
                        <ENT>68.56</ENT>
                        <ENT>46.78</ENT>
                        <ENT>40.47</ENT>
                    </ROW>
                    <TNOTE>Source: Appendix A-2, CARB Staff Report. Due to rounding, the totals may not agree to the hundredth of a tpd.</TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD3">3. The EPA's Review of the State's Submission</HD>
                <P>
                    We have reviewed the 2012 base year emissions inventory in the 2016 WMD Attainment Plan and the inventory methodologies used by CARB and the District for consistency with CAA requirements and EPA guidance. First, as required by EPA regulations, we find that the 2012 inventory includes estimates for VOC and NO
                    <E T="52">X</E>
                     for a typical ozone season weekday, and that CARB has provided adequate documentation explaining how the emissions are calculated. Second, we find that the 2012 base year emissions inventory in the 2016 WMD Attainment Plan reflects appropriate emissions models and methodologies, and, therefore, represents a comprehensive, accurate, and current inventory of actual emissions during that year in the WMD. Third, we find that selection of year 2012 for the base year emissions inventory is appropriate because it is consistent with the 2011 RFP baseline year (from the 2018 SIP Update) because both inventories are derived from a common set of models and methods. Therefore, the EPA is proposing to approve the 2012 emissions inventory in the 2016 WMD Attainment Plan as meeting the requirements for a base year inventory set forth in CAA section 182(a)(1) and 40 CFR 51.1115.
                </P>
                <P>With respect to future year baseline projections, we have reviewed the growth and control factors and find them acceptable, and conclude that the future baseline emissions projections in the 2016 WMD Attainment Plan reflect appropriate calculation methods and the latest planning assumptions.</P>
                <P>Furthermore, we note that the future year baseline projections account for emissions reductions from control measures in adopted state and local rules and regulations. As a general matter, the EPA will approve a SIP revision that takes emissions reduction credit for such control measures only where the EPA has approved the control measures as part of the SIP. Tables 1 and 2 in the technical support document (TSD) supporting this action document the approval of all rules within the West Mojave Desert. Table 5 of the CARB Staff Report documents the specific rules considered in the development of the emissions inventory.</P>
                <P>
                    With respect to mobile sources, the EPA has taken action in recent years to approve CARB mobile source regulations into the California SIP.
                    <SU>54</SU>
                    <FTREF/>
                     We therefore find that the future year baseline projections in the 2016 WMD Attainment Plan are properly supported by SIP-approved stationary and mobile source control measures.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         See 81 FR 39424 (June 16, 2016), 82 FR 14446 (March 21, 2017), and 83 FR 23232 (May 18, 2018).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Emissions Statements</HD>
                <HD SOURCE="HD3">1. Statutory and Regulatory Requirements</HD>
                <P>
                    Section 182(a)(3)(B)(i) of the Act requires each state to submit a SIP revision requiring owners or operators of stationary sources of VOC or NO
                    <E T="52">X</E>
                     to provide the state with statements of actual emissions from such sources. Statements must be submitted at least every year and must contain a certification that the information contained in the statement is accurate to the best knowledge of the individual certifying the statement. Section 182(a)(3)(B)(ii) of the Act allows states to waive the emission statement requirement for any class or category of stationary sources that emit less than 25 tpy of VOC or NO
                    <E T="52">X</E>
                    , if the state provides an inventory of emissions from such class or category of sources as part of the base year or periodic inventories required under CAA sections 182(a)(1) and 182(a)(3)(A), based on the use of emission factors established by the EPA or other methods acceptable to the EPA.
                </P>
                <P>
                    The preamble of the 2008 Ozone SRR states that if an area has a previously approved emissions statement rule for the 1997 ozone NAAQS or the 1-hour ozone NAAQS that covers all portions of the nonattainment area for the 2008 ozone NAAQS, such rule should be sufficient for purposes of the emissions statement requirement for the 2008 ozone NAAQS.
                    <SU>55</SU>
                    <FTREF/>
                     The state should review the existing rule to ensure it is adequate and, if so, may rely on it to meet the emissions statement requirement for the 2008 ozone NAAQS. Where an existing emissions statement requirement is still adequate to meet the requirements of this rule, states can provide the rationale for that determination to the EPA in a written statement in the SIP to meet this requirement. States should identify the various requirements and how each is met by the existing emissions statement program. Where an emissions statement requirement is modified for any reason, the state must provide the revisions to the emissions statement as part of its SIP.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         80 FR 12264, at 12291 (March 6, 2015).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Summary of the State's Submission</HD>
                <P>
                    The 2016 WMD Attainment Plan addresses compliance with the emissions statement requirement in CAA section 182(a)(3)(B) for the 2008 ozone NAAQS by reference to AVAQMD Rule 107 and MDAQMD Rule 107.
                    <SU>56</SU>
                    <FTREF/>
                     These rules require, among other things, emissions reporting within the West Mojave Desert from all stationary sources of NO
                    <E T="52">X</E>
                     and VOC with emissions over 25 tpy.
                    <SU>57</SU>
                    <FTREF/>
                     The EPA approved AVAQMD Rule 107 on April 11, 2013 (78 FR 21545) and MDAQMD Rule 107 on May 26, 2004 (69 FR 29880) as revisions to each District's portion of the California SIP. AVAQMD and MDAQMD letters to CARB state that these rules continue to meet the emission statement requirements of CAA section 182(a)(3)(B) and that the Districts rely on these rules to meet the 
                    <PRTPAGE P="24815"/>
                    emissions statement requirements for the 2008 ozone standards.
                    <SU>58</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         Addendum A to Appendix D and Addendum A to Appendix E of the CARB Staff Report.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         Id.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         Appendix D1 and D2 and Appendix E1 and E1 of the CARB Staff Report.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. The EPA's Review of the State's Submission</HD>
                <P>
                    For this action, we have reviewed AVAQMD Rule 107 and MDAQMD Rule 107 for compliance with the specific requirements for emissions statement rules under CAA section 182(a)(3)(B). We agree with the Districts' findings: That these rules apply within the entire ozone nonattainment area and that the nonattainment area is the same for both the 1997 Ozone NAAQS and the 2008 ozone NAAQS; that the rules apply to all stationary sources of VOC and NO
                    <E T="52">X</E>
                    , except those emitting less than 25 tpy for which the Districts have waived the requirement (consistent with CAA section 182(a)(3)(B)(ii)); and that the rules require reporting, on an annual basis, of total emissions of VOC and NO
                    <E T="52">X</E>
                    . We also find that AVAQMD Rule 107 and MDAQMD Rule 107 require certification that the information provided to the Districts is accurate to the best knowledge of the individual certifying the emissions data, as required under CAA section 182(a)(3)(B).
                </P>
                <P>Therefore, we propose to approve the emissions statement element of the 2016 WMD Attainment Plan as meeting the requirements of CAA section 182(a)(3)(B) and the 40 CFR 51.1102.</P>
                <HD SOURCE="HD2">C. Reasonably Available Control Measures Demonstration</HD>
                <HD SOURCE="HD3">1. Statutory and Regulatory Requirements</HD>
                <P>
                    CAA section 172(c)(1) requires that each attainment plan provide for the implementation of all RACM as expeditiously as practicable (including such reductions in emissions from existing sources in the area as may be obtained through implementation of reasonably available control technology (RACT)), and also provide for attainment of the NAAQS. The 2008 Ozone SRR requires that, for each nonattainment area required to submit an attainment demonstration, the state concurrently submit a SIP revision demonstrating that it has adopted all RACM necessary to demonstrate attainment as expeditiously as practicable and to meet any RFP requirements.
                    <SU>59</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>59</SU>
                         40 CFR 51.1112(c).
                    </P>
                </FTNT>
                <P>
                    The EPA has previously provided guidance interpreting the RACM requirement in the General Preamble for the Implementation of the Clean Air Act Amendments of 1990 (“General Preamble”) and in a memorandum entitled “Guidance on the Reasonably Available Control Measures (RACM) Requirement and Attainment Demonstration Submissions for Ozone Nonattainment Areas.” 
                    <SU>60</SU>
                    <FTREF/>
                     In summary, to address the requirement to adopt all RACM, states should consider all potentially reasonable control measures for source categories in the nonattainment area to determine whether they are reasonably available for implementation in that area and whether they would, if implemented individually or collectively, advance the area's attainment date by one year or more.
                    <SU>61</SU>
                    <FTREF/>
                     Any measures that are necessary to meet these requirements that are not already either federally promulgated, or part of the state's SIP, or otherwise creditable in the SIP, must be submitted in enforceable form as part of the state's attainment plan for the area.
                    <SU>62</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>60</SU>
                         General Preamble, 57 FR 13498 at 13560 (April 16, 1992); memorandum dated November 30, 1999, from John Seitz, Director, OAQPS, to EPA Regional Air Directors, Regions I-X, Subject: “Guidance on the Reasonably Available Control Measures (RACM) Requirement and Attainment Demonstration Submissions for Ozone Nonattainment Areas.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>61</SU>
                         Id. See also 44 FR 20372 (April 4, 1979), and memorandum dated December 14, 2000, from John S. Seitz, Director, OAQPS, to Regional Air Directors, titled “Additional Submission on RACM From States with Severe One-Hour Ozone Nonattainment Area SIPs.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>62</SU>
                         For ozone nonattainment areas classified as Moderate or above, CAA section 182(b)(2) also requires implementation of RACT for all major sources of VOC and for each VOC source category for which the EPA has issued a Control Techniques Guideline (CTG). CAA section 182(f) requires that RACT under section 182(b)(2) also apply to major stationary sources of NO
                        <E T="52">X</E>
                        . In Extreme areas, a major source is a stationary source that emits or has the potential to emit at least 10 tpy of VOC or NO
                        <E T="52">X</E>
                         (see CAA section 182(e) and (f)). Under the 2008 Ozone SRR, states were required to submit SIP revisions meeting the RACT requirements of CAA sections 182(b)(2) and 182(f) no later than 24 months after the effective date of designation for the 2008 Ozone NAAQS and to implement the required RACT measures as expeditiously as practicable but no later than January 1 of the 5th year after the effective date of designation (
                        <E T="03">see</E>
                         40 CFR 51.1112(a)). California submitted the CAA section 182 RACT SIP for AVAQMD and MDAQMD on October 23, 2015 and September 9, 2015, respectively. The EPA conditionally approved these submissions at 82 FR 46923 (October 10, 2017) and 83 FR 5921 (February 12, 2018).
                    </P>
                </FTNT>
                <P>
                    CAA section 172(c)(6) requires that nonattainment area plans include enforceable emission limitations, and such other control measures, means or techniques (including economic incentives such as fees, marketable permits, and auctions of emission rights), as well as schedules and timetables for compliance, as may be necessary or appropriate to provide for timely attainment of the NAAQS.
                    <SU>63</SU>
                    <FTREF/>
                     Under the 2008 Ozone SRR, all control measures needed for attainment must be implemented no later than the beginning of the attainment year ozone season.
                    <SU>64</SU>
                    <FTREF/>
                     The attainment year ozone season is defined as the ozone season immediately preceding a nonattainment area's outermost attainment date.
                    <SU>65</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>63</SU>
                         See also CAA section 110(a)(2)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>64</SU>
                         40 CFR 51.1108(d).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>65</SU>
                         40 CFR 51.1100(h).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Summary of the State's Submission</HD>
                <HD SOURCE="HD3">a. The Districts' RACM Analysis</HD>
                <P>
                    The AVAQMD and MDAQMD Attainment Plans explain that they incorporate all RACM, and that the Districts have adopted or committed in the Attainment Plans to adopt all such measures.
                    <SU>66</SU>
                    <FTREF/>
                     The Plans note the Districts' reviews of stationary source rules conducted during the development of the RACT SIPs submitted to the EPA in 2015,
                    <SU>67</SU>
                    <FTREF/>
                     and set out the Districts' schedules for adoption of rules identified in those reviews.
                    <SU>68</SU>
                    <FTREF/>
                     The CARB Staff Report includes a further RACM assessment from each District confirming that the Districts have examined existing control measures and determined that no additional RACT or mobile source controls will advance the attainment date for the West Mojave Desert for the 2008 ozone standard.
                    <SU>69</SU>
                    <FTREF/>
                     These assessments also note that photochemical modeling shows the WMD would attain the ozone NAAQS if not for upwind emissions from the South Coast Air Basin and San Joaquin Valley.
                    <SU>70</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>66</SU>
                         AVAQMD Attainment Plan, 6-7, and MDAQMD Attainment Plan, 7.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>67</SU>
                         “2015 8-Hour Ozone Reasonably Available Control Technology (RACT) SIP Analysis: Antelope Valley Air Quality Management District” and “2015 8-Hour Ozone Reasonably Available Control Technology (RACT) SIP Analysis: Mojave Desert Air Quality Management District.” The EPA conditionally approved these submissions at 82 FR 46923 (October 10, 2017) and 83 FR 5921 (February 12, 2018), respectively.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>68</SU>
                         AVAQMD Attainment Plan, 17, and MDAQMD Attainment Plan, 19.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>69</SU>
                         CARB Staff Report, Appendix D-3 and E-3. See also CARB Staff Report, 10.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>70</SU>
                         CARB Staff Report, Appendix D-3 and E-3. This finding is supported by Appendix B of the CARB Staff Report, which contains a conceptual model explaining the formation of ozone in the WMD, and the heavy influence of transport from the South Coast Air Basin.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">b. CARB'S RACM Analysis</HD>
                <P>
                    Source categories for which CARB has primary jurisdiction for reducing emissions in California include most new and existing on- and off-road engines and vehicles, motor vehicle fuels, and consumer products. CARB's RACM assessment is contained in the Appendix E, “Ozone RACM Assessment,” of both the AVAQMD and MDAQMD Attainment Plans. Appendix 
                    <PRTPAGE P="24816"/>
                    F, “CARB Adopted Mobile Source Programs,” of these attainment plans also includes a general description of CARB's key mobile source regulations and programs and a comprehensive table listing on- and off-road mobile source regulatory actions taken by CARB from 1985 through 2016. The RACM assessment contains CARB's evaluation of mobile source and other statewide control measures that reduce emissions of NO
                    <E T="52">X</E>
                     and VOC in the WMD.
                </P>
                <P>Given the need for substantial emissions reductions from mobile and area sources to meet the NAAQS in California nonattainment areas, CARB has established stringent control measures for on-road and off-road mobile sources and the fuels that power them. California has unique authority under CAA section 209 (subject to a waiver by the EPA) to adopt and implement new emission standards for many categories of on-road vehicles and engines, and new and in-use off-road vehicles and engines.</P>
                <P>
                    CARB's mobile source program extends beyond regulations that are subject to the waiver or authorization process set forth in CAA section 209, to include standards and other requirements to control emissions from in-use heavy-duty trucks and buses, gasoline and diesel fuel specifications, and many other types of mobile sources. Generally, these regulations have been submitted and approved as revisions to the California SIP.
                    <SU>71</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>71</SU>
                         See, 
                        <E T="03">e.g.,</E>
                         the EPA's approval of standards and other requirements to control emissions from in-use heavy-duty diesel-powered trucks, at 77 FR 20308 (April 4, 2012), revisions to the California on-road reformulated gasoline and diesel fuel regulations at 75 FR 26653 (May 12, 2010), and revisions to the California motor vehicle inspection and maintenance program at 75 FR 38023 (July 1, 2010).
                    </P>
                </FTNT>
                <P>The Districts' Attainment Plans include CARB's RACM analysis for mobile source measures in the West Mojave Desert. In this analysis, CARB concludes: </P>
                <EXTRACT>
                    <P>
                        There are no reasonable regulatory control measures excluded from use in this plan; therefore, there are no emissions reductions associated with unused regulatory control measures. As a result, California's mobile source control programs fully meet the requirements for RACM.
                        <SU>72</SU>
                        <FTREF/>
                    </P>
                </EXTRACT>
                <FTNT>
                    <P>
                        <SU>72</SU>
                         AVAQMD Attainment Plan, Appendix E-7; MDAQMD Attainment Plan, Appendix E-7.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">c. Local Jurisdictions' RACM Analysis and Transportation Control Measures</HD>
                <P>
                    The supplemental RACM assessments included as addendums to appendices D and E of the CARB Staff Report address the Districts' RACM findings, including for transportation control measures (TCMs). These addendums state that the Districts examined existing control measures and determined that controls from RACT and mobile source emission control programs will not advance the West Mojave Desert's attainment year for the 2008 ozone standards.
                    <SU>73</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>73</SU>
                         CARB Staff Report, Appendix D-3 and E-3.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. The EPA's Review of the State's Submission</HD>
                <P>
                    The TSD for this action includes additional analysis to evaluate the Districts' and CARB's RACM assessments.
                    <SU>74</SU>
                    <FTREF/>
                     In that analysis, we estimate that a 1.2 tpd reduction of NO
                    <E T="52">X</E>
                     emissions would be necessary to advance attainment by one year from 2026 to 2025, and conservatively identify no more than 1.04 tpd of additional reductions that could be achieved through implementation of potential RACM for stationary sources. Based on this analysis, we agree with the Districts' and CARB's conclusion that there are no additional RACM that would advance attainment of the 2008 ozone standards in the WMD by at least one year.
                </P>
                <FTNT>
                    <P>
                        <SU>74</SU>
                         Technical Support Document, Clean Air Plans; 2008 8-Hour Ozone Nonattainment Area Requirements; West Mojave Desert, California, U.S. EPA Region IX, September 2020.
                    </P>
                </FTNT>
                <P>
                    We also find that CARB's consumer products program comprehensively addresses emissions from consumer products in the WMD. CARB measures are more stringent than the EPA's consumer products regulation promulgated in 1998,
                    <SU>75</SU>
                    <FTREF/>
                     and generally exceed the controls in place throughout other areas of the country. We agree with CARB's conclusion that its mobile source regulations include all reasonably available controls.
                </P>
                <FTNT>
                    <P>
                        <SU>75</SU>
                         63 FR 48819 (September 11, 1998).
                    </P>
                </FTNT>
                <P>For the WMD, given the significant influence of pollutant transport from the South Coast Air Basin and the minimal and diminishing emissions benefits generally associated with TCMs, no new TCMs implemented in the WMD, alone or in combination with potential additional rules, would contribute to advancing the attainment date in the WMD by one year. Therefore, no new TCMs are required to satisfy the RACM requirement in the WMD.</P>
                <P>For the foregoing reasons, and as addressed more fully in the TSD for this action, we propose to find that the 2016 Attainment Plan provides for the implementation of all RACM as required by CAA section 172(c)(1) and 40 CFR 51.1112(c).</P>
                <HD SOURCE="HD2">D. Attainment Demonstration</HD>
                <HD SOURCE="HD3">1. Statutory and Regulatory Requirements</HD>
                <P>
                    An attainment demonstration consists of the following: (1) Technical analyses, such as base year and future year modeling, to locate and identify sources of emissions that are contributing to violations of the ozone NAAQS within the nonattainment area (
                    <E T="03">i.e.,</E>
                     analyses related to the emissions inventory for the nonattainment area and the emissions reductions necessary to attain the standard); (2) a list of adopted measures (including RACT controls) with schedules for implementation and other means and techniques necessary and appropriate for demonstrating RFP and attainment as expeditiously as practicable but no later than the outside attainment date for the area's classification; (3) a RACM analysis; and (4) contingency measures required under sections 172(c)(9) and 182(c)(9) of the CAA that can be implemented without further action by the state or the EPA to cover emissions shortfalls in RFP plans and failures to attain.
                    <SU>76</SU>
                    <FTREF/>
                     This subsection of this proposed rule addresses the first two components of the attainment demonstration—the technical analyses and a review of adopted measures. Section III.C of this document, “Reasonably Available Control Measures Demonstration,” addresses the RACM component, and section III.G, “Contingency Measures,” addresses the contingency measures component of the attainment demonstration in the Attainment Plans.
                </P>
                <FTNT>
                    <P>
                        <SU>76</SU>
                         78 FR 34178, 34184 (June 6, 2013), the EPA's proposed rule for implementing the 2008 ozone NAAQS.
                    </P>
                </FTNT>
                <P>
                    With respect to the technical analyses, section 182(c)(2)(A) of the CAA requires that a plan for an ozone nonattainment area classified “Serious” or above include a “demonstration that the plan . . . will provide for attainment of the ozone [NAAQS] by the applicable attainment date. This attainment demonstration must be based on photochemical grid modeling or any other analytical method determined . . . to be at least as effective.” The attainment demonstration predicts future ambient concentrations for comparison to the NAAQS, making use of available information on measured concentrations, meteorology, and current and projected emissions inventories of ozone precursors, including the effect of control measures in the plan. Areas classified Severe-15 for the 2008 ozone NAAQS must demonstrate attainment as expeditiously as practicable, but no later than 15 years 
                    <PRTPAGE P="24817"/>
                    after the effective date of designation as nonattainment. The WMD was designated nonattainment for the 2008 ozone NAAQS effective July 20, 2012,
                    <SU>77</SU>
                    <FTREF/>
                     and accordingly must demonstrate attainment of the standards by no later than July 20, 2027.
                    <SU>78</SU>
                    <FTREF/>
                     An attainment demonstration must show attainment of the standards for a full calendar year before the attainment date, so in practice, Severe-15 nonattainment areas must demonstrate attainment no later than 2026.
                </P>
                <FTNT>
                    <P>
                        <SU>77</SU>
                         77 FR 30088 (May 21, 2012).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>78</SU>
                         80 FR 12264 (March 6, 2015).
                    </P>
                </FTNT>
                <P>
                    The EPA's recommended procedures for modeling ozone as part of an attainment demonstration are contained in “Modeling Guidance for Demonstrating Attainment of Air Quality Goals for Ozone, PM
                    <E T="52">2.5</E>
                    , and Regional Haze” (“Modeling Guidance”).
                    <SU>79</SU>
                    <FTREF/>
                     The Modeling Guidance includes recommendations for a modeling protocol, model input preparation, model performance evaluation, use of model output for the numerical NAAQS attainment test, and modeling documentation. Air quality modeling is performed using meteorology and emissions from a base year, and the predicted concentrations from this base case modeling are compared to air quality monitoring data from that year to evaluate model performance. Once the model performance is determined to be acceptable, future year emissions are simulated with the model. The relative (or percent) change in modeled concentration due to future emissions reductions provides a relative response factor (RRF). Each monitoring site's RRF is applied to its monitored base year design value to provide the future design value for comparison to the NAAQS. The Modeling Guidance also recommends supplemental air quality analyses, which may be used as part of a weight of evidence (WOE) analysis. A WOE analysis corroborates the attainment demonstration by considering evidence other than the main air quality modeling attainment test, such as trends and additional monitoring and modeling analyses.
                </P>
                <FTNT>
                    <P>
                        <SU>79</SU>
                         “Modeling Guidance for Demonstrating Attainment of Air Quality Goals for Ozone, PM
                        <E T="52">2.5</E>
                        , and Regional Haze,” EPA 454/R-18-009 (November 2018); available at 
                        <E T="03">https://www.epa.gov/scram/state-implementation-plan-sip-attainment-demonstration-guidance.</E>
                         See also December 2014 draft of this guidance, available at the same website. The December 2014 draft guidance was available during development of the Plan; the final version differs mainly in organization, and in updates to the regional haze portion and to other document references. Additional EPA modeling guidance can be found in 40 CFR 51 Appendix W, Guideline on Air Quality Models, 82 FR 5182 (January 17, 2017); available at 
                        <E T="03">https://www.epa.gov/scram/clean-air-act-permit-modeling-guidance.</E>
                    </P>
                </FTNT>
                <P>
                    The Modeling Guidance also does not require a particular year to be used as the base year for 8-hour ozone plans.
                    <SU>80</SU>
                    <FTREF/>
                     The Modeling Guidance states that the most recent year of the National Emissions Inventory may be appropriate for use as the base year for modeling, but that other years may be more appropriate when considering meteorology, transport patterns, exceptional events, or other factors that may vary from year to year.
                    <SU>81</SU>
                    <FTREF/>
                     Therefore, the base year used for the attainment demonstration need not be the same year used to meet the requirements for emissions inventories and RFP.
                </P>
                <FTNT>
                    <P>
                        <SU>80</SU>
                         Modeling Guidance at section 2.7.1, 35.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>81</SU>
                         Id.
                    </P>
                </FTNT>
                <P>
                    With respect to the list of adopted measures, CAA section 172(c)(6) requires that nonattainment area plans include enforceable emissions limitations, and such other control measures, means or techniques (including economic incentives such as fees, marketable permits, and auctions of emission rights), as well as schedules and timetables for compliance, as may be necessary or appropriate to provide for timely attainment of the NAAQS.
                    <SU>82</SU>
                    <FTREF/>
                     Under the 2008 Ozone SRR, all control measures needed for attainment must be implemented no later than the beginning of the attainment year ozone season.
                    <SU>83</SU>
                    <FTREF/>
                     The attainment year ozone season is defined as the ozone season immediately preceding a nonattainment area's outermost attainment date.
                    <SU>84</SU>
                    <FTREF/>
                     For the West Mojave Desert, the outermost attainment year is 2026.
                </P>
                <FTNT>
                    <P>
                        <SU>82</SU>
                         See also CAA section 110(a)(2)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>83</SU>
                         40 CFR 51.1108(d).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>84</SU>
                         40 CFR 51.1100(h).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Summary of the State's Submission</HD>
                <HD SOURCE="HD3">a. Photochemical Modeling</HD>
                <P>
                    The 2016 WMD Attainment Plan includes photochemical modeling for the 2008 ozone NAAQS. The South Coast Air Quality Management District (SCAQMD) performed the air quality modeling for the 2016 WMD Attainment Plan, as part of the Final 2016 Air Quality Management Plan for the South Coast Air Quality Management District (“SCAQMD 2016 AQMP”).
                    <SU>85</SU>
                    <FTREF/>
                     The modeling relies on a 2012 base year and demonstrates attainment of the 2008 ozone NAAQS by the applicable Severe-15 area attainment year (
                    <E T="03">i.e.,</E>
                     2026).
                </P>
                <FTNT>
                    <P>
                        <SU>85</SU>
                         Appendix V, Final 2016 Air Quality Management Plan, March 2017, SCAQMD. See AVAQMD Attainment Plan, 31, and MDAQMD Attainment Plan, 33.
                    </P>
                </FTNT>
                <P>The modeling and modeled attainment demonstration are described in Chapter 4, “Attainment Demonstration,” of the 2016 WMD Attainment Plan and in Appendix D, “Western Mojave Desert Modeling Analysis.” The AVAQMD Attainment Plan and the MDAQMD Attainment Plan also reference Appendix V of the SCAQMD 2016 AQMP for additional information on the modeled attainment demonstration.</P>
                <P>The modeling protocol is in Chapter 2, “Modeling Protocol,” of Appendix V of the SCAQMD 2016 AQMP and contains all the elements recommended in the Modeling Guidance. Those include the following: Selection of model, time period to model, modeling domain, and model boundary conditions and initialization procedures; a discussion of emissions inventory development and other model input preparation procedures; model performance evaluation procedures; selection of days; and other details for calculating RRFs. Appendix V of the SCAQMD 2016 AQMP also provides the coordinates of the modeling domain and thoroughly describes the development of the modeling emissions inventory, its spatial and temporal allocation, its temperature dependence, and quality assurance procedures.</P>
                <P>The modeling analysis uses version 5.0.2 of the Community Multiscale Air Quality (CMAQ) photochemical model, developed by the EPA. To prepare meteorological input for CMAQ, the modeling analysis uses the Weather and Research Forecasting model version 3.6 (WRF) from the National Center for Atmospheric Research. CMAQ and WRF are both recognized in the Modeling Guidance as technically sound, state-of-the-art models. The areal extent and the horizontal and vertical resolution used in these models are adequate for modeling West Mojave Desert ozone.</P>
                <P>
                    The SCAQMD assessed the performance of the WRF meteorological model through a series of simulations, and the SCAQMD concluded that the daily WRF simulation for 2012 provided representative meteorological fields that characterized the observed conditions well. The SCAQMD's conclusions are supported by hourly time series graphs of wind speed, direction, and temperature.
                    <SU>86</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>86</SU>
                         Attachment 1 (“WRF Model Performance Time Series”), Chapter 3 (“Meteorological Modeling and Sensitivity Analyses”), Appendix V (“Modeling and Attainment Demonstration”) of the 2016 SCAQMD AQMP.
                    </P>
                </FTNT>
                <P>
                    Ozone model performance statistics are described in Appendix D, “West Mojave Desert Community Multiscale Air Quality Model Performance Analysis,” of both the AVAQMD and MDAQMD Attainment Plans, which include tables of statistics 
                    <PRTPAGE P="24818"/>
                    recommended in the Modeling Guidance for 8-hour daily maximum ozone for the WMD. This section presents hourly time series, as well as density scatter plots and plots of bias against concentration. Note that because only relative changes are used from the modeling, the overprediction or underprediction of absolute ozone concentrations does not mean that future concentrations will be overestimated or underestimated.
                </P>
                <P>After model performance for the 2012 base case was accepted, the model was applied to develop RRFs for the attainment demonstration. This entailed running the model with the same meteorological inputs as before, but with adjusted emissions inventories to reflect the expected changes between 2012 and the 2026 attainment year. The base year or “reference year” modeling inventory was the same as the inventory for the modeling base case. The 2026 inventory projects the base year into the future by including the effect of economic growth and emissions control measures. The set of 153 days from May 1 through September 30, 2012, was simulated and analyzed to determine daily 8-hour average maximum ozone concentrations for the 2020 emissions inventory. To develop the RRFs for the 2008 ozone NAAQS, only the top 10 days were used.</P>
                <P>
                    The Modeling Guidance addresses attainment demonstrations with ozone NAAQS based on 8-hour averages. For the 2008 ozone NAAQS, Appendix D of the 2016 WMD Attainment Plan includes the attainment test procedure consistent with the Modeling Guidance. The RRFs were calculated as the ratio of future to base year concentrations. The resulting RRFs were then applied to 2012 weighted base year design values 
                    <SU>87</SU>
                    <FTREF/>
                     for each monitor to arrive at a 2026 future year design value.
                    <SU>88</SU>
                    <FTREF/>
                     The 2016 WMD Attainment Plan narrowly projects that the West Mojave Desert will reach modeled attainment in 2023, with the highest ozone design value of 0.0759 ppm at the Phelan monitor site (station number: 06-071-0012); this value demonstrates attainment of the corresponding 2008 ozone NAAQS of 0.075 ppm.
                    <SU>89</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>87</SU>
                         The Modeling Guidance recommends that RRFs be applied to the average of three three-year design values centered on the base year, in this case the design values for 2010-2012, 2011-2013, and 2012-2014. This amounts to a 5-year weighted average of individual year 4th-high concentrations, centered on the base year of 2012, and so is referred to as a weighted design value.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>88</SU>
                         Table 5 of Appendix A-1 of the CARB Staff Report.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>89</SU>
                         Appendix P of 40 CFR part 50 for a discussion of reporting and handling procedures for the primary and secondary ozone standards that discusses truncating the third digit to the right of the decimal place.
                    </P>
                </FTNT>
                <P>
                    Appendix B of the CARB Staff Report presents a WOE analysis with further discussion of the modeling for the area. The WOE analysis includes the following: An evaluation of ambient ozone trends; precursor emissions trends for the region (
                    <E T="03">i.e.,</E>
                     the South Coast Air Basin, San Joaquin Valley, and the WMD); an evaluation of diurnal ozone monitoring trends; and a conceptual model that describes the conditions that create the exceedances of the 2008 ozone NAAQS. These evaluations complement the photochemical modeling analysis for the area and show that the area's timely attainment is dependent on continuing future reductions from implementation of control measures in neighboring upwind nonattainment areas. The WOE analysis concludes that, based on these upwind reductions from neighboring nonattainment areas, the WMD will attain the 2008 ozone standard by 2026.
                    <SU>90</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>90</SU>
                         Appendix B, CARB Staff Report, B-30. The TSD for this action includes additional discussion of the modeled attainment demonstration and WOE analysis that support this conclusion.
                    </P>
                </FTNT>
                <P>
                    Finally, Appendix D of each of the Districts' Attainment Plans includes an unmonitored area analysis for the 2008 ozone NAAQS to assess the attainment status of locations other than monitoring sites. The unmonitored area analysis in the 2016 WMD Attainment Plan shows concentrations below the 2008 ozone NAAQS for all locations.
                    <SU>91</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>91</SU>
                         Figure 3: 2023 Predicted 8-hr Ozone Design Values, Appendix D, of both districts Attainment Plans.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">b. Control Strategy</HD>
                <P>
                    The control strategy for attainment of the 2008 ozone NAAQS in the WMD relies on timely attainment in 2023 of the 1997 ozone NAAQS in the upwind Los Angeles-South Coast Air Basin,
                    <SU>92</SU>
                    <FTREF/>
                     which is the same year the WMD model shows attainment. The attainment plan for the 2008 ozone NAAQS for the South Coast Air Basin, which has been previously approved by the EPA, projects a 277 tpd reduction in NO
                    <E T="52">X</E>
                     and a 121 tpd reduction in VOC from 2012 base year emissions (522 tpd for NO
                    <E T="52">X</E>
                     and 500 tpd for VOC).
                    <SU>93</SU>
                    <FTREF/>
                     In addition, the 2008 ozone attainment plan for the San Joaquin Valley, which has also been previously approved by the EPA, projects a 214.6 tpd reduction of NO
                    <E T="52">X</E>
                     and 34.4 tpd reduction of VOC in 2023, from 2012 base year emissions (339.6 tpd for NO
                    <E T="52">X</E>
                     and 337.3 tpd for VOC in 2011).
                    <SU>94</SU>
                    <FTREF/>
                     Both upwind areas continue to show emission reductions through 2026 and beyond.
                </P>
                <FTNT>
                    <P>
                        <SU>92</SU>
                         Appendix B, CARB Staff Report, B-2.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>93</SU>
                         Approval of Air Quality Implementation Plans; California; South Coast Air Basin; 1-Hour and 8-Hour Ozone Nonattainment Area Requirements, Proposed Rule, 84 FR 28132 (June 17, 2019). EPA finalized approval of the South Coast plan for the 2008 ozone NAAQS at 84 FR 52005 (October 1, 2019).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>94</SU>
                         Air Quality State Implementation Plans; Approvals and Promulgations: Clean Air Plans; 2008 8-Hour Ozone Nonattainment Area Requirements; San Joaquin Valley, California, Proposed Rule 83 FR 61346 (November 28, 2018). EPA finalized approval of the San Joaquin Valley plan for the 2008 ozone NAAQS at 84 FR 3302 (February 12, 2018).
                    </P>
                </FTNT>
                <P>
                    Within the WMD, the control strategy for attainment of the 2008 ozone NAAQS in the 2016 WMD Attainment Plan relies primarily on emissions reductions from baseline (
                    <E T="03">i.e.,</E>
                     already-adopted) measures. These baseline control measures include the Districts' stationary source rules,
                    <SU>95</SU>
                    <FTREF/>
                     and CARB's mobile source and consumer product rules adopted through 2016, as listed in Appendix F of the 2016 WMD Attainment Plan, “CARB Adopted Mobile Source Programs.” The attainment demonstration and base year emissions inventory use a 2012 base year (101.09 tpd of NO
                    <E T="52">X</E>
                     and 43.69 tpd of VOC), and consistent with 
                    <E T="03">South Coast II,</E>
                     the RFP demonstration relies on a 2011 baseline year.
                    <SU>96</SU>
                    <FTREF/>
                     The attainment year emissions estimate for the attainment demonstration is the same throughout the 2016 WMD Attainment Plan and 2018 SIP Update (68.5 tpd of NO
                    <E T="52">X</E>
                     and 40.5 tpd of VOC) and represents a 30.3 percent NO
                    <E T="52">X</E>
                     reduction and a 13.4 percent VOC reduction from the 2012 emissions inventory base year emissions.
                </P>
                <FTNT>
                    <P>
                        <SU>95</SU>
                         Technical Support Document: Clean Air Plans; 2008 8-Hour Ozone Nonattainment Area Requirements; West Mojave Desert, California, EPA-R09-OAR-2020-0254, Tables 1 and 2.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>96</SU>
                         The modeling base year emissions were taken from Table 1 and Appendix A of the AVAQMD and MDAQMD Attainment Plans. The CARB Staff Report notes 2012 base year emissions from the Districts' plans were average day emissions, 
                        <E T="03">i.e.,</E>
                         averaged over the entire year, rather than average summer day emissions, which are included in Appendix A of the CARB Staff Report and were submitted as the 2012 base year emissions.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">c. Attainment Demonstration</HD>
                <P>
                    Chapter 4 of the Districts' Attainment Plans describes the attainment demonstration in general terms, including photochemical modeling results. Chapter 4 references Appendix V of the SCAQMD 2016 AQMP, which provides information on the modeling protocol. Appendix D of the District's Attainment Plans contains model results and performance for the WMD. The WOE analysis in Appendix B to the CARB Staff Report includes additional supporting information to complement the photochemical modeling and to provide context for this attainment 
                    <PRTPAGE P="24819"/>
                    demonstration, such as ambient ozone data, a conceptual model of ozone formation, anthropogenic emission trends, ozone trends, and a discussion of the attainment projections. Baseline measures are expected to reduce 2012 base year emissions of NO
                    <E T="52">X</E>
                     by 30.7 percent and VOC emissions by 13 percent by 2026, and to attain the 2008 ozone NAAQS in the WMD by 2023, three years ahead of the outermost attainment year, 2026.
                </P>
                <HD SOURCE="HD3">3. The EPA's Review of the State's Submission</HD>
                <HD SOURCE="HD3">a. Photochemical Modeling</HD>
                <P>The EPA has reviewed the modeling platform and agrees that the CMAQ (version 5.0.2) modeling platform, and the WRF (version 3.6.1) meteorological fields are appropriate for the ozone attainment demonstration. After review, the EPA is satisfied that the meteorological model, WRF, performed adequately. The diurnal variation of temperature, humidity and surface wind are well represented by WRF. The EPA has also reviewed the time series, scatter plots, and ozone performance, and determined that overall, the CMAQ photochemical modeling performance for ozone is acceptable.</P>
                <P>We are proposing to find the air quality modeling adequate to support the attainment demonstrations for the 2008 ozone NAAQS, based on reasonable meteorological and ozone modeling performance, supported by the weight of evidence analyses.</P>
                <HD SOURCE="HD3">b. Control Strategy</HD>
                <P>
                    Based on our review of the emissions inventory documentation in the CARB Staff Report, we find that CARB and the Districts have used the most recent planning and activity assumptions, emissions models, and methodologies to estimate the effect of the control strategy on the baseline and milestone year emissions inventories. The 2016 WMD Attainment Plan relies on state and locally adopted baseline control measures, 
                    <E T="03">i.e.,</E>
                     already-adopted control measures, to achieve the emissions reductions needed to attain the 2008 ozone NAAQS. The baseline measures are approved into the SIP and, as such, are fully creditable within the attainment demonstration analysis. Accordingly, we propose to find that the emissions reductions that are relied on for attainment are creditable and sufficient to provide for attainment.
                </P>
                <HD SOURCE="HD3">c. Attainment Demonstration</HD>
                <P>Based on our review of the 2016 WMD Attainment Plan and our proposed findings that the photochemical modeling and control strategy are acceptable and demonstrate attainment by July 20, 2027, we propose to approve the attainment demonstration for the 2008 ozone NAAQS in the 2016 WMD Attainment Plan as meeting the requirements of CAA section 182(c)(2)(A) and 40 CFR 51.1108. The Districts' Attainment Plans and the WOE in the CARB Staff Report demonstrate that the ozone design value in the WMD will meet the 0.075 ppm standard by 2026, and therefore will meet the attainment date of July 20, 2027, for the 2008 ozone standard. While the submitted modeling projects that attainment is possible in advance of the 2026 deadline, the EPA is relying on the modeling, additional information provided in the WOE, and current ozone trends, to conclude that the WMD will attain the 2008 ozone NAAQS by 2026, consistent with the outermost attainment date of July 20, 2027. See the TSD for additional information.</P>
                <HD SOURCE="HD2">E. Rate of Progress Plan and Reasonable Further Progress Demonstration</HD>
                <HD SOURCE="HD3">1. Statutory and Regulatory Requirements</HD>
                <P>Requirements for RFP are specified in CAA sections 172(c)(2), 182(b)(1), and 182(c)(2)(B). CAA section 172(c)(2) requires that plans for nonattainment areas provide for RFP, which is defined at CAA section 171(1) as such annual incremental reductions in emissions of the relevant air pollutant as are required under part D, “Plan Requirements for Nonattainment Areas,” or may reasonably be required by the EPA for the purpose of ensuring attainment of the applicable NAAQS by the applicable date. CAA section 182(b)(1) specifically requires that ozone nonattainment areas that are classified as “Moderate” or above demonstrate a 15 percent reduction in VOC between the years of 1990 and 1996. The EPA has typically referred to section 182(b)(1) as the rate of progress (ROP) requirement. For ozone nonattainment areas classified as Serious or higher, section 182(c)(2)(B) requires reductions averaged over each consecutive 3-year period beginning 6 years after the baseline year until the attainment date of at least 3 percent of baseline emissions per year. CAA section 182(c)(2)(B)(ii) allows an amount less than 3 percent of such baseline emissions each year if the state demonstrates to the EPA that the plan includes all measures that can feasibly be implemented in the area in light of technological achievability.</P>
                <P>
                    The 2008 Ozone SRR considers areas classified Moderate or higher to have met the ROP requirements of CAA section 182(b)(1) if the area has a fully approved 15 percent ROP plan for the 1-hour or 1997 8-hour ozone standards, provided the boundaries of the ozone nonattainment areas are the same.
                    <SU>97</SU>
                    <FTREF/>
                     For such areas, the RFP requirements of CAA section 172(c)(2) require areas classified as Moderate to provide a 15 percent emission reduction of ozone precursors within 6 years of the baseline year. Areas classified as Serious or higher must meet the RFP requirements of CAA section 182(c)(2)(B) by providing an 18 percent reduction of ozone precursors in the first 6-year period, and an average ozone precursor emission reduction of 3 percent per year for all remaining 3-year periods thereafter.
                    <SU>98</SU>
                    <FTREF/>
                     Under CAA 182(c)(2)(C), a state may substitute NO
                    <E T="52">X</E>
                     emissions reductions for VOC emissions reductions.
                </P>
                <FTNT>
                    <P>
                        <SU>97</SU>
                         80 FR 12264, 12271 (March 6, 2015).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>98</SU>
                         Id.
                    </P>
                </FTNT>
                <P>
                    Except as specifically provided in CAA section 182(b)(1)(C), emission reductions from all SIP-approved, federally promulgated, or otherwise SIP-creditable measures that occur after the baseline are creditable for purposes of demonstrating that the RFP targets are met. Because the EPA has determined that the passage of time has caused the effect of certain exclusions to be 
                    <E T="03">de minimis,</E>
                     the RFP demonstration is no longer required to calculate and specifically exclude reductions from measures related to motor vehicle exhaust or evaporative emissions promulgated by January 1, 1990; regulations concerning Reid vapor pressure promulgated by November 15, 1990; measures to correct previous RACT requirements; and measures required to correct previous vehicle inspection and maintenance (I/M) programs.
                    <SU>99</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>99</SU>
                         40 CFR 51.1110(a)(7).
                    </P>
                </FTNT>
                <P>
                    The 2008 Ozone SRR requires the RFP baseline year to be the most recent calendar year for which a complete triennial inventory is required to be submitted to the EPA (
                    <E T="03">i.e.,</E>
                     2011). As discussed above, the 2008 Ozone SRR provided states with the opportunity to use an alternative baseline year for RFP,
                    <SU>100</SU>
                    <FTREF/>
                     but this provision was vacated by the D.C. Circuit in the 
                    <E T="03">South Coast II</E>
                     decision.
                </P>
                <FTNT>
                    <P>
                        <SU>100</SU>
                         40 CFR 51.1110(b).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Summary of the State's Submission</HD>
                <P>
                    The 2016 WMD Attainment Plan addresses the 15 percent ROP requirement by noting that the EPA had proposed approval of the 15 percent ROP plan for the 1997 ozone NAAQS for the WMD, and that the 1997 ozone nonattainment area covers the entire 
                    <PRTPAGE P="24820"/>
                    nonattainment area for the 2008 ozone standards.
                    <SU>101</SU>
                    <FTREF/>
                     The EPA approved the 15 percent ROP demonstration for the 1997 ozone NAAQS, effective July 24, 2017.
                    <SU>102</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>101</SU>
                         Chapter 3 of both Districts' Attainment Plans.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>102</SU>
                         82 FR 28560 (June 23, 2017).
                    </P>
                </FTNT>
                <P>
                    With respect to the RFP demonstration requirement, the 2016 WMD Attainment Plan includes an RFP demonstration derived from a 2012 RFP baseline year.
                    <SU>103</SU>
                    <FTREF/>
                     In response to the 
                    <E T="03">South Coast II</E>
                     decision, CARB developed the 2018 SIP Update, which includes a section that replaces the RFP portion of the 2016 WMD Attainment Plan with an updated RFP demonstration based on a 2011 RFP baseline year.
                    <SU>104</SU>
                    <FTREF/>
                     To develop the 2011 RFP baseline inventory, CARB relied on actual emissions reported from industrial point sources for year 2011. For emissions from smaller stationary sources and area sources, CARB backcast emissions from 2012 to 2011 using the same growth and control factors as were used for the 2016 WMD Attainment Plan. To develop the emissions inventories for the 2017, 2020 and 2023 RFP milestone years, CARB also relied upon the same growth and control factors as the 2016 WMD Attainment Plan. Therefore, the emissions estimates for the attainment year, 2026, are consistent in both the 2018 SIP Update and the 2016 WMD Attainment Plan.
                </P>
                <FTNT>
                    <P>
                        <SU>103</SU>
                         Chapter 3 of both Districts' Attainment Plans.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>104</SU>
                         Chapter VI of the 2018 SIP Update.
                    </P>
                </FTNT>
                <P>Documentation for the WMD RFP baseline and milestone emissions inventories is found in the 2018 SIP Update on pages 36-37 and in Appendix A of the 2018 SIP Update on pages A-19 through A-22. The RFP baseline emissions inventories reflect rules identified in Table 5 of the CARB Staff Report.</P>
                <P>
                    Table 2 provides a summary of CARB's emissions estimates in tpd for VOC and NO
                    <E T="52">X</E>
                     for the 2011 RFP baseline year, the 2017, 2020, 2023 RFP milestone years, and the 2026 RFP milestone/attainment year, evaluated relative to the percentage reductions necessary to demonstrate RFP.
                </P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s100,12,12,12,12,12">
                    <TTITLE>Table 2—WMD RFP Demonstration for the 2008 Ozone NAAQS </TTITLE>
                    <TDESC>[Summer planning inventory, tpd or percent]</TDESC>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1">2011</CHED>
                        <CHED H="1">2017</CHED>
                        <CHED H="1">2020</CHED>
                        <CHED H="1">2023</CHED>
                        <CHED H="1">2026</CHED>
                    </BOXHD>
                    <ROW EXPSTB="05" RUL="s">
                        <ENT I="21">
                            <E T="02">VOCs</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Baseline VOC</ENT>
                        <ENT>48.7</ENT>
                        <ENT>41.5</ENT>
                        <ENT>40.4</ENT>
                        <ENT>40.4</ENT>
                        <ENT>40.5</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Transportation conformity safety margin</ENT>
                        <ENT/>
                        <ENT>0</ENT>
                        <ENT>0</ENT>
                        <ENT>0</ENT>
                        <ENT>0.2</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Baseline VOC + safety margin</ENT>
                        <ENT>48.7</ENT>
                        <ENT>41.5</ENT>
                        <ENT>40.4</ENT>
                        <ENT>40.4</ENT>
                        <ENT>40.7</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Required % change since 2011</ENT>
                        <ENT/>
                        <ENT>18%</ENT>
                        <ENT>27%</ENT>
                        <ENT>36%</ENT>
                        <ENT>45%</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Target VOC level</ENT>
                        <ENT/>
                        <ENT>40.0</ENT>
                        <ENT>35.6</ENT>
                        <ENT>31.2</ENT>
                        <ENT>26.8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Apparent shortfall/surplus, tpd</ENT>
                        <ENT/>
                        <ENT>−1.5</ENT>
                        <ENT>−4.8</ENT>
                        <ENT>−9.2</ENT>
                        <ENT>−13.9</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Apparent shortfall ( − )/surplus ( + ) in VOC</ENT>
                        <ENT/>
                        <ENT>−3.1%</ENT>
                        <ENT>−9.9%</ENT>
                        <ENT>−18.8%</ENT>
                        <ENT>−28.4%</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            VOC shortfall previously provided by NO
                            <E T="0732">X</E>
                             substitution, %
                        </ENT>
                        <ENT/>
                        <ENT>0</ENT>
                        <ENT>3.1%</ENT>
                        <ENT>9.9%</ENT>
                        <ENT>18.8%</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Actual VOC shortfall ( − )/surplus ( + ), %</ENT>
                        <ENT/>
                        <ENT>−3.1%</ENT>
                        <ENT>−6.8%</ENT>
                        <ENT>−8.9%</ENT>
                        <ENT>−9.6%</ENT>
                    </ROW>
                    <ROW EXPSTB="05" RUL="s">
                        <ENT I="21">
                            <E T="02">NO</E>
                            <E T="0735">X</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">
                            Baseline NO
                            <E T="0732">X</E>
                        </ENT>
                        <ENT>98.4</ENT>
                        <ENT>84.5</ENT>
                        <ENT>79.8</ENT>
                        <ENT>72.1</ENT>
                        <ENT>68.5</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Transportation conformity safety margin</ENT>
                        <ENT>0</ENT>
                        <ENT>0</ENT>
                        <ENT>0</ENT>
                        <ENT>0</ENT>
                        <ENT>0.4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Baseline NO
                            <E T="0732">X</E>
                             + safety margin
                        </ENT>
                        <ENT>98.4</ENT>
                        <ENT>84.5</ENT>
                        <ENT>79.8</ENT>
                        <ENT>72.1</ENT>
                        <ENT>68.9</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Change in NO
                            <E T="0732">X</E>
                             since 2011, tpd
                        </ENT>
                        <ENT/>
                        <ENT>13.8</ENT>
                        <ENT>18.6</ENT>
                        <ENT>26.2</ENT>
                        <ENT>29.4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Change in NO
                            <E T="0732">X</E>
                             since 2011, %
                        </ENT>
                        <ENT/>
                        <ENT>14.1%</ENT>
                        <ENT>18.9%</ENT>
                        <ENT>26.7%</ENT>
                        <ENT>29.9%</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            NO
                            <E T="0732">X</E>
                             reductions used for VOC substitution through last milestone year, %
                        </ENT>
                        <ENT/>
                        <ENT>0</ENT>
                        <ENT>3.1%</ENT>
                        <ENT>9.9%</ENT>
                        <ENT>18.8%</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            NO
                            <E T="0732">X</E>
                             reductions since 2011 available for VOC substitution in this milestone year, %
                        </ENT>
                        <ENT/>
                        <ENT>14.1%</ENT>
                        <ENT>15.8%</ENT>
                        <ENT>16.7%</ENT>
                        <ENT>11.1%</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            NO
                            <E T="0732">X</E>
                             reductions since 2011 available for VOC substitution in this milestone year, %
                        </ENT>
                        <ENT/>
                        <ENT>3.1%</ENT>
                        <ENT>6.8%</ENT>
                        <ENT>8.9%</ENT>
                        <ENT>9.6%</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            NO
                            <E T="0732">X</E>
                             reductions since 2011 surplus after meeting VOC substitution needs in this milestone year, %
                        </ENT>
                        <ENT/>
                        <ENT>10.9%</ENT>
                        <ENT>9.0%</ENT>
                        <ENT>7.9%</ENT>
                        <ENT>1.5%</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Total shortfall for RFP</ENT>
                        <ENT/>
                        <ENT>0%</ENT>
                        <ENT>0%</ENT>
                        <ENT>0%</ENT>
                        <ENT>0%</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">RFP met?</ENT>
                        <ENT/>
                        <ENT>Yes</ENT>
                        <ENT>Yes</ENT>
                        <ENT>Yes</ENT>
                        <ENT>Yes</ENT>
                    </ROW>
                    <TNOTE>Source: Table VI-2, 2018 SIP Update.</TNOTE>
                </GPOTABLE>
                <P>
                    The revised RFP demonstration calculates future year VOC targets from the 2011 baseline, consistent with CAA 182(c)(2)(B)(i), which requires reductions of “at least 3 percent of baseline emissions each year,” and it substitutes NO
                    <E T="52">X</E>
                     reductions for VOC reductions beginning in milestone year 2017 to meet VOC emission targets. NO
                    <E T="52">X</E>
                     substitution is permitted under EPA regulations at 40 CFR 51.1110(a)(2)(i)(C) and 40 CFR 51.1110(a)(2)(ii)(B). As stated in the WOE in the CARB Staff Report, “given Western Mojave's downwind location from the only two extreme ozone nonattainment areas in the country, it is expected that ozone formation would be limited by available NO
                    <E T="52">X</E>
                     emissions,” meaning that NO
                    <E T="52">X</E>
                     reductions would be more effective at reducing ozone concentrations than VOC reductions. For the WMD, CARB concluded that the revised RFP demonstration meets the applicable requirements for each milestone year as well as the attainment year.
                </P>
                <HD SOURCE="HD3">3. The EPA's Review of the State's Submission</HD>
                <P>
                    Consistent with the 2008 Ozone SRR, the EPA's final approval of the 15 percent ROP demonstration for the 1997 ozone NAAQS fulfills the requirements of CAA section 182(b)(1) for WMD for the 2008 ozone NAAQS.
                    <SU>105</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>105</SU>
                         82 FR 13086 (March 9, 2017).
                    </P>
                </FTNT>
                <P>
                    With respect to the RFP demonstration requirement, based on 
                    <PRTPAGE P="24821"/>
                    our review of the emissions inventory documentation in the 2018 SIP Update, we find that CARB and the District have used the most recent planning and activity assumptions, emissions models, and methodologies in developing the RFP baseline and milestone year emissions inventories. We have also reviewed and verified the calculations in Table VI-3 of the 2018 SIP Update. Furthermore, we find that NO
                    <E T="52">X</E>
                     emission reductions are as effective as VOC emission reductions in reducing levels of ozone within the Western Mojave Desert.
                    <SU>106</SU>
                    <FTREF/>
                     For these reasons, we have determined that the 2018 SIP Update demonstrates RFP in the 2017, 2020, and 2023 milestone years as well as the 2026 milestone/attainment year, consistent with applicable CAA requirements and EPA guidance. Therefore, we propose to approve the RFP demonstration for the WMD for the 2008 ozone NAAQS under sections 172(c)(2) and 182(c)(2)(B) of the CAA and 40 CFR 51.1110(a)(2)(ii).
                </P>
                <FTNT>
                    <P>
                        <SU>106</SU>
                         Additional evaluation of this matter is discussed in Section V of the TSD supporting this notice.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">F. Transportation Control Strategies and Measures To Offset Emissions Increases From Vehicle Miles Traveled</HD>
                <HD SOURCE="HD3">1. Statutory and Regulatory Requirements</HD>
                <P>
                    Section 182(d)(1)(A) of the Act requires a state to submit a revision for each area classified as Serious or above that identifies and adopts specific enforceable transportation control strategies (TCSs) and transportation control measures (TCMs) to offset any growth in emissions from growth in vehicle miles traveled (VMT) or number of vehicle trips in such area.
                    <SU>107</SU>
                    <FTREF/>
                     Herein, we use “VMT” to refer to vehicle miles traveled and refer to the related SIP requirement as the “VMT emissions offset requirement.” In addition, we refer to the SIP revision intended to demonstrate compliance with the VMT emissions offset requirement as the “VMT emissions offset demonstration.”
                </P>
                <FTNT>
                    <P>
                        <SU>107</SU>
                         CAA section 182(d)(1)(A) includes three separate elements. In short, under section 182(d)(1)(A), states are required to adopt transportation control strategies and measures (1) to offset growth in emissions from growth in VMT, and, (2) in combination with other emission reduction requirements, to demonstrate RFP, and (3) to demonstrate attainment. For more information on the EPA's interpretation of the three elements of section 182(d)(1)(A), see 77 FR 58067, at 58068 (September 19, 2012) (proposed withdrawal of approval of South Coast VMT emissions offset demonstrations).
                    </P>
                </FTNT>
                <P>
                    In 
                    <E T="03">Association of Irritated Residents</E>
                     v. 
                    <E T="03">EPA,</E>
                     the United States Court of Appeals for the Ninth Circuit (“Ninth Circuit”) ruled that additional TCMs are required whenever vehicle emissions are projected to be higher than they would have been had VMT not increased, even when aggregate vehicle emissions are actually decreasing.
                    <SU>108</SU>
                    <FTREF/>
                     In response to the Ninth Circuit's decision, the EPA issued a memorandum titled “Guidance on Implementing Clean Air Act Section 182(d)(1)(A): Transportation Control Measures and Transportation Control Strategies to Offset Growth in Emissions Due to Growth in Vehicle Miles Travelled” (“August 2012 Guidance”).
                    <SU>109</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>108</SU>
                         
                        <E T="03">Association of Irritated Residents</E>
                         v. 
                        <E T="03">EPA,</E>
                         632 F.3d. 584, at 596-597 (9th Cir. 2011), reprinted as amended on January 27, 2012, 686 F.3d 668, further amended February 13, 2012 (“
                        <E T="03">Association of Irritated Residents”</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>109</SU>
                         Memorandum from Karl Simon, Director, Transportation and Climate Division, Office of Transportation and Air Quality, to Carl Edlund, Director, Multimedia Planning and Permitting Division, EPA Region VI, and Deborah Jordan, Director, Air Division, EPA Region IX, August 30, 2012.
                    </P>
                </FTNT>
                <P>
                    The August 2012 Guidance discusses the meaning of TCSs and TCMs and recommends that both TCSs and TCMs be included in the calculations made for the purpose of determining the degree to which any hypothetical growth in emissions due to growth in VMT should be offset. Generally, TCSs encompass many types of controls (including, for example, motor vehicle emissions limitations, I/M programs, alternative fuel programs, other technology-based measures, and TCMs) that would fit within the regulatory definition of “control strategy.” 
                    <SU>110</SU>
                    <FTREF/>
                     Such measures include, but are not limited to, those listed in CAA section 108(f). TCM is defined at 40 CFR 51.100(r) as meaning “any measure that is directed toward reducing emissions of air pollutants from transportation sources,” including, but not limited to, those listed in section 108(f) of the CAA. TCMs generally refer to programs intended to reduce VMT, the number of vehicle trips, or traffic congestion, including, 
                    <E T="03">e.g.,</E>
                     programs for improved public transit, designation of certain lanes for passenger buses and high-occupancy vehicles, and trip reduction ordinances.
                </P>
                <FTNT>
                    <P>
                        <SU>110</SU>
                         See, 
                        <E T="03">e.g.,</E>
                         40 CFR 51.100(n). TCMs are defined at 40 CFR 51.100(r) as meaning any measure that is directed toward reducing emissions of air pollutants from transportation sources.
                    </P>
                </FTNT>
                <P>The August 2012 Guidance explains how states may demonstrate that the VMT emissions offset requirement is satisfied in conformance with the Ninth Circuit's ruling. The August 2012 Guidance recommends that states estimate emissions for the nonattainment area's base year and attainment year. One emissions inventory is developed for the base year, and three different emissions inventory scenarios are developed for the attainment year. For the attainment year, the state would present three emissions estimates, two of which would represent hypothetical emissions scenarios that would provide the basis to identify the growth in emissions due solely to the growth in VMT, and one that would represent projected actual motor vehicle emissions after fully accounting for projected VMT growth and offsetting emissions reductions obtained by all creditable TCSs and TCMs. See the August 2012 Guidance for specific details on how states might conduct the calculations.</P>
                <P>The base year on-road VOC emissions should be calculated using VMT in that year and should reflect all enforceable TCSs and TCMs in place in the base year. This would include vehicle emissions standards, state and local control programs such as I/M programs or fuel rules, and any additional implemented TCSs and TCMs that were already required by or credited in the SIP as of that base year.</P>
                <P>The first of the emissions calculations for the attainment year would be based on the projected VMT and trips for that year and assume that no new TCSs or TCMs beyond those already credited in the base year inventory have been put in place since the base year. This calculation demonstrates how emissions would hypothetically change if no new TCSs or TCMs were implemented, and VMT and trips were allowed to grow at the projected rate from the base year. This estimate would show the potential for an increase in emissions due solely to growth in VMT and trips. This represents a “no action” scenario. Emissions in the attainment year in this scenario may be lower than those in the base year due to fleet turnover; however, if VMT and/or numbers of vehicle trips are projected to increase in the attainment year, emissions would still likely be higher than if VMT had held constant.</P>
                <P>
                    The second of the attainment year's emissions calculations would assume that no new TCSs or TCMs beyond those already credited have been put in place since the base year, but it would also assume that there was no growth in VMT and trips between the base year and attainment year. This estimate reflects the hypothetical emissions level that would have occurred if no further TCMs or TCSs had been put in place and if VMT and trip levels had held constant since the base year. Like the “no action” attainment year estimate described above, emissions in the attainment year may be lower than those in the base year due to fleet turnover, but in this case emissions would not be 
                    <PRTPAGE P="24822"/>
                    influenced by any growth in VMT or trips. This emissions estimate would reflect a ceiling on the attainment emissions that should be allowed to occur under the statute as interpreted by the Ninth Circuit because it shows what would happen under a scenario in which no offsetting TCSs or TCMs have yet been put in place and VMT and trips are held constant during the period from the area's base year to its attainment year. This represents a “VMT offset ceiling” scenario. These two hypothetical status quo estimates are necessary steps in identifying the target level of emissions from which states determine whether further TCMs or TCSs, beyond those that have been adopted and implemented in reality, would need to be adopted and implemented in order to fully offset any increase in emissions due solely to VMT and trips identified in the “no action” scenario.
                </P>
                <P>
                    Finally, the state would present the emissions that are actually expected to occur in the area's attainment year after taking into account reductions from all enforceable TCSs and TCMs put in place after the baseline year. This estimate would be based on the VMT and trip levels expected to occur in the attainment year (
                    <E T="03">i.e.,</E>
                     the VMT and trip levels from the first estimate) and all of the TCSs and TCMs expected to be in place and for which the SIP will take credit in the area's attainment year, including any TCMs and TCSs put in place since the base year. This represents the “projected actual” attainment year scenario. If this emissions estimate is less than or equal to the emissions ceiling that was established in the second of the attainment year calculations, the TCSs or TCMs for the attainment year would be sufficient to fully offset the identified hypothetical growth in emissions.
                </P>
                <P>Alternatively, if the estimated projected actual attainment year emissions are still greater than the ceiling that was established in the second of the attainment year emissions calculations, even after accounting for post-baseline year TCSs and TCMs, the state would need to adopt and implement additional TCSs or TCMs to further offset the growth in emissions. The additional TCSs or TCMs would need to bring the actual emissions down to at least the “had VMT and trips held constant” ceiling estimated in the second of the attainment year calculations, in order to meet the VMT offset requirement of section 182(d)(1)(A) as interpreted by the Ninth Circuit.</P>
                <HD SOURCE="HD3">2. Summary of the State's Submission</HD>
                <P>
                    The VMT emissions offset demonstration for the WMD for the 2008 ozone NAAQS is contained in Chapter 3 of the Districts' Attainment Plans.
                    <SU>111</SU>
                    <FTREF/>
                     For the VMT emissions offset demonstration, CARB used EMFAC2014, the latest EPA-approved motor vehicle emissions model for California available at the time the 2016 WMD Attainment Plan was developed.
                    <SU>112</SU>
                    <FTREF/>
                     The EMFAC2014 model estimates the on-road emissions from two combustion processes (
                    <E T="03">i.e.,</E>
                     running exhaust and start exhaust) and four evaporative processes (
                    <E T="03">i.e.,</E>
                     hot soak, running losses, diurnal losses, and resting losses). The EMFAC2014 model combines trip-based VMT data from the regional transportation planning agency (
                    <E T="03">i.e.,</E>
                     SCAG), starts data based on household travel surveys, and vehicle population data from the California Department of Motor Vehicles. These sets of data are combined with corresponding emission rates to calculate emissions.
                </P>
                <FTNT>
                    <P>
                        <SU>111</SU>
                         AVAQMD Attainment Plan, 23, and MDAQMD Attainment Plan, 25.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>112</SU>
                         On August 15, 2019, the EPA approved and announced the availability of EMFAC2017, the latest update to the EMFAC model for use by State and local governments to meet CAA requirements. See 84 FR 41717.
                    </P>
                </FTNT>
                <P>Emissions from running exhaust, start exhaust, hot soak, and running losses are a function of how much a vehicle is driven. Emissions from these processes are thus directly related to VMT and vehicle trips, and the analysis included these emissions in the calculations that provide the basis for the WMD VMT emissions offset demonstration. The analysis did not include emissions from resting loss and diurnal loss processes in the analysis because such emissions are related to vehicle population, not to VMT or vehicle trips, and thus are not part of “any growth in emissions from growth in vehicle miles traveled or numbers of vehicle trips in such area” under CAA section 182(d)(1)(A).  </P>
                <P>The WMD VMT emissions offset demonstration uses a 2012 base year. The base year for VMT emissions offset demonstration purposes should generally be the same base year used for nonattainment planning purposes. In section III.A of this document, the EPA is proposing to approve the 2012 base year inventory for the WMD for the purposes of the 2008 ozone NAAQS, and thus, the selection of 2012 as the base year for the WMD VMT emissions offset demonstration for the 2008 ozone NAAQS is appropriate.</P>
                <P>
                    The WMD VMT emissions offset demonstration also includes the previously described three different attainment year scenarios (
                    <E T="03">i.e.,</E>
                     no action, VMT offset ceiling, and projected actual). The 2016 WMD Attainment Plan provides a demonstration of attainment of the 2008 ozone NAAQS in the WMD by the applicable attainment date, based on the controlled 2026 emissions inventory. As described in section III.D of this document, the EPA is proposing to approve the attainment demonstration for the 2008 ozone NAAQS for the WMD, and thus, we find the selection of year 2026 as the attainment year for the VMT emissions offset demonstration for the 2008 ozone NAAQS to be acceptable.
                </P>
                <P>Table 3 summarizes the relevant distinguishing parameters for each of the emissions scenarios and shows CARB's corresponding VOC emissions estimates for the demonstration for the 2008 ozone NAAQS.</P>
                <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s25,12,12,12,12,12,12">
                    <TTITLE>Table 3—VMT Emissions Offset Inventory Scenarios and Results for 2008 Ozone NAAQS</TTITLE>
                    <BOXHD>
                        <CHED H="1">Scenario</CHED>
                        <CHED H="1">VMT</CHED>
                        <CHED H="2">Year</CHED>
                        <CHED H="2">1,000 miles/day</CHED>
                        <CHED H="1">Starts</CHED>
                        <CHED H="2">Year</CHED>
                        <CHED H="2">1,000/day</CHED>
                        <CHED H="1">Controls</CHED>
                        <CHED H="2">Year</CHED>
                        <CHED H="1">
                            VOC
                            <LI>emissions</LI>
                        </CHED>
                        <CHED H="2">Tpd</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Base Year</ENT>
                        <ENT>2012</ENT>
                        <ENT>26,536</ENT>
                        <ENT>2012</ENT>
                        <ENT>4,470</ENT>
                        <ENT>2012</ENT>
                        <ENT>12.4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">No Action</ENT>
                        <ENT>2026</ENT>
                        <ENT>34,724</ENT>
                        <ENT>2026</ENT>
                        <ENT>5,238</ENT>
                        <ENT>2012</ENT>
                        <ENT>6.5</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VMT Offset Ceiling</ENT>
                        <ENT>2012</ENT>
                        <ENT>26,536</ENT>
                        <ENT>2012</ENT>
                        <ENT>4,470</ENT>
                        <ENT>2012</ENT>
                        <ENT>5.3</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Actual Projected</ENT>
                        <ENT>2026</ENT>
                        <ENT>34,724</ENT>
                        <ENT>2026</ENT>
                        <ENT>5,238</ENT>
                        <ENT>2026</ENT>
                        <ENT>4.6</ENT>
                    </ROW>
                    <TNOTE>Source: AVAQMD Attainment Plan, 23-27, and MDAQMD Attainment Plan, 26-29.</TNOTE>
                </GPOTABLE>
                <PRTPAGE P="24823"/>
                <HD SOURCE="HD3">3. The EPA's Review of the State's Submission</HD>
                <P>Based on our review of the WMD VMT emissions offset demonstration in the 2016 WMD Attainment Plan, we find CARB's analysis to be consistent with our August 2012 Guidance and consistent with the emissions and vehicle activity estimates provided by CARB in support of the 2016 AQMP. We agree that the TCSs and TCMs in place for the area are sufficient to offset the growth in emissions from growth in VMT and vehicle trips in the WMD for the purposes of the 2008 8-hour ozone standards. As such, we find that the WMD VMT emissions offset demonstration complies with the VMT emissions offset requirement in CAA section 182(d)(1)(A). Therefore, we propose approval of the WMD VMT emissions offset demonstration portion of the 2016 WMD Attainment Plan.</P>
                <HD SOURCE="HD2">G. Contingency Measures</HD>
                <HD SOURCE="HD3">1. Statutory and Regulatory Requirements</HD>
                <P>
                    Under the CAA, SIPs for 8-hour ozone nonattainment areas classified under subpart 2 as Moderate or above must include contingency measures consistent with sections 172(c)(9) and 182(c)(9). Contingency measures are additional controls or measures to be implemented in the event an area fails to make RFP or to attain the NAAQS by the attainment date. The SIP should contain trigger mechanisms for the contingency measures, specify a schedule for implementation, and indicate that the measure will be implemented without significant further action by the state or the EPA.
                    <SU>113</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>113</SU>
                         70 FR 71612 (November 29, 2005). See also 2008 Ozone SRR, 80 FR 12264, 12285 (March 6, 2015).
                    </P>
                </FTNT>
                <P>
                    Neither the CAA nor the EPA's implementing regulations establish a specific level of emissions reductions that implementation of contingency measures must achieve, but the EPA's 2008 Ozone SRR reiterates the EPA's policy that contingency measures should generally provide for emissions reductions approximately equivalent to one year's worth progress, amounting to reductions of 3 percent of the baseline emissions inventory for the nonattainment area.
                    <SU>114</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>114</SU>
                         80 FR 12264, 12285 (March 6, 2015).
                    </P>
                </FTNT>
                <P>
                    It has been the EPA's longstanding interpretation of CAA section 172(c)(9) that states may meet the contingency measure requirement by relying on federal measures (
                    <E T="03">e.g.,</E>
                     federal mobile source measures based on the incremental turnover of the motor vehicle fleet each year) and local measures already scheduled for implementation that provide emissions reductions in excess of those needed to provide for RFP or expeditious attainment. The key is that the Act requires contingency measures to provide for additional emissions reductions that are not relied on for RFP or attainment and that are not included in the RFP or attainment demonstrations as meeting part or all of the contingency measure requirements. The purpose of contingency measures is to provide continued emissions reductions while a plan is being revised to meet the missed milestone or attainment date.
                </P>
                <P>
                    The EPA has approved numerous SIPs under this interpretation—
                    <E T="03">i.e.,</E>
                     SIPs that use as contingency measures one or more federal or local measures that are in place and provide reductions in excess of the reductions required by the attainment demonstration or RFP plan,
                    <SU>115</SU>
                    <FTREF/>
                     and there is case law supporting the EPA's interpretation in this regard.
                    <SU>116</SU>
                    <FTREF/>
                     However, in 
                    <E T="03">Bahr</E>
                     v. 
                    <E T="03">EPA,</E>
                     the Ninth Circuit rejected the EPA's interpretation of CAA section 172(c)(9) as allowing for early implementation of contingency measures.
                    <SU>117</SU>
                    <FTREF/>
                     The Ninth Circuit concluded that contingency measures must take effect at the time the area fails to make RFP or attain by the applicable attainment date, not before.
                    <SU>118</SU>
                    <FTREF/>
                     The D.C. Circuit recently reached a similar conclusion regarding the contingency measure provisions in CAA sections 172(c)(9) and 182(c)(9), in 
                    <E T="03">Sierra Club</E>
                     v. 
                    <E T="03">EPA.</E>
                    <SU>119</SU>
                    <FTREF/>
                     Following these decisions, states cannot rely on early-implemented measures to comply with the contingency measure requirements under CAA section 172(c)(9) and 182(c)(9).
                </P>
                <FTNT>
                    <P>
                        <SU>115</SU>
                         See, 
                        <E T="03">e.g.,</E>
                         62 FR 15844 (April 3, 1997) (direct final rule approving an Indiana ozone SIP revision); 62 FR 66279 (December 18, 1997) (final rule approving an Illinois ozone SIP revision); 66 FR 30811 (June 8, 2001) (direct final rule approving a Rhode Island ozone SIP revision); 66 FR 586 (January 3, 2001) (final rule approving District of Columbia, Maryland, and Virginia ozone SIP revisions); and 66 FR 634 (January 3, 2001) (final rule approving a Connecticut ozone SIP revision).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>116</SU>
                         See, 
                        <E T="03">e.g., LEAN</E>
                         v. 
                        <E T="03">EPA,</E>
                         382 F.3d 575 (5th Cir. 2004) (upholding contingency measures that were previously required and implemented where they were in excess of the attainment demonstration and RFP SIP).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>117</SU>
                         
                        <E T="03">Bahr</E>
                         v. 
                        <E T="03">EPA,</E>
                         836 F.3d at 1235-1237 (9th Cir. 2016) (“
                        <E T="03">Bahr</E>
                        ”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>118</SU>
                         Id. at 1235-1237.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>119</SU>
                         
                        <E T="03">Sierra Club</E>
                         v. 
                        <E T="03">EPA,</E>
                         985 F.3d 1055 (D.C. Cir. 2021) (“
                        <E T="03">Sierra Club</E>
                        ”).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Summary of the State's Submission</HD>
                <P>
                    The Districts and CARB had largely prepared the 2016 WMD Attainment Plan prior to the 
                    <E T="03">Bahr</E>
                     and 
                    <E T="03">Sierra Club</E>
                     decisions; therefore, the plan relies solely upon surplus emissions reductions from already implemented control measures in the RFP milestone years to demonstrate compliance with the RFP milestone contingency measures requirements of CAA sections 172(c)(9) and 182(c)(9).
                    <SU>120</SU>
                    <FTREF/>
                     The plan also demonstrates compliance with the attainment contingency measures requirements using surplus emissions reductions (in the year after the attainment year), and separately identifies use of the State's enhanced I/M program as an attainment contingency measure.
                    <SU>121</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>120</SU>
                         AQAQMD Attainment Plan, 20; MDAQMD Attainment Plan, 22.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>121</SU>
                         Id. AQAQMD Attainment Plan, 18; MDAQMD Attainment Plan, 20.
                    </P>
                </FTNT>
                <P>
                    In the 2018 SIP Update, CARB revised the RFP demonstration for the 2008 ozone NAAQS for the WMD and recalculated the extent of surplus emission reductions in the milestone years. Consistent with the 
                    <E T="03">Bahr</E>
                     decision (and the later 
                    <E T="03">Sierra Club</E>
                     decision), the 2018 SIP Update does not rely on the surplus or incremental emissions reductions to comply with the contingency measures requirements of sections 172(c)(9) and 182(c)(9) but instead documents the extent to which future baseline emissions would provide surplus emissions reductions beyond those required to meet applicable contingency measure requirements, to provide context for determining the magnitude of the contingency measures needed for the 2008 ozone NAAQS.
                </P>
                <P>
                    The 2018 SIP Update identifies one year's worth of RFP as approximately 1.5 tpd of VOC. The 2018 SIP Update estimates surplus NO
                    <E T="52">X</E>
                     reductions for RFP as ranging from approximately 10.7 tpd in 2017 to 7.8 tpd in 2023, and estimates that implementation of the state control measures will result in an additional 0.2 tpd VOC and 1.6 tpd of NO
                    <E T="52">X</E>
                     emissions reductions occuring in the year after the attainment year.
                    <SU>122</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>122</SU>
                         2018 SIP Update, Chapter VI, Tables VI-4, VI-5, and VI-6.
                    </P>
                </FTNT>
                <P>
                    In subsequent communications, CARB has clarified that the proposed contingency measure would involve implementation of enhanced I/M specifically in those areas of the WMD subject to MDAQMD jurisdiction that are currently subject only to basic I/M requirements.
                    <SU>123</SU>
                    <FTREF/>
                     As described by the MDAQMD, within 30 days of a finding by the EPA that the WMD has either failed to meet an RFP milestone for the 2008 ozone NAAQS or failed to attain the 2008 ozone NAAQS by the 
                    <PRTPAGE P="24824"/>
                    attainment deadline, the MDAQMD Executive Officer will transmit a formal letter to the California Bureau of Automotive Repair (BAR) requesting implementation of the enhanced I/M program throughout the entirety of the portion of the WMD that is subject to the District's jurisdiction. Upon receiving the District's letter, BAR would initiate the program and notify the relevant stakeholders of the updated requirements in the area. This procedure is described in section 44003(c) of the California Health and Safety Code, and no additional regulations would need to be adopted.
                    <SU>124</SU>
                    <FTREF/>
                     CARB estimates that implementation of the enhanced I/M program for this region will result in additional emissions reductions of 0.03 tpd of VOC and 0.04 tpd of NO
                    <E T="52">X</E>
                    .
                    <SU>125</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>123</SU>
                         Email dated November 20, 2020, from Ariel Fideldy (CARB) to Tom Kelly (EPA), Subject: West Mojave Desert Contingency Measures.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>124</SU>
                         Letter dated March 29, 2021, from Brad Poiriez, Executive Officer, MDAQMD, to Richard Corey, Executive Officer, CARB. The EPA approved California Health and Safety Code section 44003(c) into the California SIP at 75 FR 38023 (July 1, 2010).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>125</SU>
                         Letter dated April 9, 2021, from Michael Benjamin, Chief, Air Quality Planning and Science Division, CARB, to Deborah Jordan, Acting Regional Administrator, EPA Region IX. CARB indicates that these figures represent conservative estimates of the potential emissions reductions that would result from implementation of the contingency measure, because they are derived from residential populations that may underrepresent the actual vehicle populations located within the zip codes currently subject to basic I/M. See Attachment A to letter dated April 9, 2021, from Michael Benjamin, Chief, Air Quality Planning and Science Division, CARB, to Deborah Jordan, Acting Regional Administrator, EPA Region IX.
                    </P>
                </FTNT>
                <P>
                    The MDAQMD has committed to submit a Board resolution further detailing the circumstances, timing, and procedure for implementing this contingency measure, within eleven months of the EPA's final conditional approval of the contingency measures element of the 2016 WMD Attainment Plan.
                    <SU>126</SU>
                    <FTREF/>
                     CARB, in turn, has committed to submit the Board resolution to the EPA for SIP approval within 12 months of the EPA's final conditional approval.
                    <SU>127</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>126</SU>
                         Letter dated March 29, 2021, from Brad Poiriez, Executive Officer, MDAQMD, to Richard Corey, Executive Officer, CARB.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>127</SU>
                         Letter dated April 9, 2021, from Michael Benjamin, Chief, Air Quality Planning and Science Division, CARB, to Deborah Jordan, Acting Regional Administrator, EPA Region IX.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. The EPA's Review of the State's Submission</HD>
                <P>Sections 172(c)(9) and 182(c)(9) of the CAA require contingency measures to address potential failure to achieve RFP milestones or failure to attain the NAAQS by the applicable attainment date. To evaluate the contingency measure element of the 2016 WMD Attainment Plan, we find it useful to distinguish between contingency measures to address potential failure to achieve RFP milestones (“RFP contingency measures”) and contingency measures to address potential failure to attain the NAAQS (“attainment contingency measures”).</P>
                <P>With respect to the RFP contingency measure requirement, we have reviewed the surplus emissions estimates in each of the RFP milestone years, as shown in the 2018 SIP Update, and find that the calculations are correct. Therefore, we agree that the emission estimates from the 2018 SIP Update provide surplus reductions well beyond those necessary to demonstrate RFP in the RFP milestone years. While such surplus emissions reductions in the RFP milestone years do not represent contingency measures themselves, we believe they are relevant in evaluating the adequacy of RFP contingency measures that are submitted (or will be submitted) to meet the requirements of sections 172(c)(9) and 182(c)(9).</P>
                <P>
                    In this case, the MDAQMD and CARB have committed to develop, adopt, and submit a Board resolution further detailing the circumstances, timing, and procedure for implementing enhanced I/M requirements in the portion of the WMD that is currently subject to basic I/M, should the WMD fail to meet an RFP milestone. The specific commitment of the MDAQMD upon an RFP milestone failure (
                    <E T="03">i.e.,</E>
                     changing from basic to enhanced I/M) complies with the requirements in CAA sections 172(c)(9) and 182(c)(9) because it would be undertaken if the area fails to meet an RFP milestone and would take effect without further significant action by the District, the State, or the EPA.
                    <SU>128</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>128</SU>
                         Section 182(c)(3) of the CAA requires states with ozone nonattainment areas classified under subpart 2 as Serious or above to implement an enhanced motor vehicle I/M program in each urbanized area within the nonattainment area. Section 182(c)(3) further explains that urbanized areas are “defined by the Bureau of the Census, with a 1980 population of 200,000 or more.” Because parts of the MDAQMD within the WMD were not considered urbanized areas in 1980, only part of the WMD is subject to enhanced I/M. All of the area under the jurisdiction of the AVAQMD is subject to enhanced I/M.
                    </P>
                </FTNT>
                <P>
                    To assess the adequacy of the RFP contingency measure (once adopted and submitted), we next consider the magnitude of emissions reductions the measure would provide if triggered. Neither the CAA nor the EPA's implementing regulations for the ozone NAAQS establish a specific amount of emissions reductions that implementation of contingency measures must achieve, but we generally expect that contingency measures should provide for emissions reductions equivalent to approximately one year's worth of RFP, which, for ozone, amounts to reductions of 3 percent of the baseline emissions inventory for the nonattainment area. For the 2008 ozone NAAQS in the WMD, one year's worth of RFP is approximately 1.5 tpd of VOC, or 3.0 tpd of NO
                    <E T="52">X</E>
                     reductions, or a combination of the two calculated on a percentage basis.
                    <SU>129</SU>
                    <FTREF/>
                     In its commitment letter, CARB conservatively estimates the potential additional emissions reductions from the contingency measure commitments at 0.03 tpd of VOC and 0.04 tpd of NO
                    <E T="52">X</E>
                    . While these amounts collectively reflect less than one year's worth of RFP, the 2018 SIP Update provides the larger SIP planning context with which to judge the adequacy of the to-be-submitted District contingency measures, by calculating the surplus emissions reductions estimated to be achieved in the RFP milestone years. The estimates of surplus NO
                    <E T="52">X</E>
                     reductions range from 10.7 to 7.8 tpd, depending on the RFP year, which represents more than twice one year's worth of progress (3.0 tpd of NO
                    <E T="52">X</E>
                    ).
                    <SU>130</SU>
                    <FTREF/>
                     The surplus reflects already implemented regulations and is primarily the result of vehicle turnover, which refers to the ongoing replacement by individuals, companies, and government agencies of older, more polluting vehicles and engines with newer vehicles and engines. In light of these surplus NO
                    <E T="52">X</E>
                     emissions reductions in the RFP milestone years, the emissions reductions from the committed contingency measure are adequate to meet the contingency measure requirements of the CAA with respect to RFP milestones.
                </P>
                <FTNT>
                    <P>
                        <SU>129</SU>
                         The 2011 baseline for VOC and NO
                        <E T="52">X</E>
                         is 48.7 tpd and 98.4 tpd, respectively, as shown in table VI-1 of the 2018 SIP Update. Three percent of these baselines is 1.5 tpd of VOC and 3.0 tpd of NO
                        <E T="52">X</E>
                        .
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>130</SU>
                         2018 SIP Update, Table VI-5.
                    </P>
                </FTNT>
                <P>
                    For attainment contingency measure purposes, we evaluate the emissions reductions from the District's contingency measures in the context of the expected reduction in emissions within the WMD in the year following the attainment year, relative to those occurring in the attainment year. In 2027, VOC and NO
                    <E T="52">X</E>
                     emissions for the WMD are expected to be approximately 0.2 and 1.6 tpd, respectively, lower than the emissions in 2026. Considered together, the continuing reductions from already-implemented measures and the emissions reductions from the MDAQMD's contingency measure provide for emissions reductions near to, but below, one year's worth of progress.
                    <SU>131</SU>
                    <FTREF/>
                     Therefore, we find that the 
                    <PRTPAGE P="24825"/>
                    contingency measures described in the MDAQMD's and CARB's commitment letters would provide sufficient emissions reductions to satisfy the attainment contingency measures requirement, even though reductions from the measures would be lower than one year's worth of RFP.
                </P>
                <FTNT>
                    <P>
                        <SU>131</SU>
                         Combined reductions (0.23 tpd VOC and 1.64 tpd NO
                        <E T="52">X</E>
                        ) represent 70 percent of one year's RFP (15.3 percent of 1.5 tpd VOC; 54.7 percent of 3.0 
                        <PRTPAGE/>
                        tpd NO
                        <E T="52">X</E>
                        ). Further emissions reductions are projected to occur in upwind areas in the year following the attainment year (see, 
                        <E T="03">e.g.,</E>
                         2016 AQMP, Chapter 3), and we anticipate that these reductions will drive additional reductions in ozone concentrations in the WMD in this period, consistent with the strong influence of upwind emissions on nonattainment in the WMD.
                    </P>
                </FTNT>
                <P>For these reasons, we propose to conditionally approve the contingency measures element of the 2016 WMD attainment plan, as supplemented by the commitment from the MDAQMD and CARB to adopt and submit an MDAQMD Board resolution detailing the circumstances, timing, and procedure for implementing the contingency measure requirements of CAA sections 172(c)(9) and 182(c)(9). Our proposed approval is conditional because it relies upon specific commitments from MDAQMD and CARB. Conditional approvals are authorized under CAA section 110(k)(4).</P>
                <HD SOURCE="HD2">H. Motor Vehicle Emissions Budgets for Transportation Conformity</HD>
                <HD SOURCE="HD3">1. Statutory and Regulatory Requirements</HD>
                <P>Section 176(c) of the CAA requires federal actions in nonattainment and maintenance areas to conform to the SIP's goals of eliminating or reducing the severity and number of violations of the NAAQS and achieving expeditious attainment of the standards. Conformity to the SIP's goals means that such actions will not: (1) Cause or contribute to violations of a NAAQS, (2) worsen the severity of an existing violation, or (3) delay timely attainment of any NAAQS or any interim milestone.</P>
                <P>
                    Actions involving Federal Highway Administration (FHWA) or Federal Transit Administration (FTA) funding or approval are subject to the EPA's transportation conformity rule, codified at 40 CFR part 93, subpart A. Under this rule, metropolitan planning organizations (MPO) in nonattainment and maintenance areas coordinate with state and local air quality and transportation agencies, the EPA, the FHWA, and the FTA to demonstrate that an area's regional transportation plans and transportation improvement programs conform to the applicable SIP. This demonstration is typically done by showing that estimated emissions from existing and planned highway and transit systems are less than or equal to the motor vehicle emissions budgets (MVEBs or “budgets”) contained in all control strategy SIPs. Budgets are generally established for specific years and specific pollutants or precursors. Ozone plans should identify budgets for on-road emissions of ozone precursors (NO
                    <E T="52">X</E>
                     and VOC) in the area for each RFP milestone year and, if the plan demonstrates attainment, the attainment year.
                    <SU>132</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>132</SU>
                         40 CFR 93.102(b)(2)(i).
                    </P>
                </FTNT>
                <P>
                    For motor vehicle emissions budgets to be approvable, they must meet, at a minimum, the EPA's adequacy criteria (40 CFR 93.118(e)(4) and (5)) and be approvable under all pertinent SIP requirements. To meet these requirements, the MVEBs must be consistent with the approvable attainment and RFP demonstrations and reflect all of the motor vehicle control measures contained in the attainment and RFP demonstrations.
                    <SU>133</SU>
                    <FTREF/>
                     Budgets may include a safety margin representing the difference between projected emissions and the total amount of emissions estimated to satisfy any requirements for attainment or RFP.
                </P>
                <FTNT>
                    <P>
                        <SU>133</SU>
                         40 CFR 93.118(e)(4)(iii), (iv) and (v). For more information on the transportation conformity requirements and applicable policies on MVEBs, please visit our transportation conformity website at: 
                        <E T="03">http://www.epa.gov/otaq/stateresources/transconf/index.htm.</E>
                    </P>
                </FTNT>
                <P>
                    The EPA's process for determining adequacy of a MVEB consists of three basic steps: (1) Providing public notification of a SIP submission; (2) providing the public the opportunity to comment on the MVEB during a public comment period; and, (3) making a finding of adequacy or inadequacy.
                    <SU>134</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>134</SU>
                         40 CFR 93.118.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Summary of the State's Submission</HD>
                <P>
                    The 2016 WMD Attainment Plan includes budgets for the 2018, 2021, and 2024 RFP milestone years, and a 2026 attainment year. The budgets for 2018, 2021, and 2024 were derived from the 2012 RFP baseline year and the associated RFP milestone years. These budgets are affected by the 
                    <E T="03">South Coast II</E>
                     decision vacating the alternative baseline year provision, and therefore, the EPA has not previously acted on the budgets.
                </P>
                <P>
                    The 2018 SIP Update revised the RFP demonstration consistent with the 
                    <E T="03">South Coast II</E>
                     decision (
                    <E T="03">i.e.,</E>
                     by using a 2011 RFP baseline year) and identifies new budgets for the WMD for VOC and NO
                    <E T="52">X</E>
                     for each updated RFP milestone year through 2026. The budgets in the 2018 SIP Update replace the budgets contained in the 2016 WMD Attainment Plan. Like the budgets in the 2016 WMD Attainment Plan, the budgets in the 2018 SIP Update were calculated using EMFAC2014, the version of CARB's EMFAC model approved by the EPA for estimating emissions from on-road vehicles operating in California at the time the 2016 WMD Attainment Plan and 2018 SIP Update were developed. The budgets in the 2018 SIP Update reflect updated VMT estimates from SCAG's 2016-2040 Regional Transportation Plan/Sustainable Communities Strategy, Amendment 2, adopted in July 2017, and align with the emissions inventory, RFP and attainment demonstrations in the 2016 WMD Attainment Plan. Additionally, the budgets in the 2018 SIP Update are more precise because they are rounded up to the nearest tenth of a tpd, instead of the nearest whole number.
                    <SU>135</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>135</SU>
                         For instance, the 2016 WMD Attainment Plan estimates that 2026 on-road vehicle emissions (summer planning inventory) would be 7 tpd for VOC and 11 tpd for NO
                        <E T="52">X</E>
                        . See Appendix A, A-23 through A-26. The corresponding budgets from the 2018 SIP Update are 6.2 tpd for VOC and 10.2 tpd for NO
                        <E T="52">X</E>
                        . See Table VI-3 and surrounding discussion in Section V of the TSD for this action for additional detail.
                    </P>
                </FTNT>
                <P>
                    The conformity budgets for NO
                    <E T="52">X</E>
                     and VOC in the 2018 SIP Update for the WMD are provided in Table 4 below.
                </P>
                <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s50,12,12,12,12,12,12">
                    <TTITLE>Table 4—West Mojave Desert Motor Vehicle Emissions Budgets in the 2018 SIP Update</TTITLE>
                    <TDESC>
                        [tpd, average summer weekday] 
                        <E T="0731">a</E>
                    </TDESC>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1">2020</CHED>
                        <CHED H="2">VOC</CHED>
                        <CHED H="2">
                            NO
                            <E T="0732">X</E>
                        </CHED>
                        <CHED H="1">2023</CHED>
                        <CHED H="2">VOC</CHED>
                        <CHED H="2">
                            NO
                            <E T="0732">X</E>
                        </CHED>
                        <CHED H="1">2026</CHED>
                        <CHED H="2">VOC</CHED>
                        <CHED H="2">
                            NO
                            <E T="0732">X</E>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">On-Road Inventory</ENT>
                        <ENT>7.87</ENT>
                        <ENT>17.57</ENT>
                        <ENT>6.73</ENT>
                        <ENT>10.98</ENT>
                        <ENT>5.98</ENT>
                        <ENT>9.79</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">Safety Margin</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>0.2</ENT>
                        <ENT>0.4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT>7.87</ENT>
                        <ENT>17.57</ENT>
                        <ENT>6.73</ENT>
                        <ENT>10.98</ENT>
                        <ENT>6.18</ENT>
                        <ENT>10.19</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="24826"/>
                        <ENT I="01">
                            MVEBs 
                            <SU>b</SU>
                        </ENT>
                        <ENT>7.9</ENT>
                        <ENT>17.6</ENT>
                        <ENT>6.8</ENT>
                        <ENT>11.0</ENT>
                        <ENT>6.2</ENT>
                        <ENT>10.2</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>a</SU>
                         Source: Table VI-3 from the 2018 SIP Update.
                    </TNOTE>
                    <TNOTE>
                        <SU>b</SU>
                         Rounded up to the next tenth of a ton.
                    </TNOTE>
                </GPOTABLE>
                <P>
                    The submittal letters for both the 2016 WMD Attainment Plan and the 2018 SIP Update include a request from CARB that the EPA limit the duration of our approval of the budgets to last only until the effective date of future EPA adequacy findings for replacement budgets.
                    <SU>136</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>136</SU>
                         Letter dated April 9, 2021, from Michael Benjamin, Chief, Air Quality Planning and Science Division, CARB, to Deborah Jordan, Acting Regional Administrator, EPA Region IX, and letter dated December 5, 2018, from Richard Corey, Executive Officer, CARB, to Mike Stoker, Regional Administrator, EPA Region IX.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. The EPA's Review of the State's Submission</HD>
                <P>
                    As part of our review of the approvability of the budgets in the 2018 SIP Update, we have evaluated the budgets using our adequacy criteria in 40 CFR 93.118(e)(4) and (5). We will complete the adequacy review concurrently with our final action on the 2016 WMD Attainment Plan. The EPA is not required under its transportation conformity rule to find budgets adequate prior to proposing approval of them.
                    <SU>137</SU>
                    <FTREF/>
                     Today, the EPA is announcing that the adequacy process for these budgets begins and the public has 30 days to comment on their adequacy, per the transportation conformity regulation at 40 CFR 93.118(f)(2)(i) and (ii).
                </P>
                <FTNT>
                    <P>
                        <SU>137</SU>
                         Under the transportation conformity regulations, the EPA may review the adequacy of submitted motor vehicle emission budgets simultaneously with the EPA's approval or disapproval of the submitted implementation plan. 40 CFR 93.118(f)(2).
                    </P>
                </FTNT>
                <P>
                    As documented in Table 5 of section V of the EPA's TSD for this proposal, we preliminarily conclude that the budgets in the 2018 SIP Update for the West Mojave Desert meet each adequacy criterion. While adequacy and approval are two separate actions, reviewing the budgets in terms of the adequacy criteria informs the EPA's decision to propose to approve the budgets. We have completed our detailed review of the 2016 WMD Attainment Plan and the 2018 SIP Update, and we are proposing herein to approve the attainment and RFP demonstrations. We have also reviewed the budgets in the 2018 SIP Update and found that they are consistent with the attainment and RFP demonstrations for which we are proposing 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). Therefore, we are proposing to approve the 2023 and 2026 budgets in the 2018 SIP Update. At the point when we finalize our adequacy process or approve the budgets for the 2008 ozone NAAQS in the 2018 SIP Update as proposed (whichever occurs first; note that they could also occur concurrently per 40 CFR 93.118(f)(2)(iii)), then these budgets will replace the budgets that we previously found adequate for use in transportation conformity determinations.
                    <SU>138</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>138</SU>
                         We found adequate the budgets from the Antelope Valley-Western Mojave Desert 8-hour Ozone Early Progress Plan (February 2008) for the 1997 ozone NAAQS at 73 FR 24594 (May 5, 2008). The budgets in Table VI-3 of the 2018 SIP Update for the 2008 ozone NAAQS are lower than the corresponding budgets approved for the 1997 ozone NAAQS. The current budgets of 22 tpd for VOC and 77 tpd for NO
                        <E T="52">X</E>
                         for all years, would be replaced by budgets of 6.8 tpd for VOC and 11.0 tpd for NO
                        <E T="52">X</E>
                         in 2023 and 6.2 tpd for VOC and 10.2 tpd for NO
                        <E T="52">X</E>
                         in 2026.
                    </P>
                </FTNT>
                <P>
                    Under our transportation conformity rule, as a general matter, once budgets are approved, they cannot be superseded by revised budgets submitted for the same CAA purpose and the same year(s) addressed by the previously approved SIP submittal until the EPA approves the revised budgets as a SIP revision. In other words, as a general matter, such approved budgets cannot be superseded by revised budgets found adequate, but rather only through approval of the revised budgets, unless the EPA specifies otherwise in its approval of a SIP by limiting the duration of the approval to last only until subsequently submitted budgets are found adequate.
                    <SU>139</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>139</SU>
                         40 CFR 93.118(e)(1).
                    </P>
                </FTNT>
                <P>
                    In this instance, CARB's submittal letters transmitting the 2016 WMD Attainment Plan and 2018 SIP Update requested that we limit the duration of our approval to the effective date of an EPA adequacy finding for subsequently submitted budgets, and on April 9, 2021, CARB provided further explanation for its request. Generally, we will consider a state's request to limit an approval of a budget only if the request includes the following elements: 
                    <SU>140</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>140</SU>
                         67 FR 69139 (November 15, 2002) (final action limiting our prior approval of budgets in certain California SIPs).
                    </P>
                </FTNT>
                <P>• An acknowledgement and explanation as to why the budgets under consideration have become outdated or deficient;</P>
                <P>• A commitment to update the budgets as part of a comprehensive SIP update; and</P>
                <P>• A request that the EPA limit the duration of its approval to the time when new budgets have been found to be adequate for transportation conformity purposes.</P>
                <P>CARB's request includes an explanation for why the budgets have become, or will become, outdated or deficient. In short, CARB requested that we limit the duration of the approval of the budgets in light of the EPA's recent approval of EMFAC2017, an updated version of the EMFAC2014 model used for the budgets in the 2018 SIP Update. EMFAC2017 updates vehicle mix and emissions data of the previously approved version of the model, EMFAC2014.</P>
                <P>In light of the approval of EMFAC2017, CARB requests that the budgets from the 2016 WMD Attainment Plan, for which we are proposing approval in this action, will be revised using EMFAC2017 in 2022. CARB's request also states, “without the ability to replace the applicable transportation conformity emissions budgets with submitted budgets found adequate using the budget adequacy process, the benefits of using the updated data may not be realized for a year or more after the SIPs are submitted, due to the SIP approval process.”</P>
                <P>
                    We note that CARB has not committed to update the budgets as part of a comprehensive SIP update, but as a practical matter, CARB must submit a SIP revision that includes updated demonstrations as well as the updated budgets to meet the adequacy criteria in 
                    <PRTPAGE P="24827"/>
                    40 CFR 93.118(e)(4) for the 2015 ozone NAAQS in 2022,
                    <SU>141</SU>
                    <FTREF/>
                     and thus, we do not need a specific commitment for such a plan at this time. For the reasons provided above, and in light of CARB's explanation for why the budgets will become outdated and should be replaced upon an adequacy finding for updated budgets, we propose to limit the duration of our approval of the budgets in the 2018 SIP Update until we find revised budgets based on EMFAC2017 to be adequate.
                </P>
                <FTNT>
                    <P>
                        <SU>141</SU>
                         Under 40 CFR 93.118(e)(4), the EPA will not find a budget in a submitted SIP to be adequate unless, among other criteria, the budgets, when considered together with all other emissions sources, are consistent with applicable requirements for RFP and attainment. 40 CFR 93.118(e)(4)(iv).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">I. Other Clean Air Act Requirements Applicable to Severe Ozone Nonattainment Areas</HD>
                <P>In addition to the requirements discussed above, title 1, subpart D of the CAA includes other provisions applicable to Severe ozone nonattainment areas, such as the WMD. We describe these provisions and their current status below for informational purposes only.</P>
                <HD SOURCE="HD3">1. Enhanced Vehicle Inspection and Maintenance Programs</HD>
                <P>
                    Section 182(c)(3) of the CAA requires states with ozone nonattainment areas classified under subpart 2 as Serious or above to implement an enhanced motor vehicle I/M program in each urbanized area within the nonattainment area. As discussed in Section III.G.3 of this document, Section 182(c)(3) further explains that urbanized areas are “defined by the Bureau of the Census, with a 1980 population of 200,000 or more.” Because parts of the MDAQMD within the WMD were not considered urbanized areas in 1980, only part of the WMD is subject to enhanced I/M.
                    <SU>142</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>142</SU>
                         As described in section III.G.2 of this document, the State has committed to adopt a contingency measure to implement enhanced I/M throughout the portion of the WMD that is currently subject to basic I/M, in the event that the area fails to meet an RFP milestone or to attain the 2008 NAAQS by the attainment date.
                    </P>
                </FTNT>
                <P>
                    Consistent with the 2008 Ozone SRR, no new I/M programs are currently required for nonattainment areas for the 2008 ozone NAAQS.
                    <SU>143</SU>
                    <FTREF/>
                     The EPA previously approved the California I/M program in the West Mojave Desert as meeting the requirements of the CAA and applicable EPA regulations for enhanced I/M programs.
                    <SU>144</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>143</SU>
                         2008 Ozone SRR, 80 FR 12264, at 12283 (March 6, 2015). 
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>144</SU>
                         75 FR 38023 (July 1, 2010).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. New Source Review Rules</HD>
                <P>
                    Section 182(a)(2)(C) of the CAA requires states to develop SIP revisions containing permit programs for each of its ozone nonattainment areas. The SIP revisions are to include requirements for permits in accordance with CAA sections 172(c)(5) and 173 for the construction and operation of each new or modified major stationary source for VOC and NO
                    <E T="52">X</E>
                     anywhere in the nonattainment area.
                    <SU>145</SU>
                    <FTREF/>
                     The 2008 Ozone SRR includes provisions and guidance for nonattainment new source review (NSR) programs.
                    <SU>146</SU>
                    <FTREF/>
                     We will address the NSR requirements for the 2008 ozone NAAQS in the WMD in a separate action.
                </P>
                <FTNT>
                    <P>
                        <SU>145</SU>
                         See also CAA sections 182(e).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>146</SU>
                         80 FR 12264 (March 6, 2015).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. Clean Fuels Fleet Program</HD>
                <P>Sections 182(c)(4)(A) and 246 of the CAA require California to submit to the EPA for approval into the SIP measures to implement a Clean Fuels Fleet Program. Section 182(c)(4)(B) of the CAA allows states to opt out of the federal clean-fuel vehicle fleet program by submitting a SIP revision consisting of a program or programs that will result in at least equivalent long-term reductions in ozone precursors and toxic air emissions.</P>
                <P>
                    In 1994, CARB submitted a SIP revision to the EPA to opt out of the federal clean-fuel fleet program and included a demonstration that California's low-emissions vehicle program achieved emissions reductions at least as large as would be achieved by the federal program. The EPA approved the SIP revision to opt out of the federal program on August 27, 1999.
                    <SU>147</SU>
                    <FTREF/>
                     There have been no changes to the federal Clean Fuels Fleet program since the EPA approved the California SIP revision to opt out of the federal program, and thus, no corresponding changes to the SIP are required. Thus, we find that the California SIP revision to opt out of the federal program, as approved in 1999, meets the requirements of CAA sections 182(c)(4)(A) and 246 for the WMD for the 2008 ozone standards.
                </P>
                <FTNT>
                    <P>
                        <SU>147</SU>
                         64 FR 46849 (August 27, 1999).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">4. Gasoline Vapor Recovery</HD>
                <P>
                    Section 182(b)(3) of the CAA requires states to submit a SIP revision by November 15, 1992, that requires owners or operators of gasoline dispensing systems to install and operate gasoline vehicle refueling vapor recovery (“Stage II”) systems in ozone nonattainment areas classified as Moderate and above. California's ozone nonattainment areas implemented Stage II vapor recovery well before the passage of the CAA Amendments of 1990.
                    <SU>148</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>148</SU>
                         General Preamble, 57 FR 13498 at 13514 (April 16, 1992).
                    </P>
                </FTNT>
                <P>
                    Section 202(a)(6) of the CAA requires the EPA to promulgate standards requiring motor vehicles to be equipped with onboard refueling vapor recovery (ORVR) systems. The EPA promulgated the first set of ORVR system regulations in 1994 for phased implementation on vehicle manufacturers, and since the end of 2006, essentially all new gasoline-powered light- and medium-duty vehicles are ORVR-equipped.
                    <SU>149</SU>
                    <FTREF/>
                     Section 202(a)(6) also authorizes the EPA to waive the SIP requirement under CAA section 182(b)(3) for installation of Stage II vapor recovery systems after such time as the EPA determines that ORVR systems are in widespread use throughout the motor vehicle fleet. Effective May 16, 2012, the EPA waived the requirement of CAA section 182(b)(3) for Stage II vapor recovery systems in ozone nonattainment areas regardless of classification.
                    <SU>150</SU>
                    <FTREF/>
                     Thus, a SIP submittal meeting CAA section 182(b)(3) is not required for the 2008 ozone NAAQS.
                </P>
                <FTNT>
                    <P>
                        <SU>149</SU>
                         77 FR 28772, at 28774 (May 16, 2012).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>150</SU>
                         40 CFR 51.126(b).
                    </P>
                </FTNT>
                <P>
                    While a SIP submittal meeting CAA section 182(b)(3) is not required for the 2008 ozone NAAQS, under California state law (
                    <E T="03">i.e.,</E>
                     Health and Safety Code section 41954), CARB is required to adopt procedures and performance standards for controlling gasoline emissions from gasoline marketing operations, including transfer and storage operations. State law also authorizes CARB, in cooperation with local air districts, to certify vapor recovery systems, to identify defective equipment and to develop test methods. CARB has adopted numerous revisions to its vapor recovery program regulations and continues to rely on its vapor recovery program to achieve emissions reductions in ozone nonattainment areas in California.
                </P>
                <P>
                    In the WMD, the installation and operation of CARB-certified vapor recovery equipment is required and enforced through AVAQMD Rule 461, “Gasoline Transfer and Dispensing,” approved into the SIP on October 21, 2008, and MDAQMD Rule 461, “Gasoline Transfer and Dispensing,” approved into the SIP on May 1, 2020.
                    <SU>151</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>151</SU>
                         76 FR 5277 (January 31, 2011) and 85 FR 25293 (May 1, 2020).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">5. Enhanced Ambient Air Monitoring</HD>
                <P>
                    Section 182(c)(1) of the CAA requires that all ozone nonattainment areas 
                    <PRTPAGE P="24828"/>
                    classified as Serious or above implement measures to enhance and improve monitoring for ambient concentrations of ozone, NO
                    <E T="52">X</E>
                    , and VOC, and to improve monitoring of emissions of NO
                    <E T="52">X</E>
                     and VOC. The enhanced monitoring network for ozone is referred to as the photochemical assessment monitoring station (PAMS) network. The EPA promulgated final PAMS regulations on February 12, 1993.
                    <SU>152</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>152</SU>
                         58 FR 8452 (February 12, 1993).
                    </P>
                </FTNT>
                <P>
                    On November 10, 1993, CARB submitted to the EPA a SIP revision addressing the PAMS network for six ozone nonattainment areas in California, including the WMD, to meet the enhanced monitoring requirements of CAA section 182(c)(1). The EPA determined that the PAMS SIP revision met all applicable requirements for enhanced monitoring and the EPA PAMS regulations and approved the PAMS submittal into the California SIP.
                    <SU>153</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>153</SU>
                         82 FR 45191 (September 28, 2017). This action addressed 1-hour ozone nonattainment areas. The area identified as Southeast Desert Modified Air Quality Management Area for the 1-hour ozone NAAQS has been split into two separate nonattainment areas for the 1997 and 2008 ozone NAAQS, the WMD and Riverside County (Coachella Valley).
                    </P>
                </FTNT>
                <P>
                    Prior to 2006, the EPA's ambient air monitoring regulations in 40 CFR part 58, “Ambient Air Quality Surveillance,” set forth specific SIP requirements (see former 40 CFR 52.20). In 2006, the EPA significantly revised and reorganized 40 CFR part 58.
                    <SU>154</SU>
                    <FTREF/>
                     Under revised 40 CFR part 58, SIP revisions are no longer required; rather, compliance with EPA monitoring regulations is established through review of required annual monitoring network plans.
                    <SU>155</SU>
                    <FTREF/>
                     The 2008 Ozone SRR made no changes to these requirements.
                    <SU>156</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>154</SU>
                         71 FR 61236 (October 17, 2006).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>155</SU>
                         40 CFR 58.2(b) now provides that, “The requirements pertaining to provisions for an air quality surveillance system in the SIP are contained in this part.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>156</SU>
                         The 2008 ozone SRR addresses PAMS-related requirements at 80 FR 12264, 12291 (March 6, 2015).
                    </P>
                </FTNT>
                <P>
                    The 2016 WMD Attainment Plan does not specifically address the enhanced ambient air monitoring requirement in CAA section 182(c)(1). However, we note that CARB includes the ambient monitoring network within the WMD in its annual monitoring network plan that is submitted to the EPA, and that we have approved the most recent annual monitoring network plan (“Annual Network Plan Covering Monitoring Operations in 25 California Air Districts, July 2020” or “2018 ANP”), which includes the enhanced ambient air monitoring element for the WMD.
                    <SU>157</SU>
                    <FTREF/>
                     Based on our review and approval of the 2020 ANP with respect to the WMD and our earlier approval of the PAMS SIP revision, we propose to find that CARB, AVAQMD and MDAQMD meet the enhanced monitoring requirements under CAA section 182(c)(1) for the WMD with respect to the 2008 ozone NAAQS.
                </P>
                <FTNT>
                    <P>
                        <SU>157</SU>
                         The EPA approved the 2020 ANP in a letter dated November 5, 2020, from Gwen Yoshimura, Manager, Air Quality Analysis Office, EPA Region IX, to Ravi Ramalingam, Chief, Consumer Products and Air Quality Assessment Branch, Air Quality Planning and Science Division, CARB.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">6. CAA Section 185 Fee Program</HD>
                <P>
                    Section 185 of the CAA requires that the SIP for each Severe and Extreme ozone nonattainment area provide that, if the area fails to attain by its applicable attainment date, each major stationary source of VOC and NO
                    <E T="52">X</E>
                     located in the area shall pay a fee to the state as a penalty for such failure for each calendar year beginning after the attainment date, until the area is redesignated as an attainment area for ozone. States are not yet required to submit a SIP revision that meets the requirements of CAA section 185 for the 2008 ozone NAAQS.
                    <SU>158</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>158</SU>
                         See 40 CFR 51.1117. For the WMD, a section 185 SIP revision for the 2008 ozone standards will be due on July 20, 2022.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Proposed Action</HD>
                <P>For the reasons discussed in this notice, under CAA section 110(k)(3), the EPA is proposing to approve as a revision to the California SIP the following portions of the 2016 WMD Attainment Plan for the 2008 ozone NAAQS, submitted by CARB on June 2, 2017, and the 2018 SIP Update, submitted on December 11, 2018:</P>
                <P>• Base year emissions inventory element in the 2016 WMD Attainment Plan as meeting the requirements of CAA sections 172(c)(3) and 182(a)(1) and 40 CFR 51.1115;</P>
                <P>• Emissions statement element in the 2016 WMD Attainment Plan as meeting the requirements of CAA section 182(a)(3)(B) and 40 CFR 51.1102;</P>
                <P>• RACM demonstration element in the 2016 WMD Attainment Plan, as meeting the requirements of CAA section 172(c)(1) and 40 CFR 51.1112(c);</P>
                <P>• Attainment demonstration element in the 2016 WMD Attainment Plan as meeting the requirements of CAA section 182(c)(2)(A) and 40 CFR 51.1108;</P>
                <P>• RFP demonstration element in the 2018 SIP Update 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);</P>
                <P>• VMT emissions offset demonstration element in the 2016 WMD Attainment Plan as meeting the requirements of CAA section 182(d)(1)(A) and 40 CFR 51.1102; and</P>
                <P>• Motor vehicle emissions budgets in the 2018 SIP Update for the 2023 RFP milestone year and the 2026 attainment year (see Table 4 of this notice) because they are consistent with the RFP and attainment demonstrations proposed for approval herein and meet the other criteria in 40 CFR 93.118(e).</P>
                <P>We are also proposing to find that the:</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 with respect to the WMD;</P>
                <P>• Enhanced monitoring in the WMD meets the requirements of CAA section 182(c)(1) and 40 CFR 51.1102; and</P>
                <P>• Enhanced vehicle inspection and maintenance program element in the WMD meets the requirements of CAA section 182(c)(3) and 40 CFR 51.1102.</P>
                <P>Lastly, we are proposing, under CAA section 110(k)(4), to conditionally approve the contingency measure element of the 2016 WMD Attainment Plan as meeting the requirements of CAA sections 172(c)(9) and 182(c)(9) for RFP contingency measures. Our proposed approval is based on commitments by the District and CARB to supplement the element through submission, as a SIP revision (within one year of final conditional approval action), a MDAQMD Board resolution detailing the circumstances, timing, and procedure for implementing enhanced vehicle inspection and maintenance for areas within WMD currently subject to basic I/M, if an RFP milestone is not met or the area fails to attain the 2008 ozone NAAQS by the attainment date.</P>
                <P>The EPA is soliciting public comments on the issues discussed in this document. We will accept comments from the public on this proposal for the next 30 days and will consider comments before taking final action.</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 
                    <PRTPAGE P="24829"/>
                    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. 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, 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: May 4, 2021.</DATED>
                    <NAME>Deborah Jordan,</NAME>
                    <TITLE>Acting Regional Administrator, Region IX. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09842 Filed 5-7-21; 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-2021-0078; FRL-10022-86-Region 9]</DEPDOC>
                <SUBJECT>Finding of Failure To Attain the 2008 Lead and 2010 Sulfur Dioxide Standards; Arizona; Hayden and Miami 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 determine that the Hayden lead (Pb) nonattainment area (NAA) failed to attain the 2008 Pb primary and secondary national ambient air quality standards (NAAQS or “standards”) by the applicable attainment date of October 3, 2019. This proposed determination is based upon monitored air quality data from November 2015-December 2018 for the 2008 Pb NAAQS. The EPA is also proposing to determine that the Hayden and Miami sulfur dioxide (SO
                        <E T="52">2</E>
                        ) NAAs failed to attain the 2010 1-hour SO
                        <E T="52">2</E>
                         primary NAAQS by the applicable attainment date of October 4, 2018, based upon monitored air quality data from January 2015-December 2017. If the EPA finalizes these determinations as proposed, the State of Arizona will be required to submit revisions to the Arizona State Implementation Plan (SIP) that, among other elements, provide for expeditious attainment of the 2008 Pb and 2010 SO
                        <E T="52">2</E>
                         standards.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Any comments must arrive by June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by Docket ID No. EPA-R09-OAR-2021-0078 at 
                        <E T="03">http://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>
                        Ben Leers, Air Planning Office (AIR-2), EPA Region IX, (415) 947-4279, 
                        <E T="03">Leers.Benjamin@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. The 2008 Pb and 2010 SO
                        <E T="52">2</E>
                         National Ambient Air Quality Standards
                    </FP>
                    <FP SOURCE="FP1-2">
                        B. Designations, Classifications, and Attainment Dates for the 2008 Pb and 2010 SO
                        <E T="52">2</E>
                         National Ambient Air Quality Standards
                    </FP>
                    <FP SOURCE="FP-2">II. Proposed Determinations and Consequences</FP>
                    <FP SOURCE="FP1-2">A. Applicable Statutory and Regulatory Provisions</FP>
                    <FP SOURCE="FP1-2">B. Monitoring Network Considerations</FP>
                    <FP SOURCE="FP1-2">C. Data Considerations and Proposed Determination</FP>
                    <FP SOURCE="FP1-2">
                        D. Consequences for Pb and SO
                        <E T="52">2</E>
                         Nonattainment Areas Failing To Attain Standards by Attainment Dates
                    </FP>
                    <FP SOURCE="FP-2">III. Proposed Action and Request for Public Comment</FP>
                    <FP SOURCE="FP-2">IV. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Background</HD>
                <HD SOURCE="HD2">
                    A. The 2008 Pb and 2010 SO
                    <E T="54">2</E>
                     National Ambient Air Quality Standards
                </HD>
                <P>
                    Under section 109 of the Clean Air Act (CAA or “Act”), the EPA has established primary and secondary NAAQS for certain pervasive air pollutants (referred to as “criteria pollutants”) and conducts periodic reviews of the NAAQS to determine whether they should be revised or whether new NAAQS should be established. The primary NAAQS represent ambient air quality standards the attainment and maintenance of which the EPA has determined, including a margin of safety, are requisite to protect the public health. 
                    <PRTPAGE P="24830"/>
                    The secondary NAAQS represent ambient air quality standards the attainment and maintenance of which the EPA has determined are requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of such air pollutant in the ambient air.
                </P>
                <HD SOURCE="HD3">1. The 2008 Pb Standard</HD>
                <P>
                    Under the CAA, the EPA must establish NAAQS for criteria pollutants, including Pb. Pb is generally emitted in the form of particles that are deposited in water, soil, and dust. People may be exposed to Pb by inhaling it or by ingesting Pb-contaminated food, water, soil, or dust. Once in the body, Pb is quickly absorbed into the bloodstream and can result in a broad range of adverse health effects including damage to the central nervous system, cardiovascular function, kidneys, immune system, and red blood cells. Children are particularly vulnerable to Pb exposure, in part because they are more likely to ingest Pb and in part because their still-developing bodies are more sensitive to the effects of Pb. The harmful effects to children's developing nervous systems (including their brains) arising from Pb exposure may include intelligence quotient (IQ) 
                    <SU>1</SU>
                    <FTREF/>
                     loss, poor academic achievement, long-term learning disabilities, and an increased risk of delinquent behavior.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         IQ is a score created by dividing a person's mental age score, obtained by administering an intelligence test, by the person's chronological age, both expressed in terms of years and months. “Glossary of Important Assessment and Measurement Terms,” Philadelphia, PA: National Council on Measurement in Education. 2016.
                    </P>
                </FTNT>
                <P>
                    The EPA first established primary and secondary Pb standards in 1978 at 1.5 micrograms per cubic meter (µg/m
                    <SU>3</SU>
                    ) as a quarterly average.
                    <SU>2</SU>
                    <FTREF/>
                     Based on new health and scientific data, on October 15, 2008, the EPA revised the federal Pb standards to 0.15 µg/m
                    <SU>3</SU>
                     and revised the averaging time for the standards.
                    <SU>3</SU>
                    <FTREF/>
                     Since the primary and secondary Pb standards are the same, we refer to them hereafter in this document using the singular Pb standard or NAAQS. A violation of the 2008 Pb NAAQS occurs if any arithmetic 3-month mean concentration is greater than 0.15 µg/m
                    <SU>3</SU>
                    .
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         43 FR 46246 (October 5, 1978).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         73 FR 66964 (November 12, 2008).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         40 CFR 50.16.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">
                    2. The 2010 SO
                    <E T="52">2</E>
                     Standard
                </HD>
                <P>
                    Under the CAA, the EPA must also establish a NAAQS for SO
                    <E T="52">2</E>
                    . SO
                    <E T="52">2</E>
                     is primarily released to the atmosphere through the burning of fossil fuels by power plants and other industrial facilities. SO
                    <E T="52">2</E>
                     is also emitted from industrial processes including metal extraction from ore and heavy equipment that burn fuel with a high sulfur content. Short-term exposure to SO
                    <E T="52">2</E>
                     can damage the human respiratory system and increase breathing difficulties. Small children and people with respiratory conditions, such as asthma, are more sensitive to the effects of SO
                    <E T="52">2</E>
                    . Sulfur oxides at high concentrations can also react with compounds to form small particulates that can penetrate deeply into the lungs and cause health problems.
                </P>
                <P>
                    The EPA first established primary SO
                    <E T="52">2</E>
                     standards in 1971 at 0.14 parts per million (ppm) over a 24-hour averaging period and 0.3 ppm over an annual averaging period.
                    <SU>5</SU>
                    <FTREF/>
                     In June 2010, the EPA revised the NAAQS for SO
                    <E T="52">2</E>
                     to provide increased protection of public health, providing for revocation of the 1971 primary annual and 24-hour SO
                    <E T="52">2</E>
                     standards for most areas of the country following area designations under the new NAAQS.
                    <SU>6</SU>
                    <FTREF/>
                     The 2010 NAAQS is 75 parts per billion (ppb) (equivalent to 0.075 ppm) over a 1-hour averaging period.
                    <SU>7</SU>
                    <FTREF/>
                     A violation of the 2010 1-hour SO
                    <E T="52">2</E>
                     NAAQS occurs when the annual 99th percentile of ambient daily maximum 1-hour average SO
                    <E T="52">2</E>
                     concentrations, averaged over a 3-year period, exceeds 75 ppb.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         36 FR 8186 (April 30, 1971).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         40 CFR 50.4(e).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         75 FR 35520 (June 22, 2010).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         40 CFR 50.17.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">
                    B. Designations, Classifications, and Attainment Dates for the 2008 Pb and 2010 SO
                    <E T="54">2</E>
                     National Ambient Air Quality Standards
                </HD>
                <P>Following promulgation of any new or revised NAAQS, the EPA is required by CAA section 107(d) to designate areas throughout the nation as attaining or not attaining the NAAQS.</P>
                <HD SOURCE="HD3">1. Hayden 2008 Pb Nonattainment Area</HD>
                <P>
                    The initial designations for the 2008 Pb NAAQS were established in two rounds and were completed on November 22, 2010, and November 22, 2011.
                    <SU>9</SU>
                    <FTREF/>
                     The EPA initially designated the Hayden, Arizona area as unclassifiable due to insufficient monitoring data.
                    <SU>10</SU>
                    <FTREF/>
                     In June 2013, the EPA determined that quality assured, certified monitoring data collected in 2012 at the Arizona Department of Environmental Quality (ADEQ or “State”) Globe Highway monitor showed that the area was violating the Pb NAAQS. Accordingly, on May 2, 2014, the EPA proposed to redesignate the Hayden area to nonattainment for the 2008 Pb NAAQS, and on September 3, 2014, finalized the nonattainment designation, effective October 3, 2014.
                    <SU>11</SU>
                    <FTREF/>
                     Under CAA sections 172(a)(2) and 192(a), the attainment date for a Pb nonattainment area is the date by which attainment can be achieved as expeditiously as practicable, but no later than five years after the area is designated nonattainment. Therefore, the maximum attainment date for the Hayden Pb NAA is October 3, 2019.
                    <SU>12</SU>
                    <FTREF/>
                     The Hayden nonattainment area for the 2008 Pb NAAQS includes parts of Gila and Pinal counties.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         See 75 FR 71033 (November 22, 2010); 76 FR 72097 (November 22, 2011).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Arizona Department of Environmental Quality's Globe Highway monitor registered four violations of the Pb NAAQS in 2011; however, at the time of designation the data had not been quality assured and certified. Consequently, the EPA could not rely on those violations as a basis for a nonattainment designation.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         79 FR 52205 (September 3, 2014).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         ADEQ's “SIP Revision: Hayden Lead Nonattainment Area”(adopted on March 3, 2017), 18, describes “October 2019” as the attainment date for the area. Accordingly, in approving this SIP revision, 83 FR 56734 (November 14, 2018), the EPA established October 3, 2019 as the applicable attainment date for this area.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         For an exact description of the Hayden Pb NAA, refer to 40 CFR 81.303.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">
                    2. Hayden and Miami 2010 SO
                    <E T="52">2</E>
                     Nonattainment Areas
                </HD>
                <P>
                    On August 5, 2013, the EPA finalized its first round of designations for the 2010 primary SO
                    <E T="52">2</E>
                     NAAQS.
                    <SU>14</SU>
                    <FTREF/>
                     In the 2013 action, the EPA designated 29 areas in 16 states as nonattainment for the 2010 SO
                    <E T="52">2</E>
                     NAAQS, including the Hayden and Miami areas in Arizona. The Hayden SO
                    <E T="52">2</E>
                     NAA includes parts of Gila and Pinal counties and excludes the parts of Indian country located in the area. The Miami SO
                    <E T="52">2</E>
                     NAA includes parts of Gila County and excludes parts of Indian country within the area.
                    <SU>15</SU>
                    <FTREF/>
                     The EPA's initial round of designations for the 2010 SO
                    <E T="52">2</E>
                     NAAQS including the Hayden and Miami SO
                    <E T="52">2</E>
                     NAAs became effective on October 4, 2013. Pursuant to CAA sections 172(a)(2) and 192(a), the maximum attainment date for the Hayden and Miami SO
                    <E T="52">2</E>
                     NAAs is October 4, 2018, five years after the effective date of the final action designating each area as nonattainment for the 2010 SO
                    <E T="52">2</E>
                     NAAQS.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         78 FR 47191 (August 5, 2013).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         For exact descriptions of the Hayden and Miami SO
                        <E T="52">2</E>
                         NAAs, refer to 40 CFR 81.303.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Proposed Determination and Consequences</HD>
                <HD SOURCE="HD2">A. Applicable Statutory and Regulatory Provisions</HD>
                <P>
                    Section 179(c)(1) of the CAA requires the EPA to determine whether a nonattainment area attained an applicable standard by the applicable 
                    <PRTPAGE P="24831"/>
                    attainment date based on the area's air quality as of the attainment date.
                </P>
                <P>
                    A determination of whether an area's air quality meets applicable standards is generally based upon the most recent three years of complete, quality-assured data gathered at established state and local air monitoring stations (SLAMS) in a nonattainment area and entered into the EPA's Air Quality System (AQS) database.
                    <SU>16</SU>
                    <FTREF/>
                     Data from ambient air monitors operated by state and local agencies in compliance with the EPA monitoring requirements must be submitted to AQS.
                    <SU>17</SU>
                    <FTREF/>
                     Monitoring agencies annually certify that these data are accurate to the best of their knowledge.
                    <SU>18</SU>
                    <FTREF/>
                     All data are reviewed to determine the area's air quality status in accordance with 40 CFR part 50, Appendix R (for Pb) and Appendix T (for SO
                    <E T="52">2</E>
                    ).
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         AQS is the EPA's repository of ambient air quality data.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         40 CFR 58.16.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         40 CFR 58.15.
                    </P>
                </FTNT>
                <P>
                    We note that when determining the attainment status of SO
                    <E T="52">2</E>
                     nonattainment areas, in addition to ambient monitoring data, the EPA may also consider air quality dispersion modeling and/or a demonstration that the control strategy in the SIP has been fully implemented.
                    <SU>19</SU>
                    <FTREF/>
                     With regard to the use of monitoring data for such determinations, the EPA's 2014 SO
                    <E T="52">2</E>
                     Guidance specifically notes that “[i]f the EPA determines that the air quality monitors located in the affected area are located in the area of maximum concentration, the EPA may be able to use the data from these monitors to make the determination of attainment without the use of air quality modeling data.” 
                    <SU>20</SU>
                    <FTREF/>
                     This language might be read to suggest that the EPA must always assess whether the air quality monitors in the affected area are located in the area of maximum concentration prior to using monitoring data to determine an SO
                    <E T="52">2</E>
                     NAA's attainment status. However, this language was intended to refer to a situation where the EPA is considering making a determination that the area has attained the NAAQS based on a finding that all of the monitoring sites within the affected area had an attaining design value for the relevant period. As described in section II.C of this notice, in this instance, the monitoring sites in the Hayden and Miami SO
                    <E T="52">2</E>
                     NAAs did not have attaining design values for the relevant period. Consequently, even if the monitoring sites are not located in the area of maximum concentration, any monitors that would be located in the area of maximum concentration could not record concentrations lower than those recorded at the existing monitors at the Hayden and Miami sites. Accordingly, since the Hayden and Miami monitors are violating the NAAQS, it is not necessary to consider whether the monitors are located in the area of maximum concentration in order to determine that the Hayden and Miami SO
                    <E T="52">2</E>
                     NAAs did not attain the 2010 SO
                    <E T="52">2</E>
                     NAAQS by the October 4, 2018 attainment date. However, in any future assessment of whether these areas have attained the NAAQS, the EPA may assess whether the monitors are located in the area of maximum concentration and may also consider modeling and/or control implementation information, as appropriate.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         EPA, Guidance for 1-Hour SO
                        <E T="52">2</E>
                         Nonattainment Area SIP Submissions (April 2014) (“2014 SO
                        <E T="52">2</E>
                         Guidance”), 49.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         Id., 50.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">1. Interpretation of the 2008 Pb Standard</HD>
                <P>
                    Under EPA regulations in 40 CFR 50.16 and in accordance with 40 CFR part 50 Appendix R, the 2008 Pb standard is met when the design value is less than or equal to 0.15 µg/m
                    <SU>3</SU>
                     at each eligible monitoring site within the area. The Pb design value at each eligible monitoring site is the maximum valid 3-month arithmetic mean Pb concentration calculated over three years. The 3-month mean Pb concentrations are rounded to the nearest hundredth µg/m
                    <SU>3</SU>
                     for comparison to the NAAQS. Data completeness requirements for a given 3-month period are met if the average of the data capture rate of the three constituent monthly means is greater than or equal to 75 percent.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         See 40 CFR part 50, Appendix R sections (1)c, 4(c), and 5(b).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">
                    2. Interpretation of the 2010 SO
                    <E T="52">2</E>
                     Standard
                </HD>
                <P>
                    Under EPA regulations in 40 CFR 50.17 and in accordance with 40 CFR part 50 Appendix T, the 2010 1-hour annual SO
                    <E T="52">2</E>
                     standard is met when the design value is less than or equal to 75 ppb. Design values are calculated by computing the three-year average of the annual 99th percentile daily maximum 1-hour average concentrations.
                    <SU>22</SU>
                    <FTREF/>
                     When calculating 1-hour primary standard design values, the calculated design values are rounded to the nearest whole number or 1 ppb by convention. An SO
                    <E T="52">2</E>
                     1-hour primary standard design value is valid if it encompasses three consecutive calendar years of complete data. A year is considered complete when all four quarters are complete, and a quarter is complete when at least 75 percent of the sampling days are complete. A sampling day is considered complete if 75 percent of the hourly concentration values are reported; this includes data affected by exceptional events that have been approved for exclusion by the Administrator.
                    <SU>23</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         As defined in 40 CFR part 50, Appendix T section 1(c), daily maximum 1-hour values refer to the maximum 1-hour SO
                        <E T="52">2</E>
                         concentration values measured from midnight to midnight that are used in the NAAQS computations.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         See 40 CFR part 50, Appendix T sections 1(c), 3(b), 4(c), and 5(a).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Monitoring Network Considerations</HD>
                <P>Section 110(a)(2)(B)(i) of the CAA requires states to establish and operate air monitoring networks to compile data on ambient air quality for all criteria pollutants. The EPA's monitoring requirements are specified by regulation in 40 CFR part 58. These requirements are applicable to state, and where delegated, local air monitoring agencies that operate criteria pollutant monitors. The regulations in 40 CFR part 58 establish specific requirements for operating air quality surveillance networks to measure ambient concentrations of Pb, including requirements for measurement methods, network design, quality assurance procedures, and in the case of large urban areas, the minimum number of monitoring sites designated as SLAMS.</P>
                <P>
                    In sections 4.4 and 4.5 of Appendix D to 40 CFR part 58, the EPA specifies minimum monitoring requirements for Pb and SO
                    <E T="52">2</E>
                    , respectively, to operate at SLAMS. SLAMS produce data that are eligible for comparison with the NAAQS, and therefore, the monitor must be an approved federal reference method (FRM), federal equivalent method (FEM), or approved regional method (ARM) monitor.
                </P>
                <P>
                    The minimum number of required Pb SLAMS is described in section 4.5 of Appendix D to 40 CFR part 58. There must be at least one source-oriented SLAMS site located to measure the maximum Pb concentration in ambient air resulting from each non-airport Pb source that emits 0.50 or more tons per year (tpy) and from each airport that emits 1.0 tpy or more based on either the most recent National Emission Inventory (NEI) or other scientifically justifiable methods and data. According to the 2017 NEI, two non-airport sources in Gila County, Arizona exceeded the 0.50 tpy threshold and therefore required source-oriented Pb monitoring: The Asarco LLC Hayden Smelter and the Freeport-McMoRan Miami Smelter.
                    <SU>24</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Arizona facility-level Pb emissions data from the 2017 NEI may be accessed on the EPA NEI website at 
                        <E T="03">
                            https://www.epa.gov/air-emissions-
                            <PRTPAGE/>
                            inventories/2017-national-emissions-inventory-nei-data
                        </E>
                         and are included in our docket via an Excel spreadsheet.
                    </P>
                </FTNT>
                <PRTPAGE P="24832"/>
                <P>
                    The minimum number of required SO
                    <E T="52">2</E>
                     SLAMS is described in sections 4.4.2 and 4.4.3 of Appendix D to 40 CFR part 58. According to section 4.4.2, the minimum number of required SO
                    <E T="52">2</E>
                     monitoring sites is determined by the population weighted emissions index for each state's core based statistical area. Section 4.4.3 describes additional monitors that may be required by an EPA regional administrator.
                </P>
                <P>
                    Under 40 CFR 58.10, states are required to submit annual network plans (ANP) for ambient air monitoring networks for approval by the EPA. Within the Hayden Pb, Hayden SO
                    <E T="52">2</E>
                    , and Miami SO
                    <E T="52">2</E>
                     NAAs, ADEQ is responsible for assuring that each area meets air quality monitoring requirements. ADEQ submits annual monitoring network plans to the EPA that describe the various monitoring sites operated by ADEQ.
                    <SU>25</SU>
                    <FTREF/>
                     Each ANP discusses the status of the air monitoring network as required under 40 CFR 58.10 and addresses the operation and maintenance of the air monitoring network in the previous year. The EPA regularly reviews these ANPs for compliance with the applicable reporting requirements in 40 CFR part 58.
                    <SU>26</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         See, 
                        <E T="03">e.g.,</E>
                         “State of Arizona Air Monitoring Network Plan for the Year 2019.” Copies of Arizona's ANPs for 2016-2019 are included in the docket.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         See, 
                        <E T="03">e.g.,</E>
                         letter dated November 8, 2019, from Gwen Yoshimura, Manager, EPA Region IX, Air Quality Analysis Office, to Daniel Czecholinksi, Acting Director, Air Quality Division, ADEQ. Copies of EPA letters responding to Arizona's ANPs for 2016-2019 are included in the docket.
                    </P>
                </FTNT>
                <P>
                    The EPA also conducts regular “technical systems audits” (TSAs) during which we review and inspect ambient air monitoring programs to assess compliance with applicable regulations concerning the collection, analysis, validation, and reporting of ambient air quality data.
                    <SU>27</SU>
                    <FTREF/>
                     In our 2018 TSA of ADEQ, we concluded that ADEQ's ambient air monitoring network meets or exceeds the requirements for the minimum number of SLAMS for all criteria pollutants, including for Pb in the Hayden NAA and for SO
                    <E T="52">2</E>
                     in the Hayden and Miami NAAs.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         See 40 CFR part 58, appendix A, section 2.5.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         See letter dated April 25, 2019, from Elizabeth Adams, Director, Air Division, EPA Region IX, to Timothy Franquist, Director, Air Quality Division, ADEQ.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">1. Hayden Pb Monitoring Network</HD>
                <P>
                    ADEQ operated two Pb SLAMS during the November 2015-December 2018 data period within the Hayden Pb NAA: Globe Highway (AQS ID 04-007-1002) and Hillcrest (AQS ID 04-025-8104). The Globe Highway site is located along State Route 77 in Winkelman. The Hillcrest site, which began monitoring on January 1, 2016, is located at 123 S. Hillcrest Avenue in Hayden.
                    <SU>29</SU>
                    <FTREF/>
                     The primary and secondary monitors at each Pb monitoring site are FEM monitors.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Refer to Appendices C and D of the “State of Arizona Air Monitoring Network Plan For the Year 2019” (July 2019) for detailed descriptions and locations of each Pb monitor.
                    </P>
                </FTNT>
                <P>
                    Based on our review of ADEQ's ANPs for the years 2016-2019 
                    <SU>30</SU>
                    <FTREF/>
                     and the 2018 TSA of ADEQ's monitoring program, we propose to find that the monitoring network in the Hayden Pb NAA is adequate for the purpose of collecting ambient Pb concentration data for use in determining whether the Hayden Pb NAA attained the 2008 Pb NAAQS by the October 3, 2019 attainment date.
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         ADEQ's ANPs for 2016-2019 address the operation and maintenance of their air monitoring network for 2015-2018.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">
                    2. Hayden SO
                    <E T="52">2</E>
                     and Miami SO
                    <E T="52">2</E>
                     Monitoring Networks
                </HD>
                <P>
                    During the 2015-2017 data period, ADEQ operated one SO
                    <E T="52">2</E>
                     SLAMS in the Hayden SO
                    <E T="52">2</E>
                     NAA: Hayden Old Jail (AQS ID 04-007-1001); and three SO
                    <E T="52">2</E>
                     SLAMS in the Miami SO
                    <E T="52">2</E>
                     NAA: Miami Ridgeline (AQS ID 04-007-0009); Miami Jones Ranch (AQS ID 04-007-0011); and Miami Townsite (AQS ID 04-007-0012). The Hayden Old Jail site is located on Canyon Drive and Kennecott Avenue in Hayden. The three SO
                    <E T="52">2</E>
                     SLAMS in the Miami SO
                    <E T="52">2</E>
                     NAA are located in Miami. The Miami Ridgeline site is located on 4030 Linden Street; 
                    <SU>31</SU>
                    <FTREF/>
                     the Miami Jones Ranch site is located on Cherry Flats Road; and the Miami Townsite site is located on Sullivan Street and Davis Canyon Road. The primary monitors at each of these sites are FEM monitors.
                    <SU>21</SU>
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         The Miami Ridgeline site was closed on September 6, 2017, with EPA approval. Letter dated September 19, 2017, from Elizabeth Adams, Acting Director, Air Division, EPA Region IX, to Timothy S. Franquist, Director, Air Quality Division, ADEQ.
                    </P>
                </FTNT>
                <P>
                    Based on our review of ADEQ's ANPs for the years 2016-2018 
                    <SU>32</SU>
                    <FTREF/>
                     and the 2018 TSA of ADEQ's monitoring program, we propose to find that the monitoring networks in the Hayden SO
                    <E T="52">2</E>
                     and Miami SO
                    <E T="52">2</E>
                     NAAs are adequate for the purpose of collecting ambient SO
                    <E T="52">2</E>
                     concentration data for use in determining whether each nonattainment area attained the 2010 SO
                    <E T="52">2</E>
                     NAAQS by the October 4, 2018 attainment date.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         ADEQ's ANPs for 2016-2018 address the operation and maintenance of their air monitoring network for 2015-2017.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Data Considerations and Proposed Determination</HD>
                <P>
                    Under 40 CFR 58.15, monitoring agencies must certify, on an annual basis, data collected at all SLAMS and at all FRM, FEM, and ARM special purpose monitor stations that meet EPA quality assurance requirements. In doing so, monitoring agencies must certify that the previous year of ambient concentration and quality assurance data are completely submitted to AQS and that the ambient concentration data are accurate to the best of their knowledge. ADEQ annually certifies that the data it submits to AQS are quality assured, including data collected by ADEQ at monitoring sites in the Hayden Pb NAA, Hayden SO
                    <E T="52">2</E>
                     NAA, and Miami SO
                    <E T="52">2</E>
                     NAA.
                    <SU>33</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         See, 
                        <E T="03">e.g.,</E>
                         letter from Timothy S. Franquist, Director, Air Quality Division ADEQ, to Gwen Yoshimura, Manager, Air Quality Analysis Office, EPA Region IX, certifying calendar year 2018 ambient air quality data and quality assurance data, dated May 1, 2019. Copies of annual certification letters from 2016-2019 are included in the docket.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">1. Pb Data Considerations</HD>
                <P>
                    As noted in Section II.A of this notice, CAA section 179(c)(1) requires the EPA to determine whether a nonattainment area attained an applicable standard by the applicable attainment date, based on the area's air quality “as of the attainment date.” For the Hayden Pb NAA, for reasons discussed in Section I.B.1 of this notice, the applicable attainment date is October 3, 2019, with respect to the 2008 Pb NAAQS. In accordance with Appendix R to 40 CFR part 50, compliance with the Pb NAAQS is determined based on data from 36 consecutive valid 3-month periods (
                    <E T="03">i.e.,</E>
                     38 months, or a 3-year calendar period and the preceding November and December). Considering the applicable attainment date of October 3, 2019, for the 2008 Pb NAAQS, we must review the data collected in the Hayden Pb NAA from November 1, 2015-December 31, 2018. The Pb data collected in the Hayden Pb NAA from November 1, 2015-December 31, 2018 have been certified by ADEQ.
                    <SU>34</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         Id.
                    </P>
                </FTNT>
                <P>
                    We have also evaluated the completeness of these data in accordance with the requirements of 40 CFR part 50 Appendix R. As detailed in 40 CFR part 50 Appendix R section 4(c)(i), a 3-month mean Pb value is determined to be valid (
                    <E T="03">i.e.,</E>
                     meets data completeness requirements) if the average of the data capture rate of the three constituent monthly means is greater than or equal to 75 percent. The data collected by ADEQ at the Globe Highway monitoring site meet this 
                    <PRTPAGE P="24833"/>
                    completeness criterion for each 3-month period from November 2015-December 2018. The Hillcrest monitoring site began collecting data on January 1, 2016. Three full months of data are therefore not available for the 3-month periods from November 2015-January 2016 and December 2015-February 2016. The data collected by ADEQ at the Hillcrest monitoring site meet the Pb completeness criterion for each of the 34 available 3-month periods from January 2016-December 2018.
                    <SU>35</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         See footnote a to Table 1 of this document for a discussion of how we considered the data in these periods after initiation of the Hillcrest monitoring site.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Pb Data</HD>
                <P>
                    The Pb design values at both SLAMS within the Hayden Pb NAA for the relevant 36 consecutive 3-month periods beginning November 2015 through December 2018 are presented in Table 1 of this notice. Table 1 demonstrates that the Pb design values for the November 2015-December 2018 data period are greater than 0.15 µg/m
                    <SU>3</SU>
                     at the Globe Highway and Hillcrest monitoring sites.
                </P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,12">
                    <TTITLE>Table 1—2016-2018 Pb Design Values for the Hayden Pb Nonattainment Area</TTITLE>
                    <BOXHD>
                        <CHED H="1">Site (AQS ID)</CHED>
                        <CHED H="1">Highest 3-month rolling average</CHED>
                        <CHED H="2">2016</CHED>
                        <CHED H="2">2017</CHED>
                        <CHED H="2">2018</CHED>
                        <CHED H="1">
                            Pb design value
                            <LI>
                                (µg/m
                                <SU>3</SU>
                                )
                            </LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Globe Highway (04-007-1002)</ENT>
                        <ENT>0.14</ENT>
                        <ENT>0.21</ENT>
                        <ENT>0.15</ENT>
                        <ENT>0.21</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hillcrest (04-007-1003)</ENT>
                        <ENT>
                            <SU>a</SU>
                             0.31
                        </ENT>
                        <ENT>0.28</ENT>
                        <ENT>0.23</ENT>
                        <ENT>0.31</ENT>
                    </ROW>
                    <TNOTE>
                        <E T="02">Notes:</E>
                    </TNOTE>
                    <TNOTE>
                        <SU>a</SU>
                         Three full months of data are not available for the first two 3-month periods (
                        <E T="03">i.e.,</E>
                         November 2015-January 2016 and December 2015-February 2016) at the Hillcrest Monitoring site. However, based on the “above NAAQS level” test described in 40 CFR part 58, Appendix R, Section 4(c)(ii)(A), the February 2016 3-month rolling average of 0.31 ug/m
                        <SU>3</SU>
                         is considered valid.
                    </TNOTE>
                    <TNOTE>Source: EPA, Design Value Report, November 3, 2020.</TNOTE>
                </GPOTABLE>
                <P>
                    The 2018 annual design value site (
                    <E T="03">i.e.,</E>
                     the site with the highest design value based on November 2015-December 2018 data) is the Hillcrest site with a Pb design value of 0.31 µg/m
                    <SU>3</SU>
                    . Because the Hillcrest monitoring site began operation on January 1, 2016, three full months of monitoring data are not available for the 3-month periods from November 2015-January 2016 and December 2015-February 2016. The EPA applied the “above NAAQS level” test described in 40 CFR 50 Appendix R, Section 4(c)(ii)(A) to determine if the 3-month rolling average ending February 2016 could be considered valid. The 3-month period passed the diagnostic test described therein. Therefore, the February 2016 3-month rolling average of 0.31 µg/m
                    <SU>3</SU>
                     is considered valid.
                </P>
                <P>
                    For the area to attain the 2008 Pb NAAQS by October 3, 2019, the Pb design value reflecting data from November 2015-December 2018 at each eligible monitoring site must be equal to or less than 0.15 µg/m
                    <SU>3</SU>
                    . As shown in Table 1, the 2018 design values at both sites in the Hayden Pb NAA are greater than 0.15 µg/m
                    <SU>3</SU>
                    . Therefore, based on quality-assured and certified data for November 2015-December 2018, we are proposing to determine that the Hayden Pb NAA failed to attain the 2008 Pb standard by the October 3, 2019 attainment date.
                </P>
                <HD SOURCE="HD3">
                    3. SO
                    <E T="52">2</E>
                     Data Considerations
                </HD>
                <P>
                    For the Miami and Hayden SO
                    <E T="52">2</E>
                     NAAs, for reasons discussed in section I.B.2 of this notice, the applicable attainment date is October 4, 2018. In accordance with Appendix T to 40 CFR part 50, determinations of SO
                    <E T="52">2</E>
                     NAAQS compliance are based on three consecutive calendar years of data. To determine the air quality as of the attainment date in each nonattainment area, we must review the data collected during the three calendar years immediately preceding the attainment date for the Hayden and Miami SO
                    <E T="52">2</E>
                     NAAs, or January 1, 2015-December 31, 2017.
                </P>
                <P>
                    The SO
                    <E T="52">2</E>
                     data for the Hayden and Miami SO
                    <E T="52">2</E>
                     NAAs from January 1, 2015-December 31, 2017, have been certified by ADEQ. We have also evaluated the completeness of these data in accordance with the requirements of 40 CFR part 50, Appendix T. The data collected by ADEQ meet the quarterly completeness criterion for all 12 quarters in the three calendar years preceding the attainment date at the Hayden Old Jail and Miami Jones Ranch SO
                    <E T="52">2</E>
                     monitoring sites. The data collected by ADEQ in the three calendar years preceding the attainment date meet the quarterly completeness criteria for only 11 out of 12 quarters at the Miami Townsite SO
                    <E T="52">2</E>
                     monitor and 10 out of 12 quarters at the Miami Ridgeline SO
                    <E T="52">2</E>
                     monitor. The Miami Townsite SO
                    <E T="52">2</E>
                     monitor collected only three quarters of complete data in 2016 because a portion of the data collected in the 1st quarter of 2016 (January 2016-March 2016) was invalidated for not meeting quality assurance requirements. In 2017, the Miami Ridgeline monitor did not meet completeness criteria for the 2nd quarter (April 2017-June 2017) because a portion of data was not collected due to a collection error and machine malfunction, nor for the 4th quarter (October 2017-December 2017) because the site shut down on September 26, 2017.
                    <SU>36</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         See the March 22, 2021 AQS Raw Data Report for SO
                        <E T="52">2</E>
                         monitors in the Hayden and Miami SO
                        <E T="52">2</E>
                         NAAs showing hourly data from the Miami Townsite and Miami Ridgeline monitors throughout 2016 and 2017.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">
                    4. SO
                    <E T="52">2</E>
                     Data
                </HD>
                <P>
                    The 1-hour SO
                    <E T="52">2</E>
                     design values at each monitoring site within the Hayden and Miami SO
                    <E T="52">2</E>
                     NAAs for the 2015-2017 period are presented in Table 2. Table 2 demonstrates that the 1-hour SO
                    <E T="52">2</E>
                     design values for the 2015-2017 period are greater than 75 ppb at each eligible monitoring site.
                    <PRTPAGE P="24834"/>
                </P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,12,12,12,12,xs25">
                    <TTITLE>
                        Table 2—2015-2017 1-Hour Design Values for the Hayden and Miami SO
                        <E T="0732">2</E>
                         Nonattainment Areas
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">
                            Site
                            <LI>(AQS ID)</LI>
                        </CHED>
                        <CHED H="1">
                            Annual 99th percentile daily maximum 1-hour
                            <LI>average</LI>
                        </CHED>
                        <CHED H="2">2015</CHED>
                        <CHED H="2">2016</CHED>
                        <CHED H="2">2017</CHED>
                        <CHED H="1">
                            1-hour
                            <LI>design value</LI>
                            <LI>(ppb)</LI>
                        </CHED>
                        <CHED H="1">Design value valid?</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Hayden Old Jail (04-007-1001)</ENT>
                        <ENT>246</ENT>
                        <ENT>359</ENT>
                        <ENT>280</ENT>
                        <ENT>295</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Miami Ridgeline (04-007-0009)</ENT>
                        <ENT>171</ENT>
                        <ENT>120</ENT>
                        <ENT>
                            <SU>a</SU>
                             99
                        </ENT>
                        <ENT>130</ENT>
                        <ENT>No.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Miami Townsite (04-007-0012)</ENT>
                        <ENT>231</ENT>
                        <ENT>
                            <SU>b</SU>
                             110
                        </ENT>
                        <ENT>135</ENT>
                        <ENT>159</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Miami Jones Ranch (04-007-0011)</ENT>
                        <ENT>242</ENT>
                        <ENT>150</ENT>
                        <ENT>270</ENT>
                        <ENT>221</ENT>
                        <ENT>Yes.</ENT>
                    </ROW>
                    <TNOTE>
                        <E T="02">Notes:</E>
                    </TNOTE>
                    <TNOTE>
                        <SU>a</SU>
                         The Miami Ridgeline monitor failed to meet completeness criteria for the 2nd quarter of 2017 (April 2017-June 2017) and for the 4th quarter of 2017 (October 2017-December 2017).
                    </TNOTE>
                    <TNOTE>
                        <SU>b</SU>
                         The Miami Townsite monitor had only three quarters of complete data in 2016 because a portion of the data collected in the 1st quarter of 2016 was invalidated for not meeting quality assurance requirements.
                    </TNOTE>
                    <TNOTE>
                        <E T="02">Source:</E>
                         EPA, Design Value Report, November 30, 2020.
                    </TNOTE>
                </GPOTABLE>
                <P>
                    The data in Table 2 demonstrate that one site in the Hayden SO
                    <E T="52">2</E>
                     NAA and two sites in the Miami SO
                    <E T="52">2</E>
                     NAA failed to attain the 2010 1-hour SO
                    <E T="52">2</E>
                     NAAQS by the applicable attainment date of October 4, 2018, while a third site in the Miami NAA, the Ridgeline monitor, did not have a valid design value for this period. Though the annual 99th percentile daily maximum 1-hour average at the Miami Townsite monitor did not meet applicable completeness criteria for all three years in the 2015-2017 data period, the 3-year design value for Miami Townsite was deemed valid due to meeting the criteria in 40 CFR part 50 Appendix T, section 3(c)(i), which requires that “at least 75 percent of the days in each quarter of each of three consecutive years have at least one reported hourly value, and the design value calculated according to the procedures specified in section 5 is above the level of the primary 1-hour standard.” The 3-year design value for Miami Ridgeline is not considered valid because the site did not meet the conditions in 40 CFR part 50 Appendix T, section 3(c)(i), (ii), or (iii) to allow for incomplete design values to be considered valid.
                </P>
                <P>
                    The annual design value site in each NAA is the site with the highest design value based on 2015-2017 data. In the Hayden SO
                    <E T="52">2</E>
                     NAA, the annual design value site is the Hayden Old Jail site with a 1-hour SO
                    <E T="52">2</E>
                     design value of 295 ppb. In the Miami SO
                    <E T="52">2</E>
                     NAA, the annual design value site is the Miami Jones Ranch site with a 1-hour SO
                    <E T="52">2</E>
                     design value of 221 ppb.
                </P>
                <P>
                    For an area to attain the 2010 SO
                    <E T="52">2</E>
                     NAAQS by the October 4, 2018 attainment date, the design value based upon monitored air quality data from 2015-2017 at each eligible monitoring site must be equal to or less than 75 ppb for the 1-hour standard. Table 2 shows that the design values at each monitoring site in the Hayden and Miami SO
                    <E T="52">2</E>
                     NAAs exceed 75 ppb. Therefore, based on quality-assured and certified data for the 2015-2017 data period, we are proposing to determine that both the Hayden SO
                    <E T="52">2</E>
                     NAA and Miami SO
                    <E T="52">2</E>
                     NAA failed to attain the 2010 1-hour SO
                    <E T="52">2</E>
                     standard by the October 4, 2018 attainment date.
                </P>
                <HD SOURCE="HD2">
                    D. Consequences for Pb and SO
                    <E T="54">2</E>
                     Nonattainment Areas Failing To Attain Standards by Attainment Dates
                </HD>
                <P>
                    The consequences for Pb and SO
                    <E T="52">2</E>
                     nonattainment areas for failing to attain the standards by the applicable attainment date are set forth in CAA section 179(d). Under section 179(d), a state must submit a SIP revision for the area meeting the requirements of CAA sections 110 and 172, the latter of which requires, among other elements, a demonstration of attainment and reasonable further progress and contingency measures. In addition, under CAA section 179(d)(2), the SIP revision must include such additional measures as the EPA may reasonably prescribe, including all measures that can be feasibly implemented in the area in light of technological achievability, costs, and any non-air quality and other air quality-related health and environmental impacts. In this case, the dominant source of Pb and SO
                    <E T="52">2</E>
                     emissions in the Hayden Pb and SO
                    <E T="52">2</E>
                     NAAs is the Asarco Hayden Smelter, and the dominant source of SO
                    <E T="52">2</E>
                     emissions in the Miami SO
                    <E T="52">2</E>
                     NAA is the Freeport-McMoRan Miami Smelter. Due to the unique nature of these two facilities, which are the only two batch-process primary copper smelters in the country, we do not have adequate information to propose specific additional controls at this time. However, we are seeking comment on what additional measures could be feasibly implemented at these facilities in light of technological achievability, costs, and any non-air quality and other air quality-related health and environmental impacts. We also expect that information concerning such potential additional control measures would be collected by ADEQ as part of its development of SIP revisions to address the requirements that would be triggered by a final finding of failure to attain for these areas.
                </P>
                <P>
                    The state is required to submit the SIP revision within one year after the EPA publishes a final action in the 
                    <E T="04">Federal Registe</E>
                    r determining that the nonattainment area failed to attain the applicable Pb or SO
                    <E T="52">2</E>
                     standard. We note that on November 10, 2020, the EPA published an action partially disapproving the 2010 SO
                    <E T="52">2</E>
                     attainment plan for the Hayden nonattainment area.
                    <SU>37</SU>
                    <FTREF/>
                     Although a final finding of failure to attain will not eliminate the state's obligation to address the disapproved elements of its prior plan submittal, the EPA anticipates that Arizona's submission of a new, approvable attainment plan in response to this finding would also satisfy these obligations.
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         85 FR 71547.
                    </P>
                </FTNT>
                <P>In addition to triggering requirements for a new SIP submittal, a final determination that a nonattainment area failed to attain the NAAQS by the attainment date would trigger the implementation of contingency measures adopted under 172(c)(9).</P>
                <P>
                    Under CAA sections 179(d)(3) and 172(a)(2), the new attainment date for each nonattainment area is the date by which attainment can be achieved as expeditiously as practicable, but no later than five years after the EPA publishes a final action in the 
                    <E T="04">Federal Register</E>
                     determining that the nonattainment area failed to attain the applicable Pb or SO
                    <E T="52">2</E>
                     standard.
                    <SU>38</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         Pursuant to CAA sections 172(a)(2)(D) and 192(a), the attainment date extension provision under section 172(a)(2)(A) does not apply to the Pb or SO
                        <E T="52">2</E>
                         NAAQS.
                    </P>
                </FTNT>
                <PRTPAGE P="24835"/>
                <HD SOURCE="HD1">III. Proposed Action and Request for Public Comment</HD>
                <P>
                    Under CAA section 179(c)(1), the EPA proposes to determine that the Hayden Pb NAA failed to attain the 2008 Pb standard by the applicable attainment date of October 3, 2019. Under CAA section 179(c)(1), the EPA also proposes to determine that the Hayden SO
                    <E T="52">2</E>
                     NAA and the Miami SO
                    <E T="52">2</E>
                     NAA failed to attain the 2010 1-hour SO
                    <E T="52">2</E>
                     standard by the applicable attainment date of October 4, 2018. If finalized as proposed, the State of Arizona would be required under CAA section 179(d) to submit revisions to the SIP for the Hayden Pb NAA, Hayden SO
                    <E T="52">2</E>
                     NAA, and Miami SO
                    <E T="52">2</E>
                     NAA. The required SIP revision for each area must, among other elements, demonstrate expeditious attainment of the standards within the time period prescribed by CAA section 179(d). If finalized as proposed, the SIP revisions required under CAA section 179(d) would be due for submittal to the EPA no later than one year after the publication date of the final action.
                </P>
                <P>The EPA is soliciting public comments on the issues discussed in this notice. We will accept comments from the public on this proposal for the next 30 days. We will consider these comments before taking final action.</P>
                <HD SOURCE="HD1">IV. Statutory and Executive Order Reviews</HD>
                <P>
                    Additional information about these statutes and Executive Orders can be found at 
                    <E T="03">http://www2.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 therefore was not submitted to the Office of Management and Budget (OMB) for review.</P>
                <HD SOURCE="HD2">B. Paperwork Reduction Act (PRA)</HD>
                <P>This action does not impose an information collection burden under the provisions of the PRA because it does not contain any information collection activities.</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. This proposed action, if finalized, would require the state to adopt and submit SIP revisions to satisfy CAA requirements and would not itself directly regulate any small entities.</P>
                <HD SOURCE="HD2">D. Unfunded Mandates Reform Act (UMRA)</HD>
                <P>
                    This action does not contain any 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. This action itself imposes no enforceable duty on any state, local, or tribal governments, or the private sector. This action proposes to determine that the Hayden Pb NAA and the Hayden and Miami SO
                    <E T="52">2</E>
                     NAAs failed to attain the NAAQS by the applicable attainment dates. If finalized, this determination would trigger existing statutory timeframes for the State to submit SIP revisions. Such a determination in and of itself does not impose any federal intergovernmental mandate.
                </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. The proposed finding of failure to attain the Pb and SO
                    <E T="52">2</E>
                     NAAQS does not apply to tribal areas, and the proposed rule would not impose a burden on Indian reservation lands or other areas where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction within the Hayden Pb, Hayden SO
                    <E T="52">2</E>
                     and Miami SO
                    <E T="52">2</E>
                     nonattainment areas. Thus, this 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. Nonetheless, the EPA has notified the San Carlos Apache Tribe of the San Carlos Reservation, which borders the eastern boundary of the Hayden Pb and Hayden SO
                    <E T="52">2</E>
                     NAAs, of the proposed 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 proposed action is not subject to Executive Order 13045 because the effect of this proposed action, if finalized, would be to trigger additional planning requirements under the CAA. This proposed action does not establish an environmental standard intended to mitigate health or safety risks.</P>
                <HD SOURCE="HD2">H. Executive Order 13211, Actions That Significantly Affect Energy Supply, Distribution, or Use</HD>
                <P>This proposed rule 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>This rulemaking does not involve technical standards.</P>
                <HD SOURCE="HD2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations</HD>
                <P>The EPA believes that this action does not have disproportionately high and adverse human 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). The effect of this proposed action, if finalized, would be to trigger additional planning requirements under the CAA.</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, Lead, Pollution, Sulfur dioxide.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: April 23, 2021.</DATED>
                    <NAME>Deborah Jordan,</NAME>
                    <TITLE>Acting Regional Administrator, Region IX.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09215 Filed 5-7-21; 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-2021-0176; FRL-10023-40-Region 9]</DEPDOC>
                <SUBJECT>Approval of California Air Plan Revision, Imperial County 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>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Environmental Protection Agency (EPA) is proposing to approve a revision to the Imperial County Air 
                        <PRTPAGE P="24836"/>
                        Pollution Control District (ICAPCD or “District”) portion of the California State Implementation Plan (SIP). The revision concerns emissions of volatile organic compounds (VOCs) from gasoline transfer at bulk gasoline terminals storage. We are proposing to approve a local rule to regulate these emission sources under the Clean Air Act (CAA or the Act). 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 June 9, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by Docket ID No. EPA-R09-OAR-2021-0176 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>
                        Donnique Sherman, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105. By phone: (415) 947-4129 or by email at 
                        <E T="03">sherman.donnique@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 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 revision?</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?</FP>
                    <FP SOURCE="FP1-2">B. Does the rule meet the evaluation criteria?</FP>
                    <FP SOURCE="FP1-2">C. 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 did the State submit?</HD>
                <P>Table 1 lists the rule addressed by this proposal with the dates that it was revised by the local air agency and submitted by the California Air Resources Board (CARB).</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="xs60,12,r50,12,12">
                    <TTITLE>Table 1—Submitted Rule</TTITLE>
                    <BOXHD>
                        <CHED H="1">Local agency</CHED>
                        <CHED H="1">Rule No.</CHED>
                        <CHED H="1">Rule title</CHED>
                        <CHED H="1">Revised</CHED>
                        <CHED H="1">Submitted</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">ICAPCD</ENT>
                        <ENT>415</ENT>
                        <ENT>Transfer and Storage of Gasoline</ENT>
                        <ENT>11/03/2020</ENT>
                        <ENT>02/19/2021</ENT>
                    </ROW>
                </GPOTABLE>
                <P>On March 9, 2021, the EPA determined that the submittal for ICAPCD revised Rule 415 met 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>We approved an earlier version of Rule 415 into the SIP on February 22, 2005 (70 FR 8520). The ICAPCD adopted revisions to the SIP-approved version on November 3, 2020, and CARB submitted them to us on February 19, 2021. If we take final action to approve the November 3, 2020 version of Rule 415, this version will replace the previously approved version of the rule in the SIP.</P>
                <HD SOURCE="HD2">C. What is the purpose of the submitted rule revision?</HD>
                <P>Emissions of VOCs contribute to the production of ground-level ozone, smog and particulate matter, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. SIP-approved Rule 415 limits VOCs from the transfer and storage of gasoline, including stationary storage containers, terminals and bulk plants, gasoline delivery vessels, and vehicle fuel tanks. The rule was recently revised to lower the VOC emissions limit for gasoline transfers at bulk gasoline terminals. On March 16, 2020 (85 FR 8181), the EPA conditionally approved a portion of the California SIP revision submitted on November 14, 2017, demonstrating that control measures in the Imperial County Air Pollution Control District implemented reasonably available control technologies (RACT) for the 2008 8-hour National Ambient Air Quality Standards (NAAQS). The conditional approval was based on a commitment from the State to submit new or revised rules that would correct deficiencies in Rule 415, Transfer and Storage of Gasoline, to establish RACT-level controls for sources covered by the Control Techniques Guidelines (CTG) source category “Control of Hydrocarbons from Tank Truck Gasoline Loading Terminals” (EPA-450/2-77-026). Revisions to Rule 415 on November 3, 2020, corrected the deficiency. The EPA's technical support document (TSD) has more information about this rule.</P>
                <HD SOURCE="HD1">II. The EPA's Evaluation and Action</HD>
                <HD SOURCE="HD2">A. How is the EPA evaluating the rule?</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)), 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 RACT for each category of sources covered by a 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)). The ICAPCD regulates an ozone nonattainment area classified as Moderate for the 2008 8-hr ozone NAAQS (40 CFR 81 305). Therefore, this rule must implement RACT.</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. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean 
                    <PRTPAGE P="24837"/>
                    Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
                </P>
                <P>2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook, revised January 11, 1990).</P>
                <P>3. “Guidance Document for Correcting Common VOC &amp; Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).</P>
                <P>4. “Control of Hydrocarbons from Tank Truck Gasoline Loading Terminals,” EPA 450/2-77-026, October 1977.</P>
                <P>5. “Control of Volatile Organic Emissions from Bulk Gasoline Plants,” EPA-450/2-77-035, December 1977.</P>
                <P>6. “Design Criteria for Stage I Vapor Control Systems—Gasoline Service Stations,” EPA-450/R-75-102, November 1975.</P>
                <P>7. “Control of Volatile Organic Compound Leaks from Gasoline Tank Trucks and Vapor Collection Systems,” EPA-450/2-78-051, December 1978.</P>
                <HD SOURCE="HD2">B. Does the rule meet the evaluation criteria?</HD>
                <P>This rule meets CAA requirements and is consistent with relevant guidance regarding enforceability, RACT, and SIP revisions and fulfills the District's commitment to revise the rules to lower the emissions limit for gasoline transfers at bulk terminals in order to meet current RACT. The TSD has more information on our evaluation.</P>
                <HD SOURCE="HD2">C. Public Comment and Proposed Action</HD>
                <P>As authorized in section 110(k)(3) of the Act, the EPA proposes to fully approve the submitted rule because it fulfills all relevant requirements. In addition, we propose to convert the partial conditional approval of the District's 2008 RACT SIP, as found in 40 CFR 52.248 (i), to a full approval. We will accept comments from the public on this proposal until June 9, 2021. If we take final action to approve the submitted rule, our final action will incorporate this rule into the federally enforceable SIP.</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 requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the ICAPCD rule described in Table 1 of this preamble. 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>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 law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:</P>
                <P>• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 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. 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>
                <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: April 30, 2021.</DATED>
                    <NAME>Deborah Jordan,</NAME>
                    <TITLE>Acting Regional Administrator, Region IX.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09635 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <CFR>47 CFR Part 73</CFR>
                <DEPDOC>[MB Docket No. 21-185; RM-11906; DA 21-475; FR ID 24742]</DEPDOC>
                <SUBJECT>Television Broadcasting Services Butte, Montana</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Communications Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Commission has before it a petition for rulemaking filed by Sinclair Media Licensee, LLC (Petitioner), the licensee of KTVM-TV (NBC), channel 6, Butte, Montana. The Petitioner requests the substitution of channel 20 for channel 6 at Butte, Montana in the DTV Table of Allotments.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be filed on or before June 9, 2021 and reply comments on or before June 24, 2021.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Federal Communications Commission, Office of the Secretary, 45 L Street NE, Washington, DC 20554. In addition to filing comments with the FCC, interested parties should serve counsel for the Petitioner as follows: Paul A. Cicelski, Esq., Lerman Senter, PLLC, 2001 L Street NW, Washington, DC 20036.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Joyce Bernstein, Media Bureau, at (202) 418-1647; or Joyce Bernstein, Media Bureau, at 
                        <E T="03">Joyce.Bernstein@fcc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In support of its channel substitution request, the Petitioner states that the Commission has recognized that VHF channels have 
                    <PRTPAGE P="24838"/>
                    certain propagation characteristics which may cause reception issues for some viewers. Petitioner further states that KTVM-TV has received numerous complaints from viewers unable to receive that Station's over-the-air signal, despite being able to receive signals from other stations, and that its channel substitution proposal will result in more effective building penetration for indoor antenna reception. In addition, the Petitioner states that while the proposed channel 20 facility's noise limited contour does not completely encompass the relevant channel 6 noise limited contour, KTVM-TV is an NBC affiliate and there are two other NBC affiliated stations that serve some of the portions of the loss area. The Petitioner also submitted an analysis, using the Commission's 
                    <E T="03">TVStudy</E>
                     software analysis program, demonstrating that after taking into account service provided by the other NBC stations, all of the population located within KTVM-TV's original post-transition channel 6 noise limited contour will continue to receive NBC service, except for 66 people. The Bureau used the technical parameters of KTVM-TV's original post-transition digital channel 6 facility (File Nos. BPCDT-20080314ADF and BLCDT-20090622ADT) in determining any predicted loss which may occur from the proposed channel substitution.
                </P>
                <P>
                    This is a synopsis of the Commission's 
                    <E T="03">Notice of Proposed Rulemaking,</E>
                     MB Docket No. 21-185; RM-11906; DA 21-475, adopted April 26, 2021, and released April 26, 2021. The full text of this document is available for download at 
                    <E T="03">https://www.fcc.gov/edocs.</E>
                     To request materials in accessible formats (braille, large print, computer diskettes, or audio recordings), please send an email to 
                    <E T="03">FCC504@fcc.gov</E>
                     or call the Consumer &amp; Government Affairs Bureau at (202) 418-0530 (VOICE), (202) 418-0432 (TTY).
                </P>
                <P>
                    This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 
                    <E T="03">see</E>
                     44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to this proceeding.
                </P>
                <P>
                    Members of the public should note that all 
                    <E T="03">ex parte</E>
                     contacts are prohibited from the time a Notice of Proposed Rulemaking is issued to the time the matter is no longer subject to Commission consideration or court review, 
                    <E T="03">see</E>
                     47 CFR 1.1208. There are, however, exceptions to this prohibition, which can be found in Section 1.1204(a) of the Commission's rules, 47 CFR 1.1204(a).
                </P>
                <P>See Sections 1.415 and 1.420 of the Commission's rules for information regarding the proper filing procedures for comments, 47 CFR 1.415 and 1.420.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 47 CFR Part 73</HD>
                    <P>Television.</P>
                </LSTSUB>
                <SIG>
                    <FP>Federal Communications Commission.</FP>
                    <NAME>Thomas Horan,</NAME>
                    <TITLE>Chief of Staff, Media Bureau.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Proposed Rule</HD>
                <P>For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 73 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 73—RADIO BROADCAST SERVICE</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 73 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 47 U.S.C. 154, 155, 301, 303, 307, 309, 310, 334, 336, 339.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 73.622 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. In § 73.622 in paragraph (i), amend the Post-Transition Table of DTV Allotments under Montana by revising the entry for Butte to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 73.622 </SECTNO>
                    <SUBJECT>Digital television table of allotments.</SUBJECT>
                    <STARS/>
                    <P>(i) * * *</P>
                    <GPOTABLE COLS="2" OPTS="L1,tp0,i1" CDEF="s25,r25">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">Community</CHED>
                            <CHED H="1">Channel No.</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22"> </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="28">*    *    *    *    *</ENT>
                        </ROW>
                        <ROW EXPSTB="01" RUL="s">
                            <ENT I="21">
                                <E T="02">Montana</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="22"> </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="28">*    *    *    *    *</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Butte</ENT>
                            <ENT>5, 19, 20, 24</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="28">*    *    *    *    *</ENT>
                        </ROW>
                    </GPOTABLE>
                </SECTION>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09694 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </PRORULE>
    </PRORULES>
    <VOL>86</VOL>
    <NO>88</NO>
    <DATE>Monday, May 10, 2021</DATE>
    <UNITNAME>Notices</UNITNAME>
    <NOTICES>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="24839"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBJECT>Submission for OMB Review; Comment Request</SUBJECT>
                <DATE>May 5, 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 June 9, 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">Food Safety and Inspection Service</HD>
                <P>
                    <E T="03">Title:</E>
                     Mechanically Tenderized Beef Products.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     0583-0160.
                </P>
                <P>
                    <E T="03">Summary of Collection:</E>
                     The Food Safety and Inspection Service (FSIS) has been delegated the authority to exercise the functions of the Secretary as provided in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ). This statute mandate that FSIS protect the public by ensuring that meat products are safe, wholesome, unadulterated, and properly labeled and packaged.
                </P>
                <P>
                    <E T="03">Need and Use of the Information:</E>
                     FSIS requires the use of the descriptive designation “mechanically tenderized” on the labels of raw or partially cooked needle or blade tenderized beef products, including beef products injected with marinade or solution, unless such products are destined to be fully cooked at an official establishment. Beef products that have been needle or blade tenderized are referred to as “mechanically tenderized” products. Consumers use the information added to the labels of raw or partially cooked mechanically tenderized beef products to ensure that they thoroughly cook these products.
                </P>
                <P>
                    <E T="03">Description of Respondents:</E>
                     Business or other-for profit.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     555.
                </P>
                <P>
                    <E T="03">Frequency of Responses:</E>
                     Reporting: One time.
                </P>
                <P>
                    <E T="03">Total Burden Hours:</E>
                     19,719.
                </P>
                <SIG>
                    <NAME>Ruth Brown,</NAME>
                    <TITLE>Departmental Information Collection Clearance Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09826 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3410-DM-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBJECT>Submission for OMB Review; Comment Request</SUBJECT>
                <DATE>May 5, 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 June 9, 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">Food and Nutrition Service</HD>
                <P>
                    <E T="03">Title:</E>
                     The FNS User Access Request Form Data Collection.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     0584-0532.
                </P>
                <P>
                    <E T="03">Summary of Collection:</E>
                     The Federal Information Security Modernization Act of 2014 (Pub. L. 113-283) and Office of Management and Budget (OMB) Circular A-130, Managing Information as a Strategic Resource, establish a minimum set of controls to be included in Federal automated information security programs. Establishing controls over the provisioning of access to sensitive systems and data is directed in OMB Circular A-130.
                </P>
                <P>
                    <E T="03">Need and Use of the Information:</E>
                     The FNS User Access Request Form, FNS-674, is designed for this purpose and can be used in situations where (1) access to the FNCS network or an FNCS information system is required; (2) current access is required to be modified; and (3) access is no longer 
                    <PRTPAGE P="24840"/>
                    required and must be revoked. FNCS employees, contractors, State Agencies and partners (Food Banks, etc.) have requested access to FNCS systems via the User Access Request form. FNCS has used the information collected to grant access to the FNCS network and information systems. Information that is collected includes: Name, e-Authentication ID (if applicable), telephone number, email address, contract expiration date, temporary employee expiration date, office address, State/locality codes, system name, form type, type of access, action requested, comments and special instructions.
                </P>
                <P>
                    <E T="03">Description of Respondents:</E>
                     State and Local Government, Private Sector Businesses or other for-profits institutions.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     2,700.
                </P>
                <P>
                    <E T="03">Frequency of Responses:</E>
                     Reporting: On occasion.
                </P>
                <P>
                    <E T="03">Total Burden Hours:</E>
                     870.
                </P>
                <SIG>
                    <NAME>Ruth Brown,</NAME>
                    <TITLE>Departmental Information Collection Clearance Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09798 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3410-30-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Forest Service</SUBAGY>
                <SUBJECT>Information Collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Forest Service, USDA.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the renewal of a currently approved information collection, 
                        <E T="03">Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.</E>
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received in writing on or before July 9, 2021 to be assured of consideration. Comments received after that date will be considered to the extent practicable.</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:</E>
                          
                        <E T="03">ann.goode@usda.gov</E>
                         and/or 
                        <E T="03">d</E>
                        anne
                        <E T="03">t</E>
                        <E T="03">te.jones@usda.gov</E>
                        .
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Ann E. Goode, Branch Chief, Directives and Regulations Branch, Strategic Planning, Budget and Accountability, Forest Service, 1400 Independence Avenue SW, Washington, DC 20250.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery/Courier:</E>
                         Forest Service, USDA, 1400 Independence Avenue SW, Washington, DC 20250.
                    </P>
                    <P>Comments received in response to this notice may be made available to the public through relevant websites and upon request. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. If you send an email comment, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice.</P>
                    <P>
                        The public may request an electronic copy of the draft supporting statement and/or any comments received. Requests should be emailed to 
                        <E T="03">dannette.jones@usda.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Dannette Jones, Information Collections Officer, Directives and Regulations, Strategic Planning, Budget and Accountability, via email at 
                        <E T="03">dannette.jones@usda.gov</E>
                         or (202) 205-1295. Individuals who use telecommunication devices for the hearing-impaired (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 twenty-four hours a day, every day of the year, including holidays.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P SOURCE="NPAR">
                    <E T="03">Title:</E>
                     Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     0596-0226.
                </P>
                <P>
                    <E T="03">Expiration Date of Approval:</E>
                     July 31, 2021.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Extension with no Revision.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Agency's commitment to improve service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions but are not statistical surveys that yield quantitative results that can be generalized to the population of study.
                </P>
                <P>This feedback will provide insights into customer or stakeholder perceptions, experiences, and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative, and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public.</P>
                <P>If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable. The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:</P>
                <P>• The collections are voluntary;</P>
                <P>• The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;</P>
                <P>• The collections are noncontroversial and do not raise issues of concern to other Federal agencies;</P>
                <P>• Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;</P>
                <P>• Personally identifiable information (PII) is collected only to the extent necessary and is not retained;</P>
                <P>• Information gathered is intended to be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency (if released, the agency must indicate the qualitative nature of the information);</P>
                <P>• Information gathered will not be used for the purpose of substantially informing influential policy decisions; and</P>
                <P>• Information gathered will yield qualitative information. The collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study. Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population.</P>
                <P>
                    This type of generic clearance for qualitative information will not be used 
                    <PRTPAGE P="24841"/>
                    for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
                </P>
                <P>As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.</P>
                <P>
                    <E T="03">Type of Respondents:</E>
                     Individuals and Households, Business and Organizations, State, Local or Tribal Government.
                </P>
                <P>
                    <E T="03">Estimate of Burden per Response:</E>
                     1 to 60 Minutes.
                </P>
                <P>
                    <E T="03">Estimated Annual Number of Respondents:</E>
                     3,500,000.
                </P>
                <P>
                    <E T="03">Estimated Annual Number of Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden on Respondents:</E>
                     875,000 hours.
                </P>
                <P>
                    <E T="03">Comment is Invited:</E>
                     Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
                </P>
                <P>All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission to the Office of Management and Budget for approval.</P>
                <SIG>
                    <NAME>Amelia Steed,</NAME>
                    <TITLE>Acting Assistant Director, Formulations Branch, Strategic Planning, Budget and Accountability.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09806 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3411-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Foreign-Trade Zones Board</SUBAGY>
                <DEPDOC>[B-37-2021]</DEPDOC>
                <SUBJECT>Foreign-Trade Zone (FTZ) 20—Norfolk, Virginia; Notification of Proposed Production Activity; STIHL, Incorporated (Handheld Outdoor Power Equipment), Virginia Beach, Virginia</SUBJECT>
                <P>STIHL, Incorporated (STIHL) submitted a notification of proposed production activity to the FTZ Board for its facility in Virginia Beach, Virginia. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on May 3, 2021.</P>
                <P>STIHL already has authority to produce handheld outdoor power equipment and related parts within Subzone 20E. The current request would add two foreign status materials/components to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials/components described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.</P>
                <P>Production under FTZ procedures could exempt SITHL from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, for the foreign-status materials/components noted below, STIHL would be able to choose the duty rates during customs entry procedures that apply to blowers, trimmers, sprayers, cutters, cultivators, and chainsaws (duty rate ranges from duty-free to 4.7%). STIHL would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.</P>
                <P>The materials/components sourced from abroad include flat-rolled and cold-rolled alloy special steel products of a width less than 600 mm, and bars and rods of alloy special steel (duty-free). The request indicates that the components are subject to an antidumping/countervailing duty (AD/CVD) order if imported from certain countries. The FTZ Board's regulations (15 CFR 400.14(e)) require that merchandise subject to AD/CVD orders, or items which would be otherwise subject to suspension of liquidation under AD/CVD procedures if they entered U.S. customs territory, be admitted to the zone in privileged foreign status (19 CFR 146.41). The request also indicates that certain materials/components are subject to duties under Section 232 of the Trade Expansion Act of 1962 (Section 232) or Section 301 of the Trade Act of 1974 (Section 301), depending on the country of origin. The applicable Section 232 and Section 301 decisions require subject merchandise to be admitted to FTZs in privileged foreign status.</P>
                <P>
                    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to: 
                    <E T="03">ftz@trade.gov.</E>
                     The closing period for their receipt is June 21, 2021.
                </P>
                <P>
                    A copy of the notification will be available for public inspection in the “Reading Room” section of the Board's website, which is accessible via 
                    <E T="03">www.trade.gov/ftz.</E>
                </P>
                <P>
                    For further information, contact Juanita Chen at 
                    <E T="03">juanita.chen@trade.gov</E>
                     or 202-482-1378.
                </P>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <NAME>Elizabeth Whiteman,</NAME>
                    <TITLE>Acting Executive Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09864 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Bureau of Industry and Security</SUBAGY>
                <SUBJECT>Emerging Technology Technical Advisory Committee; Notice of Partially Closed Meeting</SUBJECT>
                <P>The Emerging Technology Technical Advisory Committee (ETTAC) will meet on May 21, 2021, at 10:30 a.m., Eastern Daylight Time. The meetings will be available via teleconference. The Committee advises the Office of the Assistant Secretary for Export Administration on the identification of emerging and foundational technologies with potential dual-use applications as early as possible in their developmental stages both within the United States and abroad.</P>
                <HD SOURCE="HD1">Agenda</HD>
                <HD SOURCE="HD2">Closed Session: 10:30 a.m.-12:30 p.m.</HD>
                <FP SOURCE="FP-1">
                    1. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3)
                    <PRTPAGE P="24842"/>
                </FP>
                <HD SOURCE="HD2">Open Session: 1:00 p.m.-3:00 p.m.</HD>
                <FP SOURCE="FP-1">1. Opening Remarks and Introduction by BIS Senior Management</FP>
                <FP SOURCE="FP-1">2. Mastering Foreign Engagement Risk in the Research Enterprise (Kevin Gamache, Ph.D., Jeff Stoff, Glenn D. Tiffert, Ph.D.)</FP>
                <FP SOURCE="FP-1">3. Q &amp; A with speakers</FP>
                <FP SOURCE="FP-1">4. Conclusion/announcements/next meeting</FP>
                <P>
                    To join the conference, submit inquiries to Ms. Yvette Springer at 
                    <E T="03">Yvette.Springer@bis.doc.gov</E>
                     no later than May 17, 2021.
                </P>
                <P>To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.</P>
                <P>The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on February 9, 2021, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § 10(d)), that the portion of the meeting dealing with pre-decisional changes to the Commerce Control List and the U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 § § 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public. For more information, call Yvette Springer at (202) 482-2813.</P>
                <SIG>
                    <NAME>Yvette Springer,</NAME>
                    <TITLE>Committee Liaison Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09790 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-JT-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Bureau of Industry and Security</SUBAGY>
                <SUBJECT>Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Application for NATO International Bidding</SUBJECT>
                <P>
                    The Department of Commerce will submit the following information collection request 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. We invite the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. Public comments were previously requested via the 
                    <E T="04">Federal Register</E>
                     on January 12, 2021, during a 60-day comment period. This notice allows for an additional 30 days for public comments.
                </P>
                <P>
                    <E T="03">Agency:</E>
                     Bureau of Industry and Security.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Application for NATO International Bidding.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     0694-XXXX.
                </P>
                <P>
                    <E T="03">Form Number(s):</E>
                     BIS-4023P.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Regular submission New Information Collection.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     50.
                </P>
                <P>
                    <E T="03">Average Hours per Response:</E>
                     1.
                </P>
                <P>
                    <E T="03">Burden Hours:</E>
                     50.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     This new proposed information collection replaces previously approved generic collection 0694-0128. All U.S. firms desiring to participate in the NATO International Competitive Bidding (ICB) process under the NATO Security Investment Program (NSIP) must be certified as technically, financially and professionally competent. The U.S. Department of Commerce provides the Declaration of Eligibility that certifies these firms. Any such firm seeking certification is required to submit a completed Form BIS-4023P along with a current annual financial report and a resume of past projects in order to become certified and placed on the Consolidated List of Eligible Bidders.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On Occasion.
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Voluntary.
                </P>
                <P>
                    <E T="03">Legal Authority:</E>
                     Section 401 (10) of Executive order 12656 (November 18, 1988), 15 U.S.C. Section 1512.
                </P>
                <P>
                    This information collection request may be viewed at 
                    <E T="03">www.reginfo.gov.</E>
                     Follow the instructions to view the Department of Commerce collections currently under review by OMB.
                </P>
                <P>
                    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 and entering the title of the collection.
                </P>
                <SIG>
                    <NAME>Sheleen Dumas,</NAME>
                    <TITLE>Department PRA Clearance Officer, Office of the Chief Information Officer, Commerce Department.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09859 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-33-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[C-489-817]</DEPDOC>
                <SUBJECT>Oil Country Tubular Goods From the Republic of Turkey: Final Results and Partial Rescission of Countervailing Duty Administrative Review; 2018</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Department of Commerce (Commerce) determines that Borusan Mannesmann Boru Sanayi ve Ticaret A.S. (Borusan), exporter/producer of oil country tubular goods (OCTG) from the Republic of Turkey (Turkey), received 
                        <E T="03">de minimis</E>
                         net countervailable subsidies during the period of review (POR), January 1, 2018, through December 31, 2018. Commerce is also rescinding this review with respect to five non-selected companies for which the customs data show no reviewable entries during the POR.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable May 10, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Dusten Hom, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5075.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTAL INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On January 26, 2021, Commerce published the 
                    <E T="03">Preliminary Results</E>
                     of this administrative review.
                    <SU>1</SU>
                    <FTREF/>
                     We invited parties to comment on the 
                    <E T="03">Preliminary Results.</E>
                     No interested party submitted comments. Borusan requested to participate in a hearing with Commerce, but because no party submitted comments, Commerce did not hold a hearing.
                    <SU>2</SU>
                    <FTREF/>
                     Commerce conducted this 
                    <PRTPAGE P="24843"/>
                    review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Oil Country Tubular Goods from the Republic of Turkey: Preliminary Results of Countervailing Duty Administrative Review, Rescission in Part, and Intent to Rescind in Part; 2018,</E>
                         86 FR 7069 (January 26, 2021) (
                        <E T="03">Preliminary Results</E>
                        ), and accompanying Preliminary Decision Memorandum (PDM).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         Borusan's Letter, “Oil Country Tubular Goods from Turkey, Case No. C-489-817; BMB's Request to Participate in Hearing,” dated February 25, 2021; 
                        <E T="03">see also</E>
                         19 CFR 351.310 (c) (“At the 
                        <PRTPAGE/>
                        hearing, an interested party may make an affirmative presentation only on arguments included in that party's case brief and may make a rebuttal presentation only on arguments included in that party's rebuttal brief”).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">
                    Scope of the Order 
                    <E T="0133">3</E>
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See Certain Oil Country Tubular Goods from India and the Republic of Turkey: Countervailing Duty Orders and Amended Affirmative Final Countervailing Duty Determination for India,</E>
                         79 FR 53688 (September 10, 2014) (
                        <E T="03">Order</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    The merchandise covered by the 
                    <E T="03">Order</E>
                     is certain OCTG from Turkey. For a complete description of the scope, 
                    <E T="03">see</E>
                     the Preliminary Decision Memorandum accompanying the 
                    <E T="03">Preliminary Results.</E>
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See Preliminary Results</E>
                         PDM.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Changes Since the Preliminary Results</HD>
                <P>
                    As no party submitted comments on the 
                    <E T="03">Preliminary Results,</E>
                     we made no changes in the final results of this review.
                </P>
                <HD SOURCE="HD1">Partial Rescission of Administrative Review</HD>
                <P>
                    It is Commerce's practice to rescind an administrative review of a countervailing duty order, pursuant to 19 CFR 351.213(d)(3), when there are no reviewable entries of subject merchandise during the POR for which liquidation is suspended.
                    <SU>5</SU>
                    <FTREF/>
                     Normally, upon completion of an administrative review, the suspended entries are liquidated at the countervailing duty assessment rate calculated for the review period.
                    <SU>6</SU>
                    <FTREF/>
                     Therefore, for an administrative review of a company to be conducted, there must be a reviewable, suspended entry that Commerce can instruct U.S. Customs and Border Protection (CBP) to liquidate at the calculated countervailing duty assessment rate calculated for the review period.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See, e.g., Lightweight Thermal Paper from the People's Republic of China: Notice of Rescission of Countervailing Duty Administrative Review; 2015,</E>
                         82 FR 14349 (March 20, 2017); 
                        <E T="03">see also Circular Welded Carbon Quality Steel Pipe from the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2017,</E>
                         84 FR 14650 (April 11, 2019).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.212(b)(2).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         19 CFR 351.213(d)(3).
                    </P>
                </FTNT>
                <P>
                    According to the CBP import data, the five non-selected companies subject to this review, did not have reviewable entries of subject merchandise during the POR for which liquidation is suspended.
                    <SU>8</SU>
                    <FTREF/>
                     Because there is no evidence on the record of this segment of the proceeding to indicate that these companies had entries, exports, or sales of subject merchandise to the United States during the POR, we are rescinding the administrative review with respect to these companies consistent with 19 CFR 351.213(d)(3).
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         These five companies are: Bakir Grup Makine Imalat Bakim Montaj Demontaj Sanayi ve Ticaret Ltd. Sti.; Hydra Insaat Sanayi ve Ticaret Anonim Sirketi; Kalibre Boru Sanayi ve Ticaret; NETBORU San. ve Dis. Tic. Koll. Sti.; and Yilmaz Pipo.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Final Results of the Administrative Review</HD>
                <P>In accordance with section 777A(e)(1) of the Act and 19 CFR 351.221(b)(5), we determine the following net countervailable subsidy rate for Borusan, for the period January 1, 2018, through December 31, 2018:</P>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s100,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Company</CHED>
                        <CHED H="1">
                            Subsidy rate
                            <LI>
                                (percent 
                                <E T="03">ad valorem</E>
                                )
                            </LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            Borusan Mannesmann Boru Sanayi ve Ticaret A.S., Borusan Istikbal Ticaret, Borusan Lojistik Dag. Deg. Tas Ve, Borusan Mannesmann Boru Yatirim Holding A.Ş., and Borusan Holding A.Ş.
                            <SU>9</SU>
                        </ENT>
                        <ENT>
                            0.38 (
                            <E T="03">de minimis</E>
                            )
                        </ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">
                    Assessment Rates
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Commerce has determined that Borusan Mannesmann Boru Sanayi ve Ticaret A.S.; Borusan Istikbal Ticaret.; Borusan Lojistik Dag. Deg. Tas Ve; Borusan Mannesmann Boru Yatirim Holding A.Ş.; and Borusan Holding A.Ş. are cross-owned. 
                        <E T="03">See</E>
                         Preliminary Decision Memorandum.
                    </P>
                </FTNT>
                <P>
                    Commerce shall determine, and CBP shall assess, countervailing duties on all appropriate entries covered by this review, pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(2). Because we calculated a 
                    <E T="03">de minimis</E>
                     countervailable subsidy rate for Borusan in the final results of this review, we intend to instruct CBP to liquidate the appropriate entries without regard to countervailing duties in accordance with 19 CFR 351.212(b)(2) and 19 CFR 351.106(c)(1).
                </P>
                <P>
                    With respect to the companies for which this administrative review is rescinded (
                    <E T="03">i.e.,</E>
                     Bakir Grup Makine Imalat Bakim Montaj Demontaj Sanayi ve Ticaret Ltd. Sti.; Hydra Insaat Sanayi ve Ticaret Anonim Sirketi; Kalibre Boru Sanayi ve Ticaret; NETBORU San. ve Dis. Tic. Koll. Sti.; and Yilmaz Pipo), countervailing duties shall be assessed at rates equal to the cash deposit rate required at the time of entry, or withdrawal from warehouse, for consumption, during the period January 1, 2018, through December 31, 2018, in accordance with 19 CFR 351.212(c)(1)(i).
                </P>
                <P>
                    Commerce intends to issue appropriate assessment instructions to CBP no earlier than 35 days after the date of this publication of the final results of this review in the 
                    <E T="04">Federal Register</E>
                    . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired (
                    <E T="03">i.e.,</E>
                     within 90 days of publication).
                </P>
                <HD SOURCE="HD1">Cash Deposit Requirements</HD>
                <P>Pursuant to section 751(a)(2)(C) of the Act, Commerce also intends to instruct CBP to collect cash deposits of estimated countervailing duties at the appropriate rates. For shipments of subject merchandise by Borusan entered, or withdrawn from warehouse, for consumption on or after the date of publication of these final results, the cash deposit rate will be zero. For all non-reviewed firms, CBP will continue to collect cash deposits of estimated countervailing duties at the most recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.</P>
                <HD SOURCE="HD1">Administrative Protective Order</HD>
                <P>This notice serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is sanctionable violation.</P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>These final results are issued and published in accordance with sections 751(a)(1) and 777(i) of the Act.</P>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Christian Marsh,</NAME>
                    <TITLE>Acting Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09840 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="24844"/>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[C-570-136]</DEPDOC>
                <SUBJECT>Certain Chassis and Subassemblies Thereof From the People's Republic of China: Countervailing Duty Order and Amended Final Affirmative Countervailing Duty Determination</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Based on affirmative final determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC), Commerce is issuing a countervailing duty (CVD) order on certain chassis and subassemblies thereof (chassis) from the People's Republic of China (China). In addition, Commerce is amending its final determination with respect to chassis from China to correct a ministerial error.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable May 10, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>William Langley or Nicholas Czajkowski, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3861 or (202) 482-1395, respectively.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    In accordance with sections 705(a), 705(d), and 777(i)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.210(c), on March 22, 2021, Commerce published its affirmative final determination that countervailable subsidies are being provided to producers and exporters of chassis from China.
                    <SU>1</SU>
                    <FTREF/>
                     In the investigation of chassis from China, the Coalition of American Chassis Manufacturers (the petitioner) submitted a timely allegation on the record that Commerce made a ministerial error in the final CVD determination on chassis from China.
                    <SU>2</SU>
                    <FTREF/>
                     Section 705(e) of the Act and 19 CFR 351.224(f) define ministerial errors as errors in addition, subtraction, or other arithmetic function, clerical errors resulting from inaccurate copying, duplication, or the like, and any other type of unintentional error which Commerce considers ministerial. We reviewed the allegation and determined that we made a ministerial error in the final CVD determination on chassis from China. 
                    <E T="03">See</E>
                     “Amendment to the Final Determination” section below for further discussion.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Certain Chassis and Subassemblies Thereof from the People's Republic of China; Final Affirmative Countervailing Duty Determination,</E>
                         86 FR 15186 (March 22, 2021) (
                        <E T="03">Final Determination</E>
                        ), and accompanying Issues and Decision Memorandum.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         Petitioner's Letter, “Certain Chassis and Subassemblies Thereof from the People's Republic of China: Ministerial Error Allegations,” dated March 22, 2021 (Ministerial Error Allegations).
                    </P>
                </FTNT>
                <P>
                    On May 3, 2021, the ITC notified Commerce of its affirmative final determination that pursuant to sections 705(b)(1)(A)(i) and 705(d) of the Act, an industry in the United States is materially injured by reason of subsidized imports of subject merchandise from China.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         ITC's Letter, “Notification of ITC Final Determination,” dated May 3, 2021 (ITC Notification Letter).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Scope of the Order</HD>
                <P>
                    The products covered by this order are certain chassis and subassemblies thereof from China. For a complete description of the scope of this order, 
                    <E T="03">see</E>
                     the appendix to this notice.
                </P>
                <HD SOURCE="HD1">Amendment to the Final Determination</HD>
                <P>
                    On March 22, 2021, the petitioner submitted a timely ministerial error allegation regarding the 
                    <E T="03">Final Determination.</E>
                    <SU>4</SU>
                    <FTREF/>
                     Commerce reviewed the record and, on April 8, 2021, agreed that the error alleged by the petitioner constituted a ministerial error within the meaning of section 705(e) of the Act and 19 CFR 351.224(f).
                    <SU>5</SU>
                    <FTREF/>
                     Specifically, Commerce found that it made an error in calculating the subsidy rates for inputs provided for less than adequate remuneration to Qingdao CIMC Special Vehicles Co., Ltd. and Dongguan CIMC Vehicle Co., Ltd. and their cross-owned companies (collectively, CIMC). Pursuant to 19 CFR 351.224(e), Commerce is amending the 
                    <E T="03">Final Determination</E>
                     to reflect the correction of the ministerial error described in the Ministerial Error Memorandum. Based on the correction, the subsidy rate for CIMCs changed from 39.14 percent to 44.32 percent. Because the all-others rate is based entirely on CIMC's 
                    <E T="03">ad valorem</E>
                     subsidy rate, the all-others rate also changed from 39.14 percent to 44.32 percent.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Ministerial Error Allegations.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Countervailing Duty Investigation of Certain Chassis and Subassemblies Thereof from the People's Republic of China: Ministerial Error Allegations in the Final Determination,” dated April 8, 2021 (Ministerial Error Memorandum) at 1-2.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Countervailing Duty Order</HD>
                <P>
                    As stated above, on May 3, 2021, in accordance with section 705(d) of the Act, the ITC notified Commerce of its final determination that an industry in the United States is materially injured within the meaning of section 705(b)(1)(A)(i) of the Act by reason of subsidized imports of chassis from China.
                    <SU>6</SU>
                    <FTREF/>
                     Therefore, in accordance with section 705(c)(2) of the Act, Commerce is issuing this CVD order. Because the ITC determined that imports of chassis from China are materially injuring a U.S. industry, unliquidated entries of such merchandise from China, entered or withdrawn from warehouse for consumption, are subject to the assessment of countervailing duties.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         ITC Notification Letter.
                    </P>
                </FTNT>
                <P>
                    Therefore, in accordance with section 706(a) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, countervailing duties for all relevant entries of chassis from China which are entered, or withdrawn from warehouse, for consumption on or after January 4, 2021, the date of publication of the 
                    <E T="03">Preliminary Determination,</E>
                    <SU>7</SU>
                    <FTREF/>
                     but will not include entries occurring after the expiration of the provisional measures period and before the publication of the ITC's final injury determination under section 705(b) of the Act, as further described in the “Provisional Measures” section of this notice.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See Certain Chassis and Subassemblies Thereof from the People's Republic of China: Preliminary Affirmative Countervailing Duty Determination,</E>
                         86 FR 56 (January 4, 2021) (
                        <E T="03">Preliminary Determination</E>
                        ), and accompanying Preliminary Decision Memorandum.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         In the 
                        <E T="03">Final Determination,</E>
                         Commerce inadvertently stated that we would instruct CBP to “suspend liquidation of entries of subject merchandise from China that were entered, or withdrawn from warehouse, for consumption, effective January 4, 2020, which is the date of publication of the 
                        <E T="03">Preliminary Determination.”</E>
                         The 
                        <E T="03">Preliminary Determination</E>
                         was published on January 4, 2021, which is the date reflected in our instructions to CBP.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Continuation of Suspension of Liquidation and Cash Deposits</HD>
                <P>Except as noted in the “Provisional Measures” section of this notice, in accordance with section 706(a)(1) of the Act, Commerce will instruct CBP to continue to suspend liquidation on all relevant entries of chassis from China. These instructions suspending liquidation will remain in effect until further notice.</P>
                <P>
                    Commerce will also instruct CBP to require cash deposits equal to the net countervailable subsidy rates indicated in the table below. Accordingly, effective on the date of publication in the 
                    <E T="04">Federal Register</E>
                     of the notice of the ITC's final affirmative injury determination, CBP must require, at the same time as importers would deposit estimated normal customs duties on 
                    <PRTPAGE P="24845"/>
                    subject merchandise, a cash deposit equal to the rates listed in the table below.
                </P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s75,9">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Company</CHED>
                        <CHED H="1">
                            Subsidy
                            <LI>rate</LI>
                            <LI>(percent)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            Qingdao CIMC Special Vehicles Co., Ltd. and Dongguan CIMC Vehicle Co., Ltd.
                            <SU>9</SU>
                        </ENT>
                        <ENT>44.32</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">All Others</ENT>
                        <ENT>44.32</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                     
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Commerce finds the following companies to be cross-owned with Qingdao CIMC Special Vehicles Co., Ltd. and Dongguan CIMC Vehicle Co., Ltd.: CIMC Vehicles (Group) Co., Ltd.; Shenzhen CIMC Vehicle Co., Ltd.; Zhumadian CIMC Huajun Casting Co., Ltd.; China International Marine Containers (Group) Co., Ltd.; Liangshan CIMC Dongyue Vehicles Co., Ltd.; Shandong Wanshida Special Vehicle Manufacturing Co., Ltd.; Yangzhou CIMC Tonghua Special Vehicles Co., Ltd.; Zhumadian CIMC Huajun Vehicle Co., Ltd.; Gansu CIMC Huajun Vehicles Co., Ltd.; CIMC Vehicles (Liaoning) Co., Ltd.; and Zhumadian CIMC Wanjia Axle Co., Ltd.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Provisional Measures</HD>
                <P>
                    Section 703(d) of the Act states that the suspension of liquidation pursuant to an affirmative preliminary determination may not remain in effect for more than four months. Commerce published the 
                    <E T="03">Preliminary Determination</E>
                     on January 4, 2021.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See Preliminary Determination.</E>
                    </P>
                </FTNT>
                <P>
                    The provisional measures period, beginning on the date of publication of the 
                    <E T="03">Preliminary Determination,</E>
                     ended on May 3, 2021. Therefore, in accordance with section 703(d) of the Act and our practice, Commerce will instruct CBP to terminate the suspension of liquidation and to liquidate, without regard to countervailing duties, unliquidated entries of chassis from China entered, or withdrawn from warehouse, for consumption after May 3, 2021, the final day on which the provisional measures were in effect, until and through the day preceding the date of publication of the ITC's final affirmative injury determination in the 
                    <E T="04">Federal Register</E>
                    . Suspension of liquidation and the collection of cash deposits will resume on the date of publication of the ITC's final determination in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>
                    This notice constitutes the CVD order with respect to chassis from China pursuant to section 706(a) of the Act. Interested parties can find a list of CVD orders currently in effect at 
                    <E T="03">http://enforcement.trade.gov/stats/iastats1.html.</E>
                </P>
                <P>This amended final determination and order is issued and published in accordance with sections 705(d) and 706(a) of the Act and 19 CFR 351.211(b) and 351.224(e).</P>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Christian Marsh,</NAME>
                    <TITLE>Acting Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
                <APPENDIX>
                    <HD SOURCE="HED">Appendix</HD>
                    <HD SOURCE="HD1">Scope of the Order</HD>
                    <P>The merchandise covered by this order is chassis and subassemblies thereof, whether finished or unfinished, whether assembled or unassembled, whether coated or uncoated, regardless of the number of axles, for carriage of containers, or other payloads (including self-supporting payloads) for road, marine roll-on/roll-off (RORO) and/or rail transport. Chassis are typically, but are not limited to, rectangular framed trailers with a suspension and axle system, wheels and tires, brakes, a lighting and electrical system, a coupling for towing behind a truck tractor, and a locking system or systems to secure the shipping container or containers to the chassis using twistlocks, slide pins or similar attachment devices to engage the corner fittings on the container or other payload.</P>
                    <P>Subject merchandise includes, but is not limited to, the following subassemblies:</P>
                    <P>• Chassis frames, or sections of chassis frames, including kingpin assemblies, bolsters consisting of transverse beams with locking or support mechanisms, goosenecks, drop assemblies, extension mechanisms and/or rear impact guards;</P>
                    <P>• Running gear assemblies or axle assemblies for connection to the chassis frame, whether fixed in nature or capable of sliding fore and aft or lifting up and lowering down, which may or may not include suspension(s) (mechanical or pneumatic), wheel end components, slack adjusters, axles, brake chambers, locking pins, and tires and wheels;</P>
                    <P>• Landing gear assemblies, for connection to the chassis frame, capable of supporting the chassis when it is not engaged to a tractor; and</P>
                    <P>• Assemblies that connect to the chassis frame or a section of the chassis frame, such as, but not limited to, pintle hooks or B-trains (which include a fifth wheel), which are capable of connecting a chassis to a converter dolly or another chassis.</P>
                    <P>Importation of any of these subassemblies, whether assembled or unassembled, constitutes an unfinished chassis for purposes of this order.</P>
                    <P>Subject merchandise also includes chassis, whether finished or unfinished, entered with or for further assembly with components such as, but not limited to: Hub and drum assemblies, brake assemblies (either drum or disc), axles, brake chambers, suspensions and suspension components, wheel end components, landing gear legs, spoke or disc wheels, tires, brake control systems, electrical harnesses and lighting systems.</P>
                    <P>Processing of finished and unfinished chassis and components such as trimming, cutting, grinding, notching, punching, drilling, painting, coating, staining, finishing, assembly, or any other processing either in the country of manufacture of the in-scope product or in a third country does not remove the product from the scope. Inclusion of other components not identified as comprising the finished or unfinished chassis does not remove the product from the scope.</P>
                    <P>Individual components entered and sold by themselves are not subject to the order, but components entered with or for further assembly with a finished or unfinished chassis are subject merchandise. A finished chassis is ultimately comprised of several different types of subassemblies. Within each subassembly there are numerous components that comprise a given subassembly.</P>
                    <P>This scope excludes dry van trailers, refrigerated van trailers and flatbed trailers. Dry van trailers are trailers with a wholly enclosed cargo space comprised of fixed sides, nose, floor and roof, with articulated panels (doors) across the rear and occasionally at selected places on the sides, with the cargo space being permanently incorporated in the trailer itself. Refrigerated van trailers are trailers with a wholly enclosed cargo space comprised of fixed sides, nose, floor and roof, with articulated panels (doors) across the rear and occasionally at selected places on the sides, with the cargo space being permanently incorporated in the trailer and being insulated, possessing specific thermal properties intended for use with self-contained refrigeration systems. Flatbed (or platform) trailers consist of load-carrying main frames and a solid, flat or stepped loading deck or floor permanently incorporated with and supported by frame rails and cross members.</P>
                    <P>The finished and unfinished chassis subject to this order are typically classified in the Harmonized Tariff Schedule of the United States (HTSUS) at subheadings: 8716.39.0090 and 8716.90.5060. Imports of finished and unfinished chassis may also enter under HTSUS subheading 8716.90.5010. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise under order is dispositive.</P>
                </APPENDIX>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09848 Filed 5-7-21; 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>
                <DEPDOC>[A-475-818]</DEPDOC>
                <SUBJECT>Certain Pasta From Italy: Final Results of Changed Circumstances Review</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        On November 9, 2020, the Department of Commerce (Commerce) published the preliminary results of the changed circumstances review (CCR) of the antidumping duty (AD) order on certain pasta from Italy and preliminarily determined that Newlat Food S.p.A. (Newlat) is not the successor-in-interest to Delverde 
                        <PRTPAGE P="24846"/>
                        Industrie Alimentari S.p.A. (Delverde). Based on our analysis for the final results, Commerce continues to find that Newlat is not the successor-in-interest to Delverde.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable May 10, 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 Avenue NW, Washington, DC 20230, telephone: (202) 482-3315.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On July 14, 1996, Commerce published in the 
                    <E T="04">Federal Register</E>
                     an AD order on certain pasta from Italy.
                    <SU>1</SU>
                    <FTREF/>
                     On July 30, 2020, Newlat requested that, pursuant to section 751(b) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.216(b), Commerce initiate and conduct a CCR of the 
                    <E T="03">Order</E>
                     to determine if Newlat is the successor-in-interest to Delverde. Newlat also requested that Commerce issue the preliminary results of this CCR in conjunction with the notice of initiation, as permitted under 19 CFR 315.221(c)(3)(ii).
                    <SU>2</SU>
                    <FTREF/>
                     The domestic industry filed no comments in response to the request for a CCR.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Notice of Antidumping Duty Order and Amended Final Determination of Sales at Less Than Fair Value: Certain Pasta from Italy,</E>
                         61 FR 38544 (July 24, 1996) (
                        <E T="03">Order</E>
                        ); 
                        <E T="03">see also Notice of Second Amendment to the Final Determination and Antidumping Duty Order: Certain Pasta from Italy,</E>
                         61 FR 42231 (August 14, 1996) (
                        <E T="03">Order</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         Newlat's Letter, “Certain Pasta from Italy—Request for Changed Circumstances Review,” dated July 30, 2020.
                    </P>
                </FTNT>
                <P>
                    On November 9, 2020, Commerce initiated the CCR and preliminarily determined that Newlat is not the successor-in-interest to Delverde.
                    <SU>3</SU>
                    <FTREF/>
                     On December 11, 2020, Newlat and the petitioners submitted case briefs regarding the 
                    <E T="03">Preliminary Results.</E>
                    <SU>4</SU>
                    <FTREF/>
                     No party submitted rebuttal briefs. On January 13, 2021, Commerce held a video conference with counsel to Newlat in lieu of the hearing requested on December 9, 2020, the request for which had been withdrawn on December 22, 2020.
                    <SU>5</SU>
                    <FTREF/>
                     Commerce received no requests from the petitioner for a hearing.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See Certain Pasta from Italy: Initiation and Preliminary Results of Changed Circumstances Review,</E>
                         85 FR 71315 (November 9, 2020) (
                        <E T="03">Preliminary Results</E>
                        ), and accompanying Preliminary Decision Memorandum.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Newlat's Letter, “Certain Pasta from Italy—Changed Circumstances Review—Case Brief,” dated December 11, 2020; 
                        <E T="03">see also</E>
                         Petitioner's Letter, “Certain Pasta from Italy—Case Brief,” dated December 11, 2020.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Commerce's Letter, “Changed Circumstances Review of Certain Pasta from Italy: Ex Parte Meeting with Counsel to Newlat,” dated January 13, 2021; 
                        <E T="03">see also</E>
                         Newlat's Letter, “Certain Pasta from Italy—Changed Circumstances Review—Request for Public Hearing,” dated December 9, 2020; 
                        <E T="03">see also</E>
                         Newlat's Letter, “Certain Pasta from Italy—Withdrawal of Hearing Request,” dated December 22, 2020.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Scope of the Order</HD>
                <P>
                    Imports covered by this 
                    <E T="03">Order</E>
                     are shipments of certain non-egg dry pasta. The merchandise subject to this 
                    <E T="03">Order</E>
                     is currently classifiable under subheadings 1901.90.9095 and 1902.19.20 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to the 
                    <E T="03">Order</E>
                     is dispositive. For the full description of the scope of the 
                    <E T="03">Order, see</E>
                     the Issues and Decision Memorandum.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         accompanying Issues and Decision Memorandum.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Final Results of Changed Circumstances Review</HD>
                <P>
                    All issues raised in the case briefs are addressed in the Issues and Decision Memorandum. A list of topics included in the Issues and Decision Memorandum is included as an Appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at 
                    <E T="03">https://access.trade.gov.</E>
                     In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at 
                    <E T="03">http://enforcement.trade.gov/frn/.</E>
                </P>
                <P>
                    For the reasons set forth in the 
                    <E T="03">Preliminary Results</E>
                     and Commerce's analysis of the comments received, Commerce continues to find that Newlat has not provided sufficient evidence to demonstrate that the management, production facilities, supplier relationships, and customer base of Newlat, after the acquisition of Delverde, are materially similar to those of Delverde before Newlat's acquisition with respect to the production and sale of subject merchandise. Thus, Commerce continues to find that Newlat is not the successor-in-interest to Delverde. For the complete successor-in-interest analysis, refer to the Preliminary Decision Memorandum.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Cash Deposit Requirements</HD>
                <P>
                    As a result of this CCR, Newlat may not receive the company-specific weighted-average dumping margin previously determined for Delverde, but instead shall continue to be subject to the cash deposit rate currently in effect for Newlat, which is the all-others rate, 15.45 percent, as determined in the 
                    <E T="03">Section 129 Final.</E>
                    <SU>8</SU>
                    <FTREF/>
                     Further, as of the date of publication of these final results in the 
                    <E T="04">Federal Register</E>
                    , entries of the merchandise produced at the Delver
                    <E T="03">de facto</E>
                    ry shall be treated as entries attributable to Newlat that are subject to the cash deposit rate in effect for Newlat.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See Implementation of the Findings of the WTO Panel in US—Zeroing (EC): Notice of Determinations Under Section 129 of the Uruguay Round Agreements Act and Revocations and Partial Revocations of Certain Antidumping Duty Orders,</E>
                         86 FR 25261 (May 4, 2007) (
                        <E T="03">Section 129 Final</E>
                        ).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Administrative Protective Order</HD>
                <P>This notice serves as a reminder to parties subject to administrative protective orders (APOs) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.306. Timely written notification of the destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.</P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>We are issuing this determination and publishing these final results in accordance with sections 751(b)(1) and 777(i)(1) of the Act and 19 CFR 351.216(b), 351.221(b) and 351.221(c)(3).</P>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Christian Marsh,</NAME>
                    <TITLE>Acting Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Appendix</HD>
                <EXTRACT>
                    <HD SOURCE="HD1">List of Topics Discussed in the Issues and Decision Memorandum</HD>
                    <FP SOURCE="FP-2">I. Summary</FP>
                    <FP SOURCE="FP-2">II. Background</FP>
                    <FP SOURCE="FP-2">III. Scope of the Order</FP>
                    <FP SOURCE="FP-2">IV. Discussion of Interested Parties Comments</FP>
                    <FP SOURCE="FP1-2">Comment 1: Whether Newlat Has Met Commerce's Successor-In-Interest Criteria</FP>
                    <FP SOURCE="FP1-2">Comment 2: Relationship Between Delverde and Newlat</FP>
                    <FP SOURCE="FP1-2">Comment 3: Evidence Supports Commerce's Successor-In-Interest Finding</FP>
                    <FP SOURCE="FP-2">V. Recommendation</FP>
                </EXTRACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09866 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="24847"/>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[A-201-837; A-570-954]</DEPDOC>
                <SUBJECT>Certain Magnesia Carbon Bricks From Mexico and the People's Republic of China: Final Results of the Expedited Second Sunset Reviews of the Antidumping Duty Orders</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>As a result of these expedited sunset reviews, the Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) orders on certain magnesia carbon bricks (MCBs) from Mexico and the People's Republic of China (China) would be likely to lead to the continuation or recurrence of dumping at the levels indicated in the “Final Results of Review” section of this notice.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable May 10, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION:</HD>
                    <P>Amaris Wade, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3874.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On September 20, 2010, Commerce published the AD orders on MCBs from China and Mexico.
                    <SU>1</SU>
                    <FTREF/>
                     On January 4, 2021, Commerce published the notice of initiation of the second sunset reviews of the 
                    <E T="03">AD Orders,</E>
                     pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).
                    <SU>2</SU>
                    <FTREF/>
                     In January 2021, Commerce received notices of intent to participate within the 15-day deadline specified in 19 CFR 351.218(d)(1)(i) from the Magnesia Carbon Bricks Fair Trade Committee (the Committee), an association comprised of three U.S. producers of MCBs: Resco Products, Inc.; Magnesita Refractories Company; and HarbisonWalker International, Inc.
                    <SU>3</SU>
                    <FTREF/>
                     The Committee claimed interested party status under section 771(9)(E) of the Act, as each member of the Committee is a manufacturer of the domestic like product.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Certain Magnesia Carbon Bricks from Mexico and the People's Republic of China: Antidumping Duty Orders,</E>
                         75 FR 57257 (September 20, 2010) (
                        <E T="03">AD Orders</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See Initiation of Five-Year (Sunset) Reviews,</E>
                         86 FR 60 (January 4, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Committee's Letter, “Domestic Industry's Notice of Intent To Participate In Sunset Review,” dated January 14, 2021; 
                        <E T="03">see also</E>
                         “Domestic Industry's Notice of Intent To Participate In Sunset Review,” dated January 14, 2021.
                    </P>
                </FTNT>
                <P>
                    On February 2, 2021, Commerce received adequate substantive responses to the notice of initiation from the Committee within the 30-day deadline specified in 19 CFR 351.218(d)(3).
                    <SU>4</SU>
                    <FTREF/>
                     We received no substantive response from respondent interested parties with respect to either of the orders covered by these sunset reviews.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Committee's Letter, “Domestic Industry's Substantive Response,” dated February 2, 2021; 
                        <E T="03">see also</E>
                         Committee's Letter, “Domestic Industry's Substantive Response,” dated February 2, 2021.
                    </P>
                </FTNT>
                <P>
                    On February 22, 2021, Commerce notified the U.S. International Trade Commission that it did not receive an adequate substantive response from respondent interested parties.
                    <SU>5</SU>
                    <FTREF/>
                     As a result, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), Commerce conducted expedited (120-day) sunset reviews of the 
                    <E T="03">AD Orders.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Commerce's Letter, “Sunset Reviews Initiated on January 4, 2021,” dated February 22, 2021.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Scope of the Orders</HD>
                <P>The scope of these orders includes certain chemically-bonded (resin or pitch), magnesia carbon bricks with a magnesia component of at least 70 percent magnesia (MgO) by weight, regardless of the source of raw materials for the MgO, with carbon levels ranging from trace amounts to 30 percent by weight, regardless of enhancements (for example, magnesia carbon bricks can be enhanced with coating, grinding, tar impregnation or coking, high temperature heat treatments, anti-slip treatments or metal casing) and regardless of whether or not antioxidants are present (for example, antioxidants can be added to the mix from trace amounts to 15 percent by weight as various metals, metal alloys, and metal carbides).</P>
                <P>Certain magnesia carbon bricks that are the subject of these orders are currently classifiable under subheadings 6902.10.1000, 6902.10.5000, 6815.91.0000, 6815.99.2000 and 6815.99.4000 of the Harmonized Tariff Schedule of the United States (HTSUS). While HTSUS subheadings are provided for convenience and customs purposes, the written description is dispositive.</P>
                <HD SOURCE="HD1">Analysis of Comments Received</HD>
                <P>
                    All issues raised in these sunset reviews are addressed in the Issues and Decision Memorandum.
                    <SU>6</SU>
                    <FTREF/>
                     The issues discussed in the Issues and Decision Memorandum are the likelihood of continuation or recurrence of dumping and the magnitude of the dumping margin likely to prevail if the orders were revoked. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at 
                    <E T="03">http://access.trade.gov.</E>
                     A list of topics discussed in the Issues and Decision Memorandum is included as an appendix to this notice. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the internet at 
                    <E T="03">http://enforcement.trade.gov/frn.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Issues and Decision Memorandum for the Expedited Second Sunset Reviews of the Antidumping Duty Orders on Certain Magnesia Carbon Bricks from Mexico and the People's Republic of China,” dated concurrently with, and hereby adopted by, this notice (Issues and Decision Memorandum).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Final Results of Reviews</HD>
                <P>
                    Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, Commerce determines that revocation of the 
                    <E T="03">AD Orders</E>
                     would be likely to lead to the continuation or recurrence of dumping at weighted-average dumping margins up to 236 percent for China and up to 57.90 percent for Mexico.
                </P>
                <HD SOURCE="HD1">Administrative Protective Order (APO)</HD>
                <P>This notice also serves as the only reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective orders is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.</P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>We are issuing and publishing the final results and this notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act, and 19 CFR 351.218.</P>
                <SIG>
                    <DATED>Dated: May 3, 2021.</DATED>
                    <NAME>Christian Marsh,</NAME>
                    <TITLE>Acting Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
                <APPENDIX>
                    <HD SOURCE="HED">Appendix</HD>
                    <HD SOURCE="HD1">List of Topics Discussed in the Issues and Decision Memorandum</HD>
                    <FP SOURCE="FP-2">I. Summary</FP>
                    <FP SOURCE="FP-2">II. Background</FP>
                    <FP SOURCE="FP-2">III. Scope of the Orders</FP>
                    <FP SOURCE="FP-2">IV. History of the Orders</FP>
                    <FP SOURCE="FP-2">V. Legal Framework</FP>
                    <FP SOURCE="FP-2">
                        VI. Discussion of the Issues
                        <PRTPAGE P="24848"/>
                    </FP>
                    <FP SOURCE="FP1-2">1. Likelihood of Continuation or Recurrence of Dumping</FP>
                    <FP SOURCE="FP1-2">2. Magnitude of the Dumping Margins Likely to Prevail</FP>
                    <FP SOURCE="FP-2">VII. Final Results of Sunset Reviews</FP>
                    <FP SOURCE="FP-2">VIII. Recommendation</FP>
                </APPENDIX>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09801 Filed 5-7-21; 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>
                <DEPDOC>[C-570-955]</DEPDOC>
                <SUBJECT>Certain Magnesia Carbon Bricks From the People's Republic of China: Final Results of the Expedited Second Five-Year Sunset Review of the Countervailing Duty Order</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>As a result of this sunset review, the Department of Commerce (Commerce) finds that revocation of the countervailing duty (CVD) order on certain magnesia carbon bricks (bricks) from the People's Republic of China (China) would be likely to lead to continuation or recurrence of countervailable subsidies at the levels indicated in the “Final Results of Review” section of this notice.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable May 10, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Mark Hoadley, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3148.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On September 21, 2010, Commerce published its CVD order on bricks from China in the 
                    <E T="04">Federal Register</E>
                    .
                    <SU>1</SU>
                    <FTREF/>
                     On January 4, 2021, Commerce published the notice of initiation of the second sunset review of the 
                    <E T="03">Order,</E>
                     pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).
                    <SU>2</SU>
                    <FTREF/>
                     Commerce received a notice of intent to participate from Magnesia Carbon Bricks Fair Trade Committee (the Committee), an 
                    <E T="03">ad hoc</E>
                     association of U.S. producers of magnesia carbon bricks, within the deadline specified in 19 CFR 351.218(d)(1)(i).
                    <SU>3</SU>
                    <FTREF/>
                     The Committee claimed interested party status under section 771(9)(E) of the Act, as a trade or business association a majority of whose members manufacture, produce, or wholesale a domestic like product in the United States and stated that each member of the Committee is a manufacturer of the domestic like product and thus, are domestic interested parties pursuant to section 771(9)(C) of the Act.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Certain Magnesia Carbon Bricks from the People's Republic of China: Countervailing Duty Order,</E>
                         75 FR 57442 (September 21, 2010) (
                        <E T="03">Order</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See Initiation of Five-Year (Sunset) Review,</E>
                         86 FR 60 (January 4, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Committee's Letter, “Second Five-Year (“Sunset”) Review the Countervailing Duty Order On Magnesia Carbon Bricks From The People's Republic of China: Domestic Industry's Notice Of Intent To Participate In Sunset Review,” dated January 14, 2021.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    Commerce received a substantive response from the Committee 
                    <SU>5</SU>
                    <FTREF/>
                     within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). We received no substantive response from any other domestic or interested parties in this proceeding, nor was a hearing requested.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Committee's Letter, “Second Five-Year (Sunset) Review of the Countervailing Duty Order On Magnesia Carbon Bricks From The People's Republic Of China: Domestic Industry's Substantive Response,” dated February 2, 2021.
                    </P>
                </FTNT>
                <P>
                    On February 22, 2021, Commerce notified the U.S. International Trade Commission (ITC) that it did not receive an adequate substantive response from respondent interested parties.
                    <SU>6</SU>
                    <FTREF/>
                     As a result, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), Commerce conducted an expedited (120-day) sunset review of this 
                    <E T="03">Order.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         Commerce's Letter, “Sunset Reviews Initiated on January 4, 2021,” dated February 22, 2021.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Scope of the Order</HD>
                <P>
                    The merchandise subject to this 
                    <E T="03">Order</E>
                     includes certain chemically-bonded (resin or pitch), magnesia carbon bricks. Certain magnesia carbon bricks that are the subject of this order are currently classifiable under subheadings 6902.10.1000, 6902.10.5000, 6815.91.0000, 6815.99.2000 and 6815.99.4000 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the merchandise covered by the scope of the 
                    <E T="03">Order</E>
                     is dispositive. For a complete description of the scope of the 
                    <E T="03">Order, see</E>
                     the accompanying Issues and Decision Memorandum.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         Memorandum, “Issues and Decision Memorandum for the Expedited Second Sunset Review of the Countervailing Duty Order on Magnesia Carbon Bricks from the People's Republic of China,” dated concurrently with, and hereby adopted by, this notice (Issues and Decision Memorandum).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Analysis of Comments Received</HD>
                <P>
                    All issues raised in this sunset review are addressed in the Issues and Decision Memorandum. A list of topics discussed in the Issues and Decision Memorandum is included as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via the Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at 
                    <E T="03">http://access.trade.gov.</E>
                     In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the internet at 
                    <E T="03">http://enforcement.trade.gov/frn/.</E>
                </P>
                <HD SOURCE="HD1">Final Results of Sunset Review</HD>
                <P>Pursuant to sections 751(c)(1) and 752(b) of the Act, we determine that revocation of the CVD order on bricks from China would be likely to lead to continuation or recurrence of countervailable subsidies at the following rates:</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s150,15">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Manufacturers/producers/exporters</CHED>
                        <CHED H="1">
                            Net countervailable subsidy
                            <LI>(percent)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">RHI Refractories Liaoning Co., Ltd. (RHIL), RHI Refractories (Dailian) Co., Ltd. (RHID), and Liaoning RHI Jinding Magnesia Co., Ltd. (RHIJ) (collectively, RHI)</ENT>
                        <ENT>3.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Liaoning Mayerton Refractories (LMR) and Dalian Mayerton Refractories Co. Ltd. (DMR) (collectively, Mayerton)</ENT>
                        <ENT>253.87</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">All Others</ENT>
                        <ENT>3.00</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="24849"/>
                <HD SOURCE="HD1">Administrative Protective Order (APO)</HD>
                <P>This notice also serves as the only reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.</P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>We are issuing and publishing the final results and this notice in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act, and 19 CFR 351.218.</P>
                <SIG>
                    <DATED>Dated: May 3, 2021.</DATED>
                    <NAME>Christian Marsh,</NAME>
                    <TITLE>Acting Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
                <APPENDIX>
                    <HD SOURCE="HED">Appendix</HD>
                    <HD SOURCE="HD1">List of Topics Discussed in the Issues and Decision Memorandum</HD>
                    <FP SOURCE="FP-2">I. Summary</FP>
                    <FP SOURCE="FP-2">II. Background</FP>
                    <FP SOURCE="FP-2">III. History of the Order</FP>
                    <FP SOURCE="FP-2">IV. Scope of the Order</FP>
                    <FP SOURCE="FP-2">V. Legal Framework</FP>
                    <FP SOURCE="FP-2">VI. Discussion of the Issues</FP>
                    <FP SOURCE="FP1-2">1. Likelihood of Continuation or Recurrence of a Countervailable Subsidy</FP>
                    <FP SOURCE="FP1-2">2. Net Countervailable Subsidy Rates Likely to Prevail</FP>
                    <FP SOURCE="FP1-2">3. Nature of the Subsidies</FP>
                    <FP SOURCE="FP-2">VII. Final Results of Sunset Review</FP>
                    <FP SOURCE="FP-2">VIII. Recommendation</FP>
                </APPENDIX>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09802 Filed 5-7-21; 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>
                <DEPDOC>[A-552-818]</DEPDOC>
                <SUBJECT>Certain Steel Nails From the Socialist Republic of Vietnam: Rescission of Antidumping Duty Administrative Review; 2019-2020</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Commerce (Commerce) is rescinding its administrative review of the antidumping duty (AD) order on certain steel nails from the Socialist Republic of Vietnam (Vietnam) for the period of review (POR) July 1, 2019, through June 30, 2020.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable May 10, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Mark Flessner, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6312.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On July 1, 2020, Commerce published in the 
                    <E T="04">Federal Register</E>
                     a notice of opportunity to request an administrative review of the AD order 
                    <SU>1</SU>
                    <FTREF/>
                     on certain steel nails from Vietnam for the POR.
                    <SU>2</SU>
                    <FTREF/>
                     On July 31, 2020, Commerce received a timely request from Mid Continent Steel &amp; Wire, Inc. (the petitioner), in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b), to conduct an administrative review of this AD order for 23 companies.
                    <SU>3</SU>
                    <FTREF/>
                     No other party requested an administrative review.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Certain Steel Nails from the Republic of Korea, Malaysia, the Sultanate of Oman, Taiwan, and the Socialist Republic of Vietnam: Antidumping Duty Orders,</E>
                         80 FR 39994 (July 13, 2015).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review,</E>
                         85 FR 39531 (July 1, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Petitioner's Letter, “Certain Steel Nails from SR of Vietnam: Request for Administrative Review,” dated July 31, 2020. There were 24 listings in this letter, but one company, Top Shipping Company Limited, was listed twice; consequently, only 23 individual companies were named.
                    </P>
                </FTNT>
                <P>
                    On September 3, 2020, Commerce published in the 
                    <E T="04">Federal Register</E>
                     a notice of initiation with respect to the following 23 companies:
                </P>
                <FP SOURCE="FP-2">1. Atlantic Manufacture Inc.</FP>
                <FP SOURCE="FP-2">2. Chia Pao Metal Co., Ltd.</FP>
                <FP SOURCE="FP-2">3. Delmar International (Vietnam) Ltd.</FP>
                <FP SOURCE="FP-2">4. Dicha Sombrilla Co., Ltd.</FP>
                <FP SOURCE="FP-2">5. Easylink Industrial Co., Ltd.</FP>
                <FP SOURCE="FP-2">6. Expeditors Vietnam Company Limited</FP>
                <FP SOURCE="FP-2">7. Gia Linh Logistics Services Co., Ltd.</FP>
                <FP SOURCE="FP-2">8. Global Logistics Solution Co., Ltd.</FP>
                <FP SOURCE="FP-2">9. Inmax Industries SDN. BHD</FP>
                <FP SOURCE="FP-2">10. Jinhai Hardware Co., Ltd.</FP>
                <FP SOURCE="FP-2">11. K-Apex Logistics (HK) Co., Limited</FP>
                <FP SOURCE="FP-2">12. KPF Vietnam Co., Ltd.</FP>
                <FP SOURCE="FP-2">13. KPF Vina Co., Ltd.</FP>
                <FP SOURCE="FP-2">14. Orient Star Transport Int'l Ltd.</FP>
                <FP SOURCE="FP-2">15. Oriental Multiple Enterprise Ltd.</FP>
                <FP SOURCE="FP-2">16. Pudong Prime Int'l Logistics Inc.</FP>
                <FP SOURCE="FP-2">17. Region Industries Co., Ltd.</FP>
                <FP SOURCE="FP-2">18. Rich State, Inc.</FP>
                <FP SOURCE="FP-2">19. Top Shipping Company Limited</FP>
                <FP SOURCE="FP-2">20. Topy Fasteners Vietnam Co., Ltd.</FP>
                <FP SOURCE="FP-2">21. Truong Vinh Ltd.</FP>
                <FP SOURCE="FP-2">22. United Nail Products Co., Ltd.</FP>
                <FP SOURCE="FP-2">
                    23. Vina Hardwares Joint Stock Company 
                    <SU>4</SU>
                    <FTREF/>
                </FP>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See Initiation of Antidumping and Countervailing Duty Administrative Reviews,</E>
                         85 FR 54983 (September 3, 2020).
                    </P>
                </FTNT>
                <P>
                    On September 24, 2020, the petitioner timely withdrew its request for an administrative review for all 23 companies.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Petitioner's Letter, “Certain Steel Nails from Vietnam—Withdrawal of Request for Administrative Review,” dated September 24, 2020.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Rescission of Administrative Review</HD>
                <P>Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation of the requested review. The petitioner withdrew its request for review for all companies by the 90-day deadline, and no other party requested an administrative review of this order. Therefore, we are rescinding the administrative review of the AD order on certain steel nails from Vietnam covering the period July 1, 2019, through June 30, 2020, in its entirety.</P>
                <HD SOURCE="HD1">Assessment</HD>
                <P>
                    Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Consistent with its recent notice,
                    <SU>6</SU>
                    <FTREF/>
                     Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the 
                    <E T="04">Federal Register</E>
                    . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired (
                    <E T="03">i.e.,</E>
                     within 90 days of publication).
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See Notice of Discontinuation of Policy to Issue Liquidation Instructions After 15 Days in Applicable Antidumping and Countervailing Duty Administrative Proceedings,</E>
                         86 FR 3995 (January 15, 2021).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Notification to Importers</HD>
                <P>
                    This notice serves as the only reminder to importers of their responsibility, under 19 CFR 351.402(f)(2), to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement may result in the presumption that reimbursement of antidumping duties occurred and the 
                    <PRTPAGE P="24850"/>
                    subsequent assessment of double antidumping duties.
                </P>
                <HD SOURCE="HD1">Notification Regarding Administrative Protective Orders</HD>
                <P>This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.</P>
                <P>This notice is published in accordance with section 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).</P>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>James Maeder,</NAME>
                    <TITLE>Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09803 Filed 5-7-21; 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>
                <DEPDOC>[A-570-945, C-570-946]</DEPDOC>
                <SUBJECT>Prestressed Concrete Steel Wire Strand From the People's Republic of China: Continuation of Antidumping and Countervailing Duty Orders</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>As a result of the determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) and countervailing duty (CVD) orders on prestressed concrete steel wire strand (PC strand) from the People's Republic of China (China) would likely lead to a continuation or recurrence of dumping, net countervailable subsidies, and material injury to an industry in the United States, Commerce is publishing a notice of continuation of the AD and CVD orders.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Applicable Date:</E>
                         Applicable May 10, 2021.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Emily Halle (AD Order) or John Hoffner (CVD Order), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0176 or (202) 482-3315, respectively.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On September 1, 2020, the ITC instituted,
                    <SU>1</SU>
                    <FTREF/>
                     and Commerce initiated,
                    <SU>2</SU>
                    <FTREF/>
                     the second sunset reviews of the AD and CVD orders on PC strand from China,
                    <SU>3</SU>
                    <FTREF/>
                     pursuant to section 751(c) of the Tariff Act of 1930 as amended (the Act). As a result of its reviews, Commerce determined that revocation of the 
                    <E T="03">Orders</E>
                     would likely lead to continuation or recurrence of dumping and of net countervailable subsidies and, therefore, Commerce notified the ITC of the magnitude of the margin of dumping and subsidy rates likely to prevail should the 
                    <E T="03">Orders</E>
                     be revoked, pursuant to sections 751(c)(1) and 752(b) and (c) of the Act.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Prestressed Concrete Steel Wire Strand from China; Institution of Five-Year Reviews,</E>
                         85 FR 54401 (September 1, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See Initiation of Five-Year (Sunset) Reviews,</E>
                         85 FR 54348 (September 1, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See Notice of Antidumping Duty Order: Prestressed Concrete Steel Wire Strand from the People's Republic of China,</E>
                         75 FR 37382 (June 29, 2010); and 
                        <E T="03">Prestressed Concrete Steel Wire Strand from the People's Republic of China: Notice of Amended Final Affirmative Countervailing Duty Determination and Notice of Countervailing Duty Order,</E>
                         75 FR 38977 (July 7, 2010) (collectively, 
                        <E T="03">Orders</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See Prestressed Concrete Steel Wire Strand from the People's Republic of China: Final Results of the Expedited Second Sunset Review of the Antidumping Duty Order</E>
                        , 85 FR 86908 (December 31, 2020); and 
                        <E T="03">Final Results of Expedited Sunset Review of Countervailing Duty Order: Prestressed Concrete Steel Wire Strand From the People's Republic of China,</E>
                         86 FR 86904 (December 31, 2020).
                    </P>
                </FTNT>
                <P>
                    On May 4, 2021, the ITC published its determination, pursuant to sections 751(c) and 752(a) of the Act, that revocation of the 
                    <E T="03">Orders</E>
                     would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See Prestressed Concrete Steel Wire Strand from China,</E>
                         86 FR 23739 (May 4, 2021).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Scope of the Orders</HD>
                <P>
                    The product covered by the 
                    <E T="03">Orders</E>
                     is PC strand, produced from wire of non-stainless, non-galvanized steel, which is suitable for use in prestressed concrete (both pretensioned and post-tensioned) applications. The product definition encompasses covered and uncovered strand and all types, grades, and diameters of PC strand. PC strand is normally sold in the United States in sizes ranging from 0.25 inches to 0.70 inches in diameter. PC strand made from galvanized wire is only excluded from the scope if the zinc and/or zinc oxide coating meets or exceeds the 0.40 oz./ft2 standard set forth in ASTM-A-475. Imports of the subject merchandise are currently classifiable under subheadings 7312.10.3010 and 7312.10.3012 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of these orders is dispositive.
                </P>
                <HD SOURCE="HD1">Continuation of the Orders</HD>
                <P>
                    As a result of the determinations by Commerce and the ITC that revocation of the 
                    <E T="03">Orders</E>
                     would likely lead to a continuation or a recurrence of dumping and net countervailable subsidies, as well as material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), Commerce hereby orders the continuation of the 
                    <E T="03">Orders</E>
                     on PC strand from China.
                </P>
                <P>
                    U.S. Customs and Border Protection will continue to collect AD and CVD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of the continuation of the 
                    <E T="03">Orders</E>
                     will be the date of publication in the 
                    <E T="04">Federal Register</E>
                     of this notice of continuation. Pursuant to section 751(c)(2) of the Act and 19 CFR 351.218(c)(2), Commerce intends to initiate the next five-year reviews of the 
                    <E T="03">Orders</E>
                     not later than 30 days prior to the fifth anniversary of the effective date of continuation.
                </P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>These five-year sunset reviews and this notice are in accordance with sections 751(c) and 751(d)(2) of the Act and published in accordance with section 777(i)(1) of the Act and 19 CFR 351.218(f)(4).</P>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Christian Marsh,</NAME>
                    <TITLE>Acting Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09841 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XB055]</DEPDOC>
                <SUBJECT>Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to the North Jetty Maintenance and Repairs Project in Coos Bay, Oregon</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <PRTPAGE P="24851"/>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; issuance of incidental harassment authorization.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS has received a request from the U.S. Army Corps of Engineers (USACE) for the re-issuance of a previously issued incidental harassment authorization (IHA) with the only change being effective dates. The initial IHA authorized take of seven species of marine mammals, by Level B harassment only, incidental to construction associated with the Coos Bay North Jetty maintenance and repairs project in Coos Bay, Oregon. The project has been delayed and none of the work covered in the initial IHA has been conducted. The initial IHA was effective from September 1, 2020, through August 31, 2021. The USACE has requested re-issuance with new effective dates of September 1, 2021, through August 31, 2022. The scope of the activities and anticipated effects remain the same, authorized take numbers are not changed, and the required mitigation, monitoring, and reporting remains the same as included in the initial IHA. NMFS is, therefore, issuing a second identical IHA to cover the incidental take analyzed and authorized in the initial IHA.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This authorization is effective from September 1, 2021 through August 31, 2022.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        An electronic copy of the final 2020 IHA previously issued to the USACE, the USACE's application, and the 
                        <E T="04">Federal Register</E>
                         notices proposing and issuing the initial IHA may be obtained by visiting 
                        <E T="03">https://www.fisheries.noaa.gov/action/incidental-take-authorization-us-army-corps-engineers-north-jetty-maintenance-and-repairs.</E>
                         In case of problems accessing these documents, please call the contact listed below (see 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        ).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Amy Fowler, Office of Protected Resources, NMFS, (301) 427-8401.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Sections 101(a)(5)(A) and (D) of the Marine Mammal Protection Act (MMPA; 16 U.S.C. 1361 
                    <E T="03">et seq.</E>
                    ) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.
                </P>
                <P>An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.</P>
                <P>NMFS has defined “negligible impact” 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>
                <P>The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.</P>
                <P>Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).</P>
                <HD SOURCE="HD1">Summary of Request</HD>
                <P>
                    On March 18, 2019, NMFS received a request from USACE for two IHAs to take marine mammals incidental to vibratory pile driving and removal associated with the North Jetty maintenance and repairs project, Coos Bay, Oregon over the course of two years with pile installation occurring during Year 1 and pile removal occurring during Year 2. The application was deemed adequate and complete on September 10, 2019. The USACE's request was for take of a small number of seven species of marine mammals by Level B harassment only. Neither USACE nor NMFS expects injury, serious injury or mortality to result from this activity and, therefore, IHAs are appropriate. The USACE, in coordination with the Oregon Department of Fish and Wildlife (ODFW) and NMFS' Northwest Region, plans to conduct pile driving and removal October 1st through February 15th and June 1st and July 31st to minimize effects to listed salmonids. Adherence to the in-water work window is part of USACE's Endangered Species Act (ESA) consultation under Standard Local Operating Procedures for Endangered Species (SLOPES) to administer actions authorized or carried out by the USACE in Oregon (SLOPES IV In-water Over-water Structures). The ODFW will make the final determination of the in-water work window. On January 3, 2020, NMFS issued the two IHAs to the USACE. The Year 1 IHA was effective from September 1, 2020 through August 31, 2021 and the Year 2 IHA was effective July 1, 2022 through June 30, 2023. On February 20, 2021, the USACE notified NMFS that the project had been delayed. None of the work identified in the year 1 IHA (
                    <E T="03">e.g.,</E>
                     pile installation) has occurred. The USACE submitted a request for a new identical IHA for Year 1 of construction that would be effective from September 1, 2021 through August 31, 2022, in order to conduct the construction work that was analyzed and authorized through the previously issued IHA (hereafter referred to as the initial IHA). Therefore, re-issuance of the IHA is appropriate.
                </P>
                <HD SOURCE="HD1">Summary of Specified Activity and Anticipated Impacts</HD>
                <P>The planned activities (including mitigation, monitoring, and reporting), authorized incidental take, and anticipated impacts on the affected stocks are the same as those analyzed and authorized through the previously issued IHA.</P>
                <P>The purpose of the USACE's construction project is to repair critically damaged sections of the Coos Bay North Jetty, monitor erosion, and to maintain stable deep-draft navigation through the entrance into Coos Bay. Repair activities completed now will reduce the risk of jetty failure or a potential breach of the Coos Bay North Spit (CBNS). The USACE maintains this jetty system and navigational channels, and is planning on conducting major repairs and rehabilitation of the North Jetty. The location, timing, and nature of the activities, including the types of equipment planned for use, are identical to those described in the initial IHA. The mitigation and monitoring are also as prescribed in the initial IHA.</P>
                <P>
                    Species that are expected to be taken by the planned activity include the harbor seal (
                    <E T="03">Phoca vitulina</E>
                    ), northern elephant seal (
                    <E T="03">Mirounga angustirostris</E>
                    ), Steller sea lion (
                    <E T="03">Eumetopias jubatus</E>
                    ), California sea lion (
                    <E T="03">Zalophus californianus</E>
                    ), gray whale (
                    <E T="03">Eschrichtius robustus</E>
                    ), harbor porpoise (
                    <E T="03">Phocoena phocoena</E>
                    ), and killer whale (
                    <E T="03">Orcinus orca</E>
                    ). A description of the methods and inputs used to estimate take anticipated to occur and, ultimately, the take that 
                    <PRTPAGE P="24852"/>
                    was authorized is found in the previous documents referenced above. The data inputs and methods of estimating take are identical to those used in the initial IHA. NMFS has reviewed recent Stock Assessment Reports, information on relevant Unusual Mortality Events, and recent scientific literature, and determined that no new information affects our original analysis of impacts or take estimate under the initial IHA.
                </P>
                <P>
                    We refer to the documents related to the initial IHA, which include the 
                    <E T="04">Federal Register</E>
                     notice of the issuance of the initial Year 1 and Year 2 IHAs for the USACE's construction work (85 FR 1140; January 9, 2020), the USACE's application, the 
                    <E T="04">Federal Register</E>
                     notice of the proposed IHAs (84 FR 56781; October 23, 2019), and all associated references and documents.
                </P>
                <HD SOURCE="HD1">Determinations</HD>
                <P>The USACE will conduct activities as analyzed in the initial IHA. As described above, the number of authorized takes of the same species and stocks of marine mammals are identical to the numbers that were found to meet the negligible impact and small numbers standards and authorized under the initial IHA and no new information has emerged that would change those findings. The re-issued Year 1 IHA includes identical required mitigation, monitoring, and reporting measures as the initial IHA, and there is no new information suggesting that our analysis or findings should change.</P>
                <P>Based on the information contained here and in the referenced documents, NMFS has determined the following: (1) The required mitigation measures will effect the least practicable impact on marine mammal species or stocks and their habitat; (2) the authorized takes will have a negligible impact on the affected marine mammal species or stocks; (3) the authorized takes represent small numbers of marine mammals relative to the affected stock abundances; and (4) the USACE's activities will not have an unmitigable adverse impact on taking for subsistence purposes as no relevant subsistence uses of marine mammals are implicated by this action.</P>
                <HD SOURCE="HD1">National Environmental Policy Act</HD>
                <P>
                    To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action with respect to environmental consequences on the human environment.
                </P>
                <P>Accordingly, NMFS has determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review. This action is consistent with categories of activities identified in CE B4 of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion.</P>
                <HD SOURCE="HD1">Endangered Species Act (ESA)</HD>
                <P>
                    Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS consults internally whenever we propose to authorize take for endangered or threatened species.
                </P>
                <P>However, no incidental take of ESA-listed species is authorized or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.</P>
                <HD SOURCE="HD1">Authorization</HD>
                <P>NMFS has issued an IHA to the USACE for in-water construction activities associated with the specified activity from September 1, 2021 through August 31, 2022. All previously described mitigation, monitoring, and reporting requirements from the initial Year 1 IHA are incorporated.</P>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <NAME>Catherine Marzin,</NAME>
                    <TITLE>Acting Director, Office of Protected Resources, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09867 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Patent and Trademark Office</SUBAGY>
                <DEPDOC>[Docket No. PTO-P-2021-0027]</DEPDOC>
                <SUBJECT>Grant of Interim Extension of the Term of U.S. Patent No. 9,364,354; Reducer®</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States Patent and Trademark Office, Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of interim patent term extension.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The United States Patent and Trademark Office has issued an order granting interim extension for a one-year interim extension of the term of U.S. Patent No. 9,364,354.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ali Salimi by telephone at (571) 272-0909; by mail marked to his attention and addressed to the Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 22313-1450; by fax marked to his attention at (571) 273-0909; or by email to 
                        <E T="03">ali.salimi@uspto.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 156 of Title 35, United States Code, generally provides that the term of a patent may be extended for a period of up to five years if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review, and that the patent may be extended for interim periods of up to one year if the regulatory review is anticipated to extend beyond the expiration date of the patent.</P>
                <P>On April 20, 2021, Neovasc Medical Ltd., the patent owner of record, timely filed an application under 35 U.S.C. 156(d)(5) for a second interim extension of the term of U.S. Patent No. 9,364,354. The patent claims the catheter implantable device, Reducer®. The application for patent term extension indicates that a Premarket Approval Application (PMA) P190035 was submitted to the Food and Drug Administration (FDA) on December 31, 2019.</P>
                <P>Review of the patent term extension application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Because the regulatory review period will continue beyond the once-extended expiration date of the patent, June 6, 2021, a second interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.</P>
                <P>A second interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 9,364,354 is granted for a period of one year from the once-extended expiration date of the patent.</P>
                <SIG>
                    <NAME>Robert Bahr,</NAME>
                    <TITLE>Deputy Commissioner for Patents, United States Patent and Trademark Office.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09846 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-16-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="24853"/>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <DEPDOC>[Docket No. ED-2021-SCC-0071]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Comment Request; Rural, Insular, Native Achievement Programs (RINAP) Progress Update—Outlying Areas and the Republic of Palau</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Elementary and Secondary Education (OESE), 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 requesting the Office of Management and Budget (OMB) to conduct an emergency review of a new information collection.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Department has requested emergency processing from OMB for this information collection request by May 31, 2021; and therefore, request interested persons to submit comments by May 26, 2021. The regular clearance process is also being initiated to provide the public with the opportunity to comment under the full comment period. Interested persons are invited to submit comments on or before July 9, 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-0071. 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 regulations.gov 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 Joanne Osborne, 202-401-1265.</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>
                     Rural, Insular, Native Achievement Programs (RINAP) Progress Update—Outlying Areas and the Republic of Palau
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1810-NEW.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     A new information 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>
                     52.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     52.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The Rural, Insular, and Native Achievement Program (RINAP), within the Office of Elementary and Secondary Education (OESE), part of the U.S. Department of Education (ED), seeks emergency approval from OMB for its progress update protocol for the Outlying Areas and the Republic of Palau. RINAP administers Section 1121 of Title I, Part A of the ESEA; Title II of Public Law 108-118 (Supplemental Education Grant (SEG)), CARES Act—Outlying Areas; Title III of CRRSA—Outlying Areas, Sections 2005 and 11006(2-3) of the ARP; Title V, Part B of the ESEA (Rural Education Achievement Program), Title VI, Part B of the ESEA (Native Hawaiian Education); and Title VI, Part C of the ESEA (Alaska Native Education). Periodic progress updates, phone, virtual, or in-person conversations during a fiscal year with authorized representatives and project directors help ensure grantees are making progress toward meeting program goals and objectives. The information shared with RINAP helps inform the selection and delivery of technical assistance to grantees and aligns structures, processes, and routines so RINAP can monitor the connection between grant administration and intended outcomes.
                </P>
                <P>
                    <E T="03">Additional Information:</E>
                     If this collection is not allowed to proceed, ED will not be able to fulfill its oversight responsibilities under 2 CFR 200.207 and 2 CFR 3474.10. Three of the four Outlying Areas have been designated for high-risk status for over ten years resulting in ED's need to more routinely monitor grantee progress and program implementation. The Risk Management Services Division of the Office of Grants Administration has determined that all ED grants awarded to the State education agency in each Outlying Area are subject to Departmental Specific Conditions applicable to that Outlying Area. In addition, two Outlying Areas are each required to have a third-party fiduciary agent to manage ED funds. Given that the funds have already been awarded to the Outlying Areas, the need for immediate and frequent monitoring and technical assistance is critical to ensure that the funds are used in accordance with grant award assurances and conditions.
                </P>
                <SIG>
                    <DATED>Dated: May 5, 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. 2021-09847 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF ENERGY</AGENCY>
                <SUBJECT>Environmental Management Site-Specific Advisory Board, Paducah; Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Environmental Management, Department of Energy.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of open virtual meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This notice announces an online virtual meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act requires that public notice of this online virtual meeting be announced in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </SUM>
                <DATES>
                    <PRTPAGE P="24854"/>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Thursday, June 17, 2021; 5:30 p.m.-7:00 p.m.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Online Virtual Meeting. To attend, please send an email to the Federal Coordinator, Robert Smith, at 
                        <E T="03">robert.smith@pppo.gov</E>
                         by no later than 5:00 p.m. CDT on Monday, June 14, 2021.
                    </P>
                    <P>
                        <E T="03">To Submit Public Comments:</E>
                         Public comments will be accepted via email prior to and after the meeting. Comments received by no later than 5:00 p.m. CDT on Monday, June 14, 2021 will be read aloud during the virtual meeting. Comments will also be accepted after the meeting, by no later than 5:00 p.m. CDT on Friday, June 25, 2021. Please submit comments to 
                        <E T="03">robert.smith@pppo.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Robert Smith, Federal Coordinator, by Phone: (270) 441-6821 or Email: 
                        <E T="03">robert.smith@pppo.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Purpose of the Board:</E>
                     The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.
                </P>
                <P>
                    <E T="03">Tentative Agenda:</E>
                </P>
                <P>• Review of Agenda</P>
                <P>• Administrative Issues</P>
                <P>• Reading of Public Comments</P>
                <P>
                    <E T="03">Public Participation:</E>
                     The online virtual meeting is open to the public. Written statements may be filed with the Board either before or after the meeting as there will not be opportunities for live public comment during this online virtual meeting. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to submit public comments should email them as directed above.
                </P>
                <P>
                    <E T="03">Minutes:</E>
                     Minutes will be available by writing or calling Robert Smith, Federal Coordinator, U.S. Department of Energy, 5507 Hobbs Rd., Kevil, KY 42053; Phone: (270) 441-6821. Minutes will also be available at the following website: 
                    <E T="03">https://www.energy.gov/pppo/pgdp-cab/listings/meeting-materials.</E>
                </P>
                <SIG>
                    <DATED>Signed in Washington, DC, on May 4, 2021.</DATED>
                    <NAME>LaTanya Butler,</NAME>
                    <TITLE>Deputy Committee Management Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09819 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6450-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBJECT>Agency Information Collection Extension</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. 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 Privacy Act Administration, OMB Control Number 1910-1700. The proposed collection will aid DOE's processing of Privacy Act requests submitted by an individual or an authorized representative, wherein he or she requests records that the government may maintain pertaining to that individual. The DOE's use of the form continues to contribute to DOE's Privacy Act processes, including, but not limited to, providing for faster processing of Privacy Act information requests by asking individuals or their authorized representatives for pertinent information needed for records retrieval.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments regarding this collection must be received on or before June 9, 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>
                        Ken Hunt, Chief Privacy Officer, U.S. Department of Energy, 19901 Germantown Road, Rm. G-302, Germantown, MD 20874 or by telephone at (301) 903-3880 or by facsimile at (301) 903-7738 or by email at 
                        <E T="03">privacyactoffice@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>
                     1910-1700; (2) 
                    <E T="03">Information Collection Request Title:</E>
                     Privacy Act Administration; (3) 
                    <E T="03">Type of Request:</E>
                     Renewal; (4) 
                    <E T="03">Purpose:</E>
                     The Privacy Act Information Request form aids DOE's processing of Privacy Act requests submitted by an individual or an authorized representative, wherein he or she requests records that the government may maintain pertaining to that individual. The DOE's use of its form continues to contribute to DOE's Privacy Act processes, including, but not limited to, providing for faster processing of Privacy Act Information requests by asking individuals or their authorized representatives for pertinent information needed for records retrieval; (5) 
                    <E T="03">Annual Estimated Number of Respondents:</E>
                     406; (6) 
                    <E T="03">Annual Estimated Number of Total Responses:</E>
                     406; (7) 
                    <E T="03">Annual Estimated Number of Burden Hours:</E>
                     135; (8) 
                    <E T="03">Annual Estimated Reporting and Recordkeeping Cost Burden:</E>
                     $7,973.
                </P>
                <P>
                    <E T="03">Statutory Authority:</E>
                     The Privacy Act of 1974, 5 U.S.C. 552(a); 10 CFR 1008.7; and DOE Order 206.1.
                </P>
                <P>
                    <E T="03">Signing Authority:</E>
                     This document of the Department of Energy was signed on April 7, 2021 by Emery Csulak, Acting Chief Information Officer, 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 May 5, 2021.</DATED>
                    <NAME>Treena V. Garrett,</NAME>
                    <TITLE>Federal Register Liaison Officer, U.S. Department of Energy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09812 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6450-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBJECT>Environmental Management Site-Specific Advisory Board, Oak Ridge; Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Environmental Management, Department of Energy.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of open virtual meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This notice announces an online virtual meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Oak Ridge. The Federal Advisory Committee Act requires that public notice of this online meeting be announced in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Wednesday, June 9, 2021; 6:00 p.m.-7:30 p.m.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Online Virtual Meeting. To attend, please send an email to: 
                        <E T="03">orssab@orem.doe.gov</E>
                         by no later than 5:00 p.m. EDT on Wednesday, June 2, 2021.
                    </P>
                    <P>
                        <E T="03">To Submit Public Comments:</E>
                         Public comments will be accepted via email 
                        <PRTPAGE P="24855"/>
                        prior to and after the meeting. Comments received by no later than 5:00 p.m. EDT on Wednesday, June 2, 2021 will be read aloud during the virtual meeting. Comments will also be accepted after the meeting, by no later than 5:00 p.m. EDT on Monday, June 14, 2021. Please submit comments to 
                        <E T="03">orssab@orem.doe.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Melyssa P. Noe, Alternate Deputy Designated Federal Officer, U.S. Department of Energy (DOE), Oak Ridge Office of Environmental Management (OREM), P.O. Box 2001, EM-942, Oak Ridge, TN 37831; Phone (865) 241-3315; or E-Mail: 
                        <E T="03">Melyssa.Noe@orem.doe.gov.</E>
                         Or visit the website at 
                        <E T="03">https://www.energy.gov/orem/services/community-engagement/oak-ridge-site-specific-advisory-board.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P SOURCE="NPAR">
                    <E T="03">Purpose of the Board:</E>
                     The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.
                </P>
                <HD SOURCE="HD1">Tentative Agenda</HD>
                <FP SOURCE="FP-1">• Comments from the Deputy Designated Federal Officer (DDFO)</FP>
                <FP SOURCE="FP-1">• Comments from the DOE, Tennessee Department of Environment and Conservation, and Environmental Protection Agency Liaisons</FP>
                <FP SOURCE="FP-1">• Presentation: Groundwater Remedies</FP>
                <FP SOURCE="FP-1">• Public Comment Period</FP>
                <FP SOURCE="FP-1">• Motions/Approval of May 12, 2021 Meeting Minutes</FP>
                <FP SOURCE="FP-1">• Status of Outstanding Recommendations</FP>
                <FP SOURCE="FP-1">• Alternate DDFO Report</FP>
                <FP SOURCE="FP-1">• Committee Reports</FP>
                <P>
                    <E T="03">Public Participation:</E>
                     The online meeting is open to the public. Written statements may be filed with the Board either before or after the meeting as there will not be opportunities for live public comment during this online virtual meeting. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to submit public comments should email them as directed above.
                </P>
                <P>
                    <E T="03">Minutes:</E>
                     Minutes will be available by writing or calling Melyssa P. Noe at the address and telephone number listed above. Minutes will also be available at the following website: 
                    <E T="03">https://www.energy.gov/orem/listings/oak-ridge-site-specific-advisory-board-meetings.</E>
                </P>
                <SIG>
                    <DATED>Signed in Washington, DC, on May 4, 2021.</DATED>
                    <NAME>LaTanya Butler,</NAME>
                    <TITLE>Deputy Committee Management Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09818 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6450-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBJECT>Environmental Management Site-Specific Advisory Board, Portsmouth; Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Environmental Management, Department of Energy.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of open virtual meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This notice announces an online virtual meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act requires that public notice of this online virtual meeting be announced in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Thursday, June 3, 2021; 6:00 p.m.-7:30 p.m.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Online Virtual Meeting. To attend, please send an email to the Federal Coordinator, Greg Simonton, at 
                        <E T="03">greg.simonton@pppo.gov</E>
                         by no later than 5:00 p.m. EDT on Monday, May 31, 2021.
                    </P>
                    <P>
                        <E T="03">To Submit Public Comments:</E>
                         Public comments will be accepted via email prior to and after the meeting. Comments received by no later than 5:00 p.m. EDT on Monday, May 31, 2021 will be read aloud during the virtual meeting. Comments will also be accepted after the meeting, by no later than 5:00 p.m. EDT on Friday, June 9, 2021. Please submit comments to 
                        <E T="03">greg.simonton@pppo.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Greg Simonton, Federal Coordinator, by Phone: (740) 897-3737 or Email: 
                        <E T="03">greg.simonton@pppo.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Purpose of the Board:</E>
                     The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.
                </P>
                <P>
                    <E T="03">Tentative Agenda:</E>
                </P>
                <P>• Approval of April 2021 Minutes</P>
                <P>• Deputy Designated Federal Officer's Comments</P>
                <P>• Federal Coordinator's Comments</P>
                <P>• Liaison's Comments</P>
                <P>• Presentation</P>
                <P>• Administrative Issues</P>
                <P>• Public Comments</P>
                <P>
                    <E T="03">Public Participation:</E>
                     The online virtual meeting is open to the public. Written statements may be filed with the Board either before or after the meeting as there will not be opportunities for live public comment during this online virtual meeting. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to submit public comments should email them as directed above.
                </P>
                <P>
                    <E T="03">Minutes:</E>
                     Minutes will be available by writing or calling Greg Simonton, Federal Coordinator, U.S. Department of Energy, Portsmouth/Paducah Project Office, P.O. Box 700, Piketon, OH 45661; Phone: (740) 897-3737. Minutes will also be available at the following website: 
                    <E T="03">https://www.energy.gov/pppo/ports-ssab/listings/meeting-materials.</E>
                </P>
                <SIG>
                    <DATED>Signed in Washington, DC, on May 4, 2021.</DATED>
                    <NAME>LaTanya Butler,</NAME>
                    <TITLE>Deputy Committee Management Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09817 Filed 5-7-21; 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. EL21-71-000]</DEPDOC>
                <SUBJECT>Macquarie Energy LLC v. PacifiCorp; Notice of Complaint</SUBJECT>
                <P>
                    Take notice that on May 3, 2021, pursuant to section 206 of the Federal Power Act, 16 U.S.C. 824e and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 (2020), Macquarie Energy LLC (Complainant) filed a formal complaint against PacifiCorp (Respondent), alleging that the Respondent has violated Commission regulations and Orders 888, 889, and 890 
                    <E T="03">et seq.</E>
                     by refusing transmission service to Macquarie, all as more fully explained in its complaint.
                </P>
                <P>The Complainant certify that copies of the complaint were served on the contacts listed for Respondent in the Commission's list of Corporate Officials.</P>
                <P>
                    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. 
                    <PRTPAGE P="24856"/>
                    The Respondent's answer, motions to intervene, and protests must be served on the Complainant.
                </P>
                <P>
                    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at 
                    <E T="03">http://www.ferc.gov.</E>
                     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://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>
                <P>
                    <E T="03">Comment Date:</E>
                     5:00 p.m. Eastern Time on May 24, 2021.
                </P>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09833 Filed 5-7-21; 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. CP15-554-009 and CP15-555-007]</DEPDOC>
                <SUBJECT>Atlantic Coast Pipeline, LLC; Eastern Gas Transmission and Storage, Inc. Notice of Intent To Prepare a Supplemental Environmental Impact Statement and Notice of Schedule for Environmental Review for the Proposed Atlantic Coast Pipeline Disposition and Restoration Plan And Supply Header Project Restoration Plan</SUBJECT>
                <P>
                    The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare a supplemental environmental impact statement (supplemental EIS) that will discuss the environmental impacts resulting from Atlantic Coast Pipeline, LLC's (Atlantic) Atlantic Coast Pipeline Disposition and Restoration Plan and Eastern Gas Transmission and Storage, Inc.'s (EGTS) 
                    <SU>1</SU>
                    <FTREF/>
                     Supply Header Project Restoration Plan.
                    <SU>2</SU>
                    <FTREF/>
                     The Commission will use this supplemental EIS in its decision-making process to determine whether Atlantic's and EGTS' proposals are in the public interest.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         On November 1, 2020, Dominion Energy sold certain companies, including Dominion Energy Transmission, Inc. (the Supply Header Project developer), to Berkshire Hathaway Energy Company; and Dominion Energy Transmission, Inc. changed its name to Eastern Gas Transmission and Storage, Inc.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The Atlantic Coast Pipeline Disposition and Restoration Plan and the Supply Header Project Restoration Plan were submitted in response to Commission staff's October 27, 2020 Data Request and can be found on FERC's eLibrary at accession numbers 20210104-5278 and 20201120-5243.
                    </P>
                </FTNT>
                <P>The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from its action whenever it considers whether or not to authorize a project or proposal. NEPA also requires the Commission to discover concerns the public may have about proposed actions. This process is referred to as “scoping.” The main goal of the scoping process is to focus the analysis in the supplemental EIS on the important environmental issues.</P>
                <P>On March 2, 2021, the Commission issued a Notice of Amendment of Certificates and Opening of Scoping Period regarding the proposed restoration activities associated with the Atlantic Coast Pipeline (ACP) and Supply Header Project (SHP). That notice opened a public scoping period of 45 days to gather input from the public and interested agencies regarding both projects.</P>
                <HD SOURCE="HD1">Summary of the Proposed Project Actions</HD>
                <P>Atlantic requests authorization to implement its strategy for the restoration of ACP project workspaces in compliance with associated permits, authorizations, and legal agreements. For the pipeline, Atlantic proposes to abandon in place all installed pipe (approximately 31.4 miles of the pipeline right-of-way) and restore lands that were cleared and graded (approximately 82.7 miles of the pipeline right-of-way), and seeks exemptions to the restoration of certain lands, to include leaving felled trees in place in areas where trees have not yet been cleared (approximately 25 miles of the pipeline right-of-way). For ACP aboveground facilities, Atlantic proposes to restore the sites, and manage the disposition of the materials and land through an investment recovery process.</P>
                <P>EGTS requests authorization to implement its strategy for the restoration of SHP workspaces in compliance with associated permits, authorizations, and legal agreements. EGTS plans to leave in place all previously installed pipe (approximately 11.7 miles) and complete final restoration of approximately 9 miles of the pipeline right-of-way that EGTS has previously cleared and/or graded. EGTS owns the properties on which SHP aboveground facilities are located and proposes to stabilize all facility sites and prepare assets for long term preservation.</P>
                <HD SOURCE="HD1">The Supplemental EIS Process and Identified Issues</HD>
                <P>
                    The supplemental EIS will discuss impacts that could occur as a result of the proposed activities related to the disposition of the projects and restoration of the project workspaces. To date, we have identified potential environmental concerns related to Atlantic's and EGTS' proposals to leave felled trees in place and abandon installed pipe, and potential impacts on wetlands and waterbodies from restoration activities. As a result, the supplemental EIS will include a reevaluation of mitigation associated with the restoration activities previously analyzed for the construction of the ACP and SHP.
                    <SU>3</SU>
                    <FTREF/>
                     The supplemental EIS will also consider revisions to land use, air emissions, and noise levels. Commission staff will also evaluate reasonable alternatives to the proposed project amendments or portions of the proposals and make recommendations on how to lessen or avoid impacts on the various resource areas.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">Atlantic Coast Pipeline and Supply Header Project Final Environmental Impact Statement,</E>
                         issued on July 21, 2017; accessible on the FERC website at: 
                        <E T="03">https://cms.ferc.gov/final-environmental-impact-statement-atlantic-coast-pipeline-and-supply-header-project.</E>
                    </P>
                </FTNT>
                <P>
                    The supplemental EIS will present Commission staff's independent analysis of the issues. The draft supplemental EIS will be available in electronic format in the public record through eLibrary 
                    <SU>4</SU>
                    <FTREF/>
                     and the Commission's natural gas environmental documents web page (
                    <E T="03">https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents</E>
                    ). If 
                    <PRTPAGE P="24857"/>
                    eSubscribed, you will receive instant email notification when the draft supplemental EIS is issued. The draft supplemental EIS will be issued for an allotted public comment period. After the comment period on the draft supplemental EIS, Commission staff will consider all timely comments and revise the document, as necessary, before issuing a final supplemental EIS.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         For instructions on connecting to eLibrary, refer to the last page of this notice.
                    </P>
                </FTNT>
                <P>
                    With this notice, the Commission is asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of these projects to formally cooperate in the preparation of the supplemental EIS.
                    <SU>5</SU>
                    <FTREF/>
                     Agencies that would like to request cooperating agency status should follow the instructions for filing comments provided under the Public Participation section of this notice. The U.S. Forest Service has already agreed to participate as a cooperating agency in the preparation of the supplemental EIS.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         The Council on Environmental Quality regulations addressing cooperating agency responsibilities are at Title 40, Code of Federal Regulations, Part 1501.6.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Environmental Mailing List</HD>
                <P>The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) for the original ACP and SHP and anyone who submits comments on the project amendments. Commission staff will update the environmental mailing list as the analysis proceeds to ensure that Commission notices related to this environmental review are sent to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project amendments.</P>
                <P>
                    A Notice of Availability of the draft supplemental EIS will be sent to the environmental mailing list and will provide instructions to access the electronic document on the FERC's website (
                    <E T="03">www.ferc.gov</E>
                    ). If you need to make changes to your name/address, or if you would like to remove your name from the mailing list, please complete one of the following steps:
                </P>
                <P>
                    (1) Send an email to 
                    <E T="03">GasProjectAddressChange@ferc.gov</E>
                     stating your request. You must include the docket number CP15-554-009 and/or CP15-555-007 in your request. If you are requesting a change to your address, please be sure to include your name and the correct address. If you are requesting to delete your address from the mailing list, please include your name and address as it appeared on this notice. This email address is unable to accept comments.
                </P>
                <P>OR</P>
                <P>
                    (2) Return the attached “Mailing List Update Form” (appendix 1).
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         The appendices referenced in this notice will not appear in the 
                        <E T="04">Federal Register</E>
                        . Copies of appendices were sent to all those receiving this notice in the mail and are available at 
                        <E T="03">www.ferc.gov</E>
                         using the link called “eLibrary” or from the Commission's Public Reference Room, 888 First Street NE, Washington, DC 20426, or call (202) 502-8371. For instructions on connecting to eLibrary, refer to the last page of this notice.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Schedule for Environmental Review</HD>
                <P>The Commission's March 2, 2021 Notice of Amendment for the ACP and SHP alerted other agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on the request for a federal authorization within 90 days of the date of issuance of the Commission staff's final supplemental EIS for the ACP and SHP. This instant notice identifies the FERC staff's planned schedule for completion of the final supplemental EIS for the ACP and SHP, which is based on an issuance of the draft supplemental EIS in July 2021. The forecasted schedule for both the draft and final supplemental EIS is based upon Atlantic and EGTS providing complete and timely responses to any future data requests. In addition, the schedule assumes that the cooperating agencies will provide input on their areas of responsibility on a timely basis.</P>
                <FP SOURCE="FP-1">Issuance of Notice of Availability of the final supplemental EIS—November 19, 2021</FP>
                <FP SOURCE="FP-1">90-day Federal Authorization Decision Deadline—February 17, 2022</FP>
                <P>If a schedule change becomes necessary for the final EIS, an additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.</P>
                <HD SOURCE="HD1">Additional Information</HD>
                <P>
                    In order to receive notification of the issuance of the EIS and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to 
                    <E T="03">https://www.ferc.gov/ferc-online/overview</E>
                     to register for eSubscription.
                </P>
                <P>
                    Additional information about the project amendment is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at 
                    <E T="03">www.ferc.gov</E>
                     using the eLibrary link. Click on the eLibrary link, click on “General Search” and enter the docket number in the “Docket Number” field. Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at 
                    <E T="03">FercOnlineSupport@ferc.gov</E>
                     or (866) 208-3676, or for TTY, contact (202) 502-8659. The eLibrary link also provides access to the texts of all formal documents issued by the Commission, such as orders, notices, and rulemakings.
                </P>
                <P>
                    Public sessions or site visits will be posted on the Commission's calendar located at 
                    <E T="03">www.ferc.gov/EventCalendar/EventsList.aspx</E>
                     along with other related information.
                </P>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09828 Filed 5-7-21; 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>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP20-467-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Dominion Energy Cove Point LNG, LP.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Report Filing: Cove Point—RP20-467 Report of Refunds.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5019.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/17/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP21-805-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Equitrans, L.P.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: Negotiated Rate Capacity Release Agreements—5/1/2021 to be effective 5/1/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5030.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/17/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP21-807-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Rover Pipeline LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: Summary of Negotiated Rate Capacity Release Agreements on 5-3-21 to be effective 5/1/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5034.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/17/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP21-808-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Eastern Shore Natural Gas Company.
                    <PRTPAGE P="24858"/>
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: Tariff Cleanup &amp; Credit Addendum Addition to be effective 6/3/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5056.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/17/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP21-809-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Alliance Pipeline L.P.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: Ovintiv Permanent Release NRAs to be effective 5/1/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5073.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/17/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP21-810-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     NEXUS Gas Transmission, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: Negotiated Rates—Various Releases eff 05-01-2021 to be effective 5/1/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5079.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/17/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP21-811-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Enable Mississippi River Transmission, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: Negotiated Rate Filing (Non-Conforming)—US Steel 5.1.2021 to be effective 5/1/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5092.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/17/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     RP21-812-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Texas Eastern Transmission, LP.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 4(d) Rate Filing: Negotiated Rates—Release eff 5-1-2021 to be effective 5/1/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5120.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/17/21.
                </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: May 4, 2021.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09831 Filed 5-7-21; 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. EL21-70-000]</DEPDOC>
                <SUBJECT>Luna Valley Solar I, LLC v. Pacific Gas and Electric Company and California Independent System Operator Corporation; Notice of Complaint</SUBJECT>
                <P>Take notice that on April 30, 2021, pursuant to section 206 of the Federal Power Act, 16 U.S.C. 824e and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 (2020), Luna Valley Solar I, LLC (Complainant) filed a formal complaint against Pacific Gas and Electric Company and California Independent System Operator Corporation (Respondents), alleging that Pacific Gas and Electric Company interconnection security demands and refusal to negotiate inconsistent with the California Independent System Operator Corporation Tariff, are unjust and unreasonable, all as more fully explained in its complaint.</P>
                <P>The Complainant certify that copies of the complaint were served on the contacts listed for Respondent in the Commission's list of Corporate Officials.</P>
                <P>Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondents' answer, motions to intervene, and protests must be served on the Complainant.</P>
                <P>
                    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at 
                    <E T="03">http://www.ferc.gov.</E>
                     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://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>
                <P>
                    <E T="03">Comment Date:</E>
                     5:00 p.m. Eastern Time on May 20, 2021.
                </P>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09827 Filed 5-7-21; 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>
                     EC21-86-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Alta Wind VIII, LLC, Granite Reliable Power, LLC, Windstar Energy LLC, Tusk Wind Holdings, LLC, Tusk Wind Holdings II, LLC, Tusk Wind Holdings III, LLC, NextEra Energy Partners, LP.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Application for Authorization Under Section 203 of the Federal Power Act of Alta Wind VIII, LLC, et al.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5292.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/24/21.
                </P>
                <P>Take notice that the Commission received the following exempt wholesale generator filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     EG21-137-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Rayos del Sol Solar Project, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Notice of Self Certification of Exempt Wholesale 
                    <PRTPAGE P="24859"/>
                    Generator Status of Rayos del Sol Solar Project, LLC.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5127.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/24/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     EG21-138-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Guernsey Power Station LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Notice of Self-Certification of Exempt Wholesale Generator Status of Guernsey Power Station LLC.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5276.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/24/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     EG21-139-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Stony Creek Energy LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Notice of Self-Certification of Exempt Wholesale Generator Status of Stony Creek Energy LLC.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5153.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <P>Take notice that the Commission received the following electric rate filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER10-1801-006; ER10-1805-007; ER10-2370-005.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     The Connecticut Light and Power Company, NSTAR Electric Company, Public Service Company of New Hampshire.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Notice of Non-Material Change in Status of The Connecticut Light and Power Company, et al.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5124.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/24/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER10-2527-010; ER10-1821-021; ER10-2400-014; ER10-2405-009; ER10-2414-012; ER10-2528-005; ER10-2529-005; ER10-2530-006; ER10-2531-012; ER10-2532-016; ER10-2533-010; ER10-2534-006; ER10-2535-012; ER10-2839-007; ER10-3097-012; ER11-4475-014; ER17-2059-008; ER19-1044-003; ER20-1608-002; ER20-1610-003.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Allegheny Ridge Wind Farm, LLC, Goshen Phase II LLC, Blue Canyon Windpower LLC, High Prairie Wind Farm II, LLC, Old Trail Wind Farm, LLC, Aragonne Wind LLC, Buena Vista Energy, LLC, Caprock Wind LLC, Cedar Creek Wind Energy, LLC, Crescent Ridge LLC, GSG, LLC, Kumeyaay Wind LLC, Mendota Hills, LLC, Midland Cogeneration Venture Limited Partnership, Bruce Power Inc., Rockland Wind Farm LLC, Puget Sound Energy, Inc., Telocaset Wind Power Partners, LLC, Mountain Breeze Wind, LLC, Lone Tree Wind, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Notice of Non-Material Change in Status of Allegheny Ridge Wind Farm, LLC.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     4/30/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210430-5750.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/21/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER20-681-002.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Tri-State Generation and Transmission Association, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Notice of Non-Material Change in Status of Tri-State Generation and Transmission Association, Inc.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/3/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210503-5101.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/24/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1778-000; TS21-2-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Guernsey Power Station, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Request of Guernsey Power Station LLC for Temporary Waivers under Section 35.28 of the Commission's Regulations.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     4/27/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210427-5245.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/18/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1821-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     St. Joseph Phase II, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Request for Prospective Tariff Waiver, et al. of St. Joseph Phase II, LLC.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     4/30/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210430-5609.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/21/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1833-000.
                </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, SA No. 6024 and Original ICSA, SA No. 6025; Queue No. AB2-135 to be effective 4/5/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5010.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1834-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Original WMPA, Service Agreement No. 6062; Queue No. AG1-253 to be effective 4/6/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5026.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1835-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Public Service Company of Colorado
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: 2021-05-04 PSC-MEAN-GlnwdSpngs-CardnellSS-COM-583-0.0.0 to be effective 7/3/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5038.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1836-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     AEP Texas Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: AEPTX-King Creek Wind Farm 1 (Apogee) 1st A&amp;R GIA to be effective 4/29/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5065.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1837-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Original WMPA, SA No. 6022; Queue No. AB1-176 to be effective 4/5/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5113.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1838-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Orangeville Energy Storage LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Baseline eTariff Filing: Application for Market-Based Rate Authorization to be effective 6/7/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5114.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1839-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Orangeville Energy Storage LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Initial rate filing: Filing of Assignment, Co-Tenancy, and Shared Facilities Agreement to be effective 6/7/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5123.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1840-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Stony Creek Energy LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Initial rate filing: Filing of Assignment, Co-Tenancy, and Shared Facilities Agreement to be effective 6/7/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5125.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1841-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Lookout Solar Park I, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Request for Limited Waiver of Tariff Provision, et al. of Lookout Solar Park I, LLC.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5141.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/18/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1842-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Richland Interconnection, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Baseline eTariff Filing: Richland Interconnection SFA Filing to be effective 5/5/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5144.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1843-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Original WMPA, SA No. 6023; Queue No. AE1-109 to be effective 4/6/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5149.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <PRTPAGE P="24860"/>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1844-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: Capital Recovery Factor for Avoidable Project Investment Cost Determinations to be effective 11/12/2020.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5154.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-1845-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Interstate Power and Light Company.
                </P>
                <P>
                    <E T="03">Description:</E>
                     § 205(d) Rate Filing: IPL Assignment Co-Tenancy Agreement Filing to be effective 5/5/2021.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     5/4/21.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20210504-5159.
                </P>
                <P>
                    <E T="03">Comments Due:</E>
                     5 p.m. ET 5/25/21.
                </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: May 4, 2021.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09830 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OPP-2016-0108; FRL-10016-66-OMS]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Renewal Request Submitted to OMB for Review and Approval; Comment Request; Notice of Supplemental Distribution of a Registered Pesticide Product (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), Notice of Supplemental Distribution of a Registered Pesticide Product (EPA ICR Number 0278.13, OMB Control Number 2070-0044) 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 February 28, 2021. EPA previously provided a 60-day public review opportunity via the 
                        <E T="04">Federal Register</E>
                         on August 17, 2020. With this submission, EPA is providing an additional 30-days for public review. 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>Comments must be received on or before June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments to EPA referencing Docket ID No. EPA-HQ-OPP-2016-0108, 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>
                        Carolyn Siu, Mission Support Division (7101M), Office of Program Support, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (703) 347-0159; email address: siu.carolyn
                        <E T="03">@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Supporting documents, including the ICR that explains in detail the information collection activities and the related burden and cost estimates that are summarized in this document, are available in the 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>
                     This information collection activity notifies the EPA of supplemental distribution of registered pesticide products. As mandated by FIFRA, as amended, EPA is responsible for the regulation of pesticides. FIFRA section 3(e) (7 U.S.C. 136a(e)) allows pesticide products with the same formulation, label claims, and manufacturer as a registered product to be distributed under the same registration as the basic product. Pesticide registrants may distribute or sell registered pesticides under a different product name in addition to the registered name, or under a different entity's name and address. Such distribution and sale are termed “supplemental distribution” and the product is termed a “distributor product.” EPA requires pesticide registrants who enter into supplemental distribution agreements with other companies to submit EPA Form 8570-5, Notice of Supplemental Distribution of a Registered Pesticide Product. Supplemental registrations are only an extension of a currently federally registered pesticide product.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     8570-5.
                </P>
                <P>
                    <E T="03">Respondents/Affected Entities:</E>
                     Pesticide and other agricultural chemical manufacturing.
                </P>
                <P>
                    <E T="03">Respondent's obligation to respond:</E>
                     Mandatory pursuant to Section 3(e) of FIFRA, as amended. Regulations pertaining to supplemental distribution of pesticide products are contained in Title 40 CFR part 152.132.
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     1,885 (total).
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Total estimated burden:</E>
                     603 hours (per year). Burden is defined at 5 CFR 1320.03(b).
                </P>
                <P>
                    <E T="03">Total estimated costs:</E>
                     $54,463 (per year), includes $0 annualized capital or operation &amp; maintenance costs.
                </P>
                <P>
                    <E T="03">Changes in the estimates:</E>
                     There are no changes in the estimated respondent burden compared with that identified in the ICR currently approved by OMB.
                </P>
                <SIG>
                    <NAME>Courtney Kerwin,</NAME>
                    <TITLE>Director, Regulatory Support Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09795 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="24861"/>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OECA-2014-0056; FRL-10022-30-OMS]</DEPDOC>
                <SUBJECT>Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Shipbuilding and Ship Repair Facilities—Surface Coating (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), NESHAP for Shipbuilding and Ship Repair Facilities—Surface Coating (EPA ICR Number 1712.11, OMB Control Number 2060-0330), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through May 31, 2021. Public comments were previously requested, via the 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         on May 12, 2020 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 neither conduct nor 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 June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2014-0056, online using 
                        <E T="03">www.regulations.gov</E>
                         (our preferred method), or by email to 
                        <E T="03">docket.oeca@epa.gov,</E>
                         or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. It is EPA 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>
                        Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address: 
                        <E T="03">yellin.patrick@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>
                     The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Shipbuilding and Ship Repair Facilities—Surface Coating applies to owners or operators of shipbuilding and ship repair facilities with primer and top -coat applications in manufacturing processes and in ship repair processes. Owners or operators of shipbuilding and ship repair facilities are required to report startup, initial performance test, and retest information. Facilities will also periodically report emission exceedances, changes to equipment, and comply with other requirements of the NESHAP. This information is being collected to assure compliance with 40 CFR part 63, subpart II.
                </P>
                <P>
                    <E T="03">Form Numbers:</E>
                     None.
                </P>
                <P>
                    <E T="03">Respondents/affected entities:</E>
                     Owners or operators of shipbuilding and ship repair surface coating facilities.
                </P>
                <P>
                    <E T="03">Respondent's obligation to respond:</E>
                     Mandatory (40 CFR part 63, subpart II).
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                    56 (total).
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     Semiannual.
                </P>
                <P>
                    <E T="03">Total estimated burden:</E>
                     28,700 hours (per year). `Burden' is defined at 5 CFR 1320.3(b).
                </P>
                <P>
                    <E T="03">Total estimated cost:</E>
                     $3,200,000 (per year), includes $0 in annualized capital/start up and/or operation &amp; maintenance costs.
                </P>
                <P>
                    <E T="03">Changes in the Estimates:</E>
                     There is no change in burden on the respondents from the most-recently approved ICR as currently identified in the OMB Inventory of Approved Burdens. This is due to two considerations: (1) The regulations have not changed over the past three years and are not anticipated to change over the next three years; and (2) the growth rate for this industry is very low or non-existent, so there is no significant change in the overall burden. Since there are no changes in the regulatory requirements and there is no significant industry growth, there are also no changes in the capital/startup or operation and maintenance (O&amp;M) costs. There is a decrease in the reported hour burden due to a correction. The previous ICR incorrect included burden for federal facilities, which has been removed in this request.
                </P>
                <SIG>
                    <NAME>Courtney Kerwin,</NAME>
                    <TITLE>Director, Regulatory Support Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09791 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[FRL-10022-14-Region 3]</DEPDOC>
                <SUBJECT>Draft TMDL for Sediment in the Indian Creek Watershed in Montgomery County, Pennsylvania</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; request for public comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Environmental Protection Agency (EPA) is publishing for public review and comment a draft total maximum daily load (TMDL) for sediment in the Indian Creek Watershed in Montgomery County, Pennsylvania pursuant to Section 303(d) of the Clean Water Act. To assist the public in their understanding of the draft TMDL and provide an overview of the TMDL process, EPA invites the public to attend a virtual public meeting. Section 303(d) of the Clean Water Act requires that each state identify those waters (called “water quality-limited segments”) for which existing technology-based pollution controls are not stringent enough to attain or maintain state water quality standards and for which total maximum daily loads (TMDLs) must be developed. A TMDL establishes a target for the total load of a particular pollutant that a waterbody can assimilate without exceeding water quality standards and divides that load into wasteload allocations, given to point sources, load allocations, given to nonpoint sources and natural background, and a margin of safety, which takes into account any uncertainty. TMDLs provide a framework to achieve water quality standards in a watershed and inform other federal and state programs of the necessary pollutant reductions needed 
                        <PRTPAGE P="24862"/>
                        by sources to achieve those standards. The draft TMDL report and information pertaining to the virtual public meeting is available from EPA Region 3's website at: 
                        <E T="03">https://www.epa.gov/tmdl/revised-sediment-tmdl-indian-creek-watershed-montgomery-county-pennsylvania.</E>
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 24, 2021. The public is welcomed to attend a virtual public meeting on June 8, 2021 from 1-2:30 p.m.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments on the draft TMDL must be received in writing and sent by electronic mail to Ms. Jillian Adair at 
                        <E T="03">adair.jillian@epa.gov</E>
                         or by mail to Ms. Jillian Adair, Water Division (3WD42), U.S. Environmental Protection Agency Region 3, 1650 Arch Street, Philadelphia, PA 19103-2029. Electronic mail submissions including body text and attachments are limited to 25 megabytes. In addition, EPA cannot receive electronic mail attachments in ZIP format (.zip). To attend the virtual public meeting, please use the weblink or conference line phone number provided at the above weblink in the 
                        <E T="02">SUMMARY</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jillian Adair at 
                        <E T="03">adair.jillian@epa.gov</E>
                         or (215) 814-5713.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On June 30, 2008, EPA established a sediment TMDL for the Indian Creek Watershed. On October 17, 2011 a complaint was filed against EPA regarding the TMDL [Civil Action No. 2:11-cv-06489-CDJ (E.D.PA)]. EPA then agreed to reconsider the TMDL and investigate several concerns raised by the plaintiffs. On March 21, 2014, EPA issued a reconsideration document, which identified certain concerns that the reference watershed approach and sediment loading rates used should be revisited. The court granted EPA's request for a voluntary remand of the 2008 sediment TMDL on April 3, 2014. EPA subsequently solicited input to seek relevant data and feedback, including four stakeholder meetings from 2014 to 2018 as part of its efforts to develop a revised draft sediment TMDL. EPA considered the information and data that were submitted by various stakeholders as part of the TMDL development effort. That information can also be accessed at the above weblink in the 
                    <E T="02">SUMMARY</E>
                    .
                </P>
                <SIG>
                    <NAME>Leslie Gillespie-Marthaler,</NAME>
                    <TITLE>Deputy Director, Water Division, Region III.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09762 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OAR-2019-0178; FRL-10023-89-OMS]</DEPDOC>
                <SUBJECT>Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Ethylene Oxide Commercial Sterilization Facilities National Emission Standards for Hazardous Air Pollutants (NESHAP) Technology Review</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 U.S. Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Ethylene Oxide Commercial Sterilization Facilities National Emission Standards for Hazardous Air Pollutants (NESHAP) Technology Review (EPA ICR Number 2623.01, OMB Control Number 2060-NEW), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). This is a request for approval of a new collection. Public comments were previously requested via the 
                        <E T="04">Federal Register</E>
                         on June 12, 2020, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A complete description of the ICR is provided 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 June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments to EPA, referencing Docket ID No. EPA-HQ-OAR-2019-0178, online using 
                        <E T="03">www.regulations.gov</E>
                         (our preferred method), by email to 
                        <E T="03">a-and-r-docket@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>
                        Mr. Matthew Witosky, Sector Policies and Programs Division (E143-05), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number: (919) 541-2865; email address: 
                        <E T="03">witosky.matthew@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Supporting documents explaining 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">https://www.regulations.gov/.</E>
                     The telephone number for the Docket Center is (202) 566-1742. For additional information about EPA's Docket Center services and the current status, please visit us online at 
                    <E T="03">https://www.epa.gov/dockets.</E>
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The NESHAP for EtO Commercial Sterilization and Fumigation Operations were finalized in December 1994 at 40 CFR part 63, subpart O. The NESHAP establishes emission standards for both major and area sources that use at least 1 ton of EtO in sterilization or fumigation operations in any 12-month period. The standards require existing and new major sources to control emissions to the level achievable by the maximum achievable control technology and require existing and new area sources to control emissions using generally available control technology. The EPA completed a residual risk and technology review for the NESHAP in 2006 and, at that time, concluded that the risk under existing standards were acceptable and provided an ample margin of safety. More recently, in 2016, the EPA released its updated Integrated Risk Information System unit risk estimate for EtO, which indicated that cancer risks from EtO were significantly higher than previously understood. Subsequently, the National Air Toxics Assessment (NATA) released in August 2018, identified EtO emissions as an important risk driver in several areas across the country. Further investigation revealed the EtO Commercial Sterilization source category contributes to some of these risks, which has led the EPA to evaluate, in greater depth, potential options to reduce emissions of EtO from the source category.
                </P>
                <P>
                    Since 2019, the EPA has been gathering additional information to evaluate opportunities to reduce EtO emissions through potential rule revisions and more immediate emission 
                    <PRTPAGE P="24863"/>
                    reduction steps. The goal of the data gathering efforts is to better understand the emissions sources, measurement and monitoring techniques, and available control technologies and their associated efficiencies. These efforts have included an advance notice of proposed rulemaking (ANPRM) requesting facility-specific data on process controls and operational practices as well as a CAA section 114 questionnaire that was distributed to 9 companies engaged in EtO commercial sterilization. The instructions and questionnaire were posted to the EPA web page where they were accessed by facilities. Electronic responses were required within 60 days or by February 6, 2020. While these data gathering efforts have been successful, there are still several important information gaps that should be filled prior to any final rulemaking activity. Therefore, the EPA is now exercising its authority under section 114(a) of the CAA to broaden its data collection efforts to include all facilities subject to 40 CFR part 63, subpart O that were not involved in the December 2019 questionnaire. The data collected through the initial questionnaire and this new ICR would enable the EPA to have a complete understanding of all emissions, emissions sources, processes, and control technologies in use at EtO sterilization facilities nationwide, providing a robust foundation for a final rulemaking.
                </P>
                <P>
                    <E T="03">Form numbers:</E>
                     Main Questionnaire; Supplement 1 (as needed); Supplement 2 (as needed); Supplement 3 (as needed).
                </P>
                <P>
                    <E T="03">Respondents/affected entities:</E>
                     Facilities subject to 40 CFR part 63, subpart O that are not included in the initial December 2019 questionnaire.
                </P>
                <P>
                    <E T="03">Respondent's obligation to respond:</E>
                     Responses to the ICR are mandatory under the authority of section 114 of the CAA. All respondents are required to fill out the main questionnaire, while Supplements 1, 2, and 3 may be filled out as needed.
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     61 (total).
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     This is a one-time questionnaire.
                </P>
                <P>
                    <E T="03">Total estimated burden:</E>
                     6,573 hours (per year). Burden is defined at 5 CFR 1320.03(b)
                </P>
                <P>
                    <E T="03">Total estimated cost:</E>
                     $604,027 (per year), includes $920 annualized capital or operation &amp; maintenance costs.
                </P>
                <P>
                    <E T="03">Changes in the estimates:</E>
                     This is a new collection. Therefore, there is no change in burden.
                </P>
                <SIG>
                    <NAME>Courtney Kerwin,</NAME>
                    <TITLE>Director, Regulatory Support Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09794 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[FRL-10023-47-Region 9]</DEPDOC>
                <SUBJECT>Public Water System Supervision Program Revision for the State of Nevada</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of tentative approval.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Notice is hereby given that the State of Nevada (State) revised its approved Public Water System Supervision (PWSS) Program under the federal Safe Drinking Water Act (SDWA) by incorporating by reference the federal Arsenic Rule The Environmental Protection Agency (EPA) has determined that the State's revisions are no less stringent than the corresponding Federal regulations and otherwise meet applicable SDWA primacy requirements. Therefore, EPA intends to approve the stated revisions to the State's PWSS Program.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>A request for a public hearing must be received on or before June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        All documents relating to this determination are available for inspection online at 
                        <E T="03">http://ndep.nv.gov/posts.</E>
                         In addition, documents relating to this determination are available for inspection by appointment between the hours of 8:30 a.m. and 4:00 p.m., Monday through Friday, except official State or Federal holidays at the following address: Nevada Department of Environmental Protection, Administration Office, 901 South Stewart Street, Suite 4001, Carson City, NV 89701. Please contact the Bureau of Safe Drinking Water at (775) 687-9521 to schedule an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jacob Jenzen, United States Environmental Protection Agency, Region 9, Drinking Water Section, via telephone number: (415) 972-3570 or email address: 
                        <E T="03">Jenzen.Jacob@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P SOURCE="NPAR">
                    <E T="03">Background.</E>
                     EPA approved the State's initial application for PWSS Program primary enforcement authority (“primacy”) on February 27, 1978 (43 FR 8030). Since initial approval, EPA has approved various revisions to Nevada's PWSS Program. For the revisions covered by this action, EPA revised the Arsenic Rule on January 22, 2001 (66 FR 6976). The revisions included a more stringent federal standard for arsenic in drinking water from 0.050 mg/L to 0.010 mg/L to better protect public health. The State submitted its final application to add the Arsenic Rule to its approved PWSS Program on December 30, 2011, followed by an application supplement on February 11, 2021. EPA has determined that the Arsenic Rule was incorporated by reference into the Nevada Administrative Code (NAC), Title 40 Chapter 445A, in a manner that Nevada's regulations are comparable to and no less stringent than the federal requirements. EPA has also determined that State's primacy revision meets all of the regulatory requirements for approval, as set forth in 40 CFR 142.12, including a side-by-side comparison of the Federal requirements and the corresponding State authorities, additional materials to support special primacy requirements of 40 CFR 142.16, and a statement by the Nevada Attorney General certifying that Nevada's laws and regulations adopted by the State to carry out the program revisions were duly adopted and are enforceable. Therefore, EPA intends to approve the State's revisions as part of its PWSS Program.
                </P>
                <P>
                    <E T="03">Public Process.</E>
                     Any interested party may request a public hearing on this determination. A request for a public hearing must be received or postmarked by June 9, 2021, and addressed to the Regional Administrator at the EPA Region 9, via the following email address: 
                    <E T="03">R9dw-program@epa.gov.</E>
                     Please note, “State Primacy Rule Determination” in the subject line of the email. The Regional Administrator may deny frivolous or insubstantial requests for a hearing. If a substantial request for a public hearing is made by June 9, 2021, EPA Region 9 will hold a public hearing. Any request for a public hearing shall include the following information: 1. The name, address, and telephone number of the individual, organization, or other entity requesting a hearing; 2. A brief statement of the requesting person's interest in the Regional Administrator's determination and a brief statement of the information that the requesting person intends to submit at such hearing; and 3. The signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.
                    <PRTPAGE P="24864"/>
                </P>
                <P>If EPA does not receive a timely and appropriate request for a hearing and the Regional Administrator does not elect to hold a hearing on her own motion, this determination shall become final and effective on June 10, 2021, and no further public notice will be issued.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>Section 1413 of the Safe Drinking Water Act, as amended, 42 U.S.C. 300g-2 (1996), and 40 CFR part 142 of the National Primary Drinking Water Regulations.</P>
                </AUTH>
                <SIG>
                    <DATED>Dated: April 30, 2021.</DATED>
                    <NAME>Deborah Jordan,</NAME>
                    <TITLE>Acting Regional Administrator, EPA Region 9.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09843 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[FRL-10022-08-OMS]</DEPDOC>
                <SUBJECT>Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of New Hampshire</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 Environmental Protection Agency's (EPA) approval of the State of New Hampshire's request to revise/modify certain of its EPA-authorized programs to allow electronic reporting.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>EPA approves the authorized program revisions/modifications as of May 10, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Shirley M. Miller, CROMERR Program Manager, U.S. Environmental Protection Agency, Office of Information Management, Mail Stop 2824T, 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-2908, 
                        <E T="03">miller.shirley@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the 
                    <E T="04">Federal Register</E>
                     (70 FR 59848) and codified as part 3 of Title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.
                </P>
                <P>
                    On September 17, 2020, the New Hampshire Department of Environmental Services (NHDES) submitted two applications titled NH Online Forms (nForm) and State and Local Emissions Inventory System (SLEIS) for revisions/modifications to its EPA-approved programs under title 40 CFR to allow new electronic reporting. EPA reviewed NHDES's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the applications met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve New Hampshire's request to revise/modify its following EPA-authorized programs to allow electronic reporting under 40 CFR parts 52, 60, 62, 63, 70, 142, 145, 239, 271, 281, and 763 to allow electronic reporting under 40 CFR parts 50-52, 60-65, 70, 141, 144, 146, 240-259, 260-270, 272-280 and 763 is being published in the 
                    <E T="04">Federal Register</E>
                    :
                </P>
                <P>
                    <E T="03">Part 52:</E>
                     Approval and Promulgation of Implementation Plans (SIP/Clean Air Act Title II) Reporting under CFR 50-52
                </P>
                <P>
                    <E T="03">Part 60:</E>
                     Standards of Performance for New Stationary Sources (NSPS/CAR/Clean Air Act Title III) Reporting under CFR 60 &amp; 65
                </P>
                <P>
                    <E T="03">Part 62:</E>
                     Approval and Promulgation of State Plans for Designated Facilities and Pollutants (NSPS/Clean Air Act Title III—Hospital/Medical) Reporting under CFR 62
                </P>
                <P>
                    <E T="03">Part 63:</E>
                     National Emission Standards for Hazardous Air Pollutants for Source Categories (NESHAP MACT/Clean Air Act Title III) Reporting under CFR 61, 63 &amp; 65
                </P>
                <P>
                    <E T="03">Part 70:</E>
                     State Operating Permit Programs (Clean Air Act Title V) Reporting under CFR 64 &amp; 70
                </P>
                <P>
                    <E T="03">Part 142:</E>
                     National Primary Drinking Water Regulations Implementation (NPDWR) Reporting under CFR 141
                </P>
                <P>
                    <E T="03">Part 145:</E>
                     State Underground Injection Control Programs (UIC) Reporting under CRF 144 &amp; 146
                </P>
                <P>
                    <E T="03">Part 239:</E>
                     Requirements for State Permit Program Determination of Adequacy (RCRA Subtitle C) Reporting under CFR 240-259
                </P>
                <P>
                    <E T="03">Part 271:</E>
                     Requirements for Authorization of State Hazardous Waste Programs (RCRA Subtitle C) Reporting under CFR 260-270, 272-279
                </P>
                <P>
                    <E T="03">Part 281:</E>
                     Technical Standards and Corrective Action Requirements for Owners and Operators of Underground Storage Tanks (UST) Reporting under CFR 280
                </P>
                <P>
                    <E T="03">Part 763:</E>
                     Asbestos Reporting under CFR 763NHDES was notified of EPA's determination to approve its application with respect to the authorized programs listed above.
                </P>
                <P>
                    Also, in this notice, EPA is informing interested persons that they may request a public hearing on EPA's action to approve the State of New Hampshire's request to revise its authorized public water system program under 40 CFR part 142, in accordance with 40 CFR 3.1000(f). Requests for a hearing must be submitted to EPA within 30 days of publication of this 
                    <E T="04">Federal Register</E>
                     notice. Such requests should include the following information:
                </P>
                <P>(1) The name, address and telephone number of the individual, organization or other entity requesting a hearing;</P>
                <P>(2) A brief statement of the requesting person's interest in EPA's determination, a brief explanation as to why EPA should hold a hearing, and any other information that the requesting person wants EPA to consider when determining whether to grant the request;</P>
                <P>(3) The signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.</P>
                <P>
                    In the event a hearing is requested and granted, EPA will provide notice of the hearing in the 
                    <E T="04">Federal Register</E>
                     not less than 15 days prior to the scheduled hearing date. Frivolous or insubstantial requests for hearing may be denied by EPA. Following such a public hearing, EPA will review the record of the hearing and issue an order either affirming this determination or rescinding such determination. If no timely request for a hearing is received and granted, EPA's approval of the State 
                    <PRTPAGE P="24865"/>
                    of New Hampshire's request to revise its part 142—National Primary Drinking Water Regulations Implementation program to allow electronic reporting will become effective 30 days after this notice is published, pursuant to CROMERR section 3.1000(f)(4).
                </P>
                <SIG>
                    <DATED>Dated: May 3, 2021.</DATED>
                    <NAME>Jennifer Campbell,</NAME>
                    <TITLE>Director, Office of Information Management. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09793 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL DEPOSIT INSURANCE CORPORATION</AGENCY>
                <SUBJECT>Notice of Termination of Receiverships</SUBJECT>
                <P>The Federal Deposit Insurance Corporation (FDIC or Receiver), as Receiver for each of the following insured depository institutions, was charged with the duty of winding up the affairs of the former institutions and liquidating all related assets. The Receiver has fulfilled its obligations and made all dividend distributions required by law.</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="xs36,r100,r50,xls36,12">
                    <TTITLE>Notice of Termination of Receiverships</TTITLE>
                    <BOXHD>
                        <CHED H="1">Fund</CHED>
                        <CHED H="1">Receivership name</CHED>
                        <CHED H="1">City</CHED>
                        <CHED H="1">State</CHED>
                        <CHED H="1">Termination date</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">10311</ENT>
                        <ENT>Cooper Star Bank</ENT>
                        <ENT>Scottsdale</ENT>
                        <ENT>AZ</ENT>
                        <ENT>05/01/2021</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10313</ENT>
                        <ENT>Tifton Banking Company</ENT>
                        <ENT>Tifton</ENT>
                        <ENT>GA</ENT>
                        <ENT>05/01/2021</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10353</ENT>
                        <ENT>Bartow County Bank</ENT>
                        <ENT>Cartersville</ENT>
                        <ENT>GA</ENT>
                        <ENT>05/01/2021</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10371</ENT>
                        <ENT>McIntosh State Bank</ENT>
                        <ENT>Jackson</ENT>
                        <ENT>GA</ENT>
                        <ENT>05/01/2021</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10377</ENT>
                        <ENT>High Trust Bank</ENT>
                        <ENT>Stockbridge</ENT>
                        <ENT>GA</ENT>
                        <ENT>05/01/2021</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10419</ENT>
                        <ENT>The First State Bank</ENT>
                        <ENT>Stockbridge</ENT>
                        <ENT>GA</ENT>
                        <ENT>05/01/2021</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10426</ENT>
                        <ENT>Central Bank of Georgia</ENT>
                        <ENT>Ellaville</ENT>
                        <ENT>GA</ENT>
                        <ENT>05/01/2021</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary, including but not limited to releases, discharges, satisfactions, endorsements, assignments, and deeds. Effective on the termination dates listed above, the Receiverships have been terminated, the Receiver has been discharged, and the Receiverships have ceased to exist as legal entities.</P>
                <EXTRACT>
                    <FP>(Authority: 12 U.S.C. 1819)</FP>
                </EXTRACT>
                <SIG>
                    <FP>Federal Deposit Insurance Corporation.</FP>
                    <DATED>Dated at Washington, DC, on May 5, 2021.</DATED>
                    <NAME>Debra A. Decker,</NAME>
                    <TITLE>Deputy Executive Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09868 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6714-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Disease Control and Prevention</SUBAGY>
                <SUBJECT>Conditional Sailing Order Technical Instructions and Operations Manual</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.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability of additional technical instructions and documents released under its Framework for Conditional Sailing Order (CSO). These documents apply to cruise ship operators with cruise ships operating in U.S. waters and cruise ship operators who are operating cruise ships outside of U.S. waters, but intend for their cruise ships to return to operating in U.S. waters while CDC's Conditional Sailing Order remains in effect.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>These documents were available April 2, 2021 and May 5, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jennifer Buigut, Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H16-4, Atlanta, GA 30329. Phone: 404-498-1600. Email: 
                        <E T="03">dgmqpolicyoffice@cdc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>On October 30, 2020 CDC issued an Agency Order establishing a framework for a phased approach to resuming cruise ship passenger operations in U.S. waters (85 FR 70153). The phased approach includes: (1) Establishment of laboratory testing of crew onboard cruise ships in U.S. waters; (2) simulated voyages designed to test a cruise ship operators' ability to mitigate COVID-19 onboard cruise ships; (3) a certification process; and (4) a return to passenger voyages in a manner that mitigates the risk of COVID-19 introduction, transmission, or spread among passengers and crew onboard ships and ashore to communities.</P>
                <P>In the initial crew testing phase, the Order additionally contained requirements for: (1) Shoreside COVID-19 laboratory screening testing of all crew currently onboard cruise ships; (2) onboard diagnostic testing capabilities for symptomatic travelers (crew and future passengers); (3) shoreside COVID-19 laboratory screening testing of all newly embarking crew; and (4) continued compliance with complete, accurate, and acknowledged, No Sail Order Response Plans.</P>
                <P>On April 2, 2021 CDC released Phase 2A Technical Instructions. Phase 2A Technical Instructions assists cruise ship operators in documenting the approval of U.S. port and local health authorities as a condition of receiving or retaining controlled free pratique to conduct a simulated voyage or to obtain a COVID-19 Conditional Sailing Certificate to commence restricted passenger voyages. This includes documenting the approval of U.S. port and local health authorities in developing medical care, housing, and port components (including a vaccination component).</P>
                <P>On May 5, 2021 CDC released two documents under Phase 2B and Phase 3 of the Conditional Sailing Framework: Technical Instructions for Simulated Voyages by Cruise Ship Operators under CDC's Framework for Conditional Sailing Order and COVID-19 Operations Manual for Simulated and Restricted Voyages under the Framework for Conditional Sailing Order.</P>
                <P>
                    The Technical Instructions for Simulated Voyages provides technical instructions for Phase 2B of CDC's CSO 
                    <PRTPAGE P="24866"/>
                    for cruise ship operators to test the efficacy of their health and safety protocols in U.S. waters. In lieu of conducting a simulated voyage, a cruise ship operator's responsible officials, at their discretion, may sign and submit to CDC an attestation under 18 U.S.C. 1001 that 98 percent of crew are fully vaccinated and submit to CDC a clear and specific vaccination plan and timeline to limit cruise ship sailings to 95 percent of passengers who have been verified by the cruise ship operator as fully vaccinated prior to sailing.
                </P>
                <P>CDC's oversight and inspection of cruise ships during simulated and restricted passenger voyages will be based on the Operations Manual. The findings and/or observations of these inspections will be shared with the cruise ship operator. Cruise ship operators are expected to align their health and safety protocols with any CDC findings and observations. Such findings and observations must also be incorporated into the cruise ship operator's simulated voyage after-action report or as a condition of applying for and retaining permission to conduct restricted passenger voyages. Based on these inspections, CDC may also issue additional recommendations to the cruise ship operator that the operator should consider for adoption into their health and safety protocols as best practices.</P>
                <P>
                    The Technical Instructions document for Cruise Ship Operator's Agreement with Port and Local Health Authorities under CDC's Framework for Conditional Sailing Order is found at 
                    <E T="03">https://www.cdc.gov/quarantine/cruise/instructions-local-agreements.html.</E>
                </P>
                <P>
                    The Technical Instructions document for Simulated Voyages by Cruise Ship Operators under CDC's Framework for Conditional Sailing Order is found at 
                    <E T="03">https://www.cdc.gov/quarantine/cruise/ti-simulated-voyages-cso.html.</E>
                </P>
                <P>
                    The COVID-19 Operations Manual for Simulated and Restricted Voyages under the Framework for Conditional Sailing Order is found at 
                    <E T="03">https://www.cdc.gov/quarantine/cruise/covid19-operations-manual-cso.html.</E>
                </P>
                <HD SOURCE="HD1">Authority</HD>
                <P>The Technical Instructions and Operations Manual are issued pursuant to the Framework for Conditional Sailing which was issued under the authority of Sections 361 and 365 of the Public Health Service Act (42 U.S.C. 264, 268) and 42 CFR 70.2, 71.31(b), 71.32(b).</P>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <NAME>Sherri Berger,</NAME>
                    <TITLE>Acting Chief of Staff, Centers for Disease Control and Prevention.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09895 Filed 5-6-21; 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 Disease Control and Prevention</SUBAGY>
                <DEPDOC>[Docket No. CDC-2021-0049]</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. The meeting will be webcast live via the World Wide Web.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The meeting will be held on May 12, 2021, from 11:00 a.m. to 5:00 p.m., EDT (dates and times subject to change, see the ACIP website for updates: 
                        <E T="03">http://www.cdc.gov/vaccines/acip/index.html</E>
                        ). The public may submit comments from May 10, 2021 through May 12, 2021.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        For more information on ACIP please visit the ACIP website: 
                        <E T="03">http://www.cdc.gov/vaccines/acip/index.html.</E>
                    </P>
                    <P>You may submit comments, identified by Docket No. CDC-2021-0049 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, GA 30329-4027, Attn: May 12, 2021 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>
                </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, GA 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 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 (VFC) 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 Director of the Centers for Disease Control and Prevention 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 COVID-19 vaccines, including use of the Pfizer-BioNTech COVID-19 vaccine under the Food and Drug Administration's (FDA) expanded Emergency Use Authorization (EUA) for adolescents 12-15 years of age. A recommendation vote(s) is 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>
                <P>
                    <E T="03">Meeting Information:</E>
                     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>
                <HD SOURCE="HD1">Public Participation</HD>
                <P>
                    Interested persons or organizations are invited to participate by submitting written views, recommendations, and 
                    <PRTPAGE P="24867"/>
                    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>
                     Written comments must be received on or before May 12, 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 May 12, 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, May 10, 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 12:00 p.m., EDT, May 11, 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. 2021-09893 Filed 5-6-21; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 4163-18-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Administration for Children and Families</SUBAGY>
                <DEPDOC>[CFDA Number: 93.676]</DEPDOC>
                <SUBJECT>Announcement of Intent To Issue Multiple Single-Source Awards To Provide Residential (Shelter) and Transitional Foster Care Services, and for Finger Print Services for Unaccompanied Children</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), Department of Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of issuance of multiple single-source awards to seven recipients.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>ACF, ORR announces the issuance of multiple Single-Source Awards to seven recipients in the amount of $65,366,800. ORR has been identifying additional permanent capacity to provide shelter for recent increases in apprehensions of Unaccompanied Children (UC) at the Southwest Border. The addition of permanent capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter and appropriate services for UC referred to its care by the Department of Homeland Security.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The proposed period of performance is May 1, 2021 to May 1, 2022.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Stephen Antkowiak, Office of Refugee Resettlement, Division of Unaccompanied Alien Children Operations, 330 Street SW, Washington, DC 20447. Phone: 202-260-6165. Email: 
                        <E T="03">stephen.antkowiak@acf.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>ORR is continuously monitoring its capacity to shelter the UC referred to HHS, as well as the information received from interagency partners, to inform any future decisions or actions.</P>
                <P>ORR has specific requirements for the provision of services. Award recipients must have the infrastructure, licensing, experience, and appropriate level of trained staff to meet those requirements.</P>
                <P>ORR announces the intent to award the following single-source awards:</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s50,9">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Recipient</CHED>
                        <CHED H="1">
                            Award
                            <LI>amount</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Child Crisis, Mesa, AZ</ENT>
                        <ENT>$5,780,118</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Catholic Guardian Services, New York, NY</ENT>
                        <ENT>5,183,433</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Center for Family Services, Camden, NJ</ENT>
                        <ENT>1,665,980</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LIRS—Shelter/TFC, Multiple Locations</ENT>
                        <ENT>27,767,725</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Baptiste Group, Memphis, TN</ENT>
                        <ENT>14,135,642</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Bethany Christian Service, Multiple Locations</ENT>
                        <ENT>7,018,576</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LIRS—Safe Release Expansion, Multiple Locations</ENT>
                        <ENT>3,815,326</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">Statutory Authority:</E>
                     This program is authorized by—
                </P>
                <P>(A) Section 462 of the Homeland Security Act of 2002, which in March 2003, transferred responsibility for the care and custody of UAC from the Commissioner of the former Immigration and Naturalization Service to the Director of ORR within HHS.</P>
                <P>
                    (B) The 
                    <E T="03">Flores</E>
                     Settlement Agreement, Case No. CV85-4544RJK (C.D. Cal. 1996), as well as the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (Pub. L. 110-457), which authorizes post release services under certain conditions to eligible children. All programs must comply with the 
                    <E T="03">Flores</E>
                     Settlement Agreement, Case No. CV85-4544-RJK (C.D. Cal. 1996); pertinent regulations; and ORR policies and procedures.
                </P>
                <SIG>
                    <NAME>Elizabeth Leo,</NAME>
                    <TITLE>Senior Grants Policy Specialist, Office of Grants Policy, Office of Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09758 Filed 5-4-21; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 4184-45-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket Nos. FDA-2020-N-2030; FDA-2017-N-4951; FDA-2017-N-5569; FDA-2020-N-1652; FDA-2017-N-7012; and FDA-2019-N-4763]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals</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) is publishing a list of information collections that have 
                        <PRTPAGE P="24868"/>
                        been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).
                    </P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
                        <E T="03">PRAStaff@fda.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The following is a list of FDA information collections recently approved by OMB under section 3507 of the PRA (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at 
                    <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E>
                     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>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12,12">
                    <TTITLE>Table 1—List of Information Collections Approved by OMB</TTITLE>
                    <BOXHD>
                        <CHED H="1">Title of collection</CHED>
                        <CHED H="1">OMB control No.</CHED>
                        <CHED H="1">Date approval expires</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Applications for FDA Approval to Market a New Drug</ENT>
                        <ENT>0910-0001</ENT>
                        <ENT>3/31/2024</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Medical Devices; Humanitarian Use Devices</ENT>
                        <ENT>0910-0332</ENT>
                        <ENT>3/31/2024</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Medical Devices; Device Tracking</ENT>
                        <ENT>0910-0442</ENT>
                        <ENT>3/31/2024</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Dispute Resolution Procedures for Science Based Decision on Products Regulated by CVM</ENT>
                        <ENT>0910-0566</ENT>
                        <ENT>3/31/2024</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics</ENT>
                        <ENT>0910-0850</ENT>
                        <ENT>3/31/2024</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion</ENT>
                        <ENT>0910-0895</ENT>
                        <ENT>3/31/2024</ENT>
                    </ROW>
                </GPOTABLE>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Acting Principal Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09811 Filed 5-7-21; 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 Nos. FDA-2021-N-0387]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Content of Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling and Recommendations for Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities</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 the notice. This notice solicits comments on the information collection associated with recommended content of medical product communications that are consistent with the FDA-required labeling and recommendations for drug and device manufacturer communications with payors, formulary committees, and similar entities.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit either electronic or written comments on the collection of information by July 9, 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 July 9, 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 July 9, 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: 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-N-0387 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Content of Medical Product Communications That Are Consistent With the FDA-Required Labeling and Recommendations for Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities.” 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 
                    <PRTPAGE P="24869"/>
                    viewable at 
                    <E T="03">https://www.regulations.gov</E>
                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
                </P>
                <P>
                    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 
                    <E T="03">https://www.regulations.gov.</E>
                     Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E>
                </P>
                <P>
                    <E T="03">Docket:</E>
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    <E T="03">https://www.regulations.gov</E>
                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
                        <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">I. Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers</HD>
                <HD SOURCE="HD2">OMB Control Number 0910-0856—Extension</HD>
                <P>This information collection supports the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) and FDA's implementing regulations that govern drug and device labeling and prescription drug and restricted device advertising. The FD&amp;C Act specifies that a drug or device shall be deemed to be misbranded if its labeling is false or misleading in any particular (section 502(a) (21 U.S.C. 352(a)) and that labeling may be considered misleading if it fails to reveal material facts about the product being promoted, including facts that are material in light of the representations made in a promotional piece (section 201(n) (21 U.S.C. 321(n))). Similarly, under sections 201(n) and 502(n) of the FD&amp;C Act and FDA's implementing regulations (21 CFR 202.1(e)(5)(i) and (iii)), an advertisement for a prescription drug must not be false or misleading with respect to side effects, contraindications, or effectiveness, or fail to reveal material facts about the product being advertised, including facts that are material in light of the representations made in a promotional piece. The FD&amp;C Act also specifies that restricted device advertisements must not be false or misleading (section 502(q)(1)) and must reveal facts that are material about the product being advertised (section 201(n)).</P>
                <P>
                    To assist respondents with the requirements drug and device labeling and prescription drug and restricted device advertising, we developed the guidance for industry entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling—Questions and Answers” (June 2018) (medical product communications guidance), available at 
                    <E T="03">https://www.fda.gov/media/133619/download.</E>
                     This medical product communications guidance includes recommendations that firms consider when developing “
                    <E T="03">consistent with the FDA-required labeling</E>
                     (CFL)” presentations in their labeling and advertising materials to help ensure the presentations are not false or misleading in violation of the FD&amp;C Act and FDA's implementing regulations. The guidance also describes FDA's thinking when examining the consistency of a firm's product communications with that product's own FDA-required labeling.
                </P>
                <P>
                    As explained in the guidance, if a firm communicates information that is not contained in its product's FDA-required labeling but that is determined to be consistent with the FDA-required labeling, FDA does not intend to rely on that communication to establish a new intended use that is different from the use or uses for which the product is legally marketed. Establishing a product's intended uses is an element in establishing certain violations under the FD&amp;C Act and Public Health Service Act. Firms' communications about their products that are consistent with the products' FDA-required labeling but that are false or misleading may subject a firm to enforcement action under the FD&amp;C Act. Thus, the guidance not only describes FDA's thinking on communications that are consistent with the FDA-required labeling, but also provides general recommendations intended to help firms comply with requirements in the FD&amp;C Act and FDA's implementing regulations for conveying information that is consistent with the FDA-required labeling in a truthful and non-misleading way. The medical product communications guidance recommends that firms accurately represent in the communications any study results or other data and information that are relied upon to support a firm's CFL promotional communication. Other 
                    <PRTPAGE P="24870"/>
                    recommendations include the clear and prominent disclosure of aspects of study design and methodology that are material for audiences to accurately interpret the information being presented (
                    <E T="03">e.g.,</E>
                     type of study, study objectives, product dosage and use regimens, control or controls used, patient population studied), as well as material limitations related to the study design, methodology, and results. Also, the guidance recommends that firms accurately characterize and contextualize the relevant information about the product, including by disclosing unfavorable or inconsistent findings. In addition, the guidance recommends that firms disclose material contextual information from the FDA-required labeling in these communications, such as data and information from studies in the FDA-required labeling that are relevant to the data or information presented in the CFL promotional communication.
                </P>
                <P>The recommendations will help ensure that health care professional and consumer audiences receive truthful information about the benefits and risks of drugs and devices in firms' CFL promotional communications and that material contextual information is included in these communications so that audiences are not misled. Accurate information helps these audiences know whether drugs or devices may be appropriate for them or their patients and know what they can expect to experience when prescribing or using these products.</P>
                <P>We estimate the burden of this collection of information as follows:</P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s100,12C,12C,12C,12C,12C">
                    <TTITLE>
                        Table 1—Estimated Annual Third-Party Disclosure Burden 
                        <SU>1</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">Information collection activity</CHED>
                        <CHED H="1">
                            Number of
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Number of
                            <LI>disclosures</LI>
                            <LI>per respondent</LI>
                        </CHED>
                        <CHED H="1">Total annual disclosures</CHED>
                        <CHED H="1">
                            Average
                            <LI>burden per</LI>
                            <LI>disclosure</LI>
                        </CHED>
                        <CHED H="1">Total hours</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Recommended information to be included when firms choose to disseminate communications that are consistent with the FDA-required labeling</ENT>
                        <ENT>324</ENT>
                        <ENT>30</ENT>
                        <ENT>9,720</ENT>
                        <ENT>4</ENT>
                        <ENT>38,880</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
                    </TNOTE>
                </GPOTABLE>
                <P>Since our last request for OMB approval, we have made no adjustments to the currently approved burden estimate.</P>
                <HD SOURCE="HD1">II. Recommendations for Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities</HD>
                <HD SOURCE="HD2">OMB Control Number 0910-0857—Extension</HD>
                <P>
                    This information collection also supports implementation of section 502(a) of the FD&amp;C Act and applicable Agency regulations. Section 502(a)(1) of the FD&amp;C Act provides that a drug or device is deemed to be misbranded “[i]f its labeling is false or misleading in any particular.” Under longstanding FDA practice and FDA's statute and regulations, and under case law, 
                    <E T="03">labeling</E>
                     encompasses more than merely the label of the drug, but extends to other written, printed, or graphic matter “accompanying such article” (section 201(m) of the FD&amp;C Act; see also 21 CFR 1.3(a)). Section 502(a) also includes a provision about communication of health care economic information (HCEI) to payors through labeling or advertising. To assist respondents in this regard, we developed the guidance for industry and review staff entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers” (June 2018) (drug and device communications guidance), available at 
                    <E T="03">https://www.fda.gov/media/133620/download.</E>
                </P>
                <P>
                    This drug and device communications guidance includes recommendations regarding information firms should include in HCEI for prescription drugs if they choose to disseminate such materials (HCEI materials) to payors, in accordance with section 502(a) of the FD&amp;C Act. Specifically, if a manufacturer communicates HCEI for approved prescription drugs (including biological products that also meet the definition of 
                    <E T="03">drug</E>
                     under the FD&amp;C Act and approved or cleared medical devices (collectively referred to as 
                    <E T="03">medical products</E>
                    )) to payors, FDA recommends that firms include in HCEI materials disseminated to payors information about: (1) Various aspects of study design and methodology of an economic analysis (
                    <E T="03">i.e.,</E>
                     type of analysis, modeling technique, patient population, perspective or viewpoint, treatment comparator, time horizon, outcome measures, cost estimates, and assumptions); (2) factors that limit generalizability of an economic analysis; limitations to an economic analysis; and (3) sensitivity analyses, if applicable, to allow for informed decision making by payors.
                </P>
                <P>Furthermore, FDA recommends that firms include other information when disseminating HCEI materials, as applicable, to provide a balanced and complete presentation. Such information includes a statement of the FDA-approved indication of the drug and a copy of the most current FDA-approved labeling. Under section 502(a) of the FD&amp;C Act, firms must also include a conspicuous and prominent statement to describe any material differences between the HCEI and the FDA-approved labeling. HCEI materials should also disclose whether certain studies or data sources were omitted from an economic analysis and how the omission of those studies or data sources may alter the conclusions presented in the analysis. Moreover, FDA recommends that HCEI materials disclose important risk information associated with the approved use of the drug, and pursuant to section 502(a) of the FD&amp;C Act, HCEI materials must disclose any additional risk information related to assumptions that vary from the approved labeling. In addition, HCEI materials should disclose potential financial or affiliation biases to the extent reasonably known by firms at the time of dissemination.</P>
                <P>The drug and device communications guidance provides similar recommendations for HCEI materials disseminated to payors about approved or cleared devices.</P>
                <P>If firms choose to make communications to payors about unapproved products or unapproved uses of approved or cleared products, FDA recommends that firms include a clear statement with their communications that the product or use is not approved or cleared and that the safety or effectiveness of the product or use has not been established.</P>
                <P>
                    We estimate the burden of this collection of information as follows:
                    <PRTPAGE P="24871"/>
                </P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s100,12,12,12,12,12">
                    <TTITLE>
                        Table 2—Estimated Annual Third-Party Disclosure Burden 
                        <SU>1</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">Information collection activity</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 responses</CHED>
                        <CHED H="1">
                            Average
                            <LI>burden per</LI>
                            <LI>response</LI>
                        </CHED>
                        <CHED H="1">Total hours</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Recommended information to be included when firms choose to disseminate HCEI materials to payors about approved prescription drugs</ENT>
                        <ENT>430</ENT>
                        <ENT>10.465</ENT>
                        <ENT>4,500</ENT>
                        <ENT>20</ENT>
                        <ENT>90,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Recommended information to be included when firms choose to disseminate HCEI materials to payors about approved or cleared devices</ENT>
                        <ENT>236</ENT>
                        <ENT>10</ENT>
                        <ENT>2,360</ENT>
                        <ENT>20</ENT>
                        <ENT>47,200</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Recommended information to be included when firms choose to disseminate information about unapproved products or unapproved uses of approved or cleared products</ENT>
                        <ENT>717</ENT>
                        <ENT>2</ENT>
                        <ENT>1,434</ENT>
                        <ENT>
                            0.5
                            <LI>(30 minutes)</LI>
                        </ENT>
                        <ENT>717</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">Follow-up information to payors regarding previously communicated information about unapproved products or unapproved uses of approved or cleared products</ENT>
                        <ENT>359</ENT>
                        <ENT>2</ENT>
                        <ENT>718</ENT>
                        <ENT>2</ENT>
                        <ENT>1,436</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>9,012</ENT>
                        <ENT/>
                        <ENT>139,353</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
                    </TNOTE>
                </GPOTABLE>
                <P>We have adjusted the estimate of burden we associate with the information collection recommendations in the guidance to reflect an increase of 2,000 hours and 100 responses annually.</P>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Acting Principal Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09809 Filed 5-7-21; 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-2011-N-0742]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution</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, we, 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 the notice. This notice solicits comments on the information collection associated with drug establishment registration and product listing requirements.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit either electronic or written comments on the collection of information by July 9, 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 July 9, 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 July 9, 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: 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-2011-N-0742 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution.” 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 
                    <PRTPAGE P="24872"/>
                    submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 
                    <E T="03">https://www.regulations.gov.</E>
                     Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E>
                </P>
                <P>
                    <E T="03">Docket:</E>
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    <E T="03">https://www.regulations.gov</E>
                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
                        <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">Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution—21 CFR Part 207</HD>
                <HD SOURCE="HD2">OMB Control Number 0910-0045—Revision</HD>
                <P>
                    This information collection supports implementation of drug establishment registration and listing requirements governed by FDA. These requirements are set forth in section 510 of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) (21 U.S.C. 360) and section 351 of the Public Health Service Act (42 U.S.C. 262) and provide for electronic submission of information. Agency regulations implementing these provisions are found in part 207 (21 CFR part 207) and set forth the scope, applicability, and content of information to be included in submissions. Except as provided in § 207.65, all information submitted under part 207 must be transmitted to FDA in an electronic format by using our electronic drug registration and listing system, in a form that we can process, review, and archive. For more information pertaining to drug establishment registration and listing, we invite you to visit our website at: 
                    <E T="03">https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site.</E>
                </P>
                <P>We are revising the information collection to include the collection of certain information required by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Section 3112 of the CARES Act requires that registrants under section 510 of the FD&amp;C Act must annually report the amount of each drug listed that was manufactured, prepared, propagated, compounded, or processed for commercial distribution. Section 3112(e) also authorizes FDA to require that registrants report this information electronically. Finally, section 3112(e) granted FDA the authority to require that registrants report this information at the time a public health emergency is declared.</P>
                <P>
                    To assist respondents to the information collection with the current electronic reporting requirements, we issued the guidance document entitled “Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing” (June 2009), available from our website at: 
                    <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing.</E>
                     Guidance on the submission of the reporting required in section 3112(e) of the CARES Act is included on CDER's 2021 guidance agenda available from our website at: 
                    <E T="03">https://www.fda.gov/media/134778/download.</E>
                     Agency guidance documents are issued consistent with our good guidance practice regulations in 21 CFR 10.115, which provide for public comment at any time.
                </P>
                <P>
                    <E T="03">Registration under part 207:</E>
                     Unless otherwise exempt under section 510(g) of the FD&amp;C Act or § 207.13, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug that is imported or offered for import into the United States. When operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments. Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under part 207. We will accept registration or listing information submitted by a private label distributor only if the distributor is acting as an authorized agent for and submitting information that pertains to an establishment that manufactures, repacks, relabels, or salvages drugs.
                </P>
                <P>
                    <E T="03">Listing requirements under part 207:</E>
                     Under § 207.41, registrants must list each drug that it manufactures, repacks, 
                    <PRTPAGE P="24873"/>
                    relabels, or salvages for commercial distribution. Each domestic registrant must list each such drug regardless of whether the drug enters interstate commerce. When operations are conducted at more than one establishment, and common ownership and control exists among all the establishments, the parent, subsidiary, or affiliate company may submit listing information for any drug manufactured, repacked, relabeled, or salvaged at any such establishment. A drug manufactured, repacked, or relabeled for private label distribution must be listed in accordance with the requirements in § 207.41(c).
                </P>
                <P>We estimate the burden of the information collection as follows:</P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s100,12,12,12,r50,12">
                    <TTITLE>
                        Table 1—Estimated Annual Reporting Burden 
                        <SU>1</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">Information collection activity; 21 CFR/statutory citation</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 responses</CHED>
                        <CHED H="1">Average burden per response</CHED>
                        <CHED H="1">Total hours</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Initial establishment registration; §§ 207.17, 207.21, and 207.25</ENT>
                        <ENT>1,480</ENT>
                        <ENT>2</ENT>
                        <ENT>2,960</ENT>
                        <ENT>1</ENT>
                        <ENT>2,960</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Annual review and update of registration information (including expedited updates); § 207.29</ENT>
                        <ENT>10,000</ENT>
                        <ENT>1</ENT>
                        <ENT>10,000</ENT>
                        <ENT>0.5 (30 minutes)</ENT>
                        <ENT>5,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Initial listing (including National Drug Code); §§ 207.33, 207.41, 207.45, 207.49, 207.53, 207.54, and 207.55</ENT>
                        <ENT>1,713</ENT>
                        <ENT>7.28</ENT>
                        <ENT>12,470</ENT>
                        <ENT>1.5</ENT>
                        <ENT>18,705</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">June and December review and update (or certification) of listing; §§ 207.35 and 207.57</ENT>
                        <ENT>5,300</ENT>
                        <ENT>20</ENT>
                        <ENT>106,000</ENT>
                        <ENT>0.75 (45 minutes)</ENT>
                        <ENT>79,500</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Waiver requests; § 207.65</ENT>
                        <ENT>1</ENT>
                        <ENT>1</ENT>
                        <ENT>1</ENT>
                        <ENT>0.5 (30 minutes)</ENT>
                        <ENT>1</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Public disclosure exemption request; § 207.81(c)</ENT>
                        <ENT>100</ENT>
                        <ENT>1</ENT>
                        <ENT>100</ENT>
                        <ENT>1</ENT>
                        <ENT>100</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">Manufacturing amount information; Section 3112 CARES Act</ENT>
                        <ENT>12,800</ENT>
                        <ENT>22.5</ENT>
                        <ENT>288,000</ENT>
                        <ENT>0.25 (15 minutes)</ENT>
                        <ENT>72,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT>419,531</ENT>
                        <ENT/>
                        <ENT>178,266</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
                    </TNOTE>
                </GPOTABLE>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s100,12C,12C,12C,12C,12C">
                    <TTITLE>
                        Table 2—Estimated Annual Recordkeeping Burden 
                        <SU>1</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">Information collection from guidance recommendations</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
                            <LI>burden per</LI>
                            <LI>recordkeeping</LI>
                        </CHED>
                        <CHED H="1">Total hours</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Preparing Standard Operating Procedures for creating and uploading the Structured Product Labeling file</ENT>
                        <ENT>1,000</ENT>
                        <ENT>1</ENT>
                        <ENT>1,000</ENT>
                        <ENT>40</ENT>
                        <ENT>40,000</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
                    </TNOTE>
                </GPOTABLE>
                <P>According to internal data, we estimate 1,480 respondents will submit 2,960 new establishment registrations annually. We estimate that 10,000 registrants will provide 10,000 annual reviews and updates of registration information (including expedited updates) or reviews and certifications that no changes have occurred. The estimates include the registration of establishments for both domestic and foreign manufacturers, repackers, relabelers, and drug product salvagers, and registration information submitted by anyone acting as an authorized agent for an establishment that manufactures, repacks, relabels, or salvages drugs. The estimates include an additional 80 positron emission tomography drug producers who are not exempt from registration and approximately 30 manufacturers of plasma derivatives.</P>
                <P>We assume 1 hour is necessary for registrants to submit initial registration information electronically for each new establishment. We assume 30 minutes is necessary for each annual review and update of registration information (including any expedited updates) or each review and certification that no changes have occurred. Our estimate reflects the average amount of time and effort necessary to register a domestic or foreign establishment, and the average amount of time and effort necessary to review and update registration information, or review registration information and certify no changes have occurred.</P>
                <P>Based on the number of drugs listed annually since June 2009, we estimate 1,713 registrants will report approximately 12,469 new listings annually (including the information submitted to obtain a labeler code and to reserve a National Drug Code (NDC) for future use). Based on the number of drugs in our listing database and the current number of changes to listing information submitted, we estimate 5,300 registrants will each report 20 reviews and updates (including the information submitted to revise an NDC) for a total of 106,000 annually. The estimates for the number of drug listings include both domestic and foreign listings, listings submitted by registrants for products sold under their own names as well as products intended for private label distribution, and information submitted related to an NDC and to obtain a labeler code. The estimate for the number of drugs subject to the listing requirements includes positron emission tomography drugs and approximately 30 plasma derivatives. The estimates for the number of June and December reviews and updates of listing information include the number of changes to drug characteristics pertaining to the drug product code to obtain a new NDC and the reports of the withdrawal of an approved drug from sale under § 314.81(b)(3)(iii) (21 CFR 314.81(b)(3)(iii)).</P>
                <P>
                    Based on our experience with electronically listing submissions since June 2009, we assume it takes 1 hour and 30 minutes to submit information electronically for each drug listed for the first time (for both foreign and domestic registrant listings). These estimates are an average of the time it will take manufacturers, repackers, relabelers, and drug product salvagers, with drug product salvagers taking 
                    <PRTPAGE P="24874"/>
                    considerably less time than manufacturers. The estimates include the time for submitting the content of labeling and other labeling in an electronic format (for drugs subject to an approved marketing application, the electronic submission of the content of labeling under § 314.50(l)(1)(i) is approved under OMB control number 0910-0001). We assume it takes 45 minutes for each June and December review and update. These estimates represent the average amount of time to review and update listing information or to review and certify that no changes have occurred. The estimates include the time for submitting any labeling for each drug, changes to the drug's characteristics submitted for a new NDC, and reports of the withdrawal of an approved drug from sale under § 314.81(b)(3)(iii).
                </P>
                <P>Finally, although we expect most respondents will already have prepared a standard operating procedure (SOP) for the electronic submission of drug establishment registration and drug listing information, we estimate each year additional firms will need to create an SOP as recommended in the guidance. We therefore estimate 1,000 firms will expend approximately 40 hours to prepare, review, and approve an SOP, for a total of 40,000 hours annually.</P>
                <P>While we retain the currently approved burden estimates for information collection associated with provisions in part 207, we have adjusted our estimate upward by 72,000 hours and 288,000 responses to account for information collection associated with the new manufacturing amount information element required by the CARES Act.</P>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Acting Principal Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09805 Filed 5-7-21; 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>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 meetings of the Board of Scientific Counselors, NHLBI.</P>
                <P>The meetings will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL HEART, LUNG, AND BLOOD INSTITUTE, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Board of Scientific Counselors, NHLBI.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 4, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:55 a.m. to 4:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate to review and evaluate personnel qualifications and performance, and competence of individual investigators.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Building, 10, 10 Center Drive Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 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 to review and evaluate personnel qualifications and performance, and competence of individual investigators.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Building 10, 10 Center Drive Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Robert S. Balaban, Ph.D., Scientific Director, Division of Intramural Research, National Institutes of Health, NHLBI, Building 10, CRC, 4th Floor, Room 1581, 10 Center Drive, Bethesda, MD 20892, 301/496-2116.
                    </P>
                    <P>Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. These meetings are closed to the public.</P>
                    <P>
                        Information is also available on the Institute's/Center's home page: 
                        <E T="03">www.nhlbi.nih.gov/meetings/index.htm,</E>
                         where an agenda and any additional information for the meeting will be posted when available.
                    </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: May 5, 2021.</DATED>
                    <NAME>David W. Freeman,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09839 Filed 5-7-21; 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 Institute of Mental Health; 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>
                         National Institute of Mental Health Initial Review Group; Mental Health Services Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 10-11, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         June 10, 2021, 1:00 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, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         June 11, 2021, 11:00 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, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Aileen Schulte, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6136, MSC 9606, Bethesda, MD 20852 301-443-1225, 
                        <E T="03">aschulte@mail.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 5, 2021. </DATED>
                    <NAME>Melanie J. Pantoja,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09813 Filed 5-7-21; 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 
                    <PRTPAGE P="24875"/>
                    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>
                         Population Sciences and Epidemiology Integrated Review Group; Social Sciences and Population Studies A Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 7-8, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 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>
                         Suzanne Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD 20892, (301) 435-1712, 
                        <E T="03">ryansj@csr.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Genes, Genomes, and Genetics Integrated Review Group; Genetic Variation and Evolution Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 9-10, 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>
                         Guoqin Yu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive Bethesda, MD 20892, (301) 435-1276, 
                        <E T="03">guoqin.yu@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Biological Chemistry and Macromolecular Biophysics Integrated Review Group; Macromolecular Structure and Function C Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 10-11, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 8:30 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>
                         William A. Greenberg, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4168, MSC 7806, Bethesda, MD 20892, (301) 435-1726, 
                        <E T="03">greenbergwa@csr.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group; Nutrition and Metabolism in Health and Disease Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 10-11, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 8:30 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>
                         Gregory S. Shelness, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6156, Bethesda, MD 20892-7892, 301-755-4335, 
                        <E T="03">greg.shelness@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Infectious Diseases and Immunology B Integrated Review Group; Clinical Research and Field Studies of Infectious Diseases Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 10-11, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 8:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Pauline Cupit, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institute of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-827-3275, 
                        <E T="03">cupitcunninghpm@mail.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Brain Disorders and Clinical Neuroscience Integrated Review Group; Clinical Neuroimmunology and Brain Tumors Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 10-11, 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, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Aleksey Gregory Kazantsev, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5201, Bethesda, MD 20817, 301-435-1042, 
                        <E T="03">aleksey.kazantsev@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Genes, Genomes, and Genetics Integrated Review Group; Maximizing Investigators' Research Award A Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 10-11, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:30 a.m. to 8:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Emily Foley, Ph.D., Scientific Review Officer, Center for Scientific Review, Bethesda, MD 20892, 301-402-3016, 
                        <E T="03">emily.foley@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Biology of Development and Aging Integrated Review Group; Mechanisms of Cancer Therapeutics—2 Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 14-15, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 7:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Careen K. Tang-Toth, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD 20892, (301) 435-3504, 
                        <E T="03">tothct@csr.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Oncology 1-Basic Translational Integrated Review Group; Tumor Progression and Metastasis Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 15-16, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:30 a.m. to 8:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Rolf Jakobi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6187, MSC 7806, Bethesda, MD 20892, 301-495-1718, 
                        <E T="03">jakobir@mail.nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Oncology 1-Basic Translational Integrated Review Group; Cancer Etiology Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 15-16, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 8:30 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>
                         Sarita Kandula Sastry, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20782, 301-402-4788, 
                        <E T="03">sarita.sastry@nih.gov.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Population Sciences and Epidemiology Integrated Review Group; Behavioral Genetics and Epidemiology Study Section.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 16-17, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9:00 a.m. to 7:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Andrew Louden, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3137, Bethesda, MD 20817, 301-435-1985, 
                        <E T="03">loudenan@csr.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <NAME>David W. Freeman,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09834 Filed 5-7-21; 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>Clinical Center; Notice of Closed Meeting</SUBJECT>
                <P>
                    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a 
                    <PRTPAGE P="24876"/>
                    meeting of the Board of Scientific Counselors of the NIH Clinical Center.
                </P>
                <P>The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the CLINICAL CENTER, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Board of Scientific Counselors of the NIH Clinical Center.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 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>
                         Department of Nursing Presentations and interviews and RADIS Review.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Clinical Center 10 Center Drive Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 8, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 12:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         Executive Session.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         Clinical Center, 10 Center Drive, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Ronald Neumann, Senior Investigation, Clinical Center, National Institutes of Health, 10 Center Drive, Bethesda, MD 20892, 301-496-6455, 
                        <E T="03">rneumann@cc.nih.gov.</E>
                    </P>
                    <P>Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. This meeting is closed to the public.</P>
                    <P>In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.</P>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <NAME>Patricia B. Hansberger,</NAME>
                    <TITLE>Supervisory Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09838 Filed 5-7-21; 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>Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting</SUBJECT>
                <P>Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Child Health and Human Development Council.</P>
                <P>
                    The meeting will be held as a virtual meeting and is open to the public. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (
                    <E T="03">http://videocast.nih.gov/</E>
                    ).
                </P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Advisory Child Health and Human Development Council.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 7-8, 2021.
                    </P>
                    <P>Open: June 7, 2021, 12:30 p.m. to 5:00 p.m.</P>
                    <P>
                        <E T="03">Agenda:</E>
                         The agenda will include opening remarks, administrative matters, Director's Report, Division of Extramural Research Report and, other business of the Council.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, Building 31, 31 Center Drive, C-Wing, Conference Room 6, Bethesda, MD 20892, (Virtual Meeting).
                    </P>
                    <P>Closed: June 8, 2021, 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, Building 31, 31 Center Drive, C-Wing, Conference Room 6, Bethesda, MD 20892, (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Eugene Hayunga, Ph.D., Director, Office of Extramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6710B Rockledge Drive, Room 2216, Bethesda, MD 20892, 301-451-1744, 
                        <E T="03">ehayunga@mail.nih.gov.</E>
                    </P>
                    <P>Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number, and when applicable, the business or professional affiliation of the interested person.</P>
                    <P>
                        Individuals will be able to view the meeting via NIH Videocast. Select the following link for Videocast access instructions: 
                        <E T="03">http://www.nichd.nih.gov/about/advisory/nachhd/Pages/virtual-meeting.aspx.</E>
                    </P>
                    <P>
                        Information is also available on the Institute's/Center's home page: 
                        <E T="03">https://www.nichd.nih.gov/about/advisory/council,</E>
                         where an agenda and any additional information for the meeting will be posted when available.
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <NAME>Melanie J. Pantoja,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09814 Filed 5-7-21; 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 Meeting</SUBJECT>
                <P>Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Heart, Lung, and Blood Advisory Council.</P>
                <P>The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Heart, Lung, and Blood Advisory Council.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 8, 2021.
                    </P>
                    <P>
                        <E T="03">Closed:</E>
                         10:00 a.m. to 12:35 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 NIH, Rockledge 1, 6705 Rockledge Dr, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Open:</E>
                         1:00 p.m. to 5:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To Discuss Program Policies and Issues.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health,Rockledge 1, 6705 Rockledge Dr, Bethesda, MD 20892 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Virtual Access:</E>
                         The meeting will be videocast and can be accessed from the NIH 
                        <PRTPAGE P="24877"/>
                        Videocast.
                        <E T="03">https://www.nhlbi.nih.gov/about/advisory-and-peer-review-committees/advisory-council.</E>
                        Please note, the link to the videocast meeting will be posted within a week of the meeting date.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Laura K. Moen, Ph.D., Director, Division of Extramural Research Activities,National Heart, Lung, and Blood Institute,National Institutes of Health, 6705 Rockledge Drive, Room 206-Q,Bethesda, MD 20892, 301-827-5517, 
                        <E T="03">moenl@mail.nih.gov</E>
                        .
                    </P>
                    <P>Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.</P>
                    <P>
                        Information is also available on the Institute's/Center's home page: 
                        <E T="03">www.nhlbi.nih.gov/meetings/nhlbac/index.htm</E>
                        , where an agenda and any additional information for the meeting will be posted when available.
                    </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: May 5, 2021.</DATED>
                    <NAME>David W. Freeman,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09835 Filed 5-7-21; 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 Institute on Minority Health and Health Disparities; 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>
                         National Institute on Minority Health and Health Disparities Special Emphasis Panel; Special Emphasis Panel for Review of Conference Grant (R13) Applications.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 11, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         1:00 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, Gateway Plaza, 7201 Wisconsin Ave., Bethesda, MD 20817 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Ivan K. Navarro, Ph.D., Scientific Review Officer, Office of Extramural Research Administration, National Institute on Minority Health and Health Disparities, National Institutes of Health Gateway Building, 7201 Wisconsin Avenue,  Bethesda, MD 20892, 301-827-2061, 
                        <E T="03">ivan.navarro@nih.gov.</E>
                    </P>
                </EXTRACT>
                <SIG>
                    <DATED> Dated: May 5, 2021.</DATED>
                    <NAME>David W. Freeman,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09832 Filed 5-7-21; 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 Center for Advancing Translational Sciences; 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>
                         National Center for Advancing Translational Sciences Special Emphasis Panel CTSA R03 Review.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         June 30, 2021.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         1:00 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 Center for Advancing Translational Sciences, National Institutes of Health,6701 Democracy Boulevard, Room 1080, Bethesda, MD 20892 (Telephone Conference Call).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Jing Chen, Ph.D.,Scientific Review Officer,Office of Scientific Review,National Center for Advancing Translational Sciences,National Institutes of Health,6701 Democracy Boulevard, Room 1080,Bethesda, MD 20892-4874,
                        <E T="03">chenjing@mail.nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <NAME>David W. Freeman,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09837 Filed 5-7-21; 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 Center for Scientific Review Special Emphasis Panel, May 26, 2021, 11:00 a.m. to May 26, 2021, 04:00 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 April 20, 2021, 86 FR 20505.
                </P>
                <P>This notice is being amended to change the panel name of the Center for Scientific Review Special Emphasis Panel; RFA Panel: Tobacco Regulatory Science A (or B) to RFA Panel: Tobacco Regulatory Science A. The meeting is closed to the public.</P>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <NAME>David W. Freeman,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09836 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Federal Emergency Management Agency</SUBAGY>
                <DEPDOC>[Docket ID FEMA-2021-0002]</DEPDOC>
                <SUBJECT>Final Flood Hazard Determinations</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Emergency Management Agency, Department of Homeland Security.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in 
                        <PRTPAGE P="24878"/>
                        effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The date of August 24, 2021 has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at 
                        <E T="03">https://msc.fema.gov</E>
                         by the date indicated above.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email) 
                        <E T="03">patrick.sacbibit@fema.dhs.gov;</E>
                         or visit the FEMA Mapping and Insurance eXchange (FMIX) online at 
                        <E T="03">https://www.floodmaps.fema.gov/fhm/fmx_main.html.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.</P>
                <P>This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.</P>
                <P>
                    Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at 
                    <E T="03">https://msc.fema.gov.</E>
                </P>
                <P>The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.</P>
                <EXTRACT>
                    <FP>(Catalog of Federal Domestic Assistance No. 97.022, “Flood Insurance.”)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Michael M. Grimm,</NAME>
                    <TITLE>Assistant Administrator for Risk Management, Department of Homeland Security, Federal Emergency Management Agency.</TITLE>
                </SIG>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s100,r100">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Community</CHED>
                        <CHED H="1">Community map repository address</CHED>
                    </BOXHD>
                    <ROW EXPSTB="01">
                        <ENT I="21">
                            <E T="02">Yavapai County, Arizona and Incorporated Areas</E>
                        </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="21">
                            <E T="02">Docket No.: FEMA-B-2025</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Town of Dewey-Humboldt</ENT>
                        <ENT>Yavapai County Flood Control District, 1120 Commerce Drive, Prescott, AZ 86305.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Town of Prescott Valley</ENT>
                        <ENT>Engineering Division, 7501 East Skoog Boulevard, 3rd Floor, Prescott Valley, AZ 86314.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Unincorporated Areas of Yavapai County</ENT>
                        <ENT>Yavapai County Flood Control District, 1120 Commerce Drive, Prescott, AZ 86305.</ENT>
                    </ROW>
                    <ROW EXPSTB="01">
                        <ENT I="21">
                            <E T="02">Stanislaus County, California and Incorporated Areas</E>
                        </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="21">
                            <E T="02">Docket No.: FEMA-B-2036</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">City of Ceres</ENT>
                        <ENT>City Hall, 2220 Magnolia Street, Ceres, CA 95307.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Modesto</ENT>
                        <ENT>City Hall, 10th Street Place, 1010 10th Street, Modesto, CA 95354.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Newman</ENT>
                        <ENT>City Hall, 938 Fresno Street, Newman, CA 95360.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Patterson</ENT>
                        <ENT>City Hall, 1 Plaza Circle, 2nd Floor, Patterson, CA 95363.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Unincorporated Areas of Stanislaus County</ENT>
                        <ENT>Stanislaus County &amp; City of Modesto Building, 1010 10th Street, Suite 3400, Modesto, CA 95354.</ENT>
                    </ROW>
                    <ROW EXPSTB="01">
                        <ENT I="21">
                            <E T="02">Pinellas County, Florida and Incorporated Areas</E>
                        </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="21">
                            <E T="02">Docket No.: FEMA-B-1905</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">City of Belleair Beach</ENT>
                        <ENT>City Hall, 444 Causeway Boulevard, Belleair Beach, FL 33786.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Belleair Bluffs</ENT>
                        <ENT>City Hall, 2747 Sunset Boulevard, Belleair Bluffs, FL 33770.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Clearwater</ENT>
                        <ENT>Municipal Services Building, Engineering Department, 100 South Myrtle Avenue, Suite 220, Clearwater, FL 33756.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Dunedin</ENT>
                        <ENT>Community Development Building, 1415 Pinehurst Road, Unit F, Dunedin, FL 34698.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Gulfport</ENT>
                        <ENT>Community Development Department, 5330 23rd Avenue South, Gulfport, FL 33707.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Indian Rocks Beach</ENT>
                        <ENT>City Hall, 1507 Bay Palm Boulevard, Indian Rocks Beach, FL 33785.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Largo</ENT>
                        <ENT>City Hall, 201 Highland Avenue North, Largo, FL 33770.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Madeira Beach</ENT>
                        <ENT>Building Department, 300 Municipal Drive, Madeira Beach, FL 33708.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Oldsmar</ENT>
                        <ENT>City Hall, Planning and Redevelopment Department, 100 State Street West, Oldsmar, FL 34677.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Pinellas Park</ENT>
                        <ENT>Planning and Development Services, 6051 78th Avenue North, Pinellas Park, FL 33781.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Safety Harbor</ENT>
                        <ENT>Building Official's Department, 750 Main Street, Safety Harbor, FL 34695.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Seminole</ENT>
                        <ENT>City Hall, Community Development Department, 9199 113th Street, Seminole, FL 33772.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of South Pasadena</ENT>
                        <ENT>Building Department, 6940 Hibiscus Avenue South, South Pasadena, FL 33707.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="24879"/>
                        <ENT I="01">City of St. Pete Beach</ENT>
                        <ENT>City Hall, Building Department, 155 Corey Avenue, St. Pete Beach, FL 33706.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of St. Petersburg</ENT>
                        <ENT>
                            Municipal Services Center, 1 4th Street North, St. Petersburg, FL
                            <LI>33701.</LI>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Tarpon Springs</ENT>
                        <ENT>Building Department, 324 East Pine Street, Tarpon Springs, FL 34689.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Treasure Island</ENT>
                        <ENT>City Hall, Community Improvement Department, 120 108th Avenue, Treasure Island, FL 33706.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Town of Belleair</ENT>
                        <ENT>Town Hall, 901 Ponce de Leon Boulevard, Belleair, FL 33756.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Town of Belleair Shore</ENT>
                        <ENT>City Clerk's Office, 1200 Gulf Boulevard, Belleair Shore, FL 33786.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Town of Indian Shores</ENT>
                        <ENT>Building Department, 19305 Gulf Boulevard, Indian Shores, FL 33785.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Town of Kenneth City</ENT>
                        <ENT>Town Hall, 6000 54th Avenue North, Kenneth City, FL 33709.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Town of North Redington Beach</ENT>
                        <ENT>Town Hall, 190 173rd Avenue East, North Redington Beach, FL 33708.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Town of Redington Beach</ENT>
                        <ENT>Town Hall, 105 164th Avenue, Redington Beach, Florida 33708.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Town of Redington Shores</ENT>
                        <ENT>Town Hall, Building Department, 17425 Gulf Boulevard, Redington Shores, FL 33708.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Unincorporated Areas of Pinellas County</ENT>
                        <ENT>Pinellas County Building Department, 440 Court Street, Clearwater, FL 33756.</ENT>
                    </ROW>
                    <ROW EXPSTB="01">
                        <ENT I="21">
                            <E T="02">Gem County, Idaho and Incorporated Areas</E>
                        </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="21">
                            <E T="02">Docket No.: FEMA-B-1969</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">City of Emmet</ENT>
                        <ENT>Public Works and Building Department, 601 East 3rd Street, Emmett, ID 83617.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Unincorporated Areas of Gem County</ENT>
                        <ENT>Gem County Development Services Department, 109 South McKinley Avenue, Emmett, ID 83617.</ENT>
                    </ROW>
                    <ROW EXPSTB="01">
                        <ENT I="21">
                            <E T="02">Wabaunsee County, Kansas and Incorporated Areas</E>
                        </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="21">
                            <E T="02">Docket No.: FEMA-B-2018</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">City of Alma</ENT>
                        <ENT>City Hall, 326 Missouri Avenue, Alma, Kansas 66401.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Alta Vista</ENT>
                        <ENT>City Hall, 521 Main Street, Alta Vista, Kansas 66834.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Eskridge</ENT>
                        <ENT>City Hall, 110 South Main Street, Eskridge, Kansas 66423.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Harveyville</ENT>
                        <ENT>City Hall, 274 West Oak Street, Harveyville, Kansas 66431.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of McFarland</ENT>
                        <ENT>City Hall, 518 Rock Island Road, McFarland, Kansas 66501.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Paxico</ENT>
                        <ENT>City Hall, 201 Newbury Avenue, Paxico, Kansas 66526.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Unincorporated Areas of Wabaunsee County</ENT>
                        <ENT>Wabaunsee County Courthouse, 215 Kansas Avenue, Alma, Kansas 66401.</ENT>
                    </ROW>
                    <ROW EXPSTB="01">
                        <ENT I="21">
                            <E T="02">Mason County, Michigan (All Jurisdictions)</E>
                        </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="21">
                            <E T="02">Docket No.: FEMA-B-2009</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Charter Township of Pere Marquette</ENT>
                        <ENT>Pere Marquette Charter Township Hall, 1699 South Pere Marquette Highway, Ludington, MI 49431.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">City of Ludington</ENT>
                        <ENT>City Hall, 400 South Harrison Street, Ludington, MI 49431.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Township of Grant</ENT>
                        <ENT>Grant Township Hall, 835 West Hoague Road, Manistee, MI 49660.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Township of Hamlin</ENT>
                        <ENT>Hamlin Township Hall, 3775 North Jebavy Drive, Ludington, MI 49431.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Township of Summit</ENT>
                        <ENT>Summit Township Hall, 4879 West Deren Road, Ludington, MI 49431.</ENT>
                    </ROW>
                    <ROW EXPSTB="01">
                        <ENT I="21">
                            <E T="02">Oceana County, Michigan (All Jurisdictions)</E>
                        </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="21">
                            <E T="02">Docket No.: FEMA-B-2009</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Township of Benona</ENT>
                        <ENT>Benona Township Hall, 7169 West Baker Road, Shelby, MI 49455.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Township of Claybanks</ENT>
                        <ENT>Claybanks Township Hall, 7577 West Cleveland Road, New Era, MI 49446.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Township of Golden</ENT>
                        <ENT>Golden Township Hall, 5527 West Fox Road, Mears, MI 49436.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Township of Pentwater</ENT>
                        <ENT>Township Office, 500 North Hancock Street, Pentwater, MI 49449.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Township of Weare</ENT>
                        <ENT>Weare Township Hall, 6506 North Oceana Drive, Hart, MI 49420.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Village of Pentwater</ENT>
                        <ENT>Village Office, 327 South Hancock Street, Pentwater, MI 49449.</ENT>
                    </ROW>
                    <ROW EXPSTB="01">
                        <ENT I="21">
                            <E T="02">Snyder County, Pennsylvania (All Jurisdictions)</E>
                        </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="21">
                            <E T="02">Docket No.: FEMA-B-1977</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Borough of Selinsgrove</ENT>
                        <ENT>Borough Office, 1 North High Street, Selinsgrove, PA 17870.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Borough of Shamokin Dam</ENT>
                        <ENT>Municipal Building, 42 West 8th Avenue, Shamokin Dam, PA 17876.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Township of Chapman</ENT>
                        <ENT>Chapman Township Municipal Office, 1151 Wagner Hill Road, Port Trevorton, PA 17864.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Township of Monroe</ENT>
                        <ENT>Monroe Township Municipal Building, 39 Municipal Drive, Selinsgrove, PA 17870.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Township of Penn</ENT>
                        <ENT>Penn Township Municipal Building, 228 Clifford Road, Selinsgrove, PA 17870.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Township of Perry</ENT>
                        <ENT>Perry Town Hall, 18 Hoffman Hill Road, Mount Pleasant Mills, PA 17853.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Township of Union</ENT>
                        <ENT>Union Township Municipal Building, 1510 McNess Road, Port Trevorton, PA 17864.</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="24880"/>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09632 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Transportation Security Administration</SUBAGY>
                <SUBJECT>Intent To Request Extension From OMB of One Current Public Collection of Information: Law Enforcement Officer (LEO) Reimbursement Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Transportation Security Administration, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0063, abstracted below that we will submit to OMB for an extension in compliance with the Paperwork Reduction Act. The ICR describes the nature of the information collection and its expected burden. The collection involves the reimbursement of expenses incurred by airport operators for the provision of law enforcement officers to support airport checkpoint screening.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Send your comments by July 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be emailed to 
                        <E T="03">TSAPRA@tsa.dhs.gov</E>
                         or delivered to the TSA PRA Officer, Information Technology, TSA-11, Transportation Security Administration, 6595 Springfield Center Drive, Springfield, VA 20598-6011.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christina A. Walsh at the above address, or by telephone (571) 227-2062.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The ICR documentation will be available at 
                    <E T="03">http://www.reginfo.gov</E>
                     upon its submission to OMB. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to—
                </P>
                <P>(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;</P>
                <P>(2) Evaluate the accuracy of the agency's estimate of the burden;</P>
                <P>(3) Enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.</P>
                <HD SOURCE="HD1">Information Collection Requirement</HD>
                <P>
                    <E T="03">OMB Control Number 1652-0063; Law Enforcement Officer (LEO) Reimbursement Request.</E>
                     TSA has authority to enter into agreements with participants to reimburse expenses incurred by airport operators for the provision of LEOs in support of screening at airport checkpoints. 
                    <E T="03">See</E>
                     49 U.S.C. 106(l) and (m) and 114(m). Consistent with these authorities, TSA created the LEO Reimbursement Program.
                </P>
                <P>TSA requires participants in the LEO Reimbursement Program to record the details of all reimbursements sought. In order to provide for the orderly tracking of reimbursements, the LEO Reimbursement Program uses TSA Form 3503, LEO Reimbursement Request. The information collected includes, but is not limited to, information regarding the invoice, invoicing point of contact, banking and checkpoint log worksheet.</P>
                <P>
                    The LEO Reimbursement Request form is available at 
                    <E T="03">www.tsa.gov.</E>
                     Upon completion, participants submit the LEO Reimbursement Request form directly to the LEO Reimbursement Program via fax, electronic upload (via scanning the document), mail, or in person. Upon receipt, TSA reviews all request for reimbursement forms.
                </P>
                <P>TSA estimates that there will be 294 participant responses monthly, or 3,528 yearly. TSA estimates each respondent will spend approximately one hour to complete the request for reimbursement form, for a total annual hour burden of 3,528 hours.</P>
                <SIG>
                    <DATED>Dated: May 4, 2021.</DATED>
                    <NAME>Christina A. Walsh,</NAME>
                    <TITLE>TSA Paperwork Reduction Act Officer, Information Technology.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09804 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-05-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT</AGENCY>
                <DEPDOC>[Docket No. FR-7038-N-04]</DEPDOC>
                <SUBJECT>60-Day Notice of Proposed Information Collection: Survey To Assess Operational and Capacity Status of Housing Counseling Agencies Due to Disaster/National Emergency; OMB Control No.: 2502-0615</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments Due Date:</E>
                         July 9, 2021.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at 
                        <E T="03">Colette.Pollard@hud.gov</E>
                         for a copy of the proposed forms or other available information. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email Colette Pollard at 
                        <E T="03">Colette.Pollard@hud.gov</E>
                         or telephone 202-402-3400. This is not a toll-free number. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.
                    </P>
                    <P>Copies of available documents submitted to OMB may be obtained from Ms. Pollard.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
                    <PRTPAGE P="24881"/>
                </P>
                <HD SOURCE="HD1">A. Overview of Information Collection</HD>
                <P>
                    <E T="03">Title of Information Collection:</E>
                     Survey to Assess Operational Status and Capacity of Housing Counseling Agencies Due to a Disaster/National Emergency.
                </P>
                <P>
                    <E T="03">OMB Approval Number:</E>
                     2502-0615. 
                </P>
                <P>
                    <E T="03">OMB Expiration Date:</E>
                     May 31, 2021.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     None.
                </P>
                <P>
                    <E T="03">Description of the need for the information and proposed use:</E>
                     The Disaster/National Emergency Survey will assess the operational and capacity status of Housing Counseling Agencies impacted by COVID-19 and other disasters and national emergencies. This Survey is necessary to assess the impact of the disasters and national emergencies on the operation of HUD-approved housing counseling agencies. This survey will more accurately assess the current operating status and capacity of housing counseling agencies impacted by disasters or national emergencies. The information collected will be used to identify the needs of the housing counseling agency and to inform OHC about the types of support that would be the most responsive to the needs of agencies and their clients.
                </P>
                <P>
                    <E T="03">Respondents (i.e., affected public):</E>
                     Not-for-profit institutions; Local, State, or Tribal Government.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     1,614.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses:</E>
                     1,614.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     1.
                </P>
                <P>
                    <E T="03">Average Hours per Response:</E>
                     1.
                </P>
                <P>
                    <E T="03">Total Estimated Burden:</E>
                     1,614.
                </P>
                <HD SOURCE="HD1">B. Solicitation of Public Comment</HD>
                <P>This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:</P>
                <P>(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;</P>
                <P>(2) The accuracy of the agency's 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 those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses.
                </P>
                <P>HUD encourages interested parties to submit comment in response to these questions.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.</P>
                </AUTH>
                <SIG>
                    <NAME>Janet Golrick,</NAME>
                    <TITLE>Acting, Chief of Staff for the Office of Housing—Federal Housing Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09854 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4210-67-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Fish and Wildlife Service</SUBAGY>
                <DEPDOC>[FWS-R2-ES-2020-0122; FXES11130200000-212-FF02ENEH00]</DEPDOC>
                <SUBJECT>Endangered and Threatened Wildlife and Plants; Draft Recovery Plan for Kuenzler Hedgehog Cactus</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Fish and Wildlife Service, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>We, the U.S. Fish and Wildlife Service, announce the availability of our draft recovery plan for Kuenzler hedgehog cactus, a small cactus found in New Mexico. Kuenzler hedgehog cactus is listed as threatened under the Endangered Species Act. We provide this notice to seek comments from the public and Federal, Tribal, State, and local governments.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>To ensure consideration, we must receive written comments on or before July 9, 2021. However, we will accept information about any species at any time.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        <E T="03">Reviewing documents:</E>
                         You may obtain a copy of the draft recovery plan, recovery implementation strategy, and species status assessment by any one of the following methods:
                    </P>
                    <P>
                        • 
                        <E T="03">Internet:</E>
                         Go to one of the following sites:
                    </P>
                    <P>
                        ○ 
                        <E T="03">http://www.regulations.gov</E>
                         in Docket No. FWS-R2-ES-2020-0122;
                    </P>
                    <P>
                        ○ 
                        <E T="03">https://ecos.fws.gov/ecp0/profile/speciesProfile?spcode=Q1VW;</E>
                         or
                    </P>
                    <P>
                        ○ 
                        <E T="03">https://www.fws.gov/southwest/es/NewMexico/.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">U.S. mail:</E>
                         Send a request to U.S. Fish and Wildlife Service, New Mexico Ecological Services Field Office (NMESFO), 2105 Osuna NE, Albuquerque, NM 87113.
                    </P>
                    <P>
                        • 
                        <E T="03">Telephone:</E>
                         505-346-2525 or 800-299-0196.
                    </P>
                    <P>
                        <E T="03">Submitting comments:</E>
                         Submit your comments on the draft recovery plan in writing by either of the following methods:
                    </P>
                    <P>
                        ○ 
                        <E T="03">Federal eRulemaking Portal: http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments on Docket No. FWS-R2-ES-2020-0122; or
                    </P>
                    <P>
                        ○ 
                        <E T="03">U.S. mail:</E>
                         Public Comments Processing; Attn: Docket No. FWS-R2-ES-2020-0122; U.S. Fish and Wildlife Service Headquarters, MS: PRB/3W; 5275 Leesburg Pike, Falls Church, VA 22041-3803
                    </P>
                    <P>
                        For additional information about submitting comments, see Request for Public Comments and Public Availability of Comments under 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Shawn Sartorius, Field Supervisor, at the above address and phone number, or by email at 
                        <E T="03">nmesfo@fws.gov.</E>
                         Individuals who are hearing or speech impaired may call the Federal Relay Service at 1-800-877-8339 for TTY assistance.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    We, the U.S. Fish and Wildlife Service (Service), announce the availability of our draft recovery plan for Kuenzler hedgehog cactus (
                    <E T="03">Echinocereus fendleri</E>
                     var. 
                    <E T="03">kuenzleri</E>
                    ), listed as endangered in 1979 and reclassified to threatened in 2018 under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ). We request review and comment on this plan from local, State, and Federal agencies; Tribes; and the public. We will also accept any new information on the status of Kuenzler hedgehog cactus throughout the species' range to assist in finalizing the recovery plan.
                </P>
                <P>
                    Kuenzler hedgehog cactus (
                    <E T="03">Echinocereus fendleri</E>
                     var. 
                    <E T="03">kuenzleri</E>
                    ) is a small cactus that is endemic to the Sacramento Mountains in Lincoln County, New Mexico, and the Guadalupe Mountains in Eddy County, New Mexico. The draft recovery plan includes specific recovery objective, measurable criteria and management actions that, when achieved, will enable us to consider removing the Kuenzler hedgehog cactus from the Federal List of Endangered and Threatened Wildlife (List).
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>Section 4(f) of the ESA requires the development of recovery plans for listed species, unless such a plan would not promote the conservation of a particular species. Also pursuant to section 4(f) of the ESA, a recovery plan must, to the maximum extent practicable, include:</P>
                <P>(1) A description of site-specific management actions as may be necessary to achieve the plan's goals for the conservation and survival of the species;</P>
                <P>
                    (2) Objective, measurable criteria that, when met, would support a 
                    <PRTPAGE P="24882"/>
                    determination under section 4(a)(1) that the species should be removed from the List of Endangered and Threatened Species; and
                </P>
                <P>(3) Estimates of the time and costs required to carry out those measures needed to achieve the plan's goal and to achieve intermediate steps toward that goal.</P>
                <P>We used a streamlined approach to recovery planning and implementation by first conducting a species status assessment (SSA) of Kuenzler hedgehog cactus (Service 2017). An SSA is a comprehensive analysis of the species' needs, current condition, threats, and future viability. The information in the SSA provides the biological background, a threats assessment, and a basis for a strategy for recovery of Kuenzler hedgehog cactus. We then used this information to prepare an abbreviated draft recovery plan for Kuenzler hedgehog cactus that includes prioritized recovery actions, criteria for removing the species from the List, and the estimated time and cost to recovery.</P>
                <HD SOURCE="HD1">Species Background</HD>
                <P>
                    Kuenzler hedgehog cactus was federally listed as endangered in 1979 (October 26, 1979; 44 FR 61924) as 
                    <E T="03">Echinocereus kuenzleri,</E>
                     and downlisted to threatened in 2018 (May 11, 2018; 83 FR 21928). No critical habitat was designated, due to threat of collection. At the time of listing, fewer than 200 individuals had been documented at 11 locations. Biologists and botanists have since found at least 4,330 individual plants through inventories conducted from 1976 to 2015.
                </P>
                <P>This endemic cactus occurs primarily on Federal lands in New Mexico, ranging from the northwest side of the Sacramento Mountains in Lincoln County to the middle of the Guadalupe Mountains in Eddy County. The Kuenzler hedgehog cactus occupies gentle slopes (0.3-30.6 degrees) or benches with gravelly to rocky soils and southern, eastern, and western exposures (New Mexico Energy, Minerals, and Natural Resources Department 1989: pp. 93-94) in shrubby grassland and juniper savanna habitat types with tree cover varying from 2 to 25 percent, with grasses being the dominant vegetative cover (Sivinski 1999: pp. 1-2).</P>
                <P>The factors influencing the current and future health of populations include wildfire, livestock grazing, illegal collection, climate change, and small population size and low densities. These influences pose the greatest risks to the future viability of this species and are largely related to direct impacts such as mortality or removal, and habitat changes exacerbated by changing climatic conditions.</P>
                <HD SOURCE="HD1">Recovery Criteria</HD>
                <P>
                    The draft recovery criteria are summarized below. For a complete description of the rationale behind the criteria, the recovery strategy, management actions, and estimated time and costs associated with recovery, refer to the Draft Recovery Plan for Kuenzler Hedgehog Cactus (see 
                    <E T="02">ADDRESSES</E>
                     for document availability).
                </P>
                <P>
                    The ultimate recovery goal is to remove the Kuenzler hedgehog cactus from the Federal List of Endangered and Threatened Wildlife (
                    <E T="03">i.e.,</E>
                     “delist” the species) by ensuring the long-term viability of the species in the wild. In the recovery plan, we define the following criteria for “delisting,” or removal of the species from the List, based on the best available information on the species.
                </P>
                <HD SOURCE="HD2">Delisting Criteria</HD>
                <P>
                    <E T="03">Criterion 1</E>
                     (Resiliency): Demonstrate a stable or increasing trend in abundance for the northern Sacramento, southern Sacramento, and Guadalupe Mountains core sites (Fort Stanton, Elk, Texas Hills) over a 20-year period.
                </P>
                <P>
                    <E T="03">Criterion 2</E>
                     (Redundancy): Maintain a minimum of three geographically separated core sites over a 20-year period.
                </P>
                <P>
                    <E T="03">Criterion 3</E>
                     (Representation):
                </P>
                <P>3a. Maintain presence of Kuenzler hedgehog cactus at 80 percent of all known subpopulations (element occurrences) outside of the core sites over a 20-year period, with any extirpations compensated for by newly identified or colonized subpopulations.</P>
                <P>
                    3b. Maintain genetic diversity within all core sites as measured by the inbreeding coefficient for individuals within subpopulations (F
                    <E T="52">IS</E>
                    ) at or within one standard deviation of the F
                    <E T="52">IS</E>
                     from viable populations of a closely related cactus species with similar reproductive strategies.
                </P>
                <HD SOURCE="HD1">Request for Public Comments</HD>
                <P>Section 4(f) of the ESA requires us to provide public notice and an opportunity for public review and comment during recovery plan development. It is also our policy to request peer review of recovery plans (July 1, 1994; 59 FR 34270). In an appendix to the final recovery plan, we will summarize and respond to the issues raised by the public and peer reviewers. Comments may or may not result in changes to the recovery plan; comments regarding recovery plan implementation will be forwarded as appropriate to Federal or other entities so that they can be taken into account during the course of implementation of recovery actions. Responses to individual commenters will not be provided, but we will provide a summary of how we addressed substantive comments in an appendix to the final recovery plan.</P>
                <P>We invite written comments on this draft recovery plan. In particular, we are interested in additional information regarding the current threats to the species, ongoing beneficial management efforts, and the costs associated with implementing the recommended recovery actions. The species status assessment and recovery implementation strategy are accessible as supporting documents for the draft recovery plan, but we are not seeking comments on those documents.</P>
                <HD SOURCE="HD1">Public Availability of Comments</HD>
                <P>
                    All comments received, including names and addresses, will become part of the administrative record and will be available to the public. 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—will be publicly available. If you submit a hard copy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. Comments and materials we receive will be available, by appointment, for public inspection during normal business hours at our office (see 
                    <E T="02">ADDRESSES</E>
                    ).
                </P>
                <HD SOURCE="HD1">Authority</HD>
                <P>
                    We developed our draft recovery plan and publish this notice under the authority of section 4(f) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <SIG>
                    <NAME>Amy L. Lueders,</NAME>
                    <TITLE>Regional Director, Southwest Region, U.S. Fish and Wildlife Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09810 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4333-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="24883"/>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Fish and Wildlife Service</SUBAGY>
                <DEPDOC>[FWS-R8-ES-2020-N107; FXES11130000-190-FF08E00000]</DEPDOC>
                <SUBJECT>Endangered and Threatened Wildlife and Plants; Draft Recovery Plan for Mount Charleston Blue Butterfly</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Fish and Wildlife Service, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of document availability; request for public comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        We, the U.S. Fish and Wildlife Service, announce the availability of the draft recovery plan for the Mount Charleston Blue Butterfly (
                        <E T="03">Icaricia</E>
                         [
                        <E T="03">Plebejus</E>
                        ] 
                        <E T="03">shasta charlestonensis</E>
                        ), an endangered butterfly species, for public review and comment. We request review and comment on this draft recovery plan from local, State, and Federal agencies; nongovernmental organizations; and the public.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>We must receive any comments on the draft recovery plan on or before July 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        <E T="03">Document availability:</E>
                         You may obtain a copy of the recovery plan from our website at 
                        <E T="03">http://www.fws.gov/endangered/species/recovery-plans.html.</E>
                         Alternatively, you may contact the Southern Nevada Fish and Wildlife Office, U.S. Fish and Wildlife Service, 4701 North Torrey Pines Drive, Las Vegas, Nevada 89130 (telephone 702-515-5230).
                    </P>
                    <P>
                        <E T="03">Comment submission:</E>
                         If you wish to comment on the draft recovery plan, you may submit your comments in writing by any one of the following methods:
                    </P>
                    <P>
                        • 
                        <E T="03">U.S. mail:</E>
                         Field Supervisor, at the above address;
                    </P>
                    <P>
                        • 
                        <E T="03">Email: Glen_Knowles@fws.gov.</E>
                    </P>
                    <P>For additional information about submitting comments, see the Request for Public Comments and Public Availability of Comments sections below.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Glen Knowles, Field Supervisor, at 
                        <E T="03">Glen_Knowles@fws.gov</E>
                         or telephone 702-515-5230.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Recovery of endangered or threatened animals and plants to the point where they are again secure, self-sustaining members of their ecosystems is a primary goal of our endangered species program and the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ). Recovery means improvement of the status of listed species to the point at which listing is no longer necessary under the criteria specified in section 4(a)(1) of the Act. The Act requires the development of recovery plans for listed species, unless such a plan would not promote the conservation of a particular species.
                </P>
                <P>Pursuant to section 4(f) of the Act, a recovery plan must, to the maximum extent practicable, include (1) a description of site-specific management actions as may be necessary to achieve the plan's goals for the conservation and survival of the species; (2) objective, measurable criteria which, when met, would support a determination under section 4(a)(1) that the species should be removed from the List of Endangered and Threatened Species; and (3) estimates of the time and costs required to carry out those measures needed to achieve the plan's goal and to achieve intermediate steps toward that goal.</P>
                <P>The U.S. Fish had Wildlife Service (USFWS) has revised its approach to recovery planning; the revised process is called Recovery Planning and Implementation (RPI). The RPI process is intended to reduce the time needed to develop and implement recovery plans, increase recovery plan relevancy over a longer timeframe, and add flexibility to recovery plans so they can be adjusted to new information or circumstances. Under RPI, a recovery plan will include statutorily required elements (objective, measurable criteria; site-specific management actions; and estimates of time and costs), along with a concise introduction and our strategy for how we plan to achieve species recovery. The RPI recovery plan is supported by a separate Species Status Assessment, or in cases such as this one, a species biological report that provides the background information and threat assessment, which are key to recovery plan development. The essential component to flexible implementation under RPI is producing a separate working document called the Recovery Implementation Strategy (implementation strategy). The implementation strategy steps down from the more general description of actions described in the recovery plan to detail the specific, near-term activities needed to implement the recovery plan. The implementation strategy will be adaptable by being able to incorporate new information without having to concurrently revise the recovery plan, unless changes to statutory elements are required.</P>
                <P>Mount Charleston blue butterfly was federally listed as endangered under the Act in 2013 (USFWS 2013). USFWS designated critical habitat for the species in 2015 (USFWS 2015). Mount Charleston blue butterfly is endemic to the Spring Mountains in southern Nevada. Evidence of decreasing range and population size and the presence of ongoing threats to Mount Charleston blue butterfly resulted in its listing as endangered. The majority of the historic range and all currently occupied locations of the Mount Charleston blue butterfly are on lands managed by the Spring Mountains National Recreation Area, Humboldt-Toiyabe National Forest, United States Department of Agriculture Forest Service (Forest Service). Therefore, close coordination and cooperation will need to occur between the USFWS and Forest Service for recovery to be successful. Here we describe a draft recovery plan for the conservation and survival of the Mount Charleston blue butterfly.</P>
                <P>Threats facing the Mount Charleston blue butterfly increase the risk of extinction of the subspecies, given its few occurrences in a small area. The largest threats to Mount Charleston blue butterfly are the loss and degradation of habitat due to changes in natural fire regimes and succession, the implementation of recreational development projects and fuels reduction projects, and the increases in nonnative plants. These threats are likely to be exacerbated by the impact of climate change, which is anticipated to increase drought and extreme precipitation events.</P>
                <HD SOURCE="HD1">Recovery Strategy</HD>
                <P>The purpose of a recovery plan is to provide a framework for the recovery of a species so that protection under the Act is no longer necessary. A recovery plan includes scientific information about the species and provides criteria that enable us to gauge whether downlisting or delisting the species may be warranted. Furthermore, recovery plans help guide our recovery efforts by describing actions we consider necessary for each species' conservation and by estimating time and costs for implementing needed recovery measures.</P>
                <P>
                    The primary threats to be addressed through this recovery strategy are the loss and degradation of habitat due to changes in natural fire regimes and succession, the implementation of recreational development projects and fuels reduction projects, feral horses, and the increases in nonnative plants. Habitat for Mount Charleston blue butterfly may be increased through properly sited and implemented management actions to favor optimal habitat quantity, quality, and patch arrangement. Where appropriate, habitat 
                    <PRTPAGE P="24884"/>
                    that once existed may be restored; habitat that currently exists should be protected and may be enhanced or augmented; and, where conditions are suitable, new habitat may be created. After an evaluation is completed, population growth and connectivity may be assisted with translocation, if necessary, to ensure conservation and expedite recovery of the Mount Charleston blue butterfly. Evaluations, monitoring, and research will be implemented to inform decisions towards the recovery goal.
                </P>
                <P>To downlist to threatened status and ultimately delist the Mount Charleston blue butterfly will require active and ongoing protection of existing populations and occupied habitat, and discovered or established new habitat. Additional habitat and locations that can be categorized as known occupied are critical to ensure Mount Charleston blue butterfly life history processes, population growth, and connectivity will occur, thereby ensuring the genetic diversity of the species, sufficiently large populations to withstand stochastic events, and a sufficiently large number of populations to provide a safety margin to withstand catastrophic events.</P>
                <HD SOURCE="HD1">Request for Public Comments</HD>
                <P>
                    We request written comments on the draft recovery plan described in this notice. All comments received by the date specified in 
                    <E T="02">DATES</E>
                     will be considered in development of a final recovery plan for Mount Charleston blue butterfly. You may submit written comments and information by mail or email to the Southern Nevada Fish and Wildlife Office at the above address (see 
                    <E T="02">ADDRESSES</E>
                    ).
                </P>
                <HD SOURCE="HD1">Public Availability of Comments</HD>
                <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>
                <HD SOURCE="HD1">Authority</HD>
                <P>We developed this recovery plan and publish this notice under the authority of section 4(f) of the Act, 16 U.S.C. 1533(f).</P>
                <SIG>
                    <NAME>Paul Souza,</NAME>
                    <TITLE>Regional Director, Pacific Southwest Region.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09763 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4333-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Indian Affairs</SUBAGY>
                <DEPDOC>[212A2100DD/AAKC001030/A0A501010.999900]</DEPDOC>
                <SUBJECT>Rate Adjustments for Indian Irrigation Projects</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>The Bureau of Indian Affairs (BIA) owns or has an interest in irrigation projects located on or associated with various Indian reservations throughout the United States. We are required to establish irrigation assessment rates to recover the costs to administer, operate, maintain, and rehabilitate these projects. We request your comments on the proposed rate adjustments.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested parties may submit comments on the proposed rate adjustments on or before July 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may send comments on the proposed rate adjustments via email to 
                        <E T="03">comments@bia.gov.</E>
                         Please reference “Rate Adjustments for Indian Irrigation Projects” in the subject line. Or you may submit comments to the Chief, Division of Water and Power, Office of Trust Services, 13922 Denver West Parkway, Suite 300, Lakewood, Colorado 80401.
                    </P>
                    <P>
                        For details about a particular irrigation project, please use the tables in the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section to contact the regional or local office where the project is located.
                    </P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The first table in this notice provides contact information for individuals who can give further information about the irrigation projects covered by this notice. The second table provides the proposed rates for calendar year (CY) 2022 for all irrigation projects.</P>
                <HD SOURCE="HD1">What is the meaning of the key terms used in this notice?</HD>
                <P>In this notice:</P>
                <P>
                    <E T="03">Administrative costs</E>
                     mean all costs we incur to administer our irrigation projects at the local project level and are a cost factor included in calculating your operation and maintenance assessment. Costs incurred at the local project level do not normally include agency, region, or central office costs unless we state otherwise in writing.
                </P>
                <P>
                    <E T="03">Assessable acre</E>
                     means lands designated by us to be served by one of our irrigation projects, for which we collect assessments in order to recover costs for the provision of irrigation service. (
                    <E T="03">See total assessable acres.</E>
                    )
                </P>
                <P>
                    <E T="03">BIA</E>
                     means the Bureau of Indian Affairs.
                </P>
                <P>
                    <E T="03">Bill</E>
                     means our statement to you of the assessment charges and/or fees you owe the United States for administration, operation, maintenance, and/or rehabilitation. The date we mail or hand-deliver your bill will be stated on it.
                </P>
                <P>
                    <E T="03">Costs</E>
                     means the costs we incur for administration, operation, maintenance, and rehabilitation to provide direct support or benefit to an irrigation facility. (
                    <E T="03">See</E>
                     administrative costs, operation costs, maintenance costs, and rehabilitation costs).
                </P>
                <P>
                    <E T="03">Customer</E>
                     means any person or entity to whom or to which we provide irrigation service.
                </P>
                <P>
                    <E T="03">Due date</E>
                     is the date on which your bill is due and payable. This date will be stated on your bill.
                </P>
                <P>
                    <E T="03">I, me,</E>
                      
                    <E T="03">my, you</E>
                     and 
                    <E T="03">your</E>
                     mean all persons or entities that are affected by this notice.
                </P>
                <P>
                    <E T="03">Irrigation project</E>
                     means a facility or portion thereof for the delivery, diversion, and storage of irrigation water that we own or have an interest in, including all appurtenant works. The term “irrigation project” is used interchangeably with irrigation facility, irrigation system, and irrigation area.
                </P>
                <P>
                    <E T="03">Irrigation service</E>
                     means the full range of services we provide customers of our irrigation projects. This includes our activities to administer, operate, maintain, and rehabilitate our projects in order to deliver water.
                </P>
                <P>
                    <E T="03">Maintenance costs</E>
                     means costs we incur to maintain and repair our irrigation projects and associated equipment and is a cost factor included in calculating your operation and maintenance assessment.
                </P>
                <P>
                    <E T="03">Operation and maintenance (O&amp;M) assessment</E>
                     means the periodic charge you must pay us to reimburse costs of administering, operating, maintaining, and rehabilitating irrigation projects consistent with this notice and our supporting policies, manuals, and handbooks.
                </P>
                <P>
                    <E T="03">Operation or operating costs</E>
                     means costs we incur to operate our irrigation projects and equipment and is a cost factor included in calculating your O&amp;M assessment.
                </P>
                <P>
                    <E T="03">Past due bill</E>
                     means a bill that has not been paid by the close of business on the 30th day after the due date as stated 
                    <PRTPAGE P="24885"/>
                    on the bill. Beginning on the 31st day after the due date, we begin assessing additional charges accruing from the due date.
                </P>
                <P>
                    <E T="03">Rehabilitation costs</E>
                     means costs we incur to restore our irrigation projects or features to original operating condition or to the nearest state which can be achieved using current technology and is a cost factor included in calculating your O&amp;M assessment.
                </P>
                <P>
                    <E T="03">Responsible party</E>
                     means an individual or entity that owns or leases land within the assessable acreage of one of our irrigation projects and is responsible for providing accurate information to our billing office and paying a bill for an annual irrigation rate assessment.
                </P>
                <P>
                    <E T="03">Total assessable acres</E>
                     mean the total acres served by one of our irrigation projects.
                </P>
                <P>
                    <E T="03">Water delivery</E>
                     is an activity that is part of the irrigation service we provide our customers when water is available.
                </P>
                <P>
                    <E T="03">We, us,</E>
                     and 
                    <E T="03">our</E>
                     mean the United States Government, the Secretary of the Interior, the BIA, and all who are authorized to represent us in matters covered under this notice.
                </P>
                <HD SOURCE="HD1">Does this notice affect me?</HD>
                <P>This notice affects you if you own or lease land within the assessable acreage of one of our irrigation projects or if you have a carriage agreement with one of our irrigation projects.</P>
                <HD SOURCE="HD1">Where can I get information on the regulatory and legal citations in this notice?</HD>
                <P>
                    You can contact the appropriate office(s) stated in the tables for the irrigation project that serves you, or you can use the internet site for the Government Publishing Office at 
                    <E T="03">http://www.gpo.gov.</E>
                </P>
                <HD SOURCE="HD1">Why are you publishing this notice?</HD>
                <P>We are publishing this notice to inform you that we propose to adjust our irrigation assessment rates. This notice is published in accordance with the BIA's regulations governing its operation and maintenance of irrigation projects, found at 25 CFR part 171. This regulation provides for the establishment and publication of the proposed rates for annual irrigation assessments as well as related information about our irrigation projects.</P>
                <HD SOURCE="HD1">What authorizes you to issue this notice?</HD>
                <P>Our authority to issue this notice is vested in the Secretary of the Interior by 5 U.S.C. 301 and the Act of August 14, 1914 (38 Stat. 583; 25 U.S.C. 385). The Secretary has in turn delegated this authority to the Assistant Secretary—Indian Affairs under Part 209, Chapter 8.1A, of the Department of the Interior's Departmental Manual.</P>
                <HD SOURCE="HD1">When will you put the rate adjustments into effect?</HD>
                <P>We will put the rate adjustments into effect for CY 2022.</P>
                <HD SOURCE="HD1">How do you calculate irrigation rates?</HD>
                <P>We calculate annual irrigation assessment rates in accordance with 25 CFR part 171.500 by estimating the annual costs of operation and maintenance at each of our irrigation projects and then dividing by the total assessable acres for that particular irrigation project. The result of this calculation for each project is stated in the rate table in this notice.</P>
                <HD SOURCE="HD1">What kinds of expenses do you consider in determining the estimated annual costs of operation and maintenance?</HD>
                <P>Consistent with 25 CFR part 171.500, these expenses include the following:</P>
                <P>(a) Personnel salary and benefits for the project engineer/manager and project employees under the project engineer/manager's management or control;</P>
                <P>(b) Materials and supplies;</P>
                <P>(c) Vehicle and equipment repairs;</P>
                <P>(d) Equipment costs, including lease fees;</P>
                <P>(e) Depreciation;</P>
                <P>(f) Acquisition costs;</P>
                <P>(g) Maintenance of a reserve fund available for contingencies or emergency costs needed for the reliable operation of the irrigation facility infrastructure;</P>
                <P>(h) Maintenance of a vehicle and heavy equipment replacement fund;</P>
                <P>(i) Systematic rehabilitation and replacement of project facilities;</P>
                <P>(j) Contingencies for unknown costs and omitted budget items; and</P>
                <P>(k) Other expenses we determine necessary to properly perform the activities and functions characteristic of an irrigation project.</P>
                <HD SOURCE="HD1">When should I pay my irrigation assessment?</HD>
                <P>We will mail or hand deliver your bill notifying you (a) the amount you owe to the United States and (b) when such amount is due. If we mail your bill, we will consider it as being delivered no later than five business days after the day we mail it. You should pay your bill by the due date stated on the bill.</P>
                <HD SOURCE="HD1">What information must I provide for billing purposes?</HD>
                <P>All responsible parties are required to provide the following information to the billing office associated with the irrigation project where you own or lease land within the project's assessable acreage or to the billing office associated with the irrigation project with which you have a carriage agreement:</P>
                <P>(1) The full legal name of the person or entity responsible for paying the bill;</P>
                <P>(2) An adequate and correct address for mailing or hand delivering our bill; and</P>
                <P>(3) The taxpayer identification number or social security number of the person or entity responsible for paying the bill.</P>
                <HD SOURCE="HD1">Why are you collecting my taxpayer identification number or social security number?</HD>
                <P>Public Law 104-134, the Debt Collection Improvement Act of 1996, requires that we collect the taxpayer identification number or social security number before billing a responsible party and as a condition to servicing the account.</P>
                <HD SOURCE="HD1">What happens if I am a responsible party but I fail to furnish the information required to the billing office responsible for the irrigation project within which I own or lease assessable land or for which I have a carriage agreement?</HD>
                <P>If you are late paying your bill because of your failure to furnish the required information listed above, you will be assessed interest and penalties as provided below, and your failure to provide the required information will not provide grounds for you to appeal your bill or any penalties assessed.</P>
                <HD SOURCE="HD1">What can happen if I do not provide the information required for billing purposes?</HD>
                <P>We can refuse to provide you irrigation service.</P>
                <HD SOURCE="HD1">If I allow my bill to become past due, could this affect my water delivery?</HD>
                <P>
                    Yes. 25 CFR 171.545(a) states: “We will not provide you irrigation service until: (1) Your bill is paid; or (2) You make arrangement for payment pursuant to § 171.550 of this part.” If we do not receive your payment before the close of business on the 30th day after the due date stated on your bill, we will send you a past due notice. This past due notice will have additional information concerning your rights. We will consider your past due notice as delivered no later than five business 
                    <PRTPAGE P="24886"/>
                    days after the day we mail it. We follow the procedures provided in 31 CFR 901.2, “Demand for Payment,” when demanding payment of your past due bill.
                </P>
                <HD SOURCE="HD1">Are there any additional charges if I am late paying my bill?</HD>
                <P>Yes. We are required to assess interest, penalties, and administrative costs on past due bills in accordance with 31 U.S.C. 3717 and 31 CFR 901.9. The rate of interest is established annually by the Secretary of the United States Treasury (Treasury) and accrues from the date your bill is past due. If your bill becomes more than 90 days past due, you will be assessed a penalty charge of no more than six percent per year, which accrues from the date your bill became past due. Each time we try to collect your past due bill, you will be charged an administrative fee of $12.50 for processing and handling.</P>
                <HD SOURCE="HD1">What else will happen to my past due bill?</HD>
                <P>If you do not pay your bill or make payment arrangements to which we agree, we are required to transfer your past due bill to Treasury for further action. Pursuant to 31 CFR 285.12, bills that are 120 days past due will be transferred to Treasury.</P>
                <HD SOURCE="HD1">Who can I contact for further information?</HD>
                <P>The following tables are the regional and project/agency contacts for our irrigation facilities.</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s75,r150">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Project name</CHED>
                        <CHED H="1">Project project/agency contacts</CHED>
                    </BOXHD>
                    <ROW EXPSTB="01" RUL="s">
                        <ENT I="21">
                            <E T="02">Northwest Region Contacts</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="01" RUL="s">
                        <ENT I="21">Bryan Mercier, Regional Director, Bureau of Indian Affairs, Northwest Regional Office, 911 NE 11th Avenue, Portland, OR 97232-4169, Telephone: (503) 231-6702.</ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Flathead Indian Irrigation Project</ENT>
                        <ENT>Larry Nelson, Acting Irrigation Project Manager, P.O. Box 40, Pablo, MT 59855, Telephone: (406) 745-2661 Project Manager.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fort Hall Irrigation Project</ENT>
                        <ENT>Tim Gardner, Acting Irrigation Project Manager, Building #2 Bannock Avenue, Fort Hall, ID 83203-0220, Telephone: (208) 238-1992.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Wapato Irrigation Project</ENT>
                        <ENT>Pete Plant, Project Administrator, 413 South Camas Avenue, Wapato, WA 98951-0220, Telephone: (509) 877-3155 Project Administrator.</ENT>
                    </ROW>
                    <ROW EXPSTB="01" RUL="s">
                        <ENT I="21">
                            <E T="02">Rocky Mountain Region Contacts</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="01" RUL="s">
                        <ENT I="21">Susan Messerly, Regional Director, Bureau of Indian Affairs, Rocky Mountain Regional Office, 2021 4th Avenue North, Billings, MT 59101, Telephone: (406) 247-7943.</ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Blackfeet Irrigation Project</ENT>
                        <ENT>Thedis Crowe, Superintendent, Greg Tatsey, Irrigation Project Manager, Box 880, Browning, MT 59417, Telephones: (406) 338-7544 Superintendent, (406) 338-7519 Irrigation Project Manager.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Crow Irrigation Project</ENT>
                        <ENT>Clifford Serawop, Superintendent, Richard Green, Irrigation Project Manager, (Project operation &amp; maintenance performed by Water Users Association), P.O. Box 69, Crow Agency, MT 59022, Telephones: (406) 638-2672 Superintendent, (406) 247-7469 Irrigation Project Manager.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fort Belknap Irrigation Project</ENT>
                        <ENT>Mark Azure, Superintendent, Jim Gappa, Irrigation Project Manager (BIA), (Project operation &amp; maintenance contracted to Fort Belknap Indian Community under PL 93-638), 158 Tribal Way, Suite B, Harlem, MT 59526, Telephones: (406) 353-2901 Superintendent, (406) 353-8466 Irrigation Project Manager (Tribal Office).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fort Peck Irrigation Project</ENT>
                        <ENT>Anna Eder, Superintendent, Jim Gappa, Acting Irrigation Project Manager, (Project operation &amp; maintenance performed by Fort Peck Water Users Association), P.O. Box 637, Poplar, MT 59255, Telephones: (406) 768-5312 Superintendent, (406) 653-1752 Huber Wright—Lead ISO.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Wind River Irrigation Project</ENT>
                        <ENT>Leslie Shakespeare, Superintendent, Jim Gappa, Acting Irrigation Project Manager, (Project operation &amp; maintenance for Little Wind, Johnstown, and Lefthand Units contracted to Wind River Tribes under PL 93-638; Little Wind-Ray and Upper Wind Units operation &amp; maintenance performed by Ray Canal, A Canal, and Crowheart Water Users Associations), P.O. Box 158, Fort Washakie, WY 82514, Telephones: (307) 332-7810 Superintendent, (406) 247-7998 Acting Irrigation Project Manager.</ENT>
                    </ROW>
                    <ROW EXPSTB="01" RUL="s">
                        <ENT I="21">
                            <E T="02">Southwest Region Contacts</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="01" RUL="s">
                        <ENT I="21">Patricia L. Mattingly, Regional Director, Bureau of Indian Affairs, Southwest Regional Office, 1001 Indian School Road, Albuquerque, NM 87104, Telephone: (505) 563-3100.</ENT>
                    </ROW>
                    <ROW EXPSTB="00" RUL="s">
                        <ENT I="01">Pine River Irrigation Project</ENT>
                        <ENT>Priscilla Bancroft, Superintendent, Vickie Begay, Irrigation Project Manager, P.O. Box 315, Ignacio, CO 81137-0315, Telephones: (970) 563-4511, Superintendent, (970) 563-9484, Irrigation Project Manager.</ENT>
                    </ROW>
                    <ROW EXPSTB="01" RUL="s">
                        <ENT I="21">
                            <E T="02">Western Region Contacts</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="01" RUL="s">
                        <ENT I="21">Bryan Bowker, Regional Director, Bureau of Indian Affairs, Western Regional Office, 2600 North Central Avenue, 4th Floor Mailroom, Phoenix, AZ 85004, Telephone: (602) 379-6600.</ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Colorado River Irrigation Project</ENT>
                        <ENT>Davetta Ameelyenah, Superintendent, Gary Colvin, Irrigation Project Manager, 12124 1st Avenue, Parker, AZ 85344, Telephone: (928) 669-7111.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="24887"/>
                        <ENT I="01">Duck Valley Irrigation Project</ENT>
                        <ENT>Joseph McDade, Superintendent, (Project operation &amp; maintenance compacted to Shoshone-Paiute Tribes under PL 93-638), 2719 Argent Avenue, Suite 4, Gateway Plaza, Elko, NV 89801, Telephone: (775) 738-5165, (208) 759-3100 (Tribal Office).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Yuma Project, Indian Unit</ENT>
                        <ENT>Denni Shields, Superintendent, 256 South Second Avenue, Suite D, Yuma, AZ 85364, Telephone: (928) 782-1202.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">San Carlos Irrigation Project (Indian Works and Joint Works)</ENT>
                        <ENT>Ferris Begay, Project Manager, Kyle Varvel, Acting Supervisory Civil Engineer, (Portions of Indian Works operation &amp; maintenance compacted to Gila River Indian Community under PL 93-638), 13805 North Arizona Boulevard, Coolidge, AZ 85128, Telephone: (520) 723-6225.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Uintah Irrigation Project</ENT>
                        <ENT>Antonio Pingree, Superintendent, Ken Asay, Irrigation System Manager, (Project operation &amp; maintenance performed by Uintah Indian Irrigation Project Operation and Maintenance Company), P.O. Box 130, Fort Duchesne, UT 84026, Telephone: (435) 722-4300, (435) 722-4344.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Walker River Irrigation Project</ENT>
                        <ENT>Gerry Emm, Acting Superintendent, 311 East Washington Street, Carson City, NV 89701, Telephone: (775) 887-3500.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">What irrigation assessments or charges are proposed for adjustment by this notice?</HD>
                <P>The rate table below contains current final CY 2021 rates for irrigation projects where we recover costs of administering, operating, maintaining, and rehabilitating them. The table also contains proposed CY 2022 rates for all irrigation projects. An asterisk immediately following the rate category notes irrigation projects where rates are proposed for adjustment.</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="xs200,r50,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Project name</CHED>
                        <CHED H="1">Rate category</CHED>
                        <CHED H="1">
                            Final
                            <LI>2021 rate</LI>
                        </CHED>
                        <CHED H="1">
                            Proposed
                            <LI>2022 rate</LI>
                        </CHED>
                    </BOXHD>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Northwest Region Rate Table</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Flathead Irrigation Project</ENT>
                        <ENT>Basic per acre—A</ENT>
                        <ENT>$33.50</ENT>
                        <ENT>$33.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Basic per acre—B</ENT>
                        <ENT>16.75</ENT>
                        <ENT>16.75</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Minimum Charge per tract</ENT>
                        <ENT>75.00</ENT>
                        <ENT>75.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fort Hall Irrigation Project</ENT>
                        <ENT>Basic per acre *</ENT>
                        <ENT>58.50</ENT>
                        <ENT>62.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Minimum Charge per tract *</ENT>
                        <ENT>39.00</ENT>
                        <ENT>40.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fort Hall Irrigation Project—Minor Units</ENT>
                        <ENT>Basic per acre *</ENT>
                        <ENT>38.00</ENT>
                        <ENT>41.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Minimum Charge per tract *</ENT>
                        <ENT>39.00</ENT>
                        <ENT>40.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fort Hall Irrigation Project—Michaud Unit</ENT>
                        <ENT>Basic per acre *</ENT>
                        <ENT>63.50</ENT>
                        <ENT>68.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Pressure per acre *</ENT>
                        <ENT>99.50</ENT>
                        <ENT>106.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Minimum Charge per tract *</ENT>
                        <ENT>39.00</ENT>
                        <ENT>40.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wapato Irrigation Project—Toppenish/Simcoe Units</ENT>
                        <ENT>Minimum Charge per bill</ENT>
                        <ENT>25.00</ENT>
                        <ENT>25.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Basic per acre</ENT>
                        <ENT>25.00</ENT>
                        <ENT>25.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wapato Irrigation Project—Ahtanum Units</ENT>
                        <ENT>Minimum Charge per bill</ENT>
                        <ENT>30.00</ENT>
                        <ENT>30.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Basic per acre</ENT>
                        <ENT>30.00</ENT>
                        <ENT>30.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wapato Irrigation Project—Satus Unit</ENT>
                        <ENT>Minimum Charge per bill</ENT>
                        <ENT>79.00</ENT>
                        <ENT>79.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>“A” Basic per acre</ENT>
                        <ENT>79.00</ENT>
                        <ENT>79.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>“B” Basic per acre</ENT>
                        <ENT>85.00</ENT>
                        <ENT>85.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wapato Irrigation Project—Additional Works</ENT>
                        <ENT>Minimum Charge per bill</ENT>
                        <ENT>80.00</ENT>
                        <ENT>80.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Basic per acre</ENT>
                        <ENT>80.00</ENT>
                        <ENT>80.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wapato Irrigation Project—Water Rental</ENT>
                        <ENT>Minimum Charge per bill</ENT>
                        <ENT>86.00</ENT>
                        <ENT>86.00</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="22"> </ENT>
                        <ENT>Basic per acre</ENT>
                        <ENT>86.00</ENT>
                        <ENT>86.00</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Rocky Mountain Region Rate Table</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Blackfeet Irrigation Project</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>20.50</ENT>
                        <ENT>20.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Crow Irrigation Project—Willow Creek O&amp;M (includes Agency, Lodge Grass #1, Lodge Grass #2, Reno, Upper Little Horn, and Forty Mile Units)</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>28.50</ENT>
                        <ENT>28.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Crow Irrigation Project—All Others (includes Bighorn, Soap Creek, and Pryor Units)</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>28.50</ENT>
                        <ENT>28.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Crow Irrigation Project—Two Leggins Unit</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>14.00</ENT>
                        <ENT>14.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Crow Irrigation Two Leggins Drainage District</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>2.00</ENT>
                        <ENT>2.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fort Belknap Irrigation Project</ENT>
                        <ENT>Basic-per acre *</ENT>
                        <ENT>17.00</ENT>
                        <ENT>18.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fort Peck Irrigation Project</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>27.00</ENT>
                        <ENT>27.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wind River Irrigation Project—Units 2, 3 and 4</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>25.00</ENT>
                        <ENT>25.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wind River Irrigation Project—Unit 6</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>22.00</ENT>
                        <ENT>22.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wind River Irrigation Project—LeClair District (See Note #1)</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>47.00</ENT>
                        <ENT>47.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wind River Irrigation Project—Crow Heart Unit</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>16.50</ENT>
                        <ENT>16.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wind River Irrigation Project—A Canal Unit</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>16.50</ENT>
                        <ENT>16.50</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">Wind River Irrigation Project—Riverton Valley Irrigation District (See Note #1)</ENT>
                        <ENT>Basic-per acre</ENT>
                        <ENT>30.65</ENT>
                        <ENT>30.65</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Southwest Region Rate Table</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Pine River Irrigation Project</ENT>
                        <ENT>Minimum Charge per tract</ENT>
                        <ENT>50.00</ENT>
                        <ENT>50.00</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <PRTPAGE P="24888"/>
                        <ENT I="22"> </ENT>
                        <ENT>Basic-per acre *</ENT>
                        <ENT>22.00</ENT>
                        <ENT>22.50</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Western Region Rate Table</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">Colorado River Irrigation Project</ENT>
                        <ENT>Basic per acre up to 5.75 acre-feet *</ENT>
                        <ENT>61.50</ENT>
                        <ENT>64.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Excess Water per acre-foot over 5.75 acre-feet</ENT>
                        <ENT>18.00</ENT>
                        <ENT>18.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Duck Valley Irrigation Project</ENT>
                        <ENT>Basic per acre</ENT>
                        <ENT>5.30</ENT>
                        <ENT>5.30</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Yuma Project, Indian Unit (See Note #2)</ENT>
                        <ENT>Basic per acre up to 5.0 acre-feet *</ENT>
                        <ENT>154.50</ENT>
                        <ENT>( + )</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Excess Water per acre-foot over 5.0 acre-feet *</ENT>
                        <ENT>30.00</ENT>
                        <ENT>( + )</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Basic per acre up to 5.0 acre-feet (Ranch 5)* </ENT>
                        <ENT>154.50</ENT>
                        <ENT>( + )</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">San Carlos Irrigation Project (Joint Works) (See Note #3)</ENT>
                        <ENT>Basic per acre *</ENT>
                        <ENT>25.78</ENT>
                        <ENT>26.00</ENT>
                    </ROW>
                </GPOTABLE>
                <GPOTABLE COLS="5" OPTS="L2(0,,),ns,tp0,i1" CDEF="xs199,r50,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1" O="L">Proposed 2022 Construction Water Rate Schedule:</CHED>
                        <CHED H="2"> </CHED>
                        <CHED H="2">Off project construction</CHED>
                        <CHED H="2">On project construction—gravity water</CHED>
                        <CHED H="2">On project construction—pump water</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Administrative Fee</ENT>
                        <ENT>$300.00</ENT>
                        <ENT>$300.00</ENT>
                        <ENT>$300.00.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Usage Fee</ENT>
                        <ENT>$250.00 per month</ENT>
                        <ENT>No Fee</ENT>
                        <ENT>$100.00 per acre foot.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Excess Water Rate †</ENT>
                        <ENT>$5.00 per 1,000 gal.</ENT>
                        <ENT>No Charge</ENT>
                        <ENT>No Charge.</ENT>
                    </ROW>
                </GPOTABLE>
                <GPOTABLE COLS="4" OPTS="L2(0,,),ns,tp0,i1" CDEF="xs200,r50,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Project name</CHED>
                        <CHED H="1">Rate category</CHED>
                        <CHED H="1">
                            Final
                            <LI>2021 rate</LI>
                        </CHED>
                        <CHED H="1">
                            Proposed
                            <LI>2022 rate</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">San Carlos Irrigation Project (Indian Works) (See Note #4)</ENT>
                        <ENT>Basic per acre *</ENT>
                        <ENT>$97.78</ENT>
                        <ENT>$90.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Uintah Irrigation Project</ENT>
                        <ENT>Basic per acre</ENT>
                        <ENT>23.00</ENT>
                        <ENT>23.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Minimum Bill</ENT>
                        <ENT>25.00</ENT>
                        <ENT>25.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Walker River Irrigation Project</ENT>
                        <ENT>Basic per acre</ENT>
                        <ENT>31.00</ENT>
                        <ENT>31.00</ENT>
                    </ROW>
                    <TNOTE>* Notes irrigation projects where rates are adjusted.</TNOTE>
                    <TNOTE>+ These rates have not yet been determined.</TNOTE>
                    <TNOTE>† The excess water rate applies to all water used in excess of 50,000 gallons in any one month.</TNOTE>
                    <TNOTE>Note #1 O&amp;M rates for LeClair and Riverton Valley Irrigation Districts apply to Trust lands that are serviced by each irrigation district. The annual O&amp;M rates are based on budgets submitted by LeClair and Riverton Valley Irrigation Districts, respectively.</TNOTE>
                    <TNOTE>Note #2 The O&amp;M rate for the Yuma Project, Indian Unit has two components. The first component of the O&amp;M rate is established by the Bureau of Reclamation (BOR), the owner and operator of the Project. BOR's rate, which is based upon the annual budget submitted by BOR, is $151.00 for 2021 but has not been established for 2022. The second component of the O&amp;M rate is established by BIA to cover administrative costs, which includes billing and collections for the Project. The final 2021 (85 FR 47235 (August 4, 2020)) BIA rate component is $3.50/acre. The proposed 2022 BIA rate component is $4.00/acre.</TNOTE>
                    <TNOTE>Note #3 The Construction Water Rate Schedule identifies fees assessed for use of irrigation water for non-irrigation purposes.</TNOTE>
                    <TNOTE>Note #4 The O&amp;M rate for the San Carlos Irrigation Project—Indian Works has three components. The first component is established by the San Carlos Irrigation Project—Indian Works, the owner and operator of the Project; the final 2021 rate is $56.00 per acre, and proposed 2022 rate is $56.50 per acre. The second component is established by the San Carlos Irrigation Project—Joint Works; the 2021 rate is $25.78 per acre, and proposed 2022 rate is $26.00 per acre. The third component is established by the San Carlos Irrigation Project Joint Control Board; the 2021 rate is $16.00 per acre, and 2022 rate is $8.00 per acre.</TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD1">Consultation and Coordination With Tribal Governments (Executive Order 13175)</HD>
                <P>The Department of the Interior strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this notice under the Department's consultation policy and under the criteria of Executive Order 13175 and have determined there to be substantial direct effects on federally recognized Tribes because the irrigation projects are located on or associated with Indian reservations. To fulfill its consultation responsibility to Tribes and Tribal organizations, BIA communicates, coordinates, and consults on a continuing basis with these entities on issues of water delivery, water availability, and costs of administration, operation, maintenance, and rehabilitation of projects that concern them. This is accomplished at the individual irrigation project by project, agency, and regional representatives, as appropriate, in accordance with local protocol and procedures. This notice is one component of our overall coordination and consultation process to provide notice to, and request comments from, these entities when we adjust irrigation assessment rates.</P>
                <HD SOURCE="HD1">Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (Executive Order 13211)</HD>
                <P>The proposed rate adjustments are not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects is not required.</P>
                <HD SOURCE="HD1">Regulatory Planning and Review (Executive Order 12866)</HD>
                <P>These proposed rate adjustments are not a significant regulatory action and do not need to be reviewed by the Office of Management and Budget under Executive Order 12866.</P>
                <HD SOURCE="HD1">Regulatory Flexibility Act</HD>
                <P>These proposed rate adjustments are not a rule for the purposes of the Regulatory Flexibility Act because they establish “a rule of particular applicability relating to rates.”</P>
                <P>
                    5 U.S.C. 601(2).
                    <PRTPAGE P="24889"/>
                </P>
                <HD SOURCE="HD1">Unfunded Mandates Reform Act of 1995</HD>
                <P>
                    These proposed rate adjustments do not impose an unfunded mandate on state, local, or Tribal governments in the aggregate, or on the private sector, of more than $130 million per year. They do not have a significant or unique effect on State, local, or Tribal governments or the private sector. Therefore, the Department is not required to prepare a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <HD SOURCE="HD1">Takings (Executive Order 12630)</HD>
                <P>These proposed rate adjustments do not effect a taking of private property or otherwise have “takings” implications under Executive Order 12630. The proposed rate adjustments do not deprive the public, State, or local governments of rights or property.</P>
                <HD SOURCE="HD1">Federalism (Executive Order 13132)</HD>
                <P>Under the criteria in section 1 of Executive Order 13132, these proposed rate adjustments do not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement because they will not affect the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. A federalism summary impact statement is not required.</P>
                <HD SOURCE="HD1">Civil Justice Reform (Executive Order 12988)</HD>
                <P>This notice complies with the requirements of Executive Order 12988. Specifically, in issuing this notice, the Department has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct as required by section 3 of Executive Order 12988.</P>
                <HD SOURCE="HD1">Paperwork Reduction Act of 1995</HD>
                <P>These proposed rate adjustments do not affect the collections of information which have been approved by the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. The OMB Control Number is 1076-0141 and expires January 31, 2023.</P>
                <HD SOURCE="HD1">National Environmental Policy Act</HD>
                <P>The Department has determined that these proposed rate adjustments do not constitute a major Federal action significantly affecting the quality of the human environment and that no detailed statement is required under the National Environmental Policy Act of 1969, 42 U.S.C. 4321-4370(d)), pursuant to 43 CFR 46.210(i). In addition, the proposed rate adjustments do not present any of the 12 extraordinary circumstances listed at 43 CFR 46.215.</P>
                <SIG>
                    <NAME>Bryan Newland,</NAME>
                    <TITLE>Principal Deputy Assistant Secretary—Indian Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09222 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4337-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">INTERNATIONAL TRADE COMMISSION</AGENCY>
                <DEPDOC>[Investigation Nos. 701-TA-525 and 731-TA-1260-1261 (Review)]</DEPDOC>
                <SUBJECT>Certain Welded Line Pipe From Korea and Turkey; Scheduling of Expedited Five-Year Reviews</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States International Trade Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Commission hereby gives notice of the scheduling of expedited reviews pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation of the countervailing and antidumping duty orders on certain welded line pipe from Korea and Turkey would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>February 5, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Christopher W. Robinson (202-205-2542), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
                        <E T="03">https://www.usitc.gov</E>
                        ). The public record for these reviews may be viewed on the Commission's electronic docket (EDIS) at 
                        <E T="03">https://edis.usitc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P SOURCE="NPAR">
                    <E T="03">Background.</E>
                    —On February 5, 2021, the Commission determined that the domestic interested party group response to its notice of institution (85 FR 69354, November 2, 2020) of the subject five-year reviews was adequate and that the respondent interested party group response was inadequate. The Commission did not find any other circumstances that would warrant conducting full reviews.
                    <SU>1</SU>
                    <FTREF/>
                     Accordingly, the Commission determined that it would conduct expedited reviews pursuant to section 751(c)(3) of the Tariff Act of 1930 (19 U.S.C. 1675(c)(3)).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         A record of the Commissioners' votes is available from the Office of the Secretary and at the Commission's website.
                    </P>
                </FTNT>
                <P>For further information concerning the conduct of these reviews and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).</P>
                <P>
                    Please note the Secretary's Office will accept only electronic filings at this time. Filings must be made through the Commission's Electronic Document Information System (EDIS, 
                    <E T="03">https://edis.usitc.gov</E>
                    ). No in-person paper-based filings or paper copies of any electronic filings will be accepted until further notice.
                </P>
                <P>
                    <E T="03">Staff report.</E>
                    —A staff report containing information concerning the subject matter of the reviews will be placed in the nonpublic record on May 11, 2021, and made available to persons on the Administrative Protective Order service list for these reviews. A public version will be issued thereafter, pursuant to section 207.62(d)(4) of the Commission's rules.
                </P>
                <P>
                    <E T="03">Written submissions.</E>
                    —As provided in section 207.62(d) of the Commission's rules, interested parties that are parties to the reviews and that have provided individually adequate responses to the notice of institution,
                    <SU>2</SU>
                    <FTREF/>
                     and any party other than an interested party to the reviews may file written comments with the Secretary on what determination the Commission should reach in the reviews. Comments are due on or before May 18, 2021 and may not contain new factual information. Any person that is neither a party to the five-year reviews nor an interested party may submit a brief written statement (which shall not contain any new factual information) pertinent to the reviews by May 18, 2021. However, should the Department of Commerce (“Commerce”) extend the time limit for its completion of the final results of its reviews, the deadline for 
                    <PRTPAGE P="24890"/>
                    comments (which may not contain new factual information) on Commerce's final results is three business days after the issuance of Commerce's results. If comments contain business proprietary information (BPI), they must conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's 
                    <E T="03">Handbook on Filing Procedures,</E>
                     available on the Commission's website at 
                    <E T="03">https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf,</E>
                     elaborates upon the Commission's procedures with respect to filings.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The Commission has found a joint response to its notice of institution filed on behalf of American Cast Iron Pipe Company, Axis Pipe and Tube, California Steel Industries, IPSCO Tubulars Inc., Maverick Tube Corporation, Stupp Corporation, Tex-Tube Company, and Welspun Tubular LLC, and Wheatland Tube Company, domestic producers of certain welded line pipe, to each be individually adequate. Comments from other interested parties will not be accepted (
                        <E T="03">see</E>
                         19 CFR 207.62(d)(2)).
                    </P>
                </FTNT>
                <P>In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the reviews must be served on all other parties to the reviews (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.</P>
                <P>
                    <E T="03">Determination.</E>
                    —The Commission has determined these reviews are extraordinarily complicated and therefore has determined to exercise its authority to extend the review period by up to 90 days pursuant to 19 U.S.C. 1675(c)(5)(B).
                </P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>These reviews are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.</P>
                </AUTH>
                <SIG>
                    <P>By order of the Commission.</P>
                    <DATED>Issued: May 4, 2021.</DATED>
                    <NAME>Lisa Barton,</NAME>
                    <TITLE>Secretary to the Commission.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09787 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7020-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employment and Training Administration</SUBAGY>
                <SUBJECT>Workforce Information Advisory Council</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Employment and Training Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for nominations for membership on the Workforce Information Advisory Council.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Department of Labor (DOL) invites interested parties to submit nominations for individuals to serve on the Workforce Information Advisory Council (WIAC) and announces the procedures for those nominations. There are vacant positions on the WIAC representing State agencies with responsibility for workforce investment activities (State Workforce Agency representatives) and representatives of State workforce and labor market information (LMI) directors. While this notice is directed specifically to obtaining nominations for the current vacancies, LMI director and State Workforce Agency representatives, individuals qualified for the other five membership categories listed below in the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section are invited to submit nomination materials, and DOL will consider these nominees in the event that seats in those categories become available. When submitting nomination materials, please indicate the category or categories for which the nominee would like to be considered. Information regarding the WIAC can be found at 
                        <E T="03">https://www.dol.gov/agencies/eta/wioa/wiac.</E>
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Nominations for individuals to serve on the WIAC must be submitted (postmarked, if sending by mail; submitted electronically; or received, if hand delivered) by June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit nominations and supporting materials described in this 
                        <E T="04">Federal Register</E>
                         Notice by the following method:
                    </P>
                    <P>
                        <E T="03">Electronically:</E>
                         Submit nominations, including attachments, by email using the following address: 
                        <E T="03">WIAC@dol.gov</E>
                         (use subject line “Nomination—Workforce Information Advisory Council”). The Department will not accept nominations by mail, express delivery, hand delivery, messenger, courier service, or facsimile.
                    </P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Section 15 of the Wagner-Peyser Act, 29 U.S.C. 49
                    <E T="03">l</E>
                    -2, as amended by section 308 of the Workforce Innovation and Opportunity Act of 2014 (WIOA), Pub. L. 113-128, requires the Secretary of Labor (Secretary) to establish a WIAC.
                </P>
                <P>The statute, as amended, requires the Secretary, acting through the Commissioner of Labor Statistics and the Assistant Secretary for Employment and Training, to formally consult at least twice annually with the WIAC to address: (1) Evaluation and improvement of the nationwide workforce and labor market information system established by the Wagner-Peyser Act, and of the statewide systems that comprise the nationwide system, and (2) how the Department of Labor and the States will cooperate in the management of those systems. The Secretary, acting through the Bureau of Labor Statistics (BLS) and the Employment and Training Administration (ETA), and in consultation with the WIAC and appropriate federal agencies, must also develop a two-year plan for management of the labor market information system. The statute generally prescribes how the plan is to be developed and implemented, outlines the contents of the plan, and requires the Secretary to submit the plan to designated authorizing committees in the House and Senate.</P>
                <P>By law, the Secretary must “seek, review, and evaluate” recommendations from the WIAC, and respond in writing to the Council. The WIAC must make written recommendations to the Secretary on the evaluation and improvement of the workforce and labor market information system, including recommendations for the two-year plan. The two-year plan, in turn, must describe WIAC recommendations and the extent to which the plan incorporates them.</P>
                <P>The Department anticipates that the WIAC will accomplish its objectives by, for example: (1) Studying workforce and labor market information issues; (2) seeking and sharing information on innovative approaches, new technologies, and data to inform employment, skills training, and workforce and economic development decision making and policy; and (3) advising the Secretary on how the workforce and labor market information system can best support workforce development, planning, and program development.</P>
                <P>
                    Pertinent information about the WIAC, including recommendations, reports, background information, agendas, and meeting minutes, can be accessed at the WIAC's website located at 
                    <E T="03">https://www.dol.gov/agencies/eta/wioa/wiac.</E>
                </P>
                <P>The Wagner-Peyser Act, at section 15(d)(2)(B), requires the WIAC to have 14 members, appointed by the Secretary, consisting of:</P>
                <P>(1) Four members who are representatives of lead State agencies with responsibility for workforce investment activities, or State agencies described in Wagner-Peyser Act section 4 (agency designated or authorized by Governor to cooperate with the Secretary of Labor), who have been nominated by such agencies or by a national organization that represents such agencies;</P>
                <P>(2) Four members who are representatives of the State workforce and labor market information directors affiliated with the State agencies responsible for the management and oversight of the workforce and labor market information system as described in Wagner-Peyser Act section 15(e)(2), who have been nominated by the directors;</P>
                <P>
                    (3) One member who is a representative of providers of training services under WIOA section 122 
                    <PRTPAGE P="24891"/>
                    (Identification of Eligible Providers of Training Services);
                </P>
                <P>(4) One member who is a representative of economic development entities;</P>
                <P>(5) One member who is a representative of businesses, who has been nominated by national business organizations or trade associations;</P>
                <P>(6) One member who is a representative of labor organizations, who has been nominated by a national labor federation;</P>
                <P>(7) One member who is a representative of local workforce development boards, who has been nominated by a national organization representing such boards; and</P>
                <P>(8) One member who is a representative of research entities that use workforce and labor market information.</P>
                <P>The Secretary must ensure that the membership of the WIAC is geographically diverse, and that no two members appointed under clauses (1), (2), and (7) above represent the same State. Please note, the members whom the Secretary appoints to fill these vacancies will serve the balance of their predecessors' unexpired terms, in this case from the date of appointment until March 9, 2023. Members of the Council will serve on a voluntary and generally uncompensated basis, but will be reimbursed for travel expenses to attend WIAC meetings, including per diem in lieu of subsistence, as authorized by the Federal travel regulations.</P>
                <P>The WIAC is a permanent advisory council and, as such, is not governed by the Federal Advisory Committee Act's (FACA) section 14, on termination of advisory committees. In other respects, however, WIAC membership will be consistent with the FACA requirement that membership be “fairly balanced in terms of the points of view represented and the functions to be performed” (5 U.S.C. App. 2, section 5(b)(2)), as specified in Wagner-Peyser section 15(2)(B) &amp; (C), and the requirement that members come from “a cross-section of those directly affected, interested, and qualified, as appropriate to the nature and functions” of the WIAC (41 CFR 102-3.60(b)(3)). Under the FACA regulation, the composition of the WIAC will, therefore, depend upon several factors, including: (i) The WIAC's mission; (ii) the geographic, ethnic, social, economic, or scientific impact of the WIAC's recommendations; (iii) the types of specific perspectives required; (iv) the need to obtain divergent points of view on the issues before the WIAC, such as those of consumers, technical experts, the public at large, academia, business, or other sectors; and (v) the relevance of State, local, or tribal governments to the development of the WIAC's recommendations (41 CFR 102-3, Subpart B, Appendix A.).</P>
                <P>To the extent permitted by FACA and other applicable laws, WIAC membership should also be consistent with achieving the greatest impact, scope, and credibility among diverse stakeholders. The diversity in such membership includes, but is not limited to, race, gender, disability, sexual orientation, and gender identity.</P>
                <P>
                    <E T="03">Nominations Process:</E>
                     Nominations for a representative of lead State agencies with responsibility for workforce investment activities, or State agencies described in Wagner-Peyser Act section 4 (agency designated or authorized by Governor to cooperate with the Secretary of Labor), must be nominated by such agencies or by a national organization that represents such agencies. Nominations for a representative of State workforce and labor market information directors affiliated with the State agencies responsible for the management and oversight of the workforce and labor market information system as described in Wagner-Peyser Act section 15(e)(2), must be nominated by the directors.
                </P>
                <P>To nominate an individual for appointment to the WIAC, please submit, to one of the addresses listed below, the following information:</P>
                <P>• A copy of the nominee's resume or curriculum vitae;</P>
                <P>• A cover letter that provides your reason(s) for nominating the individual, the constituency area that they represent (as outlined above in the WIAC membership identification discussion), and their particular expertise for contributing to the national policy discussion on: (1) The evaluation and improvement of the nationwide workforce and labor market information system and statewide systems that comprise the nationwide system, and (2) how the Department of Labor and the States will cooperate in the management of those systems, including programs that produce employment-related statistics and State and local workforce and labor market information; and</P>
                <P>• Contact information for the nominee (name, title, business address, business phone, and business email address).</P>
                <P>
                    In addition, the cover letter must state the nomination is being made in response to this 
                    <E T="04">Federal Register</E>
                     Notice and the nominee (if nominating someone other than oneself) has agreed to be nominated and is willing to serve on the WIAC. Nominees will be appointed based on their qualifications, professional experience, and demonstrated knowledge of issues related to the purpose and scope of the WIAC, as well as diversity considerations. The Department will publish a list of the new WIAC members on the WIAC's website at 
                    <E T="03">https://www.dol.gov/agencies/eta/wioa/wiac.</E>
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Steve Rietzke, WIAC Designated Federal Officer, 
                        <E T="03">WIAC@dol.gov.</E>
                    </P>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                            Pursuant to the Wagner-Peyser Act of 1933, as amended, 29 U.S.C. 49 
                            <E T="03">et seq.;</E>
                             Workforce Innovation and Opportunity Act, Pub. L. 113-128; Federal Advisory Committee Act, as amended, 5 U.S.C. App. 2.
                        </P>
                    </AUTH>
                    <SIG>
                        <NAME>Suzan G. LeVine,</NAME>
                        <TITLE>Principal Deputy Assistant Secretary for Employment and Training Administration, Labor.</TITLE>
                    </SIG>
                </FURINF>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09792 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FN-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employment and Training Administration </SUBAGY>
                <SUBJECT>Employment and Training Administration (ETA) Program Year (PY) 2021 Workforce Innovation and Opportunity Act (WIOA) Section 167, National Farmworker Jobs Program (NFJP) Proposed Modifications to Allotment Formula</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Employment and Training Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This Notice announces proposed modifications to the allotment formula for the National Farmworker Jobs Program (NFJP), which is authorized under the Workforce Innovation and Opportunity Act (WIOA), Section 167, and presents preliminary State planning estimates for Program Year (PY) 2021. These allotments are estimates based on the funds appropriated in the Consolidated Appropriations Act, 2021 (from this point forward will be referred to as the “the Act”). The U.S. Department of Labor (DOL), Employment and Training Administration (ETA) will accept comments related to the allotment methodology, including modifications and the hold-harmless provision.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The PY 2021 NFJP allotments become effective for the grant period that begins July 1, 2021. Written comments on this notice are invited and must be received on or before May 24, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments are accepted via email to 
                        <E T="03">NFJP@dol.gov.</E>
                         Please enter “PY21 National Farmworker Jobs 
                        <PRTPAGE P="24892"/>
                        Program Grantee Allotments Public Comment” in the subject line of the email.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Questions on this notice can be submitted to the Employment and Training Administration, Office of Workforce Investment, Attention: Laura Ibañez, Unit Chief, (202) 693-3645 or Steven Rietzke, Division Chief at (202) 693-3912, or at 
                        <E T="03">NFJP@dol.gov.</E>
                    </P>
                    <P>Individuals with hearing or speech impairments may access the telephone numbers above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627 (TTY-TDD).</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This notice is published according to Section 182(d) of the WIOA, Prompt Allotment of Funds. ETA developed the formula to distribute funds geographically by state service area, based on each state service area's relative share of persons eligible for the program. The formula's original methodology is described in the 
                    <E T="04">Federal Register</E>
                     notice 64 FR 27390, May 19, 1999. That information is accessible at 
                    <E T="03">https://www.federalregister.gov/.</E>
                     In PY 2018, ETA incorporated two modifications to the allotment formula to provide more accurate estimates of each state service area's relative share of persons eligible for the program. The formula also used updated data from each of the four data files serving as the basis of the formula since 1999. The revised formula methodology is described in the 
                    <E T="04">Federal Register</E>
                     notice 83 FR 32151, July 11, 2018.
                </P>
                <P>Beginning in PY 2021, ETA is making two modifications to the allotment formula. These modifications will improve the formula's accuracy in terms of estimating the true NFJP-eligible population in state service areas, and one of the modifications is necessitated by a recent statutory change to the NFJP eligibility criteria, which Congress enacted in the FY 2021 appropriation. Section II includes further explanation of these modifications. This Notice includes the following sections:</P>
                <P>• Section II of this notice provides a discussion of the updated data that will be used to populate the formula and the proposed formula modifications.</P>
                <P>• Section III describes the hold-harmless provision for the implementation year and the following years. The hold-harmless provision is designed to provide a staged transition from old to new shares of funding for State service areas.</P>
                <P>• Section IV describes minimum funding provisions to address State service areas that would receive less than $60,000.</P>
                <P>• Section V describes the application of the formula and the hold-harmless provision using preliminary planning estimates for PY 2021.</P>
                <P>
                    This notice represents the first of a two-stage process. Upon receipt of public comments regarding this notice related to the formula methodology and modifications, ETA will consider comments and finalize the formula methodology and results. In the second stage, ETA will publish the final formula and final allotment levels in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>The Department is announcing preliminary PY 2021 allotments for the National Farmworker Jobs Program (NFJP). This notice provides information on the amount of funds available during PY 2021 to state service areas awarded grants through Funding Opportunity Announcement FOA-ETA-20-08 for the NFJP Career Services and Training grants and Housing grants. Funds to implement NFJP are appropriated in the Act. In appropriating these funds, Congress provided $87,083,000 for formula grants (of which $86,946,000 was allotted after $137,000 was set aside for program integrity), $6,256,000 for migrant and seasonal farmworker housing (of which not less than 70 percent shall be for permanent housing), and another $557,000 was set aside for discretionary purposes. Included below is the table listing the preliminary PY 2021 allotments for the NFJP Career Services and Training grants. Individual grants are awarded for Housing as a result of the grants competition and are further distributed according to language in the appropriations law requiring that of the total amount available, not less than 70 percent shall be allocated to permanent housing activities, leaving not more than 30 percent to temporary housing activities.</P>
                <HD SOURCE="HD1">II. Description of Data Files and Review of PY 2021 Modifications to the Allotment Formula</HD>
                <P>
                    As with all state planning estimates since 1999, the PY 2021 estimates are based on four data sources: (1) State-level, 2017 hired farm labor expenditure data from the United States Department of Agriculture's (USDA) Census of Agriculture (COA); (2) regional-level, 2017 average hourly earnings data from the USDA's Farm Labor Survey; (3) regional-level, 2010-2018 demographic data from the ETA's National Agricultural Workers Survey (NAWS); and, (4) 2015-2019 (5-year file) data from the United States Census Bureau's American Community Survey (ACS). A detailed description of how each data source is used within the formula is in the 
                    <E T="04">Federal Register</E>
                     notice 64 FR 27390, May 19, 1999). In addition to populating the formula with updated data, ETA is proposing two modifications that will improve the formula's accuracy in terms of estimating the true NFJP-eligible population in state service areas, and one of the modifications is necessitated by the change to the NFJP eligibility criteria applicable to the PY 2021 appropriation.
                </P>
                <P>(1) First, the Act expands program eligibility for grants funded by the PY 2021 appropriation to include farmworkers who are in families with total family incomes at or below 150 percent of the poverty line. Previously, the definition of a low income individual in WIOA section 3(36)(A)(ii) was based on whether the individual was in a family with a total family income that did not exceed the higher of the poverty line or 70 percent of the lower living standard income level. As noted above, a provision to expand program eligibility is included in the appropriations language for PY 2021. It applies to grant activities funded under the PY 2021 awards. Therefore, the PY 2021 allocations will use special tabulations of data from the American Community Survey (ACS) that reflect farmworkers with total family incomes at or below 150 percent of the poverty line. ETA will subsequently revise the PY 2022 guidance regarding the definition of “low-income individual,” as needed if the same provision is not included in subsequent appropriations.</P>
                <P>
                    (2) Second, and to more closely align the formula with the definition of eligible migrant and seasonal farmworker under WIOA Section 167(i) and 20 CFR 685.110 and clarified in the Training and Employment Guidance Letter 18-16, ETA proposes modifying how the formula accounts for crop workers who are primarily employed in agriculture. Previously, for the formula, a crop worker was considered to be primarily employed in agriculture if (1) at least 50 percent of their total individual income was from farm work, 
                    <E T="03">and</E>
                     (2) if they worked at least 25 days or earned at least $800 in crop farm work in the previous 24 months. ETA proposes the formula consider a crop worker to be primarily employed in agriculture if at least 50 percent of their total individual income is from farm work 
                    <E T="03">or</E>
                     at least 50 percent of their total employment time is in farm work.
                    <SU>1</SU>
                    <FTREF/>
                     As 
                    <PRTPAGE P="24893"/>
                    with all state planning estimates since 1999, ETA will use NAWS data to determine the share of crop labor hours in each state that was performed by crop workers who were primarily employed in agriculture, per this eligibility criterion. This modification only applies to estimates of NFJP-eligible labor hours performed by crop workers, because the data that would be needed to similarly estimate NFJP-eligible labor hours performed by animal agricultural (livestock) workers are not available. As with previous allocations of NFJP grant funds, updating the data sources used in the formula and modifying the NFJP eligibility criteria will result in changes in each state's relative share of funding. Therefore, ETA mitigates large changes in state allotments by using the StopLoss/StopGain provisions discussed in Section III.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         To determine “primarily employed in agriculture” criteria, which has two parts, ETA uses individual income from farm work.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Description of the Hold-Harmless Provision</HD>
                <P>ETA is proposing to continue the hold-harmless provision as instituted in PY 2018. The updated data resulted in significant changes for a few states and the hold-harmless provision provides for a stop loss/stop gain limit to transition to the use of the updated data. This approach is based on a state service area's previous year's allotment percentage, which is its relative share of the total formula allotments. ETA will implement the staged transition of the hold-harmless provision as follows:</P>
                <P>(1) In PY 2021, each state service area will receive an amount equal to at least 95 percent of their PY 2020 allotment percentage, as applied to the PY 2021 formula funds available;</P>
                <P>(2) In PY 2022, each state service area will receive an amount equal to at least 90 percent of their PY 2021 allotment percentage, as applied to the PY 2022 formula funds available;</P>
                <P>(3) In PY 2023, each state service area will receive an amount equal to at least 85 percent of their PY 2022 allotment percentage, as applied to the PY 2023 formula funds available.</P>
                <P>In PY 2021, 2022, and 2023, the stop gain provision provides that no state service area will receive an amount that is more than 150 percent of their previous year's allotment percentage.</P>
                <P>In PY 2024, since the Department has a responsibility to use the most current and reliable data available, amounts for the new awards will be based on updated data from the sources described in Section II, pending their availability. At that time, the Department will determine whether the changes to state allotments are significant enough to warrant another hold-harmless provision. Otherwise, allotments to each state service area will be for an amount resulting from a direct allotment of the proposed funding formula without adjustment.</P>
                <HD SOURCE="HD1">IV. Minimum Funding Provisions</HD>
                <P>A state area that would receive less than $60,000 by application of the formula will, at the option of the DOL, receive no allotment or, if practical, be combined with another adjacent state area. Funding below $60,000 is deemed insufficient for sustaining an independently administered program. However, if practical, a state jurisdiction that would receive less than $60,000 may be combined with another adjacent state area.</P>
                <HD SOURCE="HD1">V. Program Year 2021 Preliminary State Allotments</HD>
                <P>The state allotments set forth in the Table appended to this notice reflect the distribution resulting from the allotment formula described above. For PY 2020, $91,896,000 was appropriated for migrant and seasonal farmworker programs, of which $85,229,000 was appropriated for training grants and allotted based on the PY 2018 formula updates. The remaining $6,122,000 of the PY 2020 appropriation was retained to fund housing grants, and $545,000 was retained for Training and Technical Assistance. The figures in the first numerical column show the actual PY 2020 formula allotments to state service areas. The next column shows the percentage share of each allotment to the total available.</P>
                <P>For PY 2021, the funding level provided for in the Act for the migrant and seasonal farmworker program is $93,896,000 of which $87,083,000 was appropriated for training grants. After allowable funds are set aside for program integrity ($137,000), the Department will allot $86,946,000 for training grants based on the formula and data outlined in this notice. For purposes of illustrating the effects of the updates to the allotment formula, columns 3 and 4 show the state service area allotments with the application of the first-year (95 percent) hold-harmless and minimum funding provisions, followed by the percentages. The difference between PY 2021 and PY 2020 allotments is shown in column 5. Column 6 of the Table shows the allotments based on the proposed formula without the application of the hold-harmless or minimum funding provisions. The percentages are reported in column 7.</P>
                <BILCOD>BILLING CODE 4510-FN-P</BILCOD>
                <GPH SPAN="3" DEEP="640">
                    <PRTPAGE P="24894"/>
                    <GID>EN10MY21.372</GID>
                </GPH>
                <SIG>
                    <PRTPAGE P="24895"/>
                    <NAME>Suzan G. LeVine,</NAME>
                    <TITLE>Principal Deputy Assistant Secretary, Employment and Training, Labor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09799 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FN-C</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <DEPDOC>[Docket No. DOL-2021-09669]</DEPDOC>
                <SUBJECT>Privacy Act of 1974; System of Records</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Transition Assistance Program, Veterans' Training and Employment Service, Department of Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a new system of records.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Employment Navigators will be located on-site at specific military installations. Their primary duty is to assist transitioning service members by finding suitable employment before the transition to the civilian workforce occurs. This can be done directly, or with assistance from an approved Veterans' Employment and Training Service (VETS) partner entity. A cloud-based case management system is required to collect certain key data elements, including personally identifiable (PII) information, for the purposes of employment outcome analysis and return on investment calculations. Because of the nature of geographic spread of Employment Navigators, Transition Assistance Program (TAP) partners, and VETS staff, a cloud-based data entry and reporting system must be available to all users wherever internet access is available. The PII will be matched with external data sources, such as the National Directory of New Hires, to produce validated employment outcomes, as well as reducing burden on Employment Navigators to conduct follow-up assessments with services members or veterans.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        This System of Records Notice (SORN) is effective upon its publication in today's 
                        <E T="04">Federal Register</E>
                         with the exception of the routine uses. The new routine uses will not be effective until June 9, 2021 pending public comment. Comments on the new routine uses or other aspects of the SORN must be submitted on or before June 9, 2021.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Submit your comments by one of the following methods:</P>
                    <P>
                        <E T="03">Electronic Comments:</E>
                         Comments may be sent via email to SORN 
                        <E T="03">Murren.Luke@dol.gov.</E>
                         Mail: Address written submissions (including thumb drive and CD-ROM submissions) to U.S. DOL, VETS, and Attn: Luke Murren, 200 Constitution Avenue NW, Suite 2-1212, and Washington, DC 20210. 
                        <E T="03">Instructions:</E>
                         Please submit only one copy of your comments by only one method. All submissions must include the agency's name and the Docket Number DOL-2021-09669. Please be advised that comments received will become a matter of public record and will be posted without change to 
                        <E T="03">http://www.regulations.gov</E>
                        , including any personal information provided. Comments that are mailed must be received by the date indicated for consideration.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         For access to the docket to read background documents or comments, go to the Federal e-Rulemaking Portal at 
                        <E T="03">http://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Request for additional information should be submitted to the email and physical address 
                        <E T="03">Electronic Comments:</E>
                         Comments may be sent via email to 
                        <E T="03">Murren.Luke@dol.gov</E>
                         attention Luke Murren. Mail: Address written submissions to U.S. DOL, VETS, and Attn: Luke Murren, 200 Constitution Avenue NW, Suite 2-1212, and Washington, DC 20210. You may also contact Luke Murren at his work number 202-693-4711 for additional information.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The proposed system will be vital to safeguarding the information collected while receiving services from an Employment Navigator, or approved partner. This is a new DOL data collection system.</P>
                <PRIACT>
                    <HD SOURCE="HD2">SYSTEM NAME AND NUMBER:</HD>
                    <P>Employment Navigator Case Management System; DOL/VETS-7</P>
                    <HD SOURCE="HD2">SECURITY CLASSIFICATION:</HD>
                    <P>None.</P>
                    <HD SOURCE="HD2">SYSTEM LOCATION:</HD>
                    <P>Primary location: Offices in various components within the U.S. Department of Labor, at the Frances Perkins Building, 200 Constitution Avenue NW, Washington, DC 20210, or other Department offices. Additionally, duplicate versions of some or all system information may also be at satellite locations where VETS has granted direct access to support VETS operations, system backup, emergency preparedness, and/or continuity of operations. To determine the location of particular program records, contact the system manager, listed in section “SYSTEM MANAGER” below.</P>
                    <HD SOURCE="HD2">SYSTEM MANAGER(S):</HD>
                    <P>VETS Information Technology Director, U.S. Department of Labor/Veterans' Employment and Training Service (VETS), 200 Constitution Ave. NW, Room S-1212, Washington, DC 20210, Work: (202) 693-4712.</P>
                    <HD SOURCE="HD2">AUTHORITY FOR MAINTENANCE OF THE SYSTEM:</HD>
                    <P>Defense Manpower Data Center Data Base, November 23, 2011, 76 FR 72391; 38 U.S.C. 4102, Job Counseling, Training, and Placement Service for Veterans; and 10 U.S.C. 1142, Pre-separation Counselling; E.O. 9397. And pursuant to 10 U.S. Code § 1144 Employment assistance, job training assistance, and other transitional services: Department of Labor. The above referenced section requires DOL to “establish and maintain a program to furnish counseling, assistance in identifying employment and training opportunities, help in obtaining such employment and training, and other related information and services to members of the armed forces under the jurisdiction of the Secretary concerned who are being separated from active duty and the spouses of such members.” However, there is currently no way to measure the effectiveness or capture best practices of this requirement. Congress and the Office of Management and Budget have mentioned a great desire for DOL to be able to provide return-on-investment performance metrics for this program requirement. This requires analyzing data pertaining to all transitioning service members. The Department of Defense maintains this dataset, and will share the information with DOL through an established Memorandum of Understanding.</P>
                    <HD SOURCE="HD2">PURPOSE(S) OF THE SYSTEM:</HD>
                    <P>
                        The purpose of the proposed system is to enable transitioning service members and recently separated veterans' assistance in finding the best-fit career as quickly as possible. The system will allow Employment Navigators and partners to capture necessary information for DOL to conduct employment outcome analysis. The case management/reporting system should have three separate functions, with three separate roles assigned to users. The first module will allow for Employment Navigators to enter individual record data for each participant (transitioning service member) into the system. This information will be personal characteristics, services offered, and/or referral information. The second module will be accessible by TAP partner entities who will provide information on services they provided, and outcomes such as job placements, occupation employed in, and wages 
                        <PRTPAGE P="24896"/>
                        earned at start of employment. The last module will be accessible by internal DOL/VETS staff who wish to extract data entered in the first two modules mentioned above. DOL staff should be able to view logs of data entered in the system, create a data extract, and view canned reports created from either module.
                    </P>
                    <HD SOURCE="HD2">CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:</HD>
                    <P>Exiting service members participating in the United States Department of Defense (DOD) Pre-separation Counseling of the Transition Assistance Program (TAP) who complete documentation.</P>
                    <HD SOURCE="HD2">CATEGORIES OF RECORDS IN THE SYSTEM:</HD>
                    <P>Data securely stored in the system will include personal characteristics, various services received from Employment Navigators and/or TAP partners, employment outcome data, and PII required to match to NDNH for employment status and earnings.</P>
                    <HD SOURCE="HD2">RECORD SOURCE CATEGORIES:</HD>
                    <P>Data stored in this system include those captured by Employment Navigators and/or TAP partner entities at the time of service. Additional employment and earnings data will come from the NDNH.</P>
                    <HD SOURCE="HD2">ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING  CATEGORIES OF USERS AND PURPOSES OF SUCH USES:</HD>
                    <P>Each record maintained in the system will represent one transitioning service member/recently separated veteran. Routine uses for Employment Navigators and Tap partners include data entry for services received, and employment outcomes. DOL staff will utilize the system for outcome analysis, research and return on investment calculations.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR STORAGE OF RECORDS:</HD>
                    <P>Records will be stored electronically in a secure environment.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:</HD>
                    <P>Retrieval of records will only be conducted by DOL staff and approved contractors who pass a data sensitivity training module. Retrieval and analysis will be done according to: rank, military branch, military occupation specialty, employment status, quarterly earnings, and/or length of military service.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:</HD>
                    <P>Records are retained indefinitely.</P>
                    <HD SOURCE="HD2">ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:</HD>
                    <P>The system will require a username and password for all users. The system will also feature cloud-based security protocols, and servers will be located in a secure physical location.</P>
                    <HD SOURCE="HD2">RECORD ACCESS PROCEDURES:</HD>
                    <P>A request for access should be mailed or emailed to the system manager.</P>
                    <HD SOURCE="HD2">CONTESTING RECORD PROCEDURES:</HD>
                    <P>A petition for amendment should be mailed or emailed to the system manager.</P>
                    <HD SOURCE="HD2">NOTIFICATION PROCEDURES:</HD>
                    <P>Inquiry requests should be mailed or emailed to the system manager.</P>
                    <HD SOURCE="HD2">EXEMPTIONS PROMULGATED FOR THE SYSTEM:</HD>
                    <P>None.</P>
                    <HD SOURCE="HD2">HISTORY:</HD>
                    <P>
                        A 60-day notice has been published to the 
                        <E T="04">Federal Register</E>
                        , and is available to be viewed here: 
                        <E T="03">https://www.federalregister.gov/documents/2020/07/29/2020-16378/agency-information-collection-activities-comment-request.</E>
                    </P>
                </PRIACT>
                <SIG>
                    <NAME>Rachana Desai Martin,</NAME>
                    <TITLE>Senior Agency Official for Privacy, Deputy Assistant Secretary for Policy, Office of the Assistant Secretary for Administration and Management, Department of Labor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09669 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-79-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by the party listed below.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit your comments including the docket number of the petition by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Electronic Mail: zzMSHA-comments@dol.gov.</E>
                         Include the docket number of the petition in the subject line of the message.
                    </P>
                    <P>
                        2. 
                        <E T="03">Facsimile:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202-5452, Attention: S. Aromie Noe, Acting Deputy Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk in Suite 4E401. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above.
                    </P>
                    <P>MSHA will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">noe.song-ae.a@dol.gov</E>
                         (email), or 202-693-9441 (facsimile). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:</P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.</P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2021-006-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Patton Mining, LLC., P.O. Box 457, Hillsboro Illinois (ZIP 62049).
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Deer Run Mine, MSHA I.D. No. 11-03182, located in Montgomery County, Illinois.
                </P>
                <P>
                    <E T="03">Regulations Affected:</E>
                     30 CFR 75.503 (Permissible electric face equipment; maintenance); and 18.35(a)(5)(i) (Portable (trailing) cables and cords).
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 
                    <PRTPAGE P="24897"/>
                    75.503 to increase the maximum length of trailing cables supplying power to permissible equipment used in continuous mining sections. Specifically, the petitioner requests a modification of 30 CFR 18.35(a)(5)(i) to permit an increase in the maximum length of trailing cables supplying power to roof bolters beyond 500 feet. The petitioner asserts this alternate method of compliance will decrease the likelihood of cable damage and therefore enhance safety for miners handling the cable.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) Increasing the length of cable supplying power to the roof bolter machines will reduce the frequency that a section power center must be advanced, and thus, lessen handling of the cable, decrease the opportunities for cable damage, and minimize exposure to the miners handling the cable.</P>
                <P>The petitioner proposes the following:</P>
                <P>(a) This petition shall apply only to trailing cables supplying three-phase, 995-volt power to roof bolters.</P>
                <P>(b) The maximum length of the 995-volt trailing cables shall be 950 feet.</P>
                <P>(c) The 995-volt trailing cables shall not be smaller than #2 American Wire Gauge (AWG).</P>
                <P>(d) A Schweitzer Engineering Laboratories 751A (“SEL-751A”) overcurrent protection relay will be used, and a designated official of Patton Mining, LLC shall manage the password protected settings.</P>
                <P>(e) All circuit breakers used to protect #2 AWG trailing cables exceeding 700 feet in length shall have instantaneous trip units calibrated to trip at 800 amperes. The trip setting of these circuit breakers shall be password protected, and these circuit breakers shall have permanent, legible labels. Each label shall identify the circuit breaker as being suitable for protecting #2 AWG cables. This label shall be maintained legible.</P>
                <P>(f) Replacement instantaneous trip units that are used to protect #2 AWG trailing cables, shall be calibrated to trip at 800 amperes, and this setting shall be password protected.</P>
                <P>(g) During each production day, persons designated by the operator shall visually examine the trailing cables to ensure that the cables are in safe operating condition.</P>
                <P>(h) Any trailing cable that is not in safe operating condition shall be removed from service immediately and shall be repaired or replaced.</P>
                <P>(i) Each splice or repair in the trailing cables shall be made in a workmanlike manner and in accordance with the instructions of the manufacturer of the splice or repair materials. The splice or repair shall comply with 30 CFR 75.603 and 75.604.</P>
                <P>(j) Permanent warning labels shall be installed and maintained on the cover(s) of the power center identifying the location of each password protected short-circuit protection device. These labels shall warn miners not to change or alter the short-circuit settings.</P>
                <P>(k) The petitioner's alternative method shall not be implemented until miners designated to examine the integrity of the settings, verify the short-circuit settings, examine trailing cables for defects and damage according to the proper procedure have received specified training.</P>
                <P>(l) Within sixty (60) days after this petition is granted, the petitioner shall propose revisions to the mine's training plans approved under 30 CFR part 48 and submit the proposed revisions to the Coal Mine Safety and Health District Manager for the area where the mine is located. The training shall include the following elements:</P>
                <P>1. Training in mining methods and operating procedures that will protect the trailing cables against damage;</P>
                <P>2. Training in the proper procedures for examining the trailing cables to ensure the cables are in safe operating condition;</P>
                <P>3. Training in hazards of setting the instantaneous circuit breakers too high to adequately protect the trailing cables; and</P>
                <P>4. Training in how to verify the circuit interrupting device(s) protecting the trailing cable(s) are properly set and maintained.</P>
                <P>The petitioner asserts that the alternate method proposed will at all times guarantee no less than the same measure of protection afforded the miners under the mandatory standards.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Acting Deputy Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09796 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <DEPDOC>[OMB Control No. 1219-0120]</DEPDOC>
                <SUBJECT>Proposed Extension of Information Collection; Occupational Noise Exposure</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for public comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that 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 on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Occupational Noise Exposure.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments must be received on or before July 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comment as follows. Please note that late, untimely filed comments will not be considered.</P>
                    <P>
                        <E T="03">Electronic Submissions:</E>
                         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 for docket number MSHA-2021-0004. Comments submitted electronically, including attachments, to 
                        <E T="03">https://www.regulations.gov</E>
                         will be posted to the docket, with no changes. Because your comment will be made public, you are 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 your or anyone else's Social Security number or confidential business information.
                    </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.</P>
                    <P>
                        <E T="03">Written/Paper Submissions:</E>
                         Submit written/paper submissions in the following way:
                    </P>
                    <P>
                        • 
                        <E T="03">Mail/Hand Delivery:</E>
                         Mail or visit DOL-MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, VA 22202-5452.
                    </P>
                    <P>
                        • MSHA will post your comment as well as any attachments, except for information submitted and marked as confidential, in the docket at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Acting Deputy Director, Office of Standards, Regulations, and Variances, MSHA, at 
                        <E T="03">MSHA.information.collections@dol.gov</E>
                          
                        <PRTPAGE P="24898"/>
                        (email); (202) 693-9440 (voice); or (202) 693-9441 (facsimile).
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 813(h), authorizes MSHA to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811, authorizes the Secretary of Labor to develop, promulgate, and revise as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal or other mines.</P>
                <P>Noise is a harmful physical agent and one of the most pervasive health hazards in mining. Repeated exposure to high levels of sound over time causes occupational noise-induced hearing loss (NIHL), a serious physical impairment with far-reaching psychological and social effects. NIHL can be distinguished from aging and other factors that can contribute to hearing loss and it can be prevented. According to the National Institute for Occupational Safety and Health, NIHL is among the “top ten” leading occupational illnesses and injuries.</P>
                <P>At mines, various machines that generate loud sounds are used, such as drills, crushers, compressors, conveyors, trucks, loaders, and other heavy-duty equipment for the excavation, haulage, and processing of materials. The operators of these machines and miners working nearby are exposed to the high sound levels. For many years, NIHL was regarded as an inevitable consequence of working in a mine, but that is no longer the case. MSHA, the Occupational Safety and Health Administration, the U.S. military, and other organizations around the world have established and enforced standards to reduce the loss of hearing. Quieter equipment, isolation of workers from noise sources, and limiting the time workers are exposed to noise are among the many well-accepted methods that will prevent costly incidences of NIHL.</P>
                <P>Records of miner exposures to noise are necessary so that mine operators and MSHA can evaluate the need for and effectiveness of engineering controls, administrative controls, and personal protective equipment to protect miners from harmful levels of noise that can result in hearing loss. However, MSHA believes that extensive records for this purpose are not needed. These requirements are a performance-oriented approach to monitoring. Records of miner hearing examinations enable mine operators and MSHA to ensure that the controls are effective in preventing NIHL for individual miners. Records of training are needed to confirm that miners receive the information they need to become active participants in hearing conservation efforts.</P>
                <HD SOURCE="HD1">II. Desired Focus of Comments</HD>
                <P>MSHA is soliciting comments concerning the proposed information collection related to Occupational Noise Exposure. MSHA is particularly interested in comments that:</P>
                <P>• Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information has practical utility;</P>
                <P>• Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;</P>
                <P>• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>
                    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses.
                </P>
                <P>
                    Background documents related to this information collection request are available at 
                    <E T="03">https://regulations.gov</E>
                     and in DOL-MSHA located at 201 12th Street South, Suite 4E401, Arlington, VA 22202-5452. Questions about the information collection requirements may be directed to the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this notice.
                </P>
                <HD SOURCE="HD1">III. Current Actions</HD>
                <P>This information collection request concerns provisions for Occupational Noise Exposure. MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request from the previous information collection request.</P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension, without change, of a currently approved collection.
                </P>
                <P>
                    <E T="03">Agency:</E>
                     Mine Safety and Health Administration.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1219-0120.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     12,929.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Number of Responses:</E>
                     190,001.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     14,153 hours.
                </P>
                <P>
                    <E T="03">Annual Respondent or Recordkeeper Cost:</E>
                     $30,585.
                </P>
                <P>
                    Comments submitted in response to this notice will be summarized in the request for Office of Management and Budget approval of the proposed information collection request; they will become a matter of public record and will be available at 
                    <E T="03">https://www.reginfo.gov.</E>
                </P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Certifying Officer. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09797 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Occupational Safety and Health Administration</SUBAGY>
                <DEPDOC>[Docket No. OSHA-2007-0041]</DEPDOC>
                <SUBJECT>FM Approvals LLC: Grant of Expansion of Recognition and Modification to the NRTL Program's List of Appropriate Test Standards</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 final decision to expand the scope of recognition for FM Approvals LLC for expansion of recognition as a Nationally Recognized Testing Laboratory (NRTL). Additionally, OSHA announces the final decision to modify the NRTL Program's List of Appropriate Test Standards to include one additional test standard.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The expansion of the scope of recognition become effective on May 10, 2021.</P>
                </DATES>
                <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 Final Decision</HD>
                <P>
                    OSHA hereby gives notice of the expansion of the scope of recognition of FM Approvals LLC (FM) as a NRTL. This expansion covers the addition of five test standards to FM's NRTL scope 
                    <PRTPAGE P="24899"/>
                    of recognition, one of which will be added to the NRTL Program's List of Appropriate Test Standards.
                </P>
                <P>OSHA recognition of a NRTL signifies that the organization meets the requirements specified by 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition and is not a delegation or grant of government authority. As a result of recognition, employers may use products properly approved by the NRTL to meet OSHA standards that require testing and certification of the products.</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 FM, 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>FM submitted an application to OSHA to expand recognition as a NRTL to include five additional test standards on May 16, 2019 (OSHA-2007-0041-0014). 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>
                    OSHA published the preliminary notice announcing FM's expansion application in the 
                    <E T="04">Federal Register</E>
                     on February 26, 2021 (86 FR 11794). The agency requested comments by March 15, 2021, but it received no comments in response to this notice. OSHA is now proceeding with this final notice to grant expansion of FM's scope of recognition.
                </P>
                <P>
                    To obtain or review copies of all public documents pertaining to FM's application, go to 
                    <E T="03">www.regulations.gov</E>
                     or contact the Docket Office, Occupational Safety and Health Administration, U.S. Department of Labor; (202) 693-2350. Docket No. OSHA-2007-0041 contains all materials in the record concerning FM's recognition. 
                    <E T="03">Please note:</E>
                     While OSHA's Docket Office is continuing to accept and process submissions by regular mail, due to the COVD-19 pandemic, the Docket Office is closed to the public and not able to receive submissions to the docket by hand, express mail, messenger, and courier service.
                </P>
                <HD SOURCE="HD1">II. Final Decision and Order</HD>
                <P>OSHA staff examined FM's expansion application, their capability to meet the requirements of the test standards, and other pertinent information. Based on its review of this evidence, OSHA finds that FM meets the requirements of 29 CFR 1910.7 for expansion of its recognition, subject to the limitations and conditions listed below. OSHA, therefore, is proceeding with this final notice to grant FM's scope of recognition. OSHA limits the expansion of FM's recognition to testing and certification of products for demonstration of conformance to the test standards listed in Table 1 below.</P>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="xs100,r200">
                    <TTITLE>Table 1—List of Appropriate Test Standards for Inclusion in FM's NRTL Scope of Recognition</TTITLE>
                    <BOXHD>
                        <CHED H="1">Test standard</CHED>
                        <CHED H="1">Test standard title</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">* ANSI FM 3265</ENT>
                        <ENT>Spark Detection and Extinguishing Systems.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UL 268</ENT>
                        <ENT>Smoke Detectors for Fire Alarm Systems.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UL 1971</ENT>
                        <ENT>Signaling Devices for the Hearing Impaired.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UL 2127</ENT>
                        <ENT>Inert Gas Clean Agent Extinguishing System Units.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UL 2166</ENT>
                        <ENT>Halocarbon Clean Agent Extinguishing System Units.</ENT>
                    </ROW>
                    <TNOTE>* Represents the standard that OSHA is adding to the NRTL Program's List of Appropriate Test Standards.</TNOTE>
                </GPOTABLE>
                <P>In this notice, OSHA also announces the addition of a new test standard to the NRTL Program's List of Appropriate Test Standards. Table 2 below lists the standard that is new to the NRTL Program. OSHA has determined that this test standard is an appropriate test standard and will add it to the NRTL Program's List of Appropriate Test Standards.</P>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="xs100,r200">
                    <TTITLE>Table 2—Standard OSHA Is Proposing To Add to the NRTL Program's List of Appropriate Test Standards</TTITLE>
                    <BOXHD>
                        <CHED H="1">Test standard</CHED>
                        <CHED H="1">Test standard title</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">ANSI FM 3265</ENT>
                        <ENT>Spark Detection and Extinguishing Systems.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>OSHA's recognition of any NRTL for a particular test standard is limited to equipment or materials for which OSHA standards require third-party testing and certification before using them in the workplace. Consequently, if a test standard also covers any products for which OSHA does not require such testing and certification, a NRTL's scope of recognition does not include these products.</P>
                <P>The American National Standards Institute (ANSI) may approve the test standard listed above as an American National Standard. However, for convenience, we may use the designation of the standards-developing organization for the standard as opposed to the ANSI designation. Under the NRTL Program's policy (see OSHA Instruction CPL 1-0.3, Appendix C, paragraph XIV), any NRTL recognized for a particular test standard may use either the proprietary version of the test standard or the ANSI version of that standard. Contact ANSI to determine whether a test standard is currently ANSI-approved.</P>
                <HD SOURCE="HD2">A. Conditions</HD>
                <P>In addition to those conditions already required by 29 CFR 1910.7, FM must abide by the following conditions of the recognition:</P>
                <P>
                    1. FM must inform OSHA as soon as possible, in writing, of any change of ownership, facilities, or key personnel, and of any major change in its 
                    <PRTPAGE P="24900"/>
                    operations as a NRTL, and provide details of the change(s);
                </P>
                <P>2. FM must meet all the terms of its recognition and comply with all OSHA policies pertaining to this recognition; and</P>
                <P>3. FM must continue to meet the requirements for recognition, including all previously published conditions on FM's scope of recognition, in all areas for which it has recognition.</P>
                <P>Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the scope of recognition of FM, subject to the limitations and conditions specified above. OSHA also adds one standard to the NRTL Program's List of Appropriate Test Standards.</P>
                <HD SOURCE="HD1">III. 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, September 18, 2020) and 29 CFR 1910.7.</P>
                <SIG>
                    <DATED>Signed at Washington, DC, on May 4, 2021.</DATED>
                    <NAME>James S. Frederick,</NAME>
                    <TITLE>Acting Assistant Secretary of Labor for Occupational Safety and Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09800 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-26-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL ARCHIVES AND RECORDS ADMINISTRATION</AGENCY>
                <DEPDOC>[NARA-2021-028]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Archives and Records Administration (NARA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed extension request.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>We are proposing to request an extension from the Office of Management and Budget (OMB) of a currently approved information collection used by used by registrants or other authorized individuals to request information from or copies of Selective Service System (SSS) records. We invite you to comment on this proposed information collection pursuant to the Paperwork Reduction Act of 1995.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>We must receive written comments on or before July 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments by email to 
                        <E T="03">tamee.fechhelm@nara.gov.</E>
                         Because our buildings are temporarily closed during the COVID-19 restrictions, we are not able to receive comments by mail during this time.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Tamee Fechhelm, Paperwork Reduction Act Officer, by email at 
                        <E T="03">tamee.fechhelm@nara.gov</E>
                         or by telephone at 301.837.1694 with requests for additional information or copies of the proposed information collection and supporting statement.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13), we invite the public and other Federal agencies to comment on proposed information collections. If you have comments or suggestions, they should address one or more of the following points: (a) Whether the proposed information collection is necessary for NARA to properly perform its functions; (b) our estimate of the burden of the proposed information collection and its accuracy; (c) ways we could enhance the quality, utility, and clarity of the information we collect; (d) ways we could minimize the burden on respondents of collecting the information, including through information technology; and (e) whether this collection affects small businesses.</P>
                <P>We will summarize any comments you submit and include the summary in our request for OMB approval. All comments will become a matter of public record.</P>
                <P>In this notice, we solicit comments concerning the following information collection:</P>
                <P>
                    <E T="03">Title:</E>
                     Selective Service System Record Request.
                </P>
                <P>
                    <E T="03">OMB number:</E>
                     3095-0071.
                </P>
                <P>
                    <E T="03">Agency form numbers:</E>
                     NA Form 13172.
                </P>
                <P>
                    <E T="03">Type of review:</E>
                     Regular.
                </P>
                <P>
                    <E T="03">Affected public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     1,500.
                </P>
                <P>
                    <E T="03">Estimated time per response:</E>
                     2 minutes.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated total annual burden hours:</E>
                     50.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The National Personnel Records Center (NPRC) of the National Archives and Records Administration (NARA) administers the Selective Service System (SSS) records. The SSS records contain both classification records and registration cards of registrants born before January 1, 1960. When registrants or other authorized individuals request information from or copies of SSS records they must provide on forms or letters certain information about the registrant and the nature of the request. Requesters use NA Form 13172, Selective Service Record Request to obtain information from SSS records stored at NARA facilities.
                </P>
                <SIG>
                    <NAME>Swarnali Haldar,</NAME>
                    <TITLE>Executive for Information Services/CIO.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09765 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7515-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL SCIENCE FOUNDATION</AGENCY>
                <SUBJECT>Proposal Review; Notice of Meetings</SUBJECT>
                <P>In accordance with the Federal Advisory Committee Act (Pub., L. 92-463, as amended), the National Science Foundation (NSF) announces its intent to hold proposal review meetings throughout the year. The purpose of these meetings is to provide advice and recommendations concerning proposals submitted to the NSF for financial support. The agenda for each of these meetings is to review and evaluate proposals as part of the selection process for awards. The review and evaluation may also include assessment of the progress of awarded proposals. The majority of these meetings will take place at NSF, 2415 Eisenhower Avenue, Alexandria, VA 22314.</P>
                <P>These meetings will be closed to the public. The proposals being reviewed include information of a proprietary or confidential nature, including technical information; financial data, such as salaries; and personal information concerning individuals associated with the proposals. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act. NSF will continue to review the agenda and merits of each meeting for overall compliance of the Federal Advisory Committee Act.</P>
                <P>
                    These closed proposal review meetings will not be announced on an individual basis in the 
                    <E T="04">Federal Register</E>
                    . NSF intends to publish a notice similar to this on a quarterly basis. For an advance listing of the closed proposal review meetings that include the names of the proposal review panel and the time, date, place, and any information on changes, corrections, or cancellations, please visit the NSF website: 
                    <E T="03">https://www.nsf.gov/events/.</E>
                     This information may also be requested by telephoning, 703/292-8687.
                </P>
                <SIG>
                    <DATED>Dated: May 55, 2021.</DATED>
                    <NAME>Crystal Robinson,</NAME>
                    <TITLE>Committee Management Officer. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09850 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7555-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="24901"/>
                <AGENCY TYPE="N">NUCLEAR REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[NRC-2020-0185]</DEPDOC>
                <SUBJECT>Information Collection: Voluntary Reporting of Performance Indicators</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Nuclear Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of submission to the Office of Management and Budget; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “Voluntary Reporting of Performance Indicators.”</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments by June 9, 2021. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.</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">https://www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        David Cullison, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: 
                        <E T="03">Infocollects.Resource@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-2020-0185 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://www.regulations.gov/</E>
                     and search for Docket ID NRC-2020-0185. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC-2020-0185 on this website.
                </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>
                     A copy of the collection of information and related instructions may be obtained without charge by accessing ADAMS Accession No. ML19025A257. The supporting statement is available in ADAMS under Accession No. ML21060B481.
                </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. (EST), Monday through Friday, except Federal holidays.
                </P>
                <P>
                    • 
                    <E T="03">NRC's Clearance Officer:</E>
                     A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Clearance Officer, David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: 
                    <E T="03">Infocollects.Resource@nrc.gov.</E>
                </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-2020-0185 in your comment submission.
                </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 OMB, 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 comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.</P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled, “Voluntary Reporting of Performance Indicators.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.</P>
                <P>
                    The NRC published a 
                    <E T="04">Federal Register</E>
                     notice with a 60-day comment period on this information collection on January 8, 2021, (86 FR 1544).
                </P>
                <P>
                    1. 
                    <E T="03">The title of the information collection:</E>
                     “Voluntary Reporting of Performance Indicators.”
                </P>
                <P>
                    2. 
                    <E T="03">OMB approval number:</E>
                     3150-0195.
                </P>
                <P>
                    3. 
                    <E T="03">Type of submission:</E>
                     Revision.
                </P>
                <P>
                    4. 
                    <E T="03">The form number, if applicable:</E>
                     Not applicable.
                </P>
                <P>
                    5. 
                    <E T="03">How often the collection is required or requested:</E>
                     Quarterly for Performance Indicator reporting and on occasion for the Frequently Asked Question process.
                </P>
                <P>
                    6. 
                    <E T="03">Who will be required or asked to respond:</E>
                     Power reactor licensees.
                </P>
                <P>
                    7. 
                    <E T="03">The estimated number of annual responses:</E>
                     380 (359 reporting responses + 21 recordkeepers).
                </P>
                <P>
                    8. 
                    <E T="03">The estimated number of annual respondents:</E>
                     89.
                </P>
                <P>
                    9. 
                    <E T="03">The estimated number of hours needed annually to comply with the information collection requirement or request:</E>
                     The total reporting and recordkeeping burden is 77,734 (76,660 hours reporting + 1,074 hours recordkeeping).
                </P>
                <P>
                    10. 
                    <E T="03">Abstract:</E>
                     As part of a joint industry-NRC initiative, the NRC receives information submitted voluntarily by power reactor licensees regarding selected performance attributes known as performance indicators (PIs). Performance indicators are objective measures of the performance of licensee systems or programs. The NRC uses PI information and inspection results in its Reactor Oversight Process (ROP) to make decisions about plant performance and regulatory response. Licensees transmit PIs electronically to reduce burden on themselves and the NRC. Licensees also participate in the ROP Performance Indicator Frequently Asked Question (FAQ) process that it is used to resolve interpretation issues with NEI 99-02. The FAQ process and white papers may also be used to propose changes to NEI 99-02 guidance and the PI Program. The NRC and industry review FAQs and white papers and work to achieve resolution during periodic public meetings.
                </P>
                <SIG>
                    <DATED>Dated: May 5, 2021.</DATED>
                    <PRTPAGE P="24902"/>
                    <P>For the Nuclear Regulatory Commission.</P>
                    <NAME>David C. Cullison,</NAME>
                    <TITLE>NRC Clearance Officer, Office of the Chief Information Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09825 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">POSTAL SERVICE</AGENCY>
                <SUBJECT>Privavy Act; System of Records</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <SU>TM</SU>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a new system of records.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The United States Postal Service (USPS
                        <SU>TM</SU>
                        ) is proposing to create a new General Privacy Act System of Records.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>These revisions will become effective without further notice on June 9, 2021 unless comments received on or before that date result in a contrary determination.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be submitted via email to the Privacy and Records Management Office, United States Postal Service Headquarters (
                        <E T="03">privacy@usps.gov</E>
                        ). Arrangements to view copies of any written comments received, to facilitate public inspection, will be made upon request.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Janine Castorina, Chief Privacy and Records Management Officer, Privacy and Records Management Office, 202-268-3069 or 
                        <E T="03">privacy@usps.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>The world of commercial information technology resources (“IT”) is constantly changing and innovating to improve the daily lives of businesses, their employees, and their customers. This pace can often result in unanticipated obsolescence, necessitating review of an organization's already implemented solutions. For the Postal Service, legal processes and notice required by the Privacy Act present additional challenges, as new technologies will require further review for possible compliance issues to meet statutory and regulatory requirements.</P>
                <P>To better meet the changing technology world, the Postal Service will consolidate existing Systems of Records (“SOR”s) covering IT into three new, comprehensive Systems of Records. These SORs will work in tandem, with each individual SOR covering a specific group of related functions, and all three SORs working together to support a seamless technology experience.</P>
                <P>These SORs, generally, will cover the following three areas:</P>
                <P>• Infrastructure, covering records created for use throughout the entirety of a particular IT resource in addition to covering the records created from the usage of those records by users and applications.</P>
                <P>• Applications, covering records created through the regular use of an application.</P>
                <P>• Administrative, covering records created for monitoring and administration of users and applications within an IT resource.</P>
                <P>In addition to covering these three areas generally, the Postal Service will look ahead in an effort to include possible future technology solutions within this System of Records. This will give the Postal Service flexibility to more easily adapt to the advancing pace of information technology and to better fulfill its service obligations. This will also provide transparency into the collection of records relating to commercial IT, allowing Postal employees, contractors, and the public to more easily identify what we do with their information.</P>
                <HD SOURCE="HD1">Rationale for the Creation of a New USPS System of Records</HD>
                <P>Currently, records relating to the implementation of IT resources are housed primarily in USPS 500.000, Property Management Records, with other IT-related components appearing in 890.000, Sales, Marketing, Events, and Publications, and other SORs. SOR 500.000 reflects not only IT access records, but also building access and related records. This results in a mixture of uses within SOR 500.000, which reduces optimization and can result in confusion.</P>
                <P>The creation of a new SOR to encompass commercial IT resources, therefore, provides a platform which is easy to understand and allows for greater flexibility in use and maintenance. Since the new SOR will house only IT resources, the public can more easily understand what information is collected and how it is used.</P>
                <P>Further, documenting IT records within one SOR provides for greater flexibility in adding new resources as well as maintaining existing resources. For example, one application may already collect and store, for the same purpose, data elements that a new application will use. With a record already documented, the implementation process of the new technology will be streamlined while also meeting statutory and regulatory mandates.</P>
                <HD SOURCE="HD1">Description of New or Modified System of Records</HD>
                <P>This new System of Records is being developed to support the implementation of various commercial IT resources and to provide support for future implementations.</P>
                <P>This system specifically will cover categories of records referred to collectively as “Administrative.” Categories of Records in this system reference data elements created from a user or application's interactions with other applications. Applications covered in this SOR reference or incorporate data elements otherwise documented in USPS 550.000 Commercial Information Technology Resources- Infrastructure; therefore, they will not be specifically documented here unless this system references a transformative use of that element.</P>
                <P>This System of Records may overlap with elements appearing in other Systems of Records, as indicated in the Rationale for Changes to USPS System of Records section. This new System of Records will encompass commercially developed or commercially assisted IT resources. Applications developed in-house or by the Postal Service, such as Informed Delivery®, will still be represented in their own SOR.</P>
                <PRIACT>
                    <HD SOURCE="HD2">SYSTEM NAME AND NUMBER:</HD>
                    <P>550.200 Commercial Information Technology Resources—Administrative.</P>
                    <HD SOURCE="HD2">SECURITY CLASSIFICATION:</HD>
                    <P>None.</P>
                    <HD SOURCE="HD2">SYSTEM LOCATION:</HD>
                    <P>All USPS facilities and contractor sites.</P>
                    <HD SOURCE="HD2">SYSTEM MANAGER(S) AND ADDRESS:</HD>
                    <P>Chief Information Officer and Executive Vice President, United States Postal Service, 475 L'Enfant Plaza SW, Washington, DC 20260.</P>
                    <HD SOURCE="HD2">AUTHORITY FOR MAINTENANCE OF THE SYSTEM:</HD>
                    <P>39 U.S.C. 401, 403, and 404.</P>
                    <HD SOURCE="HD2">PURPOSE(S) OF THE SYSTEM:</HD>
                    <P>1. To provide active and passive monitoring and review of information system applications and user activities.</P>
                    <P>2. To generate logs and reports of information system application and user activities.</P>
                    <P>3. To provide a means of auditing commercial information system activities across applications and users.</P>
                    <HD SOURCE="HD2">CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:</HD>
                    <P>
                        1. Individuals with authorized access to USPS computers, information 
                        <PRTPAGE P="24903"/>
                        resources, and facilities, including employees, contractors, business partners, suppliers, and third parties.
                    </P>
                    <P>2. Individuals participating in web-based meetings, web-based video conferencing, web-based communication applications, and web-based collaboration applications.</P>
                    <HD SOURCE="HD2">CATEGORIES OF RECORDS IN THE SYSTEM:</HD>
                    <P>
                        1. 
                        <E T="03">General Audit Log activities:</E>
                         DateTime, IP Address, User Activity, User Item Accessed, Activity Detail, Object ID, Record Type, Client IP Address, CorrelationID, CreationTime, EventData, EventSource, ItemType, OrganizationID, UserAgent, UserKey, UserType, Version, Workload.
                    </P>
                    <P>
                        2. 
                        <E T="03">File and page activities:</E>
                         Accessed file, Change retention label for a file, Deleted file marked as a record, Checked in file, Changed record status to locked, Changed record status to unlocked, Checked out file, Copied file, Discarded file checkout, Deleted file, Deleted file from recycle bin, Deleted file from second-stage recycle bin, Detected document sensitivity mismatch, Detected malware in file, Deleted file marked as a record, Downloaded file, Modified file, Moved file, Recycled all minor versions of file, Recycled all versions of file, Recycled version of file, Renamed file, Restored file, Uploaded file, Viewed page, View signaled by client, Performed search query.
                    </P>
                    <P>
                        3. 
                        <E T="03">Folder activities:</E>
                         Copied folder, Created folder, Deleted folder, Deleted folder from recycle bin, Deleted folder from second-stage recycle bin, Modified folder, Moved folder, Renamed folder, Restored folder.
                    </P>
                    <P>
                        4. 
                        <E T="03">Cloud-based Enterprise Storage activities:</E>
                         Created list, Created list column, Created list content type, Created list item, Created site column, Created site content type, Deleted list, Deleted list column, Deleted list content type, Deleted list item, Deleted site column, Deleted site content type, Recycled list item, Restored list, Restored list item, Updated list, Updated list column, Updated list content type, Updated list item, Updated site column, Updated site content type.
                    </P>
                    <P>
                        5. 
                        <E T="03">Sharing and access request activities:</E>
                         Added permission level to site collection, Accepted access request, Accepted sharing invitation, Blocked sharing invitation, Created access request, Created a company shareable link, Created an anonymous link, Created secure link, Deleted secure link, Created sharing invitation, Denied access request, Removed a company shareable link, Removed an anonymous link, Shared filer, folder, or site, Unshared file folder or site, Updated access request, Updated an anonymous link, Updated sharing invitation, Used a company shareable link, Used an anonymous link, Used secure link, User added to secure link, User removed from secure link, Withdrew sharing invitation.
                    </P>
                    <P>
                        6. 
                        <E T="03">Synchronization activities:</E>
                         Allowed computer to sync files, Blocked computer from syncing files, Downloaded files to computer, Downloaded file changes to computer, Uploaded files to document library, Uploaded file changes to document library.
                    </P>
                    <P>
                        7. 
                        <E T="03">Site permissions activities:</E>
                         Added site collection admin, Added user of group to Cloud-based Enterprise Storage group, Broke permission level inheritance, Broke sharing inheritance, Created group, Deleted group, Modified access request setting, Modified “Members Can Share” setting, Modified permission level on site collection, Modified site permissions, Removed site collection admin, Removed permission level from site collection, Removed user or group from Cloud-based Enterprise Storage group, Requested site admin permissions, Restored sharing inheritance, Updated group.
                    </P>
                    <P>
                        8. 
                        <E T="03">Site administration activities:</E>
                         Added allowed data location, Added exempt user agent, Added geo location admin, Allowed user to create groups, Cancelled site geo move, Changed a sharing policy, Changed deice access policy, Changed exempt user agents, Changed network access policy, Completed site geo move, Created Sent To connection, Created site collection, Deleted orphaned hub site, Deleted Sent To connection, Deleted site, Enabled document preview, Enabled legacy workflow, Enabled service applications on Demand, Enabled result source for People Searched, Enabled RSS feeds, Failed site swap, Joined site to hub site, Registered hub site, Removed allowed data location, Removed geo location admin, Renamed site, Scheduled site rename, Scheduled site swap, Scheduled site geo move, Set host site, Set storage quota for geo location, Swapped site, Unjoined site from hub site, Unregistered hub site.
                    </P>
                    <P>
                        9. 
                        <E T="03">Cloud-based Email Server mailbox activities:</E>
                         Created mailbox item, Copied messages to another folder, User signed in to mailbox, Accessed mailbox items, Sent message using Send On Behalf permissions, Purged messages from mailbox, Moved messages to Deleted Items folder, Moved messages to another folder, Sent message using Send As permissions, Sent message, Updated message, Deleted messages from Deleted Items folder, New-Inbox Rule Create-Inbox Rule from email web application, Set-Inbox Rule Modify inbox rule from email web application, Update inbox rules from email web application, Added delegate mailbox permissions, Removed delegate mailbox permissions, Added permissions to folder, Modified permissions of folder, Removed permissions from folder, Added or removed user with delegate access to calendar folder, Labeled message as a record.
                    </P>
                    <P>
                        10. 
                        <E T="03">Retention policy and retention level activities:</E>
                         Created retention label, Created retention policy, Configured settings for a retention policy, Deleted retention label, Deleted retention policy, Deleted settings from a retention policy, Updated retention label, Updated retention policy, Updated settings for a retention policy, Enabled regulatory record option for retention labels.
                    </P>
                    <P>
                        11. 
                        <E T="03">User administration activities:</E>
                         Added user, Deleted user, Set license properties, Reset user password, Changed user password, Changed user license, Updated user, Set property that forces user to change password.
                    </P>
                    <P>
                        12. 
                        <E T="03">Enterprise User Administration group administration activities:</E>
                         Added group, Updated group, Deleted group, Added member to group, Removed member from group.
                    </P>
                    <P>
                        13. 
                        <E T="03">Application Administration Activities:</E>
                         Added service principal, Removed a service principal from the directory, Set delegation entry, Removed credentials from a service principal, Added delegation entry, Added credentials to a service principal, Removed delegation entry.
                    </P>
                    <P>
                        14. 
                        <E T="03">Role administration activities:</E>
                         Added member to Role, Removed a user from a directory role, Set company contact information.
                    </P>
                    <P>
                        15. 
                        <E T="03">Directory administration activities:</E>
                         Added a partner to the directory, Removed a partner from the directory, Added domain to company, Removed domain from company, Updated domain, Set domain authentication, Verified domain, Updated the federation settings for a domain, Verified email verified domain, Turned on Enterprise Information Technology Account Administration sync, Set password policy, Set company information.
                    </P>
                    <P>
                        16. 
                        <E T="03">eDiscovery activities:</E>
                         Created content search, Deleted content search, Changed content search, Started content search, Stopped content search, Started export of content search, Started export report, Previewed results of content search, Purged results of content search, Started analysis of content search, Removed export of content search, Removed preview results of content search, Removed purse action 
                        <PRTPAGE P="24904"/>
                        performed on content search, Removed analysis of content search, Removed search report, Content search preview item listed, Content search preview item viewed, Content search preview item downloaded, Downloaded export of content search, Created search permissions filter, Deleted search permissions filter, Changed search permissions filter, Created hold in eDiscovery case, Deleted hold in eDiscovery case, Changed hold in eDiscovery case, Created eDiscovery case, Deleted hold in eDiscovery case, Changed hold in eDiscovery case, Created eDiscovery case, Deleted eDiscovery data, Changed hold in eDiscovery case, Added member to eDiscovery case, Removed member from eDiscovery case, Changed eDiscovery case membership, Created eDiscovery administrator, Deleted eDiscovery administrator, Changed eDiscovery administrator membership, Remediation action created, Item deleted using Remediation, Created workingset search, Updated workingset search, Deleted workingset search, Previewed workingset search, Document viewed, Document annotated, Document downloaded, Tag created, Tag edited, Tag deleted, Tag files, Tag job, Created review set, Added Cloud-based productivity software data, Added non-service application data, Added data to another workingset, Added remediated data, Run algo job, Run export job, Run burn job, Run error remediation job, Run load comparison job, Updated case settings.
                    </P>
                    <P>
                        17. 
                        <E T="03">eDiscovery system command activities:</E>
                         Created content search, Deleted content search, Changed content search, Started content search, Stopped content search, created content search action, Deleted content search action, Created search permissions filter, Deleted search permissions filter, Changed search permissions filter, Created hold in eDiscovery case, Deleted hold in eDiscovery case, Changed hold in eDiscovery case, Created search query for eDiscovery case hold, Deleted search query for eDiscovery case hold, Changed search query for eDiscovery case hold, Created eDiscovery case, Deleted eDiscovery case, Changed eDiscovery case, Added member to eDiscovery case, Removed member from eDiscovery case, Changed eDiscovery case membership, Created eDiscovery administrator, Deleted eDiscovery administrator, Changed eDiscovery administrator membership.
                    </P>
                    <P>
                        18. 
                        <E T="03">Data Analysis application activities:</E>
                         Viewed program dashboard, Created program dashboard, Edited program dashboard, Deleted program dashboard, Shared program dashboard, Printed program dashboard, Copied program dashboard, Viewed program tile, Exported program tile data, Viewed program report, Deleted program report, Printed program report page, Created program report, Edited program report, Copied program report, Exported program artifact to another file format, Export program activity events, Updated program workspace access, Restored program workspace, Updated program workspace, Viewed program metadata, Created program dataset, Deleted program dataset, Created program group, Deleted program group, Added program group members, Retrieved program groups, Retrieved program dashboard, Retrieved data sources from program dataset, Retrieved upstream data flows from program dataflow, Retrieved data sources from program dataflow, Removed program group members, Retrieved links between datasets and dataflows, Created organizational program content pack, Created program app, Installed program app, Updated program app, Updated organization's program settings, Started program trial, Started program extended trial, Analyzed program dataset, Created program gateway, Deleted program gateway, Added data source to program gateway, Removed data source from program gateway, Changed program gateway admins, Changed program gateway data source users, Set scheduled refresh on program dataset, Unpublished program app, Deleted organizational program content pack, Renamed program dashboard, Edited program dataset, Updated capacity display name, Changed capacity state, Updated capacity admin, Changed capacity user assignment, Migrated workspace to a capacity, Removed workspace from a capacity, Retrieved program workspaces, Shared program report, Generated program Embed Token, Discover program dataset data sources, Updated program dataset data sources, Requested program dataset refresh, Binded program dataset to gateway, Changed program dataset data sources, Requested program dataset refresh, Binded program dataset to gateway, Changed program dataset connections, Took over program dataset, Updated program gateway data source credentials, Imported file to program, Updated program dataset parameters, Generated program dataflow SAS token, Created program dataflow, Updated program dataflow, Deleted program dataflow, Viewed program dataflow, Exported program dataflow, Set scheduled refresh on program dataflow, Requested program dataflow refresh, Received program dataflow secret from Key Vault, Attached dataflow storage account, Migrated dataflow storage location, Updated dataflow storage assignment permissions, Set dataflow storage location for workspace, Took ownership of program dataflow, Canceled program dataflow refresh, Created program email subscription, Updated program email subscription, Deleted program email subscription, Created program folder, Deleted program folder, Updated program folder, Added program folder access, Deleted program folder access, Updated program folder access, Posted program comment, Deleted program comment, Analyzed program report, Viewed program usage metrics, Edited program dataset endorsement, Edited program dataflow endorsement, Edited program report endorsement, Edited program app endorsement, Retrieved list of modified worksapces in program tenant, Sent a scan request in program tenant, Retrieve scan result in program tenant, Inserted snapshot for user in program tenant, Updated snapshot for user in program tenant, Deleted snapshot for user in program tenant, Inserted snapshot for user in program tenant, Updated snapshot for user in program tenant, Deleted snapshot for user in program tenant, Retrieved snapshots for user in program tenant, Edited program certification permission, Took over a program data source, Updated capacity custom settings, Created workspace for program template app, Deleted workspace for program template app, Updated settings for program template app, Updated testing permissions for program template app, Created program template app, Deleted program template app, Promoted program template app, Installed program template app, Updated parameters for installed program template app, Created install ticker for installing program template app, Updated an organizational custom visual, Created an organizational custom visual, Deleted an organizational custom visual, Custom visual requested Enterprise Information Technology Account Administration access token, Customer visual requested Cloud-based productivity software access token, Connected to program dataset from external app, Created program dataset from external app, Deleted program dataset from external app, Edited program dataset from external app, Requested program dataset refresh from external app, Requested SAS token for program storage, Requested account key for program storage, Assigned a workspace to a deployment pipeline, Removed a workspace from a deployment pipeline, Deleted 
                        <PRTPAGE P="24905"/>
                        deployment pipeline, Created deployment pipeline, Deployed to a pipeline stage, Updated deployment pipeline configuration, Updated deployment pipeline access, Added external resource, Added link to external resource, Deleted link to external resource, Updated featured tables, Applied sensitivity label to program artifact, Changed sensitivity label for program artifact, Deleted sensitivity label from program artifact.
                    </P>
                    <P>
                        19. 
                        <E T="03">Productivity Analysis activities:</E>
                         Updated privacy setting, Updated data access setting, Uploaded organization data, Created meeting exclusion, Updated preferred meeting exclusion, Execute query, Canceled query, Deleted result, Downloaded report, Accessed Odata link, Viewed query visualization, Viewed explore, Created partition, Updated partition, Deleted partition, User logged in, User logged out.
                    </P>
                    <P>
                        20. 
                        <E T="03">Briefing email activities:</E>
                         Updated user privacy settings, Updated organization privacy settings.
                    </P>
                    <P>
                        21. 
                        <E T="03">Cloud-based Collaboration Application activities:</E>
                         Created team, Deleted team, Added channel, Deleted channel, Changed organization setting, Changed team setting, Changed channel setting, User signed in to Cloud-based Collaboration Application, Added members, Changed role of members, Removed members, Added bot to team, Removed bot from team, Added tab, Removed tab, Updated tab, Added connector, Removed connector, Updated connector, Downloaded analytics report, Upgraded Cloud-based Collaboration Application device, Blocked Cloud-based Collaboration Application device, Unblocked Cloud-based Collaboration Application device, Changed configuration of Cloud-based Collaboration Application device, Enrolled Cloud-based Collaboration Application device, Installed app, Upgraded app, Uninstalled app, Published app, Updated app, Deleted app, Deleted all organization apps, Performed action on card, Added scheduling group, Edited scheduling group, Deleted scheduling group, Added shift, Edited shift, Deleted shift, Added time off, Edited time off, Deleted time off, Added open shift, Edited open shift, Deleted open shift, Shared schedule, Clocked in using Time clock, Clocked out using Time clock, Started break using Time clock, Ended break using Time clock, Added Time clock entry, Edited Time clock entry, Deleted Time clock entry, Added shift request, Responded to shift request, Canceled shift request, Changed schedule setting, Added workforce integration, Accepted off shift message.
                    </P>
                    <P>
                        22. 
                        <E T="03">Cloud-based Collaboration Application approvals activities:</E>
                         Created new approval request, Viewed approval request details, Approved approval request, Rejected approval request, Canceled approval request, Shared approval request, File attached to approval request, Reassigned approval request, Added e-signature to approval request.
                    </P>
                    <P>
                        23. 
                        <E T="03">Enterprise Social Network activities:</E>
                         Changed data retention policy, Changed network configuration, Changed network profile settings, Changed private content mode, Changed security configuration, Created file, Created group, Deleted group, Deleted message, Downloaded file, Exported data, Shared file, Suspended network user, Suspended user, Updated file description, Updated file name, Viewed file.
                    </P>
                    <P>
                        24. 
                        <E T="03">Enterprise Customer Relationship Management activities:</E>
                         Accessed out-of-box entity (deprecated), Accessed custom entity (deprecated), Accessed admin entity (deprecated), Performed bulk actions (deprecated), All Enterprise Customer Relationship Management activities, Accessed Enterprise Customer Relationship Management admin center (deprecated), Accessed internal management tool (deprecated), Signed in or out (deprecated), Activated process or plug-in (deprecated).
                    </P>
                    <P>
                        25. 
                        <E T="03">Information Systems Infrastructure Automation activities:</E>
                         Created flow, Edited flow, Deleted flow, Edited flow permissions, Deleted flow permissions, Started a Flow paid trial, Renewed a Flow paid trial.
                    </P>
                    <P>
                        26. 
                        <E T="03">Application authoring program activities:</E>
                         Created app, Edited app, Deleted app, Launched app, Published app, Marked app as Hero, Marked app as Featured, Edited app permission, Restored app version.
                    </P>
                    <P>
                        27. 
                        <E T="03">Enterprise Automation DLP activities:</E>
                         Created DLP Policy, Updated DLP Policy, Deleted DLP Policy.
                    </P>
                    <P>
                        28. 
                        <E T="03">Video platform activities:</E>
                         Created video, Edited video, Deleted video, Uploaded video, Downloaded video, Edited video permission, Viewed video, Shared video, Liked video, Unliked video, Commented on video, Deleted video comment, Uploaded video text track, Deleted video text track, Uploaded video thumbnail, Deleted video thumbnail, Replaced video permissions and channel links, Marked video public, Marked video private, Created Video platform group, Edited Video platform group, Deleted Video platform group, Edited Video platform group memberships, Created Video platform channel, Edited Video platform channel, Deleted a Video platform channel, Replaced Video platform channel thumbnails, Edited Video platform user settings, Edited tenant settings, Edited global role members, Deleted Video platform user, Deleted Video platform user's data report, Edited Video platform user, Exported Video platform user's data report, Downloaded Video platform user's data report.
                    </P>
                    <P>
                        29. 
                        <E T="03">Content explorer activities:</E>
                         Accessed item
                    </P>
                    <P>
                        30. 
                        <E T="03">Quarantine activities:</E>
                         Previewed Quarantine message, Deleted Quarantine message, Released Quarantine message, Exported Quarantine message, Viewed Quarantine Message's header.
                    </P>
                    <P>
                        31. 
                        <E T="03">Customer Key Service Encryption activities:</E>
                         Fallback to Availability Key
                    </P>
                    <P>
                        32. 
                        <E T="03">Form application activities:</E>
                         Created form, Edited form, Moved form, Deleted form, Viewed form, Previewed form, Exported form, Allowed share form for copy, Added form co-author, Removed form co-author, Viewed response page, Created response, Updated response, Deleted all responses, Deleted response, Viewed responses, Viewed response, Created summary link, Deleted summary link, Updated from phishing status, Updated user phishing status, Sent premium form product invitation, Updated form setting, Updated user setting, Listed forms.
                    </P>
                    <P>
                        33. 
                        <E T="03">Sensitivity label activities:</E>
                         Applied sensitivity label to site, Removed sensitivity label from site, Applied sensitivity label to file, Changed sensitivity label applied to file, Removed sensitivity label from file.
                    </P>
                    <P>
                        34. 
                        <E T="03">Local machine communications platform system command activities:</E>
                         Set tenant federation.
                    </P>
                    <P>
                        35. 
                        <E T="03">Search activities:</E>
                         Performed email search, Performed Cloud-based Enterprise Storage search.
                    </P>
                    <P>
                        36. 
                        <E T="03">Security analytics activities:</E>
                         Attempted to compromise accounts.
                    </P>
                    <P>
                        37. 
                        <E T="03">Device activities:</E>
                         Printed file, Deleted file, Renamed file, Created file, Modified file, Read file, Captured screen, Copied file to removable media, Copied file to network share, Copied file to clipboard, Uploaded file to cloud, File accessed by an unallowed application.
                    </P>
                    <P>
                        38. 
                        <E T="03">Information barrier activities:</E>
                         Removed segment from site, Changed segment of site, Applied segment to site.
                    </P>
                    <P>
                        39. 
                        <E T="03">On-premises DLP scanning activities:</E>
                         Matched DLP rule, Enforced DLP rule.
                    </P>
                    <P>
                        40. 
                        <E T="03">Individual Productivity Analytics activities:</E>
                         Updated user settings, Updated organization settings.
                    </P>
                    <P>
                        41. 
                        <E T="03">Exact Data Match (EDM) activities:</E>
                         Created EDM schema, Modified EDM schema, Removed EDM scheme, 
                        <PRTPAGE P="24906"/>
                        Completed EDM data upload, Failed EDM data upload.
                    </P>
                    <P>
                        42. 
                        <E T="03">Enterprise Information System Information Protection activities:</E>
                         Accessed file, Discovered file, Applied sensitivity label, Updated sensitivity label, Removed sensitivity label, Removed file, Applied protection, Changed protection, Removed protection, Received AIP heartbeat.
                    </P>
                    <P>
                        43. 
                        <E T="03">Data Repository Team Discussion Post Actions:</E>
                         Team Discussion Post Updated, Team Discussion Post Destroyed.
                    </P>
                    <P>
                        44. 
                        <E T="03">Data Repository Team Discussion Post Reply Actions:</E>
                         Team Discussion Post Reply Updated, Team Discussion Post Reply Destroyed.
                    </P>
                    <P>
                        45. 
                        <E T="03">Data Repository Enterprise Actions:</E>
                         Self-Hosted Runner Removed, Self-Hosted Runner Registered, Self-Hosted Runner Group Created, Self-Hosted Runner Group Removed, Self-Hosted Runner Removed From Group, Self-Hosted Runner Added To Group, Self-Hosted Runner Group Member List Updated, Self-Hosted Runner Group Configuration Changed, Self-Hosted Runner Updated.
                    </P>
                    <P>
                        46. 
                        <E T="03">Data Repository Hook Actions:</E>
                         Hook Created, Hook Configuration Changed, Hook Destroyed, Hook Events Altered.
                    </P>
                    <P>
                        47. 
                        <E T="03">Data Repository Integration Installation Request Actions:</E>
                         Integration Installation Request Created, Integration Installation Request Closed.
                    </P>
                    <P>
                        48. 
                        <E T="03">Data Repository Issue Action:</E>
                         Issue Destroyed.
                    </P>
                    <P>
                        49. 
                        <E T="03">Data Repository Org Actions:</E>
                         Secret Action Created, Member Creation Disabled, Two Factor Authentication Requirement Disabled, Member Creation Enabled, Two Factor Authentication Enabled, Member Invited, Self-Hosted Runner Registered, Secret Action Removed, Member Removed, Outside Collaborator Removed, Self-Hosted Runner Removed, Self-Hosted Runner Group Created, Self-Hosted Runner Group Removed, Self-Hosted Runner Group Updated, Secret Action Updated, Repository Default Branch Named Updated, Default Repository Permission Updated, Member Role Updated, Member Repository Creation Permission Updated.
                    </P>
                    <P>
                        50. 
                        <E T="03">Data Repository Organization Label Actions:</E>
                         Default Label Created, Default Label Updated, Default Label Destroyed.
                    </P>
                    <P>
                        51. 
                        <E T="03">Data Repository Oauth Application Actions:</E>
                         Oauth Application Created, Oauth Application Destroyed, Oauth Application Secret Reset, Oauth Application Token Revoked, Oauth Application Transferred.
                    </P>
                    <P>
                        52. 
                        <E T="03">Data Repository Profile Picture Actions:</E>
                         Organization Profile Picture Updated.
                    </P>
                    <P>
                        53. 
                        <E T="03">Data Repository Project Actions:</E>
                         Project Board Created, Project Board Linked, Project Board Renamed, Project Board Updated, Project Board Deleted, Project Board Unlinked, Project Board Permissions Updated, Project Board Team Permissions Updated, Project Board User Permission Updated.
                    </P>
                    <P>
                        54. 
                        <E T="03">Data Repository Protected Branch Actions:</E>
                         Branch Protection Enabled, Branch Protection Destroyed, Branch Protection Enforced For Administrators, Branch Enforcement Of Required Code Owner Enforced, Stale Pull Request Dismissal Enforced, Branch Commit Signing Updated, Pull Request Review Updated, Required Status Check Updated, Requirement For Branch To Be Up To Date Before Merging Changed, Branch Update Attempt Rejected, Branch Protection Requirement Overridden, Force Push Enabled, Force Push Disabled, Branch Deletion Enabled, Branch Deletion Disabled, Linear Commit History Enabled, Linear Commit History Disabled.
                    </P>
                    <P>
                        55. 
                        <E T="03">Data Repository Repo Actions:</E>
                         User Visibility Changed, Actions Enabled For Repository, Collaboration Member Added, Topic Added To Repository, Repository Archived, Anonymous Git Read Access Disabled, Anonymous Git Read Access Enabled, Anonymous Git Read Access Setting Locked, Anonymous Git Read Access Setting Unlocked, New Repository Created, Secret Created For Repository, Repository Deleted, Repository Enabled, Secret Removed, User Removed, Self-Hosted Runner Registered, Topic Removed From Repository, Repository Renamed, Self-Hosted Runner Updated, Repository Transferred, Repository Transfer Started, Repository Unarchived, Secret Action Updated.
                    </P>
                    <P>
                        56. 
                        <E T="03">Data Repository Dependency Graph Actions:</E>
                         Dependency Graph Disabled, Dependency Graph Disabled for New Repository, Dependency Graph Enabled, Dependency Graph Enabled for New Repository.
                    </P>
                    <P>
                        57. 
                        <E T="03">Data Repository Secret Scanning Actions:</E>
                         Secret Scanning Disabled for Individual Repository, Secret Scanning Disabled for All Repositories, Secret Scanning Disabled for New Repositories, Secret Scanning Enabled for Individual Repository, Secret Scanning Enabled for All Repositories, Secret Scanning Enabled for New Repositories.
                    </P>
                    <P>
                        58. 
                        <E T="03">Data Repository Vulnerability Alert Actions:</E>
                         Vulnerable Dependency Alert Created, Vulnerable Dependency Alert Dismissed, Vulnerable Dependency Alert Resolved.
                    </P>
                    <P>
                        59. 
                        <E T="03">Data Repository Team Actions:</E>
                         Member Added To Team, Repository Added To Team, Team Parent Changed, Team Privacy Level Changed, Team Created, Member Demoted In Team, Team Destroyed, Member Promoted In Team, Member Removed From Team, Repository Removed From Team.
                    </P>
                    <P>
                        60. 
                        <E T="03">Data Repository Team Discussion Actions:</E>
                         Team Discussion Disabled, Team Discussion Enabled.
                    </P>
                    <P>
                        61. 
                        <E T="03">Data Repository Workflow Actions:</E>
                         Workflow Run Cancelled, Workflow Run Completed, Workflow Run Created, Workflow Run Deleted, Workflow Run Rerun, Workflow Job Prepared.
                    </P>
                    <P>
                        62. 
                        <E T="03">Data Repository Account Actions:</E>
                         Billing Plan Change, Plan Change, Pending Plan Change, Pending Subscription Change.
                    </P>
                    <P>
                        63. 
                        <E T="03">Data Repository Advisory Credit Actions:</E>
                         Accept Credit, Create Credit, Decline Credit, Destroy Credit.
                    </P>
                    <P>
                        64. 
                        <E T="03">Data Repository Billing Actions:</E>
                         Change Billing Type, Change Email.
                    </P>
                    <P>
                        65. 
                        <E T="03">Data Repository Bot Alerts Actions:</E>
                         Disable Bot, Enable Bot.
                    </P>
                    <P>
                        66. 
                        <E T="03">Data Repository Bot Alerts for New Repository Actions:</E>
                         Disable Alerts, Enable Alerts.
                    </P>
                    <P>
                        67. 
                        <E T="03">Data Repository Bot Security Alerts for Update Actions:</E>
                         Disable Security Update Alerts, Enable Security Update Alerts.
                    </P>
                    <P>
                        68. 
                        <E T="03">Data Repository Bot Security Alerts for New Repository Actions:</E>
                         Disable New Repository Security Alerts, Enable New Repository Security Alerts.
                    </P>
                    <P>
                        69. 
                        <E T="03">Data Repository Environment Actions:</E>
                         Create Actions Secret, Delete, Remove Actions Secret, Update Actions Secret.
                    </P>
                    <P>
                        70. 
                        <E T="03">Data Repository Git Actions:</E>
                         Clone, Fetch, Push.
                    </P>
                    <P>
                        71. 
                        <E T="03">Data Repository Marketplace Agreement Signature Actions:</E>
                         Create.
                    </P>
                    <P>
                        72. 
                        <E T="03">Data Repository Marketplace Listing Actions:</E>
                         Approve, Create, Delist, Redraft, Reject
                    </P>
                    <P>
                        73. 
                        <E T="03">Data Repository Members Can Create Pages Actions:</E>
                         Enable, Disable
                    </P>
                    <P>
                        74. 
                        <E T="03">Data Repository Organization Credential Authorization Actions:</E>
                         Security Assertion Markup Language Single-Sign On Authorized, Security Assertion Markup Language Single-Sign On Deauthorized, Authorized Credentials Revoked.
                    </P>
                    <P>
                        75. 
                        <E T="03">Data Repository Package Actions:</E>
                         Package Version Published, Package Version Deleted, Package Deleted, Package Version Restored, Package Restored.
                    </P>
                    <P>
                        76. 
                        <E T="03">Data Repository Payment Method Actions:</E>
                         Payment Method Cleared, Payment Method Created, Payment Method Updated.
                    </P>
                    <P>
                        77. 
                        <E T="03">Data Repository Advisory Actions:</E>
                         Security Advisory Closed, Common 
                        <PRTPAGE P="24907"/>
                        Vulnerabilities And Exposures Advisory Requested, Data Repository Security Advisory Made Public, Data Repository Security Advisory Withdrawn, Security Advisory Opened, Security Advisory Published, Security Advisory Reopened, Security Advisory Updated.
                    </P>
                    <P>
                        78. 
                        <E T="03">Data Repository Content Analysis:</E>
                         Data Use Settings Enabled, Data Use Settings Disabled.
                    </P>
                    <P>
                        79. 
                        <E T="03">Data Repository Sponsors Actions:</E>
                         Repo Funding Link Button Toggle, Repo Funding Links File Action, Sponsor Sponsorship Cancelled, Sponsor Sponsorship Created, Sponsor Sponsorship Preference Changed, Sponsor Sponsorship Tier Changed, Sponsored Developer Approved, Sponsored Developer Created, Sponsored Developer Profile Updated, Sponsored Developer Request Submitted For Approval, Sponsored Developer Tier Description Updated, Sponsored Developer Newsletter Sent, Sponsored Developer Invited From Waitlist, Sponsored Developer Joined From Waitlist.
                    </P>
                    <HD SOURCE="HD2">ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:</HD>
                    <P>Standard routine uses 1. through 9. apply. In addition:</P>
                    <P>(a) Disclosure of records to appropriate agencies, entities, and persons when (1) the Postal Service suspects or has confirmed that there has been a breach of the system of records; (2) the Postal Service has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, the Postal Service (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Postal Service's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.</P>
                    <HD SOURCE="HD2">RECORD SOURCE CATEGORIES:</HD>
                    <P>Employees; contractors; suppliers; customers.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR STORAGE OF RECORDS:</HD>
                    <P>Automated database, computer storage media, and paper.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:</HD>
                    <P>Records relating to system administration are retrievable by user ID.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:</HD>
                    <P>Records relating to system administration are retained for twenty-four months.</P>
                    <HD SOURCE="HD2">ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:</HD>
                    <P>Paper records, computers, and computer storage media are located in controlled-access areas under supervision of program personnel. Computer access is limited to authorized personnel with a current security clearance, and physical access is limited to authorized personnel who must be identified with a badge.</P>
                    <P>Access to records is limited to individuals whose official duties require such access. Contractors and licensees are subject to contract controls and unannounced on-site audits and inspections.</P>
                    <P>Computers are protected by encryption, mechanical locks, card key systems, or other physical access control methods. The use of computer systems is regulated with installed security software, computer logon identifications, and operating system controls including access controls, terminal and transaction logging, and file management software.</P>
                    <HD SOURCE="HD2">RECORD ACCESS PROCEDURES:</HD>
                    <P>Requests for access must be made in accordance with the Notification Procedure above and USPS Privacy Act regulations regarding access to records and verification of identity under 39 CFR 266.5.</P>
                    <HD SOURCE="HD2">CONTESTING RECORD PROCEDURES:</HD>
                    <P>See Notification Procedure and Record Access Procedures above.</P>
                    <HD SOURCE="HD2">NOTIFICATION PROCEDURE:</HD>
                    <P>Customers wanting to know if other information about them is maintained in this system of records must address inquiries in writing to the Chief Information Officer and Executive Vice President and include their name and address.</P>
                    <HD SOURCE="HD2">EXEMPTION(S) PROMULGATED FROM THIS SYSTEM:</HD>
                    <P>None.</P>
                    <HD SOURCE="HD2">HISTORY:</HD>
                    <P>None.</P>
                </PRIACT>
                <SIG>
                    <NAME>Joshua J. Hofer,</NAME>
                    <TITLE>Attorney, Ethics &amp; Legal Compliance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09752 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Privacy Act of 1974; System of Records</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <SU>TM</SU>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a new system of records.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The United States Postal Service (USPS
                        <SU>TM</SU>
                        ) is proposing to create a new General Privacy Act System of Records.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This new System of Records will become effective without further notice on June 9, 2021, unless comments received on or before that date result in a contrary determination.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be submitted via email to the Privacy and Records Management Office, United States Postal Service Headquarters (
                        <E T="03">privacy@usps.gov</E>
                        ). Arrangements to view copies of any written comments received, to facilitate public inspection, will be made upon request.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Janine Castorina, Chief Privacy and Records Management Officer, Privacy and Records Management Office, 202-268-3069 or 
                        <E T="03">privacy@usps.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>The world of commercial information technology resources (“IT”) is constantly changing and innovating to improve the daily lives of businesses, their employees, and their customers. This pace can often result in unanticipated obsolescence, necessitating review of an organization's already implemented solutions. For the Postal Service, legal processes and notice required by the Privacy Act present additional challenges, as new technologies will require further review for possible compliance issues to meet statutory and regulatory requirements.</P>
                <P>To better meet the changing technology world, the Postal Service will consolidate existing Systems of Records (“SOR”s) covering IT into three new, comprehensive Systems of Records. These SORs will work in tandem, with each individual SOR covering a specific group of related functions, and all three SORs working together to support a seamless technology experience.</P>
                <P>These SORs, generally, will cover the following three areas:</P>
                <P>
                    • Infrastructure, covering records created for use throughout the entirety of a particular IT resource in addition to covering the records created from the usage of those records by users and applications.
                    <PRTPAGE P="24908"/>
                </P>
                <P>• Applications, covering records created through the regular use of an application.</P>
                <P>• Administrative, covering records created for monitoring and administration of users and applications within an IT resource.</P>
                <P>In addition to covering these three areas generally, the Postal Service will look ahead in an effort to include possible future technology solutions within this System of Records. This will give the Postal Service flexibility to more easily adapt to the advancing pace of information technology and to better fulfill its service obligations. This will also provide transparency into the collection of records relating to commercial IT, allowing Postal employees, contractors, and the public to more easily identify what we do with their information.</P>
                <HD SOURCE="HD1">Rationale for the Creation of a New USPS System of Records</HD>
                <P>Currently, records relating to the implementation of IT resources are housed primarily in USPS 500.000, Property Management Records, with other IT-related components appearing in USPS 890.000, Sales, Marketing, Events, and Publications and other SORs. SOR 500.000 reflects not only IT access records, but also building access and related records. This results in a mixture of uses within SOR 500.000, which reduces optimization and can result in confusion.</P>
                <P>The creation of a new SOR to encompass commercial IT resources, therefore, provides a platform which is easy to understand and allows for greater flexibility in use and maintenance. Since the new SOR will house only IT resources, the public can more easily understand what information is collected and how it is used.</P>
                <P>Further, documenting IT records within one SOR provides for greater flexibility in adding new resources as well as maintaining existing resources. For example, one application may already collect and store, for the same purpose, data elements that a new application will use. With a record already documented, the implementation process of the new technology will be streamlined while also meeting statutory and regulatory mandates.</P>
                <HD SOURCE="HD1">Description of New or Modified System of Records</HD>
                <P>This new system of records is being developed to support the implementation of various commercial IT resources and to provide support for future implementations.</P>
                <P>This system specifically will cover categories of records referred to collectively as “Infrastructure.” Categories of Records in this system reference data elements created in one application and passed through to multiple applications. This SOR also contains Categories of Records that reference transformations or analysis of those data elements resulting from interactions with users or applications. Data elements documented within this system may be passed through or referenced by records otherwise contained in systems USPS 550.100 Commercial Information Technology Resources- Applications and USPS 550.200 Commercial Information Technology Resources—Administrative; therefore, those elements will not be specifically documented within those systems unless those systems utilize those elements in a transformative manner.</P>
                <P>This System of Records may overlap with elements appearing in other Systems of Records, as indicated in the Rationale for Changes to USPS System of Records section. This new System of Records will encompass commercially developed or commercially assisted IT resources. Applications developed in-house or by the Postal Service, such as Informed Delivery®, will still be represented in their own SOR.</P>
                <PRIACT>
                    <HD SOURCE="HD2">SYSTEM NAME AND NUMBER:</HD>
                    <P>550.000 Commercial Information Technology Resources—Infrastructure</P>
                    <HD SOURCE="HD2">SECURITY CLASSIFICATION:</HD>
                    <P>None.</P>
                    <HD SOURCE="HD2">SYSTEM LOCATION:</HD>
                    <P>All USPS facilities and contractor sites.</P>
                    <HD SOURCE="HD2">SYSTEM MANAGER(S):</HD>
                    <P>Chief Information Officer and Executive Vice President, United States Postal Service, 475 L'Enfant Plaza SW, Washington, DC 20260.</P>
                    <HD SOURCE="HD2">AUTHORITY FOR MAINTENANCE OF THE SYSTEM:</HD>
                    <P>39 U.S.C. 401, 403, and 404.</P>
                    <HD SOURCE="HD2">PURPOSE(S) OF THE SYSTEM:</HD>
                    <P>1. To provide USPS employees, contractors, and other authorized individuals with hierarchical access to and accounts for commercial information technology resources administered by the Postal Service and based on least privileged access.</P>
                    <P>2. To facilitate a cohesive software experience and simplify ease of use by sharing user and application data across participating IT programs.</P>
                    <P>3. To authenticate user identity for the purpose of accessing USPS information systems.</P>
                    <P>4. To assess user attributes and assign related access privileges.</P>
                    <P>5. To authenticate suppliers and contractors and facilitate further access to downstream Postal Service information systems.</P>
                    <P>6. To provide active and passive monitoring of information systems, applications, software, devices, and users for information security risks.</P>
                    <P>7. To review information systems, applications, software, devices, and users to ensure compliance with USPS regulations.</P>
                    <P>8. To facilitate and support cybersecurity investigations of detected or reported information security incidents.</P>
                    <P>9. To administer programs, processes, and procedures to assess information security risks and to detect information security threats and vulnerabilities.</P>
                    <P>10. To provide tools and analytics for USPS employees and contractors to measure work productivity and improve efficiency.</P>
                    <P>11. To improve manager-subordinate relationships within their formal reporting structure through data-based insights generated from their own email and related electronic communications with subordinates.</P>
                    <HD SOURCE="HD2">CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:</HD>
                    <P>1. Individuals with authorized access to USPS computers, information resources, and facilities, including employees, contractors, business partners, suppliers, and third parties.</P>
                    <P>2. Individuals participating in web-based meetings, web-based video conferencing, web-based communication applications, and web-based collaboration applications.</P>
                    <HD SOURCE="HD2">CATEGORIES OF RECORDS IN THE SYSTEM:</HD>
                    <P>
                        1. 
                        <E T="03">Information System Account Access records:</E>
                         Records relating to the access or use of an information system, application, or piece of software, including; Name, User ID, Email Address, User Type, User Role, Job Title, Department, Manager, Company, Street Address, State Or Province, Country Or Region, Work Phone Number(s), Employee Identification Number (EIN), Advanced Computing Environment (ACE) ID, License Information, Action Initiated, Datetime, User Principle Name, Usage Location, Alternate Email Address, Proxy Address, Age Group, IP Address, MAC Address, Password, Multi-Factor Authentication Credentials, Security Questions, Security Answers, Passcode, Geolocation Data, User Profile Picture, Picture Metadata, Information Technology Account Administration 
                        <PRTPAGE P="24909"/>
                        User Configuration Status, Supplier Credentials, Supplier Company Codes, Conditional Access Attributes.
                    </P>
                    <P>
                        2. 
                        <E T="03">Security Analytics records:</E>
                         Records relating to the gathering, analysis, review, monitoring, and investigation of information system security risks, including; User Investigation Priority Score, User Identity Risk Level, User Lateral Movement Paths, User Devices Numbers, User Account Numbers, User Resources Numbers, User Locations Numbers, User Matches Files Numbers, User Locations, Apps Used By User, User Groups, User Last Seen Date, User Affiliation, User Domain, App Instance, Organizational Groups, User Account Status, Activity ID, Activity Objects, Activity Type, Administrative Activity, Alert ID, Applied Action, Activity Date, Device Tag, Activity Files And Folders, Impersonated Activities, App Instance Activity, App Location Activity, Activity Matched Policy, Activity Registered ISP, Activity Source, Activity User, Activity User Agent, Activity User Agent Tag, Application Risk Score, Application Activity, User Software Deactivation, User Software Installation, User Software Removal, Last Date Of Software Execution, internet Application Transaction Counts, Data Volume Upload, Data Volume Download, Data Sensitivity Classification, internet Protocol, internet Port, internet Access History.
                    </P>
                    <P>
                        3. 
                        <E T="03">Productivity Analytics records:</E>
                         Records relating to the gathering, analysis, review, and investigation of information system utilization, including; Calendar Appointments, Email Read Rate, Email Response Rate, Operating System Activity History, Email Timestamp, Statements Made In Email Body, Email Sender, Email Recipient, Email Subject Line, Calendar Event Type, Calendar Event Status, Calendar Event Category, Calendar Event Subject, Calendar Event Duration, Calendar Event Attendees, Meeting Organizer, Meeting Invitees, Meeting Subject Line, Meeting Scheduled Time, Meeting Attendee Status, Meeting Scheduled Location, Web Call Organizer, Web Call Invitees, Web Call Scheduled Time, Web Call Joined Time, Web Call Duration, Web Call Status, Web Call Join Status, Number Of Collaborative Audio Calls Made, Number Of Collaborative Video Calls Made, Chat Initiator, Chat Recipient, Chat IM Sent Time, Number Of Cloud-Based Personal Storage Documents Worked On, Number Of Cloud-Based Enterprise Storage Documents Worked On, Device Name.
                    </P>
                    <HD SOURCE="HD2">RECORD SOURCE CATEGORIES:</HD>
                    <P>Employees; contractors; suppliers; customers.</P>
                    <HD SOURCE="HD2">ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND PURPOSES OF SUCH USES:</HD>
                    <P>Standard routine uses 1. through 9. apply. In addition:</P>
                    <P>(a) Disclosure of records to appropriate agencies, entities, and persons when (1) the Postal Service suspects or has confirmed that there has been a breach of the system of records; (2) the Postal Service has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, the Postal Service (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Postal Service's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR STORAGE OF RECORDS:</HD>
                    <P>Automated database, computer storage media, and paper.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:</HD>
                    <P>1. Records relating to information system access are retrievable by name, email address, username, geolocation data, and ACE ID.</P>
                    <P>2. Records relating to security analysis are retrievable by name, unique user ID, email address, geolocation data, IP address and computer name.</P>
                    <P>3. Records relating to productivity are retrievable by name, email address, and ACE ID.</P>
                    <P>4. Records relating to third-parties are retrievable by name, email address, user name, and IP address.</P>
                    <HD SOURCE="HD2">POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:</HD>
                    <P>1. Records relating to information system access are retained twenty-four months after last access.</P>
                    <P>2. Records relating to security analysis are retained for twenty-four months.</P>
                    <P>3. Records relating to productivity are retained for twenty-four months.</P>
                    <P>4. Records relating to third-parties are retained for twenty-four months.</P>
                    <HD SOURCE="HD2">ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:</HD>
                    <P>Paper records, computers, and computer storage media are located in controlled-access areas under supervision of program personnel. Computer access is limited to authorized personnel with a current security clearance, and physical access is limited to authorized personnel who must be identified with a badge.</P>
                    <P>Access to records is limited to individuals whose official duties require such access. Contractors and licensees are subject to contract controls and unannounced on-site audits and inspections.</P>
                    <P>Computers are protected by encryption, mechanical locks, card key systems, or other physical access control methods. The use of computer systems is regulated with installed security software, computer logon identifications, and operating system controls including access controls, terminal and transaction logging, and file management software.</P>
                    <HD SOURCE="HD2">RECORD ACCESS PROCEDURES:</HD>
                    <P>Requests for access must be made in accordance with the Notification Procedure above and USPS Privacy Act regulations regarding access to records and verification of identity under 39 CFR 266.5.</P>
                    <HD SOURCE="HD2">CONTESTING RECORD PROCEDURES:</HD>
                    <P>See Notification Procedure and Record Access Procedures above.</P>
                    <HD SOURCE="HD2">NOTIFICATION PROCEDURES:</HD>
                    <P>Customers wanting to know if other information about them is maintained in this system of records must address inquiries in writing to the Chief Information Officer and Executive Vice President and include their name and address.</P>
                    <HD SOURCE="HD2">EXEMPTION PROMULGATED FROM THIS SYSTEM:</HD>
                    <P>None.</P>
                    <HD SOURCE="HD2">HISTORY:</HD>
                    <P>None.</P>
                </PRIACT>
                <SIG>
                    <NAME>Joshua J. Hofer,</NAME>
                    <TITLE>Attorney, Ethics &amp; Legal Compliance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09755 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-91769; File No. SR-NYSE-2021-08]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of a Proposed Rule Change of New Rules Providing for the Registration and Obligations of Non-DMM Market Makers</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>
                    On March 12, 2021, New York Stock Exchange, Inc. (“NYSE” or “Exchange”) 
                    <PRTPAGE P="24910"/>
                    filed with the Securities and Exchange Commission (“Commission”) pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     proposed new rules providing for the registration and obligations of Non-DMM Market Makers. The proposed rule change was published for comment in the 
                    <E T="04">Federal Register</E>
                     on March 25, 2021.
                    <SU>3</SU>
                    <FTREF/>
                     The Commission has received no comments on the proposed rule change. The Commission is approving the proposed rule change.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91377 (March 19, 2021), 86 FR 15974 (March 25, 2021) (“Notice”).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Description of the Proposed Rule Change</HD>
                <P>
                    The Exchange proposes rules governing Non-DMM Market Makers who would be electronic, off-floor market makers.
                    <SU>4</SU>
                    <FTREF/>
                     Non-DMM Market Makers would comprise a new category of market participants on the Exchange and would have responsibilities different than those of Designated Market Makers (“DMMs”) and Supplemental Liquidity Providers (“SLPs”).
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         A “Non-DMM Market Maker” would be defined as a member organization that acts as a Non-DMM Market Maker pursuant to Rule 7P. 
                        <E T="03">See</E>
                         Notice, 
                        <E T="03">id.</E>
                         at 15974.
                    </P>
                </FTNT>
                <P>Non-DMM Market Makers are not intended to replace DMMs or SLPs on the Exchange and would not assume any of the responsibilities already assigned to DMMs or SLPs pursuant to Exchange Rules (for example, Non-DMM Market Makers would not perform any trading floor functions such as those assigned to DMMs). Instead, under the proposed rules, for all securities that trade on the Exchange, a member organization may register as a Non-DMM Market Maker and be subject to obligations similar to those of Market Makers on NYSE Arca, Inc. (“NYSE Arca”) and NYSE American LLC (“NYSE American”) to, among other things, maintain continuous, two-sided trading interest in the securities in which they are registered as a Non-DMM Market Maker (“Two-Sided Obligation”) and adhere to certain pricing obligations.</P>
                <P>The Exchange proposes the following rules, based on NYSE Arca and NYSE American rules of the same number with non-substantive changes, to govern the registration and obligations of Non-DMM Market Makers on the NYSE:</P>
                <P>• Proposed Rule 1.1(p) (definition of Market Maker Authorized Trader);</P>
                <P>• Proposed Rule 1.1(t) (definition of Non-DMM Market Maker);</P>
                <P>• Proposed Rule 7.20 (Registration of Non-DMM Market Makers);</P>
                <P>• Proposed Rule 7.21 (Obligations of Market Maker Authorized Traders);</P>
                <P>• Proposed Rule 7.22 (Registration of Non-DMM Market Makers in a Security); and</P>
                <P>• Proposed Rule 7.23 (Obligations of Non-DMM Market Makers).</P>
                <P>
                    These proposed rules would be applicable only to Non-DMM Market Makers. They would not apply to DMMs or SLPs, who would continue to be governed by existing Exchange rules applicable to those market participants.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See, e.g.,</E>
                         NYSE Rules 98, 103, 103B, 104, and 107B.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Proposed Rule Changes</HD>
                <HD SOURCE="HD3">Rule 1.1</HD>
                <P>Rule 1.1 sets forth definitions of terms that are used throughout the Exchange rules. The Exchange proposes to add the following definitions to the rule:</P>
                <P>• The Exchange proposes to amend current Rule 1.1(p) to set forth the definition of “Market Maker Authorized Trader” or “MMAT.” A “Market Maker Authorized Trader” or “MMAT” would be defined as an Authorized Trader (as defined in Rule 1.1(a)) who performs market making activities pursuant to Rule 7P on behalf of a Non-DMM Market Maker.</P>
                <P>• The Exchange proposes to amend current Rule 1.1(t) to set forth the definition of “Non-DMM Market Maker.” A “Non-DMM Market Maker” would be defined as a member organization that acts as a Non-DMM Market Maker pursuant to Rule 7P. Accordingly, for purposes of Exchange rules, the term “Non-DMM Market Maker” does not include DMMs or SLPs.</P>
                <HD SOURCE="HD3">Rule 7P, Section 2</HD>
                <P>The Exchange proposes to amend Section 2 under Rule 7P, which is currently designated as “Reserved,” and rename it “Non-DMM Market Makers.” The Exchange proposes that the rules set forth in this section would apply only to the proposed new group of Non-DMM Market Makers and would not be applicable to DMMs or SLPs.</P>
                <HD SOURCE="HD3">Rule 7.20</HD>
                <P>The Exchange proposes to add Rule 7.20 and title it “Registration of Non-DMM Market Makers.” Proposed Rule 7.20 would set forth the requirements for member organizations to apply for registration as Non-DMM Market Makers. The Exchange proposes that its Non-DMM Market Makers have the same registration requirements as Market Makers on NYSE Arca and NYSE American. The Exchange proposes to require member organizations interested in acting as Non-DMM Market Makers to submit an application to the Exchange. Proposed Rule 7.20 would also set forth the criteria the Exchange may consider in determining whether to approve or disapprove a prospective Non-DMM Market Maker's application and specify how a Non-DMM Market Maker's registration may be suspended, terminated, or withdrawn.</P>
                <HD SOURCE="HD3">Rule 7.21</HD>
                <P>The Exchange proposes to add Rule 7.21 and title it “Obligations of Market Maker Authorized Traders.” Proposed Rule 7.21 would provide that Market Maker Authorized Traders (“MMATs”) are permitted to enter orders only for the account of the Non-DMM Market Maker for which they are registered. In addition, the proposed rule would specify the registration requirements for MMATs and the procedures for suspension and withdrawal of registration of MMATs. Specifically, the proposed rule would provide that a Non-DMM Market Maker must submit an application to the Exchange to register an associated person as an MMAT. An MMAT must meet certain requirements, and a Non-DMM Market Maker must ensure that its MMATs are qualified to perform market making activities. Proposed Rule 7.21 also provides that the Exchange may suspend or withdraw an MMAT's registration.</P>
                <HD SOURCE="HD3">Rule 7.22</HD>
                <P>
                    The Exchange proposes to add Rule 7.22 and title it “Registration of Non-DMM Market Makers in a Security.” Proposed Rule 7.22 would set forth the process for Non-DMM Market Makers to become registered in a security and the factors the Exchange may consider in approving such registration. Non-DMM Market Makers may submit a request to the Exchange to be registered in a security, and the Exchange will evaluate whether to approve such registration, taking into consideration factors including the Non-DMM Market Maker's financial resources, experience in making markets, operational capability, and the character of the market for the security. Non-DMM Market Makers will generally be permitted to register in securities in which a DMM and/or SLP is also registered, subject to the Exchange's evaluation of the character of the market 
                    <PRTPAGE P="24911"/>
                    for a given security.
                    <SU>6</SU>
                    <FTREF/>
                     Finally, the proposed rule would also describe both termination of a Non-DMM Market Maker's registration in a security by the Exchange and voluntary termination by a Non-DMM Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Orders entered by Non-DMM Market Makers will be allocated in accordance with Rules 7.36 and 7.37 and be treated as a Book Participant. Non-DMM Market Makers will not be eligible to participate in the allocation process as a DMM Participant.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Rule 7.23</HD>
                <P>The Exchange proposes to add Rule 7.23 and title it “Obligations of Non-DMM Market Makers.” Proposed Rule 7.23 would set forth the obligation of Non-DMM Market Makers to engage in a course of dealings for their own account to assist in the maintenance, insofar as reasonably practicable, of fair and orderly markets on the Exchange. The proposed rule would delineate the specific responsibilities and duties of Non-DMM Market Makers, including the Two-Sided Obligation applicable to securities in which the Non-DMM Market Maker is registered and the requirement that the interest satisfying the Two-Sided Obligation be not more than the Designated Percentage (as defined in Proposed Rule 7.23) away from the National Best Bid or Offer (“NBBO”). Proposed Rule 7.23 also provides that Non-DMM Market Makers will be subject to certain minimum capital requirements and sets forth the circumstances under which a Non-DMM Market Maker could be subject to disciplinary action or suspension or revocation of registration by the Exchange for failure to comply with the course of dealings obligations set forth in this proposed rule.</P>
                <P>Specifically, with respect to the Two-Sided Obligation, proposed Rule 7.23(a)(1)(A) provides that Non-DMM Market Makers would be required to maintain displayed interest identified as interest meeting the Two-Sided Obligation on a continuous basis during Core Trading Hours for those securities in which the Non-DMM Market Maker is registered. Proposed Rule 7.23(a)(1)(B) provides that interest satisfying a Non-DMM Market Maker's Two-Sided Obligation must not be more than the Designated Percentage away from the then current NBBO, or if there is no NBBO, not more than the Designated Percentage away from the last reported sale for that security. With respect to minimum capital requirements, proposed Rule 7.23(a)(2) provides that Non-DMM Market Makers would be required to maintain adequate minimum capital in accordance with Rule 15c3-1 under the Act.</P>
                <HD SOURCE="HD1">III. Discussion and Commission Findings</HD>
                <P>
                    After careful consideration, the Commission finds that the Exchange's proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to national securities exchanges. In particular, the Commission finds that the Exchange's proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>7</SU>
                    <FTREF/>
                     which requires that the rules of an exchange be designed, among other things, to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, and to remove impediments to and perfect the mechanism of a free and open market and a national market system.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         17 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         In approving this proposed rule change, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation. 
                        <E T="03">See</E>
                         15 U.S.C. 78c(f).
                    </P>
                </FTNT>
                <P>
                    As described above, the Exchange proposes to adopt rules for the registration and obligations of Non-DMM Market Makers that are substantially comparable to NYSE Arca and NYSE American rules. The Exchange stated that the proposed rules are designed to enable market makers that are registered on the Exchange's affiliated markets to become registered on the Exchange as Non-DMM Market Makers by meeting the same registration requirements and by agreeing to be subject to the same obligations.
                    <SU>9</SU>
                    <FTREF/>
                     The Exchange represented that the proposed Non-DMM Market Makers are not intended to supplant existing DMMs or SLPs or their roles on the Exchange and Non-DMM Market Makers would not assume any of the responsibilities already assigned to DMMs or SLPs pursuant to Exchange Rules.
                    <SU>10</SU>
                    <FTREF/>
                     According to the Exchange, the proposed rules are intended to provide for a new category of market maker that the Exchange believes will promote competition on the Exchange by enhancing the range and diversity of market making activity on the Exchange. Further, the Exchange stated that the proposal would promote competition by encouraging additional displayed liquidity. The Exchange also stated that the proposal would facilitate price discovery and promote market quality on the Exchange.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         Notice, 
                        <E T="03">supra</E>
                         note 3 at 15976.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         While the proposed obligations for Non-DMM Market Makers are less stringent than those for DMMs and SLPs, the proposed rules would not affect the existing roles or obligations of DMMs and SLPs.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <P>The Commission believes that introducing a new category of market maker—Non-DMM Market Makers—could promote competition on the Exchange. Further the Commission believes that the introduction of Non-DMM Market Makers on the Exchange and their obligations to the market as required under NYSE Rule 7.23 could provide additional, supplemental liquidity to the market and could enhance price discovery.</P>
                <P>Based on the foregoing, the Commission therefore finds that the proposed rule change is consistent with the Act.</P>
                <HD SOURCE="HD1">IV. Conclusion</HD>
                <P>
                    <E T="03">It is therefore ordered,</E>
                     pursuant to Section 19(b)(2) of the Act,
                    <SU>12</SU>
                    <FTREF/>
                     that the proposed rule change (SR-NYSE-2021-08) be, and hereby is, approved.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         15 U.S.C. 78s(b)(2).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>13</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09775 Filed 5-7-21; 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. 34-91757; File No. SR-C2-2021-008]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt a Fee Schedule To Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Cboe C2 Exchange, Inc. (“Exchange” or “C2”) 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 the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <PRTPAGE P="24912"/>
                <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 adopt a fee schedule to establish fees for Industry Members related to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                     The text of the proposed rule change is provided in Exhibit 5.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in the CAT Compliance Rule. 
                        <E T="03">See</E>
                         Chapter 7, Section B of the Exchange's Rulebook (which incorporates by reference Cboe Options Chapter 7, Section B). The Exchange and each of its affiliated exchanges (Cboe BYX Exchange, Inc., Cboe BZX Exchange, Inc., Cboe Exchange, Inc., Cboe EDGA Exchange, Inc., and Cboe EDGX Exchange, Inc.) are filing to adopt the CAT fee schedule.
                    </P>
                </FTNT>
                <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 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>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the Securities and Exchange Commission (“SEC” or “Commission”) a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are Trading Permit Holders in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Rel. No. 91555 (Apr. 14, 2021), 86 FR 21050 (April 21, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant quarter (“Total CAT Costs”).
                    <SU>7</SU>
                    <FTREF/>
                     The CAT Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4, 56-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4.
                    </P>
                </FTNT>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>9</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Proposed CAT Fee Plan Amendment at 10-11.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) Establishing 
                    <PRTPAGE P="24913"/>
                    fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>10</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                        </P>
                    </FTNT>
                </EXTRACT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the development and implementation of the CAT.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>13</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(B) 75%/25% Allocation Between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>14</SU>
                    <FTREF/>
                     Under the CAT Funding Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>15</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 12-16. Note that, in the funding model set forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 16-20.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry Member based on message traffic.
                    <SU>16</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21-22.
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>17</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>18</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>19</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 26-27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, 
                        <E T="03">see</E>
                         CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>21</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message 
                    <PRTPAGE P="24914"/>
                    traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27-30.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>22</SU>
                    <FTREF/>
                     would have a discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>23</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>24</SU>
                    <FTREF/>
                     and (2) all message traffic for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         Section 1.1 of the CAT NMS Plan. Rule 7.20(ee) defines an “Options Market Maker” as “a broker-dealer registered with an exchange for the purpose of making markets in options contracts traded on the exchange.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 30-32.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 31.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.</P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>25</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>To implement the Options Market Maker discount, the Exchange proposes to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>26</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <SU>27</SU>
                    <FTREF/>
                     regardless of where the order is ultimately routed or executed.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32-33.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio. The Equity Market Maker CAT fee then would be calculated by-multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>29</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 33.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic] discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>30</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT, would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the 
                    <PRTPAGE P="24915"/>
                    Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 33-35.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>32</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 35-37.
                    </P>
                </FTNT>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that:</P>
                <EXTRACT>
                    <P>If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).</P>
                </EXTRACT>
                <P>Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.</P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>33</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 50-51.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4th of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <EXTRACT>
                    <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>34</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended 
                    <PRTPAGE P="24916"/>
                    to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>35</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020-July 31, 2020) and certain costs from Period 2 of the Financial Accountability Milestones (which covered the period from August 1, 2020-December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 55-60.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4th of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.</P>
                <P>To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>36</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="xs90,17,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for
                            <LI>message traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="24917"/>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>38</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 60-63.
                    </P>
                </FTNT>
                <P>Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message by 1/4th of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public accounting firm and making the statements publicly available.</P>
                <P>To implement the Period 3 CAT Fee, the Exchange proposes to add proposed paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and Regulatory Utilization of Transactional Database Functionality. As discussed above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 3 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for
                            <LI>message traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 3 CAT Costs 
                            <E T="0731">39</E>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022</ENT>
                        <ENT>1st quarter of 2023.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(C) Period 4 CAT Fee</HD>
                <P>
                    As set forth
                    <FTREF/>
                     in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>40</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 
                    <PRTPAGE P="24918"/>
                    (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 63-65.
                    </P>
                </FTNT>
                <P>Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.</P>
                <P>To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the requirements set forth in Section 9.2 of the CAT NMS Plan.</P>
                <P>The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 4 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for
                            <LI>message traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 4 CAT Costs 
                            <E T="0731">41</E>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(D) Quarterly CAT Fee—Beginning 2023</HD>
                <P>
                    As provided
                    <FTREF/>
                     in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>42</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>43</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for 
                    <PRTPAGE P="24919"/>
                    Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 65-68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 66.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses collected will be treated as an operational reserve to offset future fees and will not be distributed to the Participants as profits.
                    <SU>44</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry member
                            <LI>allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for message
                            <LI>traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>45</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (A) the Prime Rate plus 300 basis points, or (B) the maximum rate permitted by applicable law.
                    <SU>46</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 68-69.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 69.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>47</SU>
                    <FTREF/>
                     which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the Act,
                    <SU>48</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, 
                    <PRTPAGE P="24920"/>
                    fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act,
                    <SU>49</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>50</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>51</SU>
                    <FTREF/>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities necessary or appropriate in furtherance of the purposes of this chapter,” 
                    <SU>52</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT fees equitably allocate CAT costs between Participants and Industry Members, and among Industry Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 70-79.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.</P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>54</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its Trading Permit Holders. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee 
                    <PRTPAGE P="24921"/>
                    determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>55</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 78-79.
                    </P>
                </FTNT>
                <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>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>56</SU>
                    <FTREF/>
                     and paragraph (f) of Rule 19b-4 
                    <SU>57</SU>
                    <FTREF/>
                     thereunder. 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 will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         17 CFR 240.19b-4(f).
                    </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-C2-2021-008 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-C2-2021-008. 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. 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. All submissions should refer to File Number SR-C2-2021-008 and should be submitted on or before
                    <FTREF/>
                     June 1, 2021.
                </FP>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         17 CFR 200.30-3(a)(12).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>58</SU>
                    </P>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09785 Filed 5-7-21; 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. 34-91752; File No. SR-NASDAQ-2021-029]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt a Fee Schedule To Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, The Nasdaq Stock Market LLC (“Nasdaq” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I, II, and III, below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    The Exchange proposes to adopt a fee schedule to establish fees for Industry Members related to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in Rule General 7 (Consolidated Audit Trail Compliance).
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is available on the Exchange's website at 
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/nasdaq/rules,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>
                    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
                    <PRTPAGE P="24922"/>
                </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>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the SEC a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are Nasdaq members in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91555 (April 14, 2017), 86 FR 21050 (April 21, 2021) (“Proposed CAT Fee Plan Amendment”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant quarter (“Total CAT Costs”).
                    <SU>7</SU>
                    <FTREF/>
                     The CAT Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic], 21074 [sic].
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic].
                    </P>
                </FTNT>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>9</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Proposed CAT Fee Plan Amendment at 21054-55.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) Establishing fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>10</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                </EXTRACT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                    </P>
                </FTNT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the 
                    <PRTPAGE P="24923"/>
                    development and implementation of the CAT.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>13</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(B) 75%/25% Allocation Between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>14</SU>
                    <FTREF/>
                     Under the CAT Funding Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>15</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21055-56 [sic]. Note that, in the funding model set forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21056-58 [sic].
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry Member based on message traffic.
                    <SU>16</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21059 [sic].
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>17</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>18</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>19</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21056-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, 
                        <E T="03">see</E>
                         CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>21</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21057-58.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>22</SU>
                    <FTREF/>
                     would have a discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>23</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>24</SU>
                    <FTREF/>
                     and (2) all message traffic 
                    <PRTPAGE P="24924"/>
                    for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         Section 1.1 of the CAT NMS Plan; Nasdaq General 7 Section 1(ee) defines an “Options Market Maker” as “a broker-dealer registered with an exchange for the purpose of making markets in options contracts traded on the exchange.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other 
                        <PRTPAGE/>
                        accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.</P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>25</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>To implement the Options Market Maker discount, the Exchange proposes to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>26</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <SU>27</SU>
                    <FTREF/>
                     regardless of where the order is ultimately routed or executed.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio. The Equity Market Maker CAT fee then would be calculated by-multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>29</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic] discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>30</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT, would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>
                    To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the 
                    <PRTPAGE P="24925"/>
                    Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.
                </P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>32</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59 [sic].
                    </P>
                </FTNT>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that</P>
                <EXTRACT>
                    <P>If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).</P>
                </EXTRACT>
                <P>Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.</P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>33</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21063.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4 of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <EXTRACT>
                    <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>34</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>35</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020-July 31, 2020) and certain costs from Period 2 of the Financial Accountability Milestones (which covered the period from August 1, 2020-December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21064-65.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>
                    Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee 
                    <PRTPAGE P="24926"/>
                    would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4 of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.
                </P>
                <P>To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>36</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,17,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT Fee</CHED>
                        <CHED H="1">
                            Quarterly industry member 
                            <LI>allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for message 
                            <LI>traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>38</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21065-66.
                    </P>
                </FTNT>
                <P>
                    Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry 
                    <PRTPAGE P="24927"/>
                    Member message by 1/4 of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.
                </P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public accounting firm and making the statements publicly available.</P>
                <P>To implement the Period 3 CAT Fee, the Exchange proposes to add proposed paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4 of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and Regulatory Utilization of Transactional Database Functionality. As discussed above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 3 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT Fee</CHED>
                        <CHED H="1">
                            Quarterly industry 
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4 of 75% of the Period 3 CAT Costs 
                            <SU>39</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4 of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4 of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4 of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022</ENT>
                        <ENT>1st quarter of 2023.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (C) Period 4 CAT Fee
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>40</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21066-67.
                    </P>
                </FTNT>
                <P>Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4 of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.</P>
                <P>
                    To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4 of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the 
                    <PRTPAGE P="24928"/>
                    Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”
                </P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the requirements set forth in Section 9.2 of the CAT NMS Plan.</P>
                <P>The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 4 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT Fee</CHED>
                        <CHED H="1">
                            Quarterly industry 
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4 of 75% of the Period 4 CAT Costs 
                            <SU>41</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4 of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4 of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4 of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (D) Quarterly CAT Fee—Beginning 2023
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>42</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>43</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4 of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067-68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4 of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses 
                    <PRTPAGE P="24929"/>
                    collected will be treated as an operational reserve to offset future fees and will not be distributed to the Participants as profits.
                    <SU>44</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT Fee</CHED>
                        <CHED H="1">
                            Quarterly industry 
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for 
                            <LI>message traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4 of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4 of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4 of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4 of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>45</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (i) the Prime Rate plus 300 basis points, or (ii) the maximum rate permitted by applicable law.
                    <SU>46</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act 
                    <SU>47</SU>
                    <FTREF/>
                    , which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the Act,
                    <SU>48</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act 
                    <SU>49</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>50</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry 
                    <PRTPAGE P="24930"/>
                    Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>51</SU>
                    <FTREF/>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities necessary or appropriate in furtherance of the purposes of this chapter,” 
                    <SU>52</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT fees equitably allocate CAT costs between Participants and Industry Members, and among Industry Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068-70.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct.
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.</P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>54</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its Nasdaq members. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>55</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21070.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
                    <SU>56</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         15 U.S.C. 78s(b)(3)(A)(ii).
                    </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: (i) necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. 
                    <PRTPAGE P="24931"/>
                    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-NASDAQ-2021-029 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-NASDAQ-2021-029. 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. 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. All submissions should refer to File Number SR-NASDAQ-2021-029 and should be submitted on or before June 1, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>57</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09779 Filed 5-7-21; 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. 34-91762; File No. SR-CboeBZX-2021-034]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt a Fee Schedule To Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Cboe BZX Exchange, Inc. (“Exchange” or “BZX”) 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 the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    Cboe BZX Exchange, Inc. (the “Exchange” or “Cboe BZX”) proposes to adopt a fee schedule to establish fees for Industry Members related to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                     The text of the proposed rule change is provided in Exhibit 5.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in the CAT Compliance Rule. 
                        <E T="03">See</E>
                         Rules 4.5 through 4.17 of the Exchange's Rulebook. The Exchange and each of its affiliated exchanges (Cboe BYX Exchange, Inc., Cboe C2 Exchange, Inc., Cboe Exchange, Inc., Cboe EDGA Exchange, Inc., and Cboe EDGX Exchange, Inc.) are filing to adopt the CAT fee schedule.
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is also available on the Exchange's website (
                    <E T="03">http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/</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 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>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the Securities and Exchange Commission (“SEC” or “Commission”) a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are Members in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Rel. No. 91555 (Apr. 14, 2021), 86 FR 21050 (April 21, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan 
                    <PRTPAGE P="24932"/>
                    Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant quarter (“Total CAT Costs”).
                    <SU>7</SU>
                    <FTREF/>
                     The CAT Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4, 56-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4.
                    </P>
                </FTNT>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>9</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Proposed CAT Fee Plan Amendment at 10-11.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) Establishing fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>10</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                        </P>
                    </FTNT>
                </EXTRACT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the development and implementation of the CAT.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>13</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(B) 75%/25% Allocation Between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>14</SU>
                    <FTREF/>
                     Under the CAT Funding Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>15</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation 
                    <PRTPAGE P="24933"/>
                    of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 12-16. Note that, in the funding model set forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 16-20.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry Member based on message traffic.
                    <SU>16</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21-22.
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>17</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>18</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>19</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 26-27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, 
                        <E T="03">see</E>
                         CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>21</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27-30.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>22</SU>
                    <FTREF/>
                     would have a discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>23</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>24</SU>
                    <FTREF/>
                     and (2) all message traffic for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         Section 1.1 of the CAT NMS Plan. Rule 4.5(ee) defines an “Options Market Maker” as “a broker-dealer registered with an exchange for the purpose of making markets in options contracts traded on the exchange.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 30-32.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 31.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.</P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>25</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>
                    To implement the Options Market Maker discount, the Exchange proposes to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message 
                    <PRTPAGE P="24934"/>
                    traffic calculation would be subject to applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.
                </P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>26</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <SU>27</SU>
                    <FTREF/>
                     regardless of where the order is ultimately routed or executed.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32-33.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio. The Equity Market Maker CAT fee then would be calculated by-multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>29</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 33.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic] discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>30</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT, would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 33-35.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>32</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 35-37.
                    </P>
                </FTNT>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that:</P>
                <EXTRACT>
                    <P>
                        If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee 
                        <PRTPAGE P="24935"/>
                        will be re-allocated among all Industry Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).
                    </P>
                </EXTRACT>
                <P>Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.</P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>33</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 50-51.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4th of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <EXTRACT>
                    <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>34</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>35</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020-July 31, 2020) and certain costs from Period 2 of the Financial Accountability Milestones (which covered the period from August 1, 2020-December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 55-60.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4th of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.</P>
                <P>To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan 
                    <PRTPAGE P="24936"/>
                    Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>36</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,12,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT Fee</CHED>
                        <CHED H="1">
                            Quarterly
                            <LI>industry</LI>
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for message
                            <LI>traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>38</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 60-63.
                    </P>
                </FTNT>
                <P>Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message by 1/4th of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public accounting firm and making the statements publicly available.</P>
                <P>
                    To implement the Period 3 CAT Fee, the Exchange proposes to add proposed paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic 
                    <PRTPAGE P="24937"/>
                    based on the prior quarter's message traffic by 1/4th of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”
                </P>
                <P>Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and Regulatory Utilization of Transactional Database Functionality. As discussed above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 3 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">
                            CAT data used for message
                            <LI>traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 3 CAT Costs 
                            <SU>39</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022</ENT>
                        <ENT>1st quarter of 2023.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (C) Period 4 CAT Fee
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>40</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 63-65.
                    </P>
                </FTNT>
                <P>Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.</P>
                <P>To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the requirements set forth in Section 9.2 of the CAT NMS Plan.</P>
                <P>
                    The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and 
                    <PRTPAGE P="24938"/>
                    operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <P>The following chart summarizes the imposition of the Period 4 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">
                            CAT data used for message traffic
                            <LI>calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 4 CAT Costs 
                            <SU>41</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (D) Quarterly CAT Fee—Beginning 2023
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>42</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>43</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 65-68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 66.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses collected will be treated as an operational reserve to offset future fees and will not be distributed to the Participants as profits.
                    <SU>44</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>
                    The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:
                    <PRTPAGE P="24939"/>
                </P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry 
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for message
                            <LI>traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>45</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (A) the Prime Rate plus 300 basis points, or (B) the maximum rate permitted by applicable law.
                    <SU>46</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 68-69.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 69.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>47</SU>
                    <FTREF/>
                     which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the Act,
                    <SU>48</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act,
                    <SU>49</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>50</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>51</SU>
                    <FTREF/>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities necessary or appropriate in furtherance of the purposes of this chapter,” 
                    <SU>52</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT 
                    <PRTPAGE P="24940"/>
                    fees equitably allocate CAT costs between Participants and Industry Members, and among Industry Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 70-79.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.</P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>54</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its Members. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>55</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 78-79.
                    </P>
                </FTNT>
                <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>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>56</SU>
                    <FTREF/>
                     and paragraph (f) of Rule 19b-4 
                    <SU>57</SU>
                    <FTREF/>
                     thereunder. 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 will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         17 CFR 240.19b-4(f).
                    </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. 
                    <PRTPAGE P="24941"/>
                    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-CboeBZX-2021-034 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-CboeBZX-2021-034. 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. 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. All submissions should refer to File Number SR-CboeBZX-2021-034 and should be submitted on or before June 1, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>58</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09769 Filed 5-7-21; 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. 34-91751; File No. SR-Phlx-2021-25]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt a Fee Schedule To Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Nasdaq PHLX LLC (“Phlx” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I, II, and III, below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    The Exchange proposes to adopt a fee schedule to establish fees for Industry Members related to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in Nasdaq General 7 (Consolidated Audit Trail Compliance) (Phlx General 7 incorporates The Nasdaq Stock Market LLC General 7 by reference).
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is available on the Exchange's website at 
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/phlx/rules,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the SEC a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are Phlx members in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91555 (April 14, 2017), 86 FR 21050 (April 21, 2021) (“Proposed CAT Fee Plan Amendment”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <P>
                    While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative following Commission approval of the Join [sic] Industry Plan Amendment to the National Market System Plan Governing the Consolidated Audit Trail filed on March 31, 2021.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91555 (April 14, 2017), 86 FR 21050 (April 21, 2021) (“Proposed CAT Fee Plan Amendment”).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant 
                    <PRTPAGE P="24942"/>
                    quarter (“Total CAT Costs”).
                    <SU>8</SU>
                    <FTREF/>
                     The CAT Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic], 21074 [sic].
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic].
                    </P>
                </FTNT>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>10</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Proposed CAT Fee Plan Amendment at 21054-55.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) Establishing fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>11</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                        <SU>12</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                        </P>
                    </FTNT>
                </EXTRACT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the development and implementation of the CAT.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>14</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(B) 75%/25% Allocation Between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>15</SU>
                    <FTREF/>
                     Under the CAT Funding Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>16</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21055-56 [sic]. Note that, in the funding model set forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21056-58 [sic].
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry 
                    <PRTPAGE P="24943"/>
                    Member based on message traffic.
                    <SU>17</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21059 [sic].
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>18</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>19</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>20</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21056-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, 
                        <E T="03">see</E>
                         CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>22</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21057-58.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>23</SU>
                    <FTREF/>
                     would have a discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>24</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>25</SU>
                    <FTREF/>
                     and (2) all message traffic for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         Section 1.1 of the CAT NMS Plan; Nasdaq General 7 Section 1(ee) defines an “Options Market Maker” as “a broker-dealer registered with an exchange for the purpose of making markets in options contracts traded on the exchange.” (Phlx General 7 incorporates The Nasdaq Stock Market LLC General 7 by reference).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.</P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>26</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>
                    To implement the Options Market Maker discount, the Exchange proposes to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to 
                    <PRTPAGE P="24944"/>
                    applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.
                </P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>27</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <SU>28</SU>
                    <FTREF/>
                     regardless of where the order is ultimately routed or executed.
                    <SU>29</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio. The Equity Market Maker CAT fee then would be calculated by-multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>30</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic] discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>31</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT, would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage.
                    <SU>32</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>33</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59 [sic].
                    </P>
                </FTNT>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that</P>
                <P>
                    If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any 
                    <PRTPAGE P="24945"/>
                    excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).
                </P>
                <P>Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.</P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>34</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21063.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4th of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>35</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>36</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020-July 31, 2020) and certain costs from Period 2 of the Financial Accountability Milestones (which covered the period from August 1, 2020-December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21064-65.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4th of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.</P>
                <P>
                    To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum 
                    <PRTPAGE P="24946"/>
                    Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”
                </P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>38</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,18,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>39</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21065-66.
                    </P>
                </FTNT>
                <P>Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message by 1/4th of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public accounting firm and making the statements publicly available.</P>
                <P>
                    To implement the Period 3 CAT Fee, the Exchange proposes to add proposed paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic 
                    <PRTPAGE P="24947"/>
                    based on the prior quarter's message traffic by 1/4th of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”
                </P>
                <P>Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and Regulatory Utilization of Transactional Database Functionality. As discussed above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 3 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 3 CAT Costs 
                            <SU>40</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022</ENT>
                        <ENT>1st quarter of 2023.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (C) Period 4 CAT Fee
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>41</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21066-67.
                    </P>
                </FTNT>
                <P>Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.</P>
                <P>To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the requirements set forth in Section 9.2 of the CAT NMS Plan.</P>
                <P>
                    The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                    <PRTPAGE P="24948"/>
                </P>
                <P>
                    The following chart summarizes the imposition of the Period 4 CAT Fee:
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 4 CAT Costs 
                            <SU>42</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(D) Quarterly CAT Fee—Beginning 2023</HD>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>43</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>44</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067-68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses collected will be treated as an operational reserve to offset future fees and will not be distributed to the Participants as profits.
                    <SU>45</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for message 
                            <LI>traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="24949"/>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>46</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (i) the Prime Rate plus 300 basis points, or (ii) the maximum rate permitted by applicable law.
                    <SU>47</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>48</SU>
                    <FTREF/>
                     which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the Act,
                    <SU>49</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act 
                    <SU>50</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>51</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>52</SU>
                    <FTREF/>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities necessary or appropriate in furtherance of the purposes of this chapter,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT fees equitably allocate CAT costs between Participants and Industry Members, and among Industry Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068-70.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the 
                    <PRTPAGE P="24950"/>
                    Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>54</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.</P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>55</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its Phlx members. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>56</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21070.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
                    <SU>57</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         15 U.S.C. 78s(b)(3)(A)(ii).
                    </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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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-Phlx-2021-25 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to File Number SR-Phlx-2021-25. 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 
                    <PRTPAGE P="24951"/>
                    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. 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. All submissions should refer to File Number SR-Phlx-2021-25 and should be submitted on or before June 1, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>58</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09778 Filed 5-7-21; 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. 34-91748; File No. SR-MEMX-2021-06]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; MEMX LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to the Handling of Displayed Odd Lot Orders and Non-Displayed Orders That Become Locked or Crossed</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 30, 2021, MEMX LLC (“MEMX” or “Exchange”) filed with the Securities and Exchange Commission (“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>
                    The Exchange is filing with the Commission a proposed rule change related to: (1) The handling of a Limit Order of Odd Lot size with a Displayed instruction that is resting on the MEMX Book and subsequently becomes locked or crossed by an away Trading Center's Protected Quotation; and (2) the handling of a Limit Order with a Non-Displayed instruction that is resting on the MEMX Book and subsequently becomes crossed by an away Trading Center's Protected Quotation.
                    <SU>5</SU>
                    <FTREF/>
                     The text of the proposed rule change is provided in Exhibit 5.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         All terms as further defined below.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <HD SOURCE="HD3">Introduction</HD>
                <P>
                    The Exchange proposes to make changes to the Exchange's Rules related to the handling of a Limit Order 
                    <SU>6</SU>
                    <FTREF/>
                     of Odd Lot 
                    <SU>7</SU>
                    <FTREF/>
                     size with a Displayed 
                    <SU>8</SU>
                    <FTREF/>
                     instruction (a “Displayed Odd Lot Order”) that is resting on the MEMX Book 
                    <SU>9</SU>
                    <FTREF/>
                     and subsequently becomes locked or crossed by an away Trading Center's 
                    <SU>10</SU>
                    <FTREF/>
                     Protected Quotation.
                    <SU>11</SU>
                    <FTREF/>
                     In addition, the Exchange proposes to make changes to the Exchange's Rules related to the handling of a Limit Order with a Non-Displayed 
                    <SU>12</SU>
                    <FTREF/>
                     instruction (a “Non-Displayed Order”) that is resting on the MEMX Book and subsequently becomes crossed by an away Trading Center's Protected Quotation.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Limit Orders are described in Exchange Rule 11.8(b) and generally defined as an order to buy or sell a stated amount of a security at a specified price or better.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         The term “Odd Lot” refers to any amount less than a Round Lot. Orders of Odd Lot size are only eligible to be Protected Quotations if aggregated to form a Round Lot. The term “Round Lot” refers to one hundred (100) shares or any multiple thereof, unless an alternative number of shares is established as a Round Lot by the listing exchange for the security. Orders that are a Round Lot are eligible to be Protected Quotations. 
                        <E T="03">See</E>
                         Exchange Rule 11.6(q).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The term “Displayed” refers to an instruction a User may attach to an order stating that the order is to be displayed by the System on the MEMX Book. 
                        <E T="03">See</E>
                         Exchange Rule 11.6(c)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         The term “MEMX Book” refers to the System's electronic file of orders. 
                        <E T="03">See</E>
                         Exchange Rule 1.5(q). The term “System” refers to the electronic communications and trading facility designated by the Board through which securities orders of Users are consolidated for ranking, execution and, when applicable, routing. 
                        <E T="03">See</E>
                         Exchange Rule 1.5(gg). The term “User” refers to any Member or Sponsored Participant who is authorized to obtain access to the System. 
                        <E T="03">See</E>
                         Exchange Rule 1.5(jj).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         The term “Trading Center” refers to other securities exchanges, facilities of securities exchanges, automated trading systems, electronic communications networks or other brokers or dealers.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         The term “Protected Quotation” refers to a quotation that is a Protected Bid or Protected Offer. The term “Protected Bid” or “Protected Offer” refers to a bid or offer in a stock that is (i) displayed by an automated trading center; (ii) disseminated pursuant to an effective national market system plan; and (iii) an automated quotation that is the best bid or best offer of a national securities exchange or association. 
                        <E T="03">See</E>
                         Exchange Rule 1.5(z).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         The term “Non-Displayed” refers to an instruction a User may attach to an order stating that the order is not to be displayed by the System on the MEMX Book. 
                        <E T="03">See</E>
                         Exchange Rule 11.6(c)(2).
                    </P>
                </FTNT>
                <P>
                    The Exchange's Rules currently describe all functionality with respect to orders of Round Lot, Mixed Lot and Odd Lot size without distinction because the Exchange generally handles these orders the same. However, the Exchange's System currently handles Displayed Odd Lot Orders differently than other orders in specific market circumstances, as described below. The Exchange proposes to codify this behavior as set forth in proposed Rules 11.6(j) and 11.8(b)(8). In addition, the Exchange proposes a change to current functionality with respect to orders with an Odd Lot size and orders with a Non-Displayed instruction that are eligible to be routed, as further described below.
                    <PRTPAGE P="24952"/>
                </P>
                <HD SOURCE="HD3">Displayed Odd Lot Orders</HD>
                <P>Currently, when an away Trading Center publishes a Protected Quotation that locks or crosses the displayed price of a Displayed Odd Lot Order and the Exchange does not have a Protected Quotation displayed at such price, such order will be cancelled by the System unless such order contains a multiple price sliding instruction, in which case such order will be re-priced pursuant to Rule 11.6(j)(1)(A). The Exchange proposes to add language to this effect to Rule 11.8(b)(8), which currently addresses the handling of Limit Orders in certain circumstances where such orders would cross Protected Quotations of other Trading Centers. As proposed, under Rule 11.8(b)(8), when an away Trading Center publishes a Protected Quotation that locks or crosses the displayed price of a resting Limit Order of Odd Lot size with a Displayed instruction and the Exchange does not have a Protected Quotation displayed at such price, such order will be cancelled by the System unless such order contains a multiple price sliding instruction, in which case such order will be re-priced pursuant to Rule 11.6(j)(1)(A), or the order is routed, as described below. The Exchange also proposes to rename Rule 11.8(b)(8) as “Locked or Crossed Market.”</P>
                <P>
                    In addition to the changes described above with respect to Rule 11.8(b)(8), the Exchange proposes to codify the re-pricing functionality applied to Displayed Odd Lot Orders with a multiple price sliding instruction that are subsequently locked or crossed by other Trading Centers. As background, the Exchange currently offers price sliding functionality that allows display-eligible orders to be permissibly ranked and displayed in accordance with Regulation NMS. Pursuant to this price sliding functionality, an order that would be a Locking or Crossing Quotation of an away Trading Center if displayed by the System on the MEMX Book at the time of entry will be ranked at the Locking Price in the MEMX Book (
                    <E T="03">i.e.,</E>
                     executable at that price but not displayed) and displayed by the System one Minimum Price Variation away (
                    <E T="03">i.e.,</E>
                     lower for a bid or higher for an offer).
                    <SU>13</SU>
                    <FTREF/>
                     In turn, once an order has been permissibly displayed by the System, such order will generally 
                    <E T="03">only be re-ranked and re-displayed to the extent it achieves a more aggressive price.</E>
                    <SU>14</SU>
                    <FTREF/>
                     In other words, once an order is displayed on the MEMX Book it will stand its ground and not be re-priced to a less aggressive price even if other Trading Centers publish Protected Quotations that lock or cross its displayed price, except in two circumstances described below; one of these circumstances is already described in MEMX Rule 11.6(j)(1)(A)(ii) and the other circumstance the Exchange proposes to codify in such Rule.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See</E>
                         MEMX Rule 11.6(j)(1)(A)(i).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         MEMX Rule 11.6(j)(1)(A)(ii) (emphasis added).
                    </P>
                </FTNT>
                <P>
                    As currently set forth in Rule 11.6(j)(1)(A)(ii), the Exchange will re-price an order resting on the MEMX Book that is subject to display-price sliding when an away Trading Center publishes a Protected Quotation at a price that locks or crosses such order's displayed price. In such circumstance, the Exchange will re-rank the order subject to display-price sliding so that the order's ranked price is the same price as the displayed price. The Exchange re-ranks an order to a less aggressive price in this circumstance to avoid potentially trading through a Protected Quotation displayed by another Trading Center (
                    <E T="03">i.e.,</E>
                     the ranked price, which is not displayed and not permitted to stand its ground, is changed to a less aggressive price to be the same price as the displayed price).
                </P>
                <P>In addition to the exception set forth in Rule 11.6(j)(1)(A)(ii) described above, the Exchange also currently re-prices a Displayed Odd Lot Order with a multiple price sliding instruction to a less aggressive price when the Exchange is not displaying a Protected Quotation at the displayed price of such order and such order's displayed price is locked or crossed by a Protected Quotation published by an away Trading Center. Specifically, when an away Trading Center publishes a Protected Quotation that locks or crosses the displayed price of a resting Displayed Odd Lot Order with a multiple price sliding instruction and the Exchange does not have a Protected Quotation displayed at such order's displayed price, the resting Displayed Odd Lot Order is re-ranked at the Locking Price in the MEMX Book and re-displayed by the System at one Minimum Price Variation lower (higher) than the Locking Price for orders to buy (sell). The Exchange proposes to codify this behavior through both the proposed amendment to Rule 11.8(b)(8), discussed above, and a proposed amendment to Rule 11.6(j)(1)(A)(ii).</P>
                <P>
                    The final codification of existing behavior proposed by the Exchange relates to the Exchange's handling of a Displayed Odd Lot Order subject to Rule 201 of Regulation SHO that is subsequently locked or crossed. As set forth in Rule 11.6(j)(2)(A), the Exchange cancels any order with a Non-Displayed instruction subject to Rule 201 of Regulation SHO when the NBB changes such that the order would be a Locking Quotation or Crossing Quotation. Because Displayed Odd Lot Orders are displayed on the Exchange's proprietary data feed but not on the consolidated market data feeds, the Exchange applies this same logic to Displayed Odd Lot Orders when such orders are subject to Rule 201 of Regulation SHO (
                    <E T="03">i.e.,</E>
                     marked short and a Short Sale Circuit Breaker is in effect). Accordingly, the Exchange cancels any Displayed Odd Lot Order subject to Rule 201 of Regulation SHO when the NBB locks or crosses the price of such an order and proposes to add language to this effect to Rule 11.6(j)(2)(A) to codify this behavior.
                </P>
                <P>In addition to codifying the current functionality regarding the handling of Displayed Odd Lot Orders that are locked or crossed by other Trading Centers as described above, the Exchange proposes to add functionality to route such orders in this circumstance to the extent the orders are eligible to be routed. Based on the proposed amendment to Rule 11.8(b)(8), when a Displayed Odd Lot Order is locked or crossed by a Protected Quotation published by another Trading Center and such order is eligible for routing such order will be routed according to the User's instructions. The Exchange believes that a User that has originally designated an order as a routable order (thus willing to remove liquidity from an away Trading Center on entry), instead of having an order of Odd Lot size canceled or price slid, would prefer to have such order routed if it is subsequently locked or crossed by a Protected Quotation published by another Trading Center.</P>
                <HD SOURCE="HD3">Examples</HD>
                <P>The below examples illustrate the proposed behavior for a Displayed Odd Lot Order.</P>
                <P>Assume the National Best Bid and Offer (“NBBO”) is $10.00 by $10.10. An order to sell 5 shares of security ABC is displayed on the MEMX Book at $10.07 (“Order 1”). Order 1 has a Short Sale instruction, however, security ABC is not currently subject to a Short Sale Circuit Breaker pursuant to Rule 201 of Regulation SHO. There are no other orders to buy or sell security ABC resting on the MEMX Book. An away Trading Center publishes a Protected Bid to buy 100 shares of security ABC at $10.08, thus updating the NBBO to $10.08 by $10.10. The handling of Order 1 will depend on the User's instructions for the order, with three potential outcomes:</P>
                <P>
                    • If Order 1 has a multiple price sliding instruction, then the order will 
                    <PRTPAGE P="24953"/>
                    be re-priced and ranked to sell at $10.08 and re-displayed at $10.09.
                </P>
                <P>• If Order 1 is eligible for routing, then the order will be routed with a limit price of $10.07 to attempt to execute against the Protected Bid displayed at $10.08 by the away Trading Center.</P>
                <P>• If Order 1 does not have a multiple price sliding instruction and is ineligible for routing, then the order will be cancelled.</P>
                <P>Assume the same example as above, however, instead assume that security ABC is currently subject to a Short Sale Circuit Breaker pursuant to Rule 201 of Regulation SHO. If an away Trading Center publishes a Protected Bid to buy 100 shares of security ABC at $10.08, thus updating the NBBO to $10.08 by $10.10, Order 1 will be cancelled. This outcome is the same even if such order has a multiple price sliding instruction or was submitted as a routable order.</P>
                <HD SOURCE="HD3">Non-Displayed Orders</HD>
                <P>
                    As set forth in current Rule 11.8(b)(8), when a Non-Displayed Order would be a Crossing Quotation if displayed at the price at which it is ranked (
                    <E T="03">i.e.,</E>
                     when an away Trading Center publishes a Protected Quotation that crosses the ranked price of such an order), the Exchange cancels such order in order to prevent a trade-through that would occur if such order were instead executed at its ranked price. The Exchange proposes to maintain this behavior for Non-Displayed Orders (including orders of Round Lot, Mixed Lot and Odd Lot size) that are not routable; however, consistent with the proposed change above regarding routable Displayed Odd Lot Orders, the Exchange proposes to route a Non-Displayed Order in such circumstance if the order is routable. Accordingly, the Exchange proposes to amend Rule 11.8(b)(8) so that a Non-Displayed Order that is eligible for routing will route according to a User's instructions when such order would be a Crossing Quotation of another Trading Center. As is the case today, if a Non-Displayed Order is not eligible for routing and an away Trading Center publishes a Protected Quotation that crosses the ranked price of such order, the order will be canceled.
                </P>
                <HD SOURCE="HD3">Examples</HD>
                <P>The below examples illustrate the proposed behavior for a Non-Displayed Order.</P>
                <P>Again, assume the National Best Bid and Offer (“NBBO”) is $10.00 by $10.10. An order to sell 100 shares of security ABC is resting non-displayed on the MEMX Book at $10.07 (“Order 2”). Order 2 has a Short Sale instruction, however, security ABC is not currently subject to a Short Sale Circuit Breaker pursuant to Rule 201 of Regulation SHO. There are no other orders to buy or sell security ABC resting on the MEMX Book. An away Trading Center publishes a Protected Bid to buy 100 shares of security ABC at $10.08, thus updating the NBBO to $10.08 by $10.10. The handling of Order 2 will depend on the User's instructions for the order, with two potential outcomes:</P>
                <P>• If Order 2 is eligible for routing, then the order will be routed with a limit price of $10.07 to attempt to execute against the Protected Bid displayed at $10.08 by the away Trading Center.</P>
                <P>• If Order 2 is ineligible for routing, then the order will be cancelled.</P>
                <P>Assume the same example as above, however that security ABC is currently subject to a Short Sale Circuit Breaker pursuant to Rule 201 of Regulation SHO. If an away Trading Center publishes a Protected Bid to buy 100 shares of security ABC at $10.08, thus updating the NBBO to $10.08 by $10.10, Order 2 will be cancelled. This outcome is the same even if such order was submitted as a routable order.</P>
                <HD SOURCE="HD3">Additional Discussion</HD>
                <P>The Exchange has implemented its System functionality in order to maintain compliance with Regulation NMS, Regulation SHO and other applicable regulations. The functionality described above, both current and proposed, is designed to ensure that the Exchange does not display quotations that would lock or cross Protected Quotations of other Trading Centers nor maintain orders at price levels at which, if executed, would trade through Protected Quotations (or at the NBB in the context of an order subject to Rule 201 of Regulation SHO). Although the exact treatment of orders of Odd Lot size described above is not explicitly required by these regulations, and indeed the Exchange could have adopted a different implementation with respect to certain points, the Exchange does believe that its implementation is consistent with such regulations and the Act, generally. In particular, although Displayed Odd Lot Orders are technically displayed by the System and thus can be accessed by market participants, such orders are not Protected Quotations and are not displayed on consolidated market data feeds. As such, the Exchange's current implementation that it is proposing to codify treats such orders in certain ways similar to the manner in which the Exchange handles Non-Displayed Orders. Further, the Exchange believes that its proposed new functionality with respect to routing proposes sufficient optionality for Users of the Exchange to determine how they wish to have their Displayed Odd Lot Orders handled in the event such orders are locked or crossed by a Protected Quotation published by an away Trading Center. In particular, by offering the ability to either be canceled, re-priced or routed away from the Exchange, the Exchange believes that Users will be able to select their preferred order handling. The Exchange similarly believes that its proposed new functionality with respect to routing Non-Displayed Orders would enable Users to select their preferred order handling with respect to such orders when an away Trading Center publishes a Protected Quotation that crosses the ranked price of such an order.</P>
                <P>
                    Based on a review of the current rules of other exchanges, certain aspects of the Exchange's current handling of Displayed Odd Lot Orders is unique and some exchanges allow such orders to stand their ground when an odd lot order is crossed by a Protected Quotation published by another Trading Center.
                    <SU>15</SU>
                    <FTREF/>
                     However, other exchanges have previously maintained similar functionality to instead cancel, route or re-price odd lot orders in such a circumstance. For instance, the Chicago Stock Exchange (“CHX”) previously offered functionality approved by the Commission that, like the Exchange's proposed functionality, treated odd lot orders and unexecuted odd lot remainders in a manner similar to non-displayed orders when CHX had no displayed round lots at a particular price level and thus allowed such orders to be cancelled or routed away from CHX.
                    <SU>16</SU>
                    <FTREF/>
                     Similarly, NYSE Arca, Inc. (“Arca”) previously maintained special functionality to re-price odd lot orders when such orders were resting on the Arca order book based on changes to the protected best bid and offer (“PBBO”).
                    <FTREF/>
                    <SU>17</SU>
                      
                    <PRTPAGE P="24954"/>
                    While the Exchange is not aware of another exchange that currently cancels a Displayed Odd Lot Order subject to Rule 201 of Regulation SHO when the NBB locks or crosses the price of such order, other exchanges have implemented functionality to treat displayed odd lots the same way that non-displayed orders are treated in the context of functionality to comply with Regulation SHO.
                    <SU>18</SU>
                    <FTREF/>
                     As described above, the Exchange cancels a Displayed Odd Lot Order subject to Rule 201 of Regulation SHO when the NBB locks or crosses the price of such an order to maintain consistent functionality with that used to handle orders resting on the MEMX Book with a Non-Displayed instruction.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See, e.g.,</E>
                         NYSE Rule 7.38, which states that round lot, mixed lot and odd lot orders are treated in the same manner on NYSE, and NYSE Rule 7.36(b)(4), which states that NYSE does not adjust the display price of limit orders on NYSE that have been locked or crossed.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 60353 (July 21, 2009), 74 FR 37076 (July 27, 2009) (SR-CHX-2009-02) (Order Granting Approval of Proposed Rule Change Related to the Rejection of Undisplayed Odd-lot Orders from the Exchange's Matching System).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 85265 (March 7, 2019), 84 FR 9175 (March 13, 2019) (SR-NYSEARCA-2019-08) (Notice of Filing and Immediate Effectiveness of Proposed Changes to Amend Certain Trading Rules including 7.38-E, relating to Odd Lots).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 75467 (July 16, 2015), 80 FR 43515, 43521 (July 22, 2015) (SR-NYSEARCA-2015-58). In describing proposed functionality to re-price sell short orders of odd lot size in circumstances where round lot orders stand their ground, the following description was used: “because Rule 201 refers to displayed in the context of an order displayed via the public data feeds, for the purposes of proposed Rule 7.16P the Exchange proposes to process all sell short odd lot orders the same as sell short orders that are ranked Priority 3—Non-Display Orders. . . .”
                    </P>
                </FTNT>
                <P>
                    With respect to the proposed option to have a resting Displayed Odd Lot Order or Non-Displayed Order that is locked and/or crossed by another Trading Center, as applicable, routed to such Trading Center, the Exchange notes that similar behavior is available on other exchanges with a variety of options and other distinct implementations.
                    <SU>19</SU>
                    <FTREF/>
                     Thus, the Exchange believes that its proposed implementation, allowing Displayed Odd Lot Orders and Non-Displayed Orders to route away from the Exchange when locked and/or crossed by a Protected Quotation published by an away Trading Center, is consistent with such features currently offered by other exchanges.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Cboe EDGX Rule 11.6(n)(2), which defines the “Super Aggressive” instruction as an instruction that an EDGX user may use to direct EDGX to route an order if an away Trading Center locks or crosses the limit price of an order resting on EDGX; further, the Super Aggressive instruction may be applied to routable orders posted to the EDGX Book with remaining size of an Odd Lot. 
                        <E T="03">See also</E>
                         Nasdaq Rules 4758(a)(1)(A)(iii) and (viii), which describe two routing strategies that route orders (including displayed odd lot orders and non-displayed orders) resting on the Nasdaq order book when such orders are locked or crossed by an away market center.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act 
                    <SU>20</SU>
                    <FTREF/>
                     in general, and furthers the objectives of Section 6(b)(5) of the Act 
                    <SU>21</SU>
                    <FTREF/>
                     in particular, in that it is designed to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system and, in general, to protect investors and the public interest.
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <P>
                    The proposed changes to the Exchange's Rules currently are designed to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system and, in general, to protect investors and the public interest. As set forth above, the Exchange's Rules describe all functionality with respect to orders of Round Lot, Mixed Lot and Odd Lot size without distinction because the Exchange generally handles these orders the same. However, in the specific circumstances set forth above, namely when an away Trading Center has published a Protected Quotation that locks or crosses the displayed price of a Displayed Odd Lot Order and the Exchange does not have a Protected Quotation at such price, the Exchange's implementation of logic to comply with Regulation NMS results in the cancellation of such orders unless a User has selected a multiple price sliding instruction, in which case an order is re-priced. The Exchange proposes to codify this behavior in its Rules and to adopt additional functionality that would route such an order that is eligible for routing. Thus, the Exchange will offer three options to Users with Displayed Odd Lot Orders on the MEMX Book. As is the case today, such orders can be repriced pursuant to the Exchange's display-price sliding logic (if entered with a multiple price sliding instruction) or cancelled when locked or crossed by an away Trading Center's Protected Quotation. In addition, the Exchange will offer routing to such away Trading Center to the extent a User submitted a routable order in the first instance. The Exchange believes that this functionality enables Users to elect an order instruction consistent with their intent to execute their orders in the marketplace. The amended functionality would ensure executions at the best available price displayed on another Trading Center, for an order to be returned to a User or to remain on the MEMX Book pursuant to the Exchange's display-price sliding functionality according to the User's instructions. The Exchange notes that other exchanges have previously maintained functionality specific to orders of odd lot size that resulted in such orders being routed, cancelled or their price adjusted.
                    <SU>22</SU>
                    <FTREF/>
                     Finally, by limiting this aspect of the proposed change to Displayed Odd Lot Orders that are locked or crossed by the Protected Quotation published by an away Trading Center, the proposal retains existing functionality with respect to the handling of all other orders with a Displayed instruction and remains consistent with the Exchange's general handling of Non-Displayed Orders. Although aspects of the Exchange's implementation of order handling rules for odd lots that are subsequently locked or crossed by a Protected Quotation published by an away Trading Centers are unique compared to existing functionality on other exchanges and the because prohibitions against both locked and crossed markets and trade-throughs do not apply to odd lot orders, pursuant to guidance published by Commission staff, exchanges are permitted to establish their own rules for handling odd-lot orders and the odd-lot portions of mixed-lot orders, and the Exchange believes its implementation is consistent with such guidance and the applicable regulations, generally.
                    <SU>23</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See supra</E>
                         notes 16-18.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Response No. 7.03 in “Responses to Frequently Asked Questions Concerning Rule 611 and Rule 610 of Regulation NMS,” Division of Trading and Markets, dated June 8, 2007.
                    </P>
                </FTNT>
                <P>
                    The Exchange further believes that routing orders away from the Exchange, whether Displayed Odd Lot Orders or Non-Displayed Orders, when such orders were routable upon initial entry to the Exchange and such orders would otherwise be cancelled is consistent with the Act, as it avoids unnecessary cancellations of orders that could instead be executed by away Trading Centers. Further, as described above, the Exchange notes that similar behavior is in place on other exchanges.
                    <SU>24</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">See supra</E>
                         note 19.
                    </P>
                </FTNT>
                <P>For the reasons set forth above, the Exchange believes the proposal promotes just and equitable principles of trade, fosters cooperation and coordination with persons engaged in facilitating transactions in securities, removes impediments to and perfects the mechanism of a free and open market and a national market system, and, in general, protects 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 result in 
                    <PRTPAGE P="24955"/>
                    any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. On the contrary, certain of the proposed changes are intended to codify current behavior on the Exchange related to the Exchange's implementation of applicable regulations and the other proposed changes are intended to provide additional optionality to the User, including the routing of orders that are already resting on the MEMX Book to away Trading Centers if such orders were routable upon initial entry to the Exchange. Thus, to the extent the change is intended to improve transparency regarding the Exchange's handling of Displayed Odd Lot Orders, such proposal does not have any direct impact on the competitive environment. The proposed change to functionality on the Exchange that would route certain orders resting on the MEMX Book is designed to encourage Users to direct their orders to the Exchange, however, while the change is competitive, the Exchange does not believe the proposed change will result in any burden on intermarket competition as it is a minor change to already available functionality. Further, the proposed new functionality is similar to functionality offered by other exchanges and would also result in additional volume on away Trading Centers instead of the Exchange, to the extent such orders are executed when routed away from the Exchange. The proposed changes to the Exchange's Rules also promote intramarket competition because they will facilitate the execution of orders that would otherwise remain unexecuted, thereby increasing the efficient functioning of the Exchange. All participants on the Exchange can utilize each of the potential features that will impact the handling of their Displayed Odd Lot Orders and Non-Displayed Orders in the event such orders are resting on the Exchange at a price that is subsequently locked or crossed by a Protected Quotation displayed by an away Trading Center. Therefore, the Exchange does not believe the proposed rule change will result in any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act.
                </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>
                    The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act 
                    <SU>25</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6) thereunder.
                    <SU>26</SU>
                    <FTREF/>
                     Because the proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative prior to 30 days from the date on which it was filed, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>27</SU>
                    <FTREF/>
                     and subparagraph (f)(6) of Rule 19b-4 thereunder.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         15 U.S.C. 78s(b)(3)(A)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         15 U.S.C. 78s(b-(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii) requires a self-regulatory organization to give the Commission written notice of its intent to file the proposed rule change, along with a brief description and text of the proposed rule change, at least five business days prior to the date of filing of the proposed rule change, or such shorter time as designated by the Commission. The Exchange has satisfied this requirement.
                    </P>
                </FTNT>
                <P>
                    A proposed rule change filed under Rule 19b-4(f)(6) 
                    <SU>29</SU>
                    <FTREF/>
                     normally does not become operative prior to 30 days after the date of its filing. However, Rule 19b-4(f)(6)(iii) 
                    <SU>30</SU>
                    <FTREF/>
                     permits the Commission to designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative upon filing. The Exchange believes a waiver is consistent with the protection of investors and the public interest because, among other things, it would allow the Exchange to route certain odd lot orders as soon as practicable, thus helping market participants to obtain timely executions even if not on the Exchange. The Commission believes that waiver of the 30-day operative delay is consistent with the protection of investors and the public interest because the proposed rule change does not raise any new or novel issues. Among other things, the proposed order handing functionalities are similar to the past practices of other exchanges. Accordingly, the Commission hereby waives the operative delay and designates the proposed rule change operative upon filing so that the benefits of this proposed rule change can be realized immediately.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         17 CFR 240.19b-4(f)(6)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         For purposes only of waiving the 30-day operative delay, the Commission also has considered the proposed rule's impact on efficiency, competition, and capital formation. 
                        <E T="03">See</E>
                         15 U.S.C. 78c(f).
                    </P>
                </FTNT>
                <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>32</SU>
                    <FTREF/>
                     to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>32</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-MEMX-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-MEMX-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 
                    <PRTPAGE P="24956"/>
                    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. 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. All submissions should refer to File Number SR-MEMX-2021-06 and should be submitted on or before June 1, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>33</SU>
                    </P>
                    <P>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09776 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <SUBJECT>Sunshine Act Meetings</SUBJECT>
                <PREAMHD>
                    <HD SOURCE="HED">TIME AND DATE:</HD>
                    <P>2:00 p.m. on Thursday, May 13, 2021.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">PLACE:</HD>
                    <P>The meeting will be held via remote means and/or at the Commission's headquarters, 100 F Street NE, Washington, DC 20549.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">STATUS:</HD>
                    <P>This meeting will be closed to the public.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">MATTERS TO BE CONSIDERED:</HD>
                    <P>Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.</P>
                    <P>
                        In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's website at 
                        <E T="03">https://www.sec.gov.</E>
                    </P>
                    <P>The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.</P>
                    <P>The subject matter of the closed meeting will consist of the following topics:</P>
                </PREAMHD>
                <EXTRACT>
                    <FP SOURCE="FP-1">Institution and settlement of injunctive actions;</FP>
                    <FP SOURCE="FP-1">Institution and settlement of administrative proceedings;</FP>
                    <FP SOURCE="FP-1">Resolution of litigation claims; and</FP>
                    <FP SOURCE="FP-1">Other matters relating to examinations and enforcement proceedings.</FP>
                </EXTRACT>
                <P>At times, changes in Commission priorities require alterations in the scheduling of meeting agenda items that may consist of adjudicatory, examination, litigation, or regulatory matters.</P>
                <PREAMHD>
                    <HD SOURCE="HED">CONTACT PERSON FOR MORE INFORMATION:</HD>
                    <P>For further information; please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.</P>
                </PREAMHD>
                <SIG>
                    <DATED>Dated: May 6, 2021.</DATED>
                    <NAME>Vanessa A. Countryman,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09939 Filed 5-6-21; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-91759; File No. SR-CboeEDGA-2021-010]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt a Fee Schedule To Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Cboe EDGA Exchange, Inc. (“Exchange” or “EDGA”) 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 the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    Cboe EDGA Exchange, Inc. (the “Exchange” or “Cboe EDGA”) proposes to adopt a fee schedule to establish fees for Industry Members related to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                     The text of the proposed rule change is provided in Exhibit 5.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in the CAT Compliance Rule. 
                        <E T="03">See</E>
                         Rules 4.5 through 4.17 of the Exchange's Rulebook. The Exchange and each of its affiliated exchanges (Cboe BYX Exchange, Inc., Cboe BZX Exchange, Inc., Cboe C2 Exchange, Inc., Cboe Exchange, Inc., and Cboe EDGX Exchange, Inc.) are filing to adopt the CAT fee schedule.
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is also available on the Exchange's website (
                    <E T="03">http://markets.cboe.com/us/equities/regulation/rule_filings/edga/</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 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>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the Securities and Exchange Commission (“SEC” or “Commission”) a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the 
                    <PRTPAGE P="24957"/>
                    Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are Members in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Rel. No. 91555 (Apr. 14, 2021), 86 FR 21050 (April 21, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant quarter (“Total CAT Costs”).
                    <SU>7</SU>
                    <FTREF/>
                     The CAT Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4, 56-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4.
                    </P>
                </FTNT>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>9</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Proposed CAT Fee Plan Amendment at 10-11.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) establishing fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>10</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                        </P>
                    </FTNT>
                </EXTRACT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the development and implementation of the CAT.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>13</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(B) 75%/25% Allocation between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>14</SU>
                    <FTREF/>
                     Under the CAT Funding Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member 
                    <PRTPAGE P="24958"/>
                    Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>15</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 12-16. Note that, in the funding model set forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 16-20.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry Member based on message traffic.
                    <SU>16</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21-22.
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>17</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>18</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>19</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 26-27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, 
                        <E T="03">see</E>
                         CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>21</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27-30.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>22</SU>
                    <FTREF/>
                     would have a discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>23</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>24</SU>
                    <FTREF/>
                     and (2) all message traffic for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         Section 1.1 of the CAT NMS Plan. Rule 4.5(ee) defines an “Options Market Maker” as “a broker-dealer registered with an exchange for the purpose of making markets in options contracts traded on the exchange.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 30-32.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 31.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.</P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>25</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>
                    To implement the Options Market Maker discount, the Exchange proposes 
                    <PRTPAGE P="24959"/>
                    to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.
                </P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>26</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <SU>27</SU>
                    <FTREF/>
                     regardless of where the order is ultimately routed or executed.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32-33.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio. The Equity Market Maker CAT fee then would be calculated by-multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>29</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 33.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic] discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>30</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT, would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 33-35.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>32</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 35-37.
                    </P>
                </FTNT>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that:</P>
                <EXTRACT>
                    <PRTPAGE P="24960"/>
                    <P>If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).</P>
                </EXTRACT>
                <P>Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.</P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>33</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 50-51.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4th of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <EXTRACT>
                    <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>34</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>35</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020-July 31, 2020) and certain costs from Period 2 of the Financial Accountability Milestones (which covered the period from August 1, 2020-December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 55-60.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4th of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.</P>
                <P>
                    To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the 
                    <PRTPAGE P="24961"/>
                    prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”
                </P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>36</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,12,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly 
                            <LI>industry </LI>
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for message traffic 
                            <LI>calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>38</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 60-63.
                    </P>
                </FTNT>
                <P>Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message by 1/4th of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public accounting firm and making the statements publicly available.</P>
                <P>
                    To implement the Period 3 CAT Fee, the Exchange proposes to add proposed 
                    <PRTPAGE P="24962"/>
                    paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”
                </P>
                <P>Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and Regulatory Utilization of Transactional Database Functionality. As discussed above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 3 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 3 CAT Costs 
                            <SU>39</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022</ENT>
                        <ENT>1st quarter of 2023.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (C) Period 4 CAT Fee
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>40</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 63-65.
                    </P>
                </FTNT>
                <P>Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.</P>
                <P>To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the requirements set forth in Section 9.2 of the CAT NMS Plan.</P>
                <P>
                    The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin 
                    <PRTPAGE P="24963"/>
                    on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <P>The following chart summarizes the imposition of the Period 4 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 4 CAT Costs 
                            <SU>41</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (D) Quarterly CAT Fee—Beginning 2023
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>42</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>43</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 65—68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 66.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses collected will be treated as an operational reserve to offset future fees and will not be distributed to the Participants as profits.
                    <SU>44</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating 
                    <PRTPAGE P="24964"/>
                    the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry 
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for message 
                            <LI>traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>45</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (A) the Prime Rate plus 300 basis points, or (B) the maximum rate permitted by applicable law.
                    <SU>46</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 68-69.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 69.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>47</SU>
                    <FTREF/>
                     which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the Act,
                    <SU>48</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act,
                    <SU>49</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>50</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>51</SU>
                    <FTREF/>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities necessary or appropriate in furtherance of the purposes of this chapter,” 
                    <SU>52</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT fees equitably allocate CAT costs between Participants and Industry Members, and among Industry 
                    <PRTPAGE P="24965"/>
                    Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 70-79.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.</P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>54</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its Members. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>55</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 78-79.
                    </P>
                </FTNT>
                <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>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>56</SU>
                    <FTREF/>
                     and paragraph (f) of Rule 19b-4 
                    <SU>57</SU>
                    <FTREF/>
                     thereunder. 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 will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         17 CFR 240.19b-4(f).
                    </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:
                    <PRTPAGE P="24966"/>
                </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-CboeEDGA-2021-010 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-CboeEDGA-2021-010. 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. 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. All submissions should refer to File Number SR-CboeEDGA-2021-010 and should be submitted on or before June 1, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>58</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09766 Filed 5-7-21; 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. 34-91760; File No. SR-CBOE-2021-030]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt a Fee Schedule to Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Cboe Exchange, Inc. (“Exchange” or “Cboe Options”) 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 the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to adopt a fee schedule to establish fees for Industry Members related to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                     The text of the proposed rule change is provided in Exhibit 5.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in the CAT Compliance Rule. 
                        <E T="03">See</E>
                         Chapter 7, Section B of the Exchange's Rulebook. The Exchange and each of its affiliated exchanges (Cboe BYX Exchange, Inc., Cboe BZX Exchange, Inc., Cboe C2 Exchange, Inc., Cboe EDGA Exchange, Inc., and Cboe EDGX Exchange, Inc.) are filing to adopt the CAT fee schedule.
                    </P>
                </FTNT>
                <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 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>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the Securities and Exchange Commission (“SEC” or “Commission”) a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are Trading Permit Holders in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Rel. No. 91555 (Apr. 14, 2021), 86 FR 21050 (April 21, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant quarter (“Total CAT Costs”).
                    <SU>7</SU>
                    <FTREF/>
                     The CAT 
                    <PRTPAGE P="24967"/>
                    Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4, 56-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4.
                    </P>
                </FTNT>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>9</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Proposed CAT Fee Plan Amendment at 10-11.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) Establishing fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>10</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                        </P>
                    </FTNT>
                      
                </EXTRACT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the development and implementation of the CAT.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>13</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(B) 75%/25% Allocation between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>14</SU>
                    <FTREF/>
                     Under the CAT Funding Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>15</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 12-16. Note that, in the funding model set forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 16-20.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry Member based on message traffic.
                    <SU>16</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of 
                    <PRTPAGE P="24968"/>
                    all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21-22.
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>17</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>18</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>19</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 26-27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, 
                        <E T="03">see</E>
                         CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>21</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27-30.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>22</SU>
                    <FTREF/>
                     would have a discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>23</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>24</SU>
                    <FTREF/>
                     and (2) all message traffic for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         Section 1.1 of the CAT NMS Plan. Rule 7.20(ee) defines an “Options Market Maker” as “a broker-dealer registered with an exchange for the purpose of making markets in options contracts traded on the exchange.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 30-32.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 31.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.</P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>25</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>To implement the Options Market Maker discount, the Exchange proposes to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry 
                    <PRTPAGE P="24969"/>
                    Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>26</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <SU>27</SU>
                    <FTREF/>
                     regardless of where the order is ultimately routed or executed.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32-33.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                        Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio.The Equity Market Maker CAT fee then would be calculated by-multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>29</SU>
                    <FTREF/>
                    by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                        Proposed CAT Fee Plan Amendment at 33.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic]discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>30</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT,would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 33-35.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>32</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 35-37.
                    </P>
                </FTNT>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that:</P>
                <EXTRACT>
                    <P>If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).</P>
                </EXTRACT>
                <P>
                    Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member 
                    <PRTPAGE P="24970"/>
                    CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.
                </P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>33</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 50-51.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4th of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <EXTRACT>
                    <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>34</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>35</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020-July 31, 2020) and certain costs from Period 2 of the Financial Accountability Milestones (which covered the period from August 1, 2020-December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 55-60.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4th of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.</P>
                <P>To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress 
                    <PRTPAGE P="24971"/>
                    Report,
                    <SU>36</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry member 
                            <LI>allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for message 
                            <LI>traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>38</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 60-63.
                    </P>
                </FTNT>
                <P>Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message by 1/4th of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public accounting firm and making the statements publicly available.</P>
                <P>
                    To implement the Period 3 CAT Fee, the Exchange proposes to add proposed paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated 
                    <PRTPAGE P="24972"/>
                    by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”
                </P>
                <P>Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and Regulatory Utilization of Transactional Database Functionality. As discussed above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 3 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 3 CAT Costs
                            <SU>39</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022</ENT>
                        <ENT>1st quarter of 2023.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (C) Period 4 CAT Fee
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>40</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 63-65.
                    </P>
                </FTNT>
                <P>Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.</P>
                <P>To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the requirements set forth in Section 9.2 of the CAT NMS Plan.</P>
                <P>
                    The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include 
                    <PRTPAGE P="24973"/>
                    fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <P>The following chart summarizes the imposition of the Period 4 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 4 CAT Costs
                            <SU>41</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (D) Quarterly CAT Fee—Beginning 2023
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>42</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>43</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 65-68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 66.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses collected will be treated as an operational reserve to offset future fees and will not be distributed to the Participants as profits.
                    <SU>44</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating 
                    <PRTPAGE P="24974"/>
                    the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>45</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (A) the Prime Rate plus 300 basis points, or (B) the maximum rate permitted by applicable law.
                    <SU>46</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 68-69.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 69.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>47</SU>
                    <FTREF/>
                     which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the Act,
                    <SU>48</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act,
                    <SU>49</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>50</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>51</SU>
                    <FTREF/>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its 
                    <PRTPAGE P="24975"/>
                    members and issuers and other persons using its facilities necessary or appropriate in furtherance of the purposes of this chapter,” 
                    <SU>52</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT fees equitably allocate CAT costs between Participants and Industry Members, and among Industry Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 70-79.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.</P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>54</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its Trading Permit Holders. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>55</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 78-79.
                    </P>
                </FTNT>
                <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>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>56</SU>
                    <FTREF/>
                     and paragraph (f) of Rule 19b-4 
                    <SU>57</SU>
                    <FTREF/>
                     thereunder. 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 will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         17 CFR 240.19b-4(f).
                    </P>
                </FTNT>
                <PRTPAGE P="24976"/>
                <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-2021-030 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-2021-030. 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. 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. All submissions should refer to File Number SR-CBOE-2021-030 and should be submitted on or before June 1, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>58</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09767 Filed 5-7-21; 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. 34-91754; File No. SR-IEX-2021-08]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations: Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Allow Discretionary Limit Orders To Be Reserve Orders</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 23, 2021, the Investors Exchange LLC (“IEX” or the “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    Pursuant to the provisions of Section 19(b)(1) under the Act,
                    <SU>3</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>4</SU>
                    <FTREF/>
                     IEX is filing with the Commission a proposed rule change to allow Discretionary Limit orders to be reserve orders. The Exchange has designated this rule change as “non-controversial” under Section 19(b)(3)(A) of the Act 
                    <SU>5</SU>
                    <FTREF/>
                     and provided the Commission with the notice required by Rule 19b-4(f)(6) thereunder.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is available at the Exchange's website at 
                    <E T="03">www.iextrading.com,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statement 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 purpose of this proposed rule filing is to amend IEX Rule 11.190 to allow a Discretionary Limit 
                    <SU>7</SU>
                    <FTREF/>
                     (“D-Limit”) order to be a reserve order.
                    <SU>8</SU>
                    <FTREF/>
                     As proposed, a D-Limit reserve order will essentially function like any other reserve order, 
                    <E T="03">i.e.,</E>
                     on entry, it will be processed as a single order, and if not fully executed, the D-Limit reserve order will post to the Order Book 
                    <SU>9</SU>
                    <FTREF/>
                     and effectively be treated by the System 
                    <SU>10</SU>
                    <FTREF/>
                     as two discrete orders: The displayed portion of the order will be a displayed D-Limit order, and the reserve portion will be a non-displayed D-Limit order. However, consistent with existing D-Limit functionality, there are two differences between D-Limit reserve orders and other reserve orders: (1) Both the displayed and non-displayed portions of a D-Limit reserve order may be subject to an automatic price adjustment during periods of quote instability; (2) D-Limit reserve orders can only execute during the Regular Market Session.
                    <SU>11</SU>
                    <FTREF/>
                     IEX also proposes to make some conforming edits to the subparagraph headers in the D-Limit order definition to align the rule text with other order definitions.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.190(b)(7).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.190(b)(2).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 1.160(p).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 1.160(nn).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 1.160(gg).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Background</HD>
                <P>
                    Since the approval of its exchange application, IEX, like other equities exchanges,
                    <SU>12</SU>
                    <FTREF/>
                     has offered Members 
                    <SU>13</SU>
                    <FTREF/>
                     a “reserve” order type, which allows 
                    <PRTPAGE P="24977"/>
                    Members to submit a partially displayed limit order,
                    <SU>14</SU>
                    <FTREF/>
                     so that a portion of the order is displayed (“display quantity”) and a portion of the order is non-displayed (“reserve quantity”).
                    <SU>15</SU>
                    <FTREF/>
                     As set forth in IEX Rule 11.190(b)(2), when Members submit a reserve order, they must specify the display quantity (which must be equal to or greater than one round lot). Upon entry, the System attempts to execute a reserve order as a single order of its full, unexecuted size. If an incoming reserve order is not fully executed, it posts to the Order Book where it is effectively treated as two discrete orders: the display quantity (“displayed portion”) and the reserve quantity (“non-displayed portion”). For the purposes of pricing reserve orders on the Order Book, displayed portions are treated as displayed orders and non-displayed portions are treated as non-displayed orders. As described in IEX Rule 11.190(h), it is possible for the non-displayed portion to rest at a different price than the displayed portion, because the displayed portion is subject to display-price sliding 
                    <SU>16</SU>
                    <FTREF/>
                     while the non-displayed portion is subject to the Midpoint Price Constraint.
                    <SU>17</SU>
                    <FTREF/>
                     If the displayed portion of the reserve order is decremented such that less than one round lot would be displayed, the displayed portion of the reserve order shall be refreshed for either (i) the original displayed quantity, or (ii) the entire reserve quantity, if the total number of unexecuted shares in the order is smaller than the original Member instructed displayed quantity. Each time the displayed portion of the order is refreshed from the reserve quantity, that portion is prioritized behind other existing displayed orders; the priority of the non-displayed portion, however, is unchanged by the refresh process.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Cboe BZX Exchange, Inc. Rule 11.9(c)(1); MEMX, LLC Rule 11.8(b)(4); The Nasdaq Stock Market LLC Rule 4703(h); and New York Stock Exchange LLC Rule 7.31(d)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 1.160(s).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.190(a)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.190(b)(2).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.190(h)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.190(h)(2).
                    </P>
                </FTNT>
                <P>
                    IEX recently introduced a new type of limit order, the D-Limit order,
                    <SU>18</SU>
                    <FTREF/>
                     which is designed to protect liquidity providers from potential adverse selection by latency arbitrage trading strategies in a fair and nondiscriminatory manner.
                    <SU>19</SU>
                    <FTREF/>
                     A D-Limit order may be a displayed or non-displayed limit order that upon entry and when posting to the Order Book is priced to be equal to and ranked at the order's limit price, but will be adjusted to a less-aggressive price during periods of quote instability, as defined in IEX Rule 11.190(g).
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 89686 (August 26, 2020), 85 FR 54438 (September 1, 2020) (SR-IEX-2019-15) (“D-Limit Approval Order”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 87814 (December 20, 2019), 84 FR 71997, 71998 (December 30, 2019) (SR-IEX-2019-15) (“D-Limit Proposal”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See</E>
                         IEX Rules 11.190(b)(7) and 11.190(g).
                    </P>
                </FTNT>
                <P>
                    Specifically, if the System receives a D-Limit buy (sell) order during a period of quote instability (
                    <E T="03">i.e.,</E>
                     the Crumbling Quote Indicator or “CQI” is on), and the D-Limit order has a limit price equal to or higher (lower) than the quote instability determination price level (“CQI Price”), the price of the order will be automatically adjusted by the System to one (1) MPV 
                    <SU>21</SU>
                    <FTREF/>
                     lower (higher) than the CQI Price (the “effective limit price”). Similarly, when unexecuted shares of a D-Limit buy (sell) order are posted to the Order Book, if a quote instability determination is made and such shares are ranked and displayed (in the case of a displayed order) by the System at a price equal to or higher (lower) than the CQI Price, the price of the order will be automatically adjusted by the System to the effective limit price. A D-Limit order with an effective limit price will not revert to the price at which it was previously ranked and displayed (in the case of a displayed order). Once the price of a D-Limit order that has been posted to the Order Book is automatically adjusted by the System, the order will continue to be ranked and displayed (in the case of a displayed order) at the effective limit price, unless subject to another automatic adjustment, or if the order is subject to the price sliding provisions of IEX Rule 11.190(h). Otherwise, a D-Limit order operates in the same manner as either a displayed or non-displayed limit order, as applicable.
                    <SU>22</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.210.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.190(b)(7).
                    </P>
                </FTNT>
                <P>
                    D-Limit orders currently cannot be a reserve order.
                    <SU>23</SU>
                    <FTREF/>
                     However, IEX has received informal feedback from Members indicating that they prefer to use reserve orders to post displayed liquidity and would like to be able to use such functionality for D-Limit orders. Based on this feedback, IEX proposes to enable D-Limit orders to be reserve orders, consistent with how IEX treats any other limit orders.
                    <SU>24</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.190(b)(7)(e)(H).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.190(b)(2)(A).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Proposal</HD>
                <P>IEX proposes to amend IEX Rules 11.190(b)(2), 11.190(b)(7), and Supplementary Material .01 to allow D-Limit orders to be submitted as a reserve order. D-Limit orders already may be submitted as either displayed or non-displayed orders, and this proposal will allow Members to submit both a displayed and non-displayed D-Limit order as a single reserve order that allows the Member to control how much of the D-Limit order is displayed at any given time.</P>
                <P>
                    As proposed, a D-Limit reserve order will essentially function like any other reserve order, 
                    <E T="03">i.e.,</E>
                     on entry, it will be processed as a single order, and if not fully executed, the D-Limit reserve order will post to the Order Book and effectively be treated by the System as two discrete orders: The displayed portion of the order will be a displayed D-Limit order, and the reserve portion will be a non-displayed D-Limit order. However, consistent with existing D-Limit functionality, there are two differences between D-Limit reserve orders and other reserve orders, as described below.
                </P>
                <P>
                    First, D-Limit reserve orders, like all D-Limit orders, will only be eligible to trade during the Regular Market Session, and a D-Limit reserve order with a Time-in-Force of “DAY” submitted before the opening of the Regular Market Session will be queued by the System until the start of the Regular Market Session.
                    <SU>25</SU>
                    <FTREF/>
                     Any D-Limit reserve orders submitted after the closing of the Regular Market Session will be rejected.
                    <SU>26</SU>
                    <FTREF/>
                     This functionality differs from other reserve orders, which may be submitted during the Pre-Market Session,
                    <SU>27</SU>
                    <FTREF/>
                     the Post Market Session,
                    <SU>28</SU>
                    <FTREF/>
                     or the Regular Market Session.
                    <SU>29</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.190(b)(7)(E)(e)
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 1.160(z).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 1.160(aa).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         
                        <E T="03">See</E>
                         IEX Rule 11.190(b)(2)(F).
                    </P>
                </FTNT>
                <P>Second, D-Limit reserve orders, as described above, may also be subject to an effective limit price if their price is adjusted by the System during a period of quote instability. Therefore, a D-Limit reserve order resting on the Order Book will function like any other reserve order except that it can never be priced above either its limit price or its effective limit price.</P>
                <P>Finally, IEX proposes to make conforming changes to IEX Rule 11.190(b)(7) to conform the subparagraph numbering with other order types described in IEX Rule 11.190(a) and (b).</P>
                <P>The following is a list of the specific proposed changes to IEX Rule 11.190:</P>
                <EXTRACT>
                    <P>• Modify IEX Rule 11.190(b)(2)(A), which currently says reserve orders must be limit orders to add the clarifying words “including a Discretionary Limit order.”</P>
                    <P>
                        • Modify IEX Rule 11.190(b)(2)(F), which describes how reserve orders may be submitted during the Pre-Market, Regular Market, and Post-Market sessions, to add the words “with the exception of Discretionary 
                        <PRTPAGE P="24978"/>
                        Limit reserve orders, which may only be submitted as set forth in IEX Rule 11.190(b)(7)(E)(v).”
                    </P>
                    <P>
                        • Modify the main paragraph of IEX Rule 11.190(b)(7) to specify that D-Limit orders may also be “partially displayed” (
                        <E T="03">i.e.,</E>
                         reserve orders).
                    </P>
                    <P>• Remove IEX Rule 11.190(b)(7)(e)(H), which states that D-Limit orders may not be reserve orders.</P>
                    <P>• Re-letter and re-number the subparagraphs of the D-Limit order definition to conform to the other order types in the rule. Specifically:</P>
                    <P>○ Re-letter IEX Rule 11.190(b)(7) subparagraphs (a)-(e) to now be subparagraphs (A)-(E)</P>
                    <P>
                        ○ Re-number the subparagraphs under IEX Rule 11.190(b)(7)(E) 
                        <SU>30</SU>
                        <FTREF/>
                         from (A)-(J) to (i)-(ix).
                    </P>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             Currently IEX Rule 11.190(b)(7)(e).
                        </P>
                    </FTNT>
                    <P>
                        • Modify IEX Rule 11.190(b)(7)(C)-(E) 
                        <SU>31</SU>
                        <FTREF/>
                         so that the three parentheticals that say “in the case of a displayed order” include the words “or the displayed portion of a reserve order.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             Currently IEX Rule 11.190(b)(7)(c)-(e).
                        </P>
                    </FTNT>
                    <P>
                        • Modify IEX Rule 11.190(b)(7)(E)(viii) 
                        <SU>32</SU>
                        <FTREF/>
                         to specify that the displayed portions of D-Limit reserve orders, like displayed D-Limit orders, are not eligible to be invited by the System to Recheck as described in IEX Rule 11.230(a)(4)(D).
                    </P>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             Currently IEX Rule 11.190(b)(7)(e)(I).
                        </P>
                    </FTNT>
                    <P>• Modify Supplementary Material .01 to IEX Rule 11.190(b) (“Reserve Orders”) to add the following language to the end of the first paragraph:</P>
                    <P>○ “D-Limit reserve orders function like any other reserve order, except they can only trade during the Regular Market Session, and if a D-Limit reserve order has been subject to an automatic price adjustment pursuant to paragraphs (b)(7)(C) and (D) of this IEX Rule, both the displayed and non-displayed portions of the D-Limit reserve order will continue to be ranked and displayed (in the case of the displayed portion) at the adjusted price. The adjusted price functions as an effective limit price for both the displayed and non-displayed portions of the D-Limit reserve order if one or both portions of the D-Limit reserve order are subsequently price adjusted pursuant to the Price Sliding provisions of paragraph (h) of this IEX Rule.”</P>
                </EXTRACT>
                <HD SOURCE="HD3">Implementation</HD>
                <P>This proposed rule change will be immediately effective upon filing. The Exchange will provide at least ten (10) days' notice to Members and market participants of the implementation timeline.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
                    <SU>33</SU>
                    <FTREF/>
                     in general, and furthers the objectives of Section 6(b)(5),
                    <SU>34</SU>
                    <FTREF/>
                     in particular, in that it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, and 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. Specifically, the Exchange believes that the proposed rule change is consistent with the protection of investors and the public interest because it is designed to provide more flexibility and opportunities for Members to add both displayed and non-displayed liquidity to the Exchange. As noted in the Purpose section, the proposed rule change is responsive to informal feedback from Members indicating that they prefer to use reserve orders to post displayed liquidity and would like to be able to use such functionality for D-Limit orders. Thus, IEX believes that the proposed rule change will attract additional liquidity to the Exchange and, to the extent it is successful in doing so, will benefit all market participants, thereby supporting the purposes of the Act 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 Exchange also believes that enabling the entry of D-Limit orders that can be partially displayed, will enhance opportunities for price discovery and increase the overall displayed (and non-displayed) liquidity profile on the Exchange, to the benefit of all market participants.
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <P>Moreover, the proposed rule change will merely combine the attributes of two existing order types—D-Limit orders and reserve orders—to expand the functionality available to Members. Consequently, the Exchange does not believe that the proposed rule change raises any novel issues not already considered by the Commission.</P>
                <P>Furthermore, IEX believes it is consistent with the purposes of the Act for D-Limit reserve orders to function like other reserve orders except for when they can be submitted and how they behave if their price was adjusted during a period of quote instability, because these two differences are essential aspects of D-Limit orders. Similarly, IEX believes that updating the reserve order description in the Supplementary Material to IEX Rule 11.190(b) is consistent with the protection of investors and the public interest by providing clarity to all market participants about how D-Limit reserve orders function, including the two ways in which their functionality differs from that of other reserve orders. Thus, these proposed changes support the purposes of the Act to remove impediments to and perfect the mechanism of a free and open market and a national market system, and in general, to protect investors and the public interest.</P>
                <P>
                    In addition, as noted in the Purpose section, a D-Limit reserve order is a combination of two order types the Commission has already approved—reserve orders 
                    <SU>35</SU>
                    <FTREF/>
                    —which are a common order type on equity exchanges 
                    <SU>36</SU>
                    <FTREF/>
                    —and D-Limit orders.
                    <SU>37</SU>
                    <FTREF/>
                     Thus, IEX does not believe that the proposed changes raise any new or novel material issues that have not already been considered by the Commission in connection with existing order types offered by IEX and other national securities exchanges.
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 78101 (June 17, 2016), 81 FR 41142 (June 23, 2016) (File No. 10—222) (approving IEX's exchange application, which included the reserve order type).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">See supra</E>
                         note 12.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         
                        <E T="03">See supra</E>
                         note 18.
                    </P>
                </FTNT>
                <P>Finally, the Exchange believes that the proposed non-substantive conforming changes to IEX Rule 11.190(b)(7) are consistent with the protection of investors and the public interest because they will have no impact on the functionality of D-Limit orders, but rather simply provide consistency and clarity in IEX's “Orders and Modifiers” rule, thereby reducing the potential for confusion of any market participants.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.</P>
                <P>
                    The Exchange does not believe that the proposed rule change will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the proposal is designed to enhance IEX's competitiveness with other markets by further enhancing IEX's reserve order and D-Limit order types. As discussed in the Purpose section, the proposal is designed to incentivize the entry of additional liquidity providing orders on IEX by offering Members the flexibility of using a reserve order to control what portion of their D-Limit orders are displayed at any time. Further, by enabling the entry of D-Limit orders that can be partially displayed, IEX believes this proposal will enhance opportunities for price discovery and increase the overall displayed (and non-displayed) liquidity profile on the 
                    <PRTPAGE P="24979"/>
                    Exchange, to the benefit of all market participants.
                </P>
                <P>The Exchange also does not believe that the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. All Members would be eligible to use a D-Limit reserve order, and all Members would be eligible to execute against any portion of a D-Limit reserve order. Moreover, the proposal would provide potential benefits to all Members to the extent that there is more liquidity available on IEX as a result of increased use of D-Limit orders attributable to the ability to enter such orders as reserve orders.</P>
                <P>Further, the proposed conforming edits to IEX Rule 11.190(b)(7) are not designed to address any competitive issue, but rather to provide additional clarity in IEX's rulebook.</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>Written comments were neither solicited nor received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The Exchange has designated this rule filing as non-controversial under Section 19(b)(3)(A) 
                    <SU>38</SU>
                    <FTREF/>
                     of the Act and Rule 19b-4(f)(6) 
                    <SU>39</SU>
                    <FTREF/>
                     thereunder. 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 and Rule 19b-4(f)(6) thereunder.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <P>
                    The Exchange believes that the proposed rule change meets the criteria of subparagraph (f)(6) of Rule 19b-4 
                    <SU>40</SU>
                    <FTREF/>
                     because it would not significantly affect the protection of investors or the public interest. Rather, the proposed rule change neither significantly affects the protection of investors or the public interest, nor does it impose any burden on competition because it would merely combine the attributes of two existing order types—D-Limit orders and reserve orders—to expand the functionality available to Members, as discussed in the Purpose section, and does not raise any new or novel material issues that have not already been considered by the Commission in connection with existing order types offered by IEX. Accordingly, IEX has designated this rule filing as non-controversial under Section 19(b)(3)(A) of the Act 
                    <SU>41</SU>
                    <FTREF/>
                     and paragraph (f)(6) of Rule 19b-4 thereunder.
                    <SU>42</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         17 CFR 240.19b-4(f)(6).
                    </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>43</SU>
                    <FTREF/>
                     of the Act to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>43</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-IEX-2021-08 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-IEX-2021-08. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. 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 offices of the Exchange. 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. All submissions should refer to File Number SR-IEX-2021-08, and should be submitted on or before
                    <FTREF/>
                     June 1, 2021.
                </FP>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         17 CFR 200.30-3(a)(12).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>44</SU>
                    </P>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09781 Filed 5-7-21; 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. 34-91756; File No. SR-GEMX-2021-03]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt a Fee Schedule To Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Nasdaq GEMX, LLC (“GEMX” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I, II, and III, below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    The Exchange proposes to adopt a fee schedule to establish fees for Industry Members related to the National Market 
                    <PRTPAGE P="24980"/>
                    System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in Rule General 7 (Consolidated Audit Trail Compliance) (GEMX General 7 incorporates The Nasdaq Stock Market LLC General 7 by reference).
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is available on the Exchange's website at 
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/gemx/rules,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the SEC a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are GEMX members in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91555 (April 14, 2017), 86 FR 21050 (April 21, 2021) (“Proposed CAT Fee Plan Amendment”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant quarter (“Total CAT Costs”).
                    <SU>7</SU>
                    <FTREF/>
                     The CAT Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic], 21074 [sic].
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic].
                    </P>
                </FTNT>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>9</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Proposed CAT Fee Plan Amendment at 21054-55.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) Establishing fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>10</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge 
                        <PRTPAGE P="24981"/>
                        members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                </EXTRACT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                    </P>
                </FTNT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the development and implementation of the CAT.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>13</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(B) 75%/25% Allocation Between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>14</SU>
                    <FTREF/>
                     Under the CAT Funding Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>15</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21055-56 [sic]. Note that, in the funding model set forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21056-58 [sic].
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry Member based on message traffic.
                    <SU>16</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21059 [sic].
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>17</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>18</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>19</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21056-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, see CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>21</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21057-58.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>22</SU>
                    <FTREF/>
                     would have a 
                    <PRTPAGE P="24982"/>
                    discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>23</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>24</SU>
                    <FTREF/>
                     and (2) all message traffic for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         Section 1.1 of the CAT NMS Plan; Nasdaq General 7 Section 1(ee) defines an “Options Market Maker” as “a broker-dealer registered with an 
                        <PRTPAGE/>
                        exchange for the purpose of making markets in options contracts traded on the exchange.” (GEMX General 7 incorporates The Nasdaq Stock Market LLC General 7 by reference).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.</P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>25</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>To implement the Options Market Maker discount, the Exchange proposes to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>26</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <SU>27</SU>
                    <FTREF/>
                     regardless of where the order is ultimately routed or executed.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio. The Equity Market Maker CAT fee then would be calculated by-multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>29</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic] discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>30</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT, would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member 
                    <PRTPAGE P="24983"/>
                    CAT Fee in accordance with their message traffic percentage.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>32</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59 [sic].
                    </P>
                </FTNT>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that</P>
                <EXTRACT>
                    <P>If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).</P>
                </EXTRACT>
                <P>Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.</P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>33</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21063.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4th of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <EXTRACT>
                    <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>34</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>35</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020—July 31, 2020) and certain costs from Period 2 of the Financial 
                    <PRTPAGE P="24984"/>
                    Accountability Milestones (which covered the period from August 1, 2020—December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21064-65.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4th of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.</P>
                <P>To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>36</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r75">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="24985"/>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>38</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21065-66.
                    </P>
                </FTNT>
                <P>Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message by ROTFLth of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public accounting firm and making the statements publicly available.</P>
                <P>To implement the Period 3 CAT Fee, the Exchange proposes to add proposed paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and Regulatory Utilization of Transactional Database Functionality. As discussed above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 3 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 3 CAT Costs 
                            <SU>39</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022</ENT>
                        <ENT>1st quarter of 2023</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (C) Period 4 CAT Fee
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>40</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21066-67.
                    </P>
                </FTNT>
                <P>
                    Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee 
                    <PRTPAGE P="24986"/>
                    owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.
                </P>
                <P>To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the requirements set forth in Section 9.2 of the CAT NMS Plan.</P>
                <P>The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>
                    The following chart summarizes the imposition of the Period 4 CAT Fee:
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 4 CAT Costs 
                            <SU>41</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(D) Quarterly CAT Fee—Beginning 2023</HD>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>42</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>43</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the 
                    <PRTPAGE P="24987"/>
                    percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067-68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses collected will be treated as an operational reserve to offset future fees and will not be distributed to the Participants as profits.
                    <SU>44</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for message traffic 
                            <LI>calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>45</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (i) the Prime Rate plus 300 basis points, or (ii) the maximum rate permitted by applicable law.
                    <SU>46</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>47</SU>
                    <FTREF/>
                     which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the 
                    <PRTPAGE P="24988"/>
                    Act,
                    <SU>48</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act 
                    <SU>49</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>50</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>51</SU>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities necessary or appropriate in furtherance of the purposes of this chapter,” 
                    <SU>52</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT fees equitably allocate CAT costs between Participants and Industry Members, and among Industry Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068-70.
                    </P>
                    <P>
                        <SU>52</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct.
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.</P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>54</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its GEMX members. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <PRTPAGE P="24989"/>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>55</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21070.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
                    <SU>56</SU>
                    <FTREF/>
                     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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         15 U.S.C. 78s(b)(3)(A)(ii).
                    </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-GEMX-2021-03 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-GEMX-2021-03. 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. 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. All submissions should refer to File Number SR-GEMX-2021-03su&gt;10 and should be submitted on or before June 1, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>57</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09784 Filed 5-7-21; 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. 34-91770; File No. SR-NSCC-2021-801]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of No Objection To Advance Notice To Amend the Supplemental Liquidity Deposit Requirements</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>
                    On March 5, 2021, National Securities Clearing Corporation (“NSCC”) filed with the Securities and Exchange Commission (“Commission”) advance notice SR-NSCC-2021-801 (“Advance Notice”) pursuant to Section 806(e)(1) of Title VIII of the Dodd-Frank Wall Street Reform and Consumer Protection Act, entitled Payment, Clearing and Settlement Supervision Act of 2010 (“Clearing Supervision Act”) 
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4(n)(1)(i) 
                    <SU>2</SU>
                    <FTREF/>
                     under the Securities Exchange Act of 1934 (“Exchange Act”) 
                    <SU>3</SU>
                    <FTREF/>
                     to amend its Supplemental Liquidity Deposit Requirements.
                    <SU>4</SU>
                    <FTREF/>
                     The Advance Notice was published for comment in the 
                    <E T="04">Federal Register</E>
                     on March 24, 2021,
                    <SU>5</SU>
                    <FTREF/>
                     and the Commission has received comments in support of the changes proposed in the Advance Notice.
                    <SU>6</SU>
                    <FTREF/>
                     The Commission is hereby providing notice of no objection to the Advance Notice.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         12 U.S.C. 5465(e)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4(n)(1)(i).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 U.S.C. 78a 
                        <E T="03">et seq.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Notice of Filing 
                        <E T="03">infra</E>
                         note 5, at 86 FR 15750.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Exchange Act Release No. 91347 (March 18, 2021), 86 FR 15750 (March 24, 2021) (File No. SR-NSCC-2021-801) (“Notice of Filing”). NSCC also filed a related proposed rule change with the Commission pursuant to Section 19(b)(1) of the Exchange Act and Rule 19b-4 thereunder. 15 U.S.C. 78s(b)(1) and 17 CFR 240.19b-4, respectively. NSCC seeks approval of the proposed changes to its rules necessary to implement the Advance Notice (the “Proposed Rule Change”). The Proposed Rule Change was published in the 
                        <E T="04">Federal Register</E>
                         on March 24, 2021. Securities Exchange Act Release No. 91350 (March 18, 2021), 86 FR 15738 (March 24, 2021) (SR-NSCC-2021-002). The comment period for the related Proposed Rule Change closed on April 14, 2021.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Comments are available at 
                        <E T="03">https://www.sec.gov/comments/sr-nscc-2021-801/srnscc2021801.htm.</E>
                         Since the proposal contained in the Advance Notice was also filed as a separate but related Proposed Rule Change, all public comments received on the proposals are considered regardless of whether the comments are submitted to the Proposed Rule Change or the Advance Notice. To date, the comments received generally support the proposal.
                    </P>
                </FTNT>
                <PRTPAGE P="24990"/>
                <HD SOURCE="HD1">II. The Advance Notice</HD>
                <HD SOURCE="HD2">A. Background</HD>
                <P>
                    As a central counterparty (“CCP”),
                    <SU>7</SU>
                    <FTREF/>
                     NSCC occupies an important role in the securities settlement system by interposing itself between counterparties to financial transactions, becoming the buyer to each seller and seller to each buyer to ensure the performance of the contract, thereby reducing the risk faced by its Members 
                    <SU>8</SU>
                    <FTREF/>
                     and contributing to global financial stability. NSCC's liquidity risk management plays an integral part in NSCC's ability to perform its role as a CCP. If a Member defaults, NSCC, as a CCP, would need to complete settlement of guaranteed transactions on the failing Member's behalf from the date of default through the remainder of the settlement cycle (currently two days for securities that settle on a regular way basis in the U.S. markets). To do so, and to meet its related regulatory requirements, NSCC seeks to maintain sufficient liquid resources in order to meet the potential funding required to settle outstanding transactions of a defaulting Member in a timely manner, as well as to hold qualifying liquid resources sufficient to meet its minimum liquidity resource requirement in each relevant currency for which it has payment obligations owed to its Members.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         17 CFR 240.17Ad-22(a)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Capitalized terms not defined herein are defined in NSCC's Rules and Procedures (“Rules”), 
                        <E T="03">available at http://dtcc.com/~/media/Files/Downloads/legal/rules/nscc_rules.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 82377 (December 21, 2017), 82 FR 61617 (December 28, 2017) (File Nos. SR-DTC-2017-004; SR-FICC-2017-008; SR-NSCC-2017-005) (approving NSCC's Liquidity Risk Management Framework).
                    </P>
                </FTNT>
                <P>
                    NSCC has a number of default liquidity resources that it considers to be qualifying liquid resources for the purposes of Rule 17Ad-22(a)(14).
                    <SU>10</SU>
                    <FTREF/>
                     These resources include: (1) Cash deposits to the NSCC Clearing Fund; 
                    <SU>11</SU>
                    <FTREF/>
                     (2) the proceeds of the issuance and private placement of (a) short-term, unsecured notes in the form of commercial paper and extendable notes (“Commercial Paper Program”),
                    <SU>12</SU>
                    <FTREF/>
                     and (b) term debt (“Term Debt Issuance”); 
                    <SU>13</SU>
                    <FTREF/>
                     (3) cash that would be obtained by drawing on NSCC's committed 364-day credit facility with a consortium of banks (“Line of Credit”); 
                    <SU>14</SU>
                    <FTREF/>
                     and (4) supplemental liquidity deposits, collected pursuant to NSCC Rule 4(A), as discussed further below.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         Notice of Filing, 
                        <E T="03">supra</E>
                         note 5, at 15751. Qualifying liquid resources include, among other things: Cash held either at the central bank of issue or at creditworthy commercial banks, and assets that are readily available and convertible into cash through prearranged funding arrangements, such as committed arrangements without material adverse change provisions, including lines of credit, foreign exchange swaps, and repurchase agreements. 17 CFR 240.17Ad-22(a)(14).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         Rule 4 (Clearing Fund) and Procedure XV (Clearing Fund Formula and Other Matters) of the Rules, 
                        <E T="03">supra</E>
                         note 8.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release Nos. 75730 (August 19, 2015), 80 FR 51638 (August 25, 2015) (File No. SR-NSCC-2015-802); 82676 (February 9, 2018), 83 FR 6912 (February 15, 2018) (File No. SR-NSCC-2017-807).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 88146 (February 7, 2020), 85 FR 8046 (February 12, 2020) (File No. SR-NSCC-2019-802).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 80605 (May 5, 2017), 82 FR 21850 (May 10, 2017) (File Nos. SR-DTC-2017-802; SR-NSCC-2017-802).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         Rule 4(A) (Supplemental Liquidity Deposits) of the Rules, 
                        <E T="03">supra</E>
                         note 8. 
                        <E T="03">See also</E>
                         Securities Exchange Act Release Nos. 70999 (December 5, 2013), 78 FR 75413 (December 11, 2013) (File No. SR-NSCC-2013-02); 71000 (December 5, 2013), 78 FR 75400 (December 11, 2013) (File No. SR-NSCC-2013-802).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Current Rules Relating to Supplemental Liquidity Deposits</HD>
                <P>
                    Currently, NSCC only collects supplemental liquidity deposits during monthly options expiry periods in order to cover the heightened liquidity exposure resulting from increased trading activity around options expiration.
                    <SU>16</SU>
                    <FTREF/>
                     NSCC only collects supplemental liquidity deposits from its 30 largest Members or group of affiliated Members (hereinafter, “Providers”).
                    <SU>17</SU>
                    <FTREF/>
                     NSCC calculates each Provider's supplemental liquidity obligation for an upcoming options expiry period using an estimate based on NSCC's highest liquidity need and the Provider's settlement activity during the prior 24-months.
                    <SU>18</SU>
                    <FTREF/>
                     Providers, in turn, must fund their supplemental liquidity obligations two business days prior to the start of the options expiry period, which NSCC will return seven business days after the end of that period.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See</E>
                         Rule 4(A), supra note 8. NSCC defines the duration of the options expiry periods in its Rules, which typically runs from the third Friday of the month to the following Tuesday. 
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Section 2 of Rule 4(A), 
                        <E T="03">supra</E>
                         note 8. NSCC may use a Provider's supplemental liquidity deposit to satisfy a loss or liability arising only from that Provider's default on its obligations to NSCC. Supplemental liquidity deposits are not otherwise subject to NSCC's Loss Allocation Waterfall. 
                        <E T="03">See</E>
                         Section 13(c) of Rule 4(A), 
                        <E T="03">supra</E>
                         note 8.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         Section 2 of Rule 4(A), 
                        <E T="03">supra</E>
                         note 8. Typically, NSCC performs this calculation, at the latest, one week prior to the start of the options expiry period.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See</E>
                         Sections 4 and 9 of Rule 4(A), 
                        <E T="03">supra</E>
                         note 8.
                    </P>
                </FTNT>
                <P>
                    In order to ensure NSCC maintains adequate liquidity resources throughout the options expiry period, providers may voluntarily prefund additional supplemental liquidity deposits at the start of the period, if it anticipates increases in its trading activity, compared to its historical activity, will create a liquidity shortfall at NSCC.
                    <SU>20</SU>
                    <FTREF/>
                     In the event a Provider fails to provide adequate voluntary prefunded deposits, NSCC may require the Provider to fund additional supplemental liquidity deposits if NSCC experiences a resulting liquidity shortfall,
                    <SU>21</SU>
                    <FTREF/>
                     which NSCC may hold for up to 90 days.
                    <SU>22</SU>
                    <FTREF/>
                     The 90-day lock-up incentivizes Providers to voluntarily prefund their supplemental liquidity deposits in order to ensure NSCC maintains adequate liquidity resources throughout the options expiry period.
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See</E>
                         Section 2 of Rule 4(A), 
                        <E T="03">supra</E>
                         note 8. 
                        <E T="03">See also,</E>
                         Notice of Filing, supra note 5, at 15752.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Section 7 of Rule 4(A), 
                        <E T="03">supra</E>
                         note 8.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See</E>
                         Section 10 of Rule 4(A), 
                        <E T="03">supra</E>
                         note 8.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Proposed Changes to the Rules Relating to Supplemental Liquidity Deposits</HD>
                <P>
                    As discussed above, NSCC may only collect supplemental liquidity deposits during monthly options expiry periods under its current Rules. However, NSCC can face sudden liquidity shortfalls on any business day, not just those business days that fall within monthly options expiry periods, particularly during volatile market conditions unrelated to options expiration.
                    <SU>23</SU>
                    <FTREF/>
                     To address this issue, NSCC proposes to change the frequency at which it may collect supplemental liquidity deposits to each business day, based on a daily calculation. This proposed approach to collecting supplemental liquidity deposits should allow NSCC to respond quickly to any sudden liquidity shortfalls arising from a Provider's activity, regardless of when those shortfalls occur.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Notice of Filing, 
                        <E T="03">supra</E>
                         note 5, at 15752.
                    </P>
                </FTNT>
                <P>
                    NSCC also proposes an alternative pro rata daily calculation in the rare event its regular daily calculation would inadvertently result in collecting supplement liquidity deposits from multiple Providers that, taken together, would significantly exceed NSCC's liquidity needs on that day. Additionally, NSCC proposes the ability to collect supplemental liquidity deposits on an intraday basis in certain instances where sudden intraday increases in liquidity risk justify shortening the amount of time NSCC is exposed to that risk, including a mandatory intraday collection in connection with monthly options expiry periods.
                    <PRTPAGE P="24991"/>
                </P>
                <HD SOURCE="HD3">1. Proposed Daily Calculation of Supplemental Liquidity Deposits</HD>
                <P>
                    A Provider 
                    <SU>24</SU>
                    <FTREF/>
                     will be obligated to provide a supplemental liquidity deposit on each business day in which its settlement activity causes a liquidity shortfall at NSCC.
                    <SU>25</SU>
                    <FTREF/>
                     NSCC will provide a notice to each Provider of the amount of its supplemental liquidity deposit, which the Provider will be required to fund within one hour of such notice.
                    <SU>26</SU>
                    <FTREF/>
                     NSCC proposes to return supplemental liquidity deposits on the next business day.
                    <SU>27</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Under the proposal, Providers will continue to be the 30 largest Members or group of affiliated Members, but NSCC proposes to simplify how it determines the 30 Providers in order to provide greater transparency and predictability in its determination. The 30 Providers will be determined daily and will be based on the Provider's settlement activity during the prior 24-months. NSCC's determination will no longer require a calculation of liquidity exposures the Providers presented to NSCC based on NSCC's qualifying liquid resources throughout a 24 month lookback period. NSCC will continue to make available to each Member daily information on NSCC's liquidity need based on that Member's settlement activity on the previous business day.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         A liquidity shortfall will arise if NSCC's daily liquidity need exceeds its qualifying liquid resources, assuming stressed market conditions. NSCC will continue to apply stress scenarios in determining its total qualifying liquid resources in order to anticipate market conditions that could cause those resources to be unavailable on that day. Because the daily calculation will be done at the start of each business day, it will be based on the qualifying liquid resources available to NSCC as of the end of the prior business day.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         NSCC's proposed timing would mirror the current requirement that is applied to its Members' Required Fund Deposits (
                        <E T="03">i.e.,</E>
                         margin), which is also calculated and collected daily, and must be funded within one hour of demand. NSCC expects to deliver notification of Provider obligations by around 8:30 a.m. ET each business day, with deposits required by no later than 9:30 a.m. ET. 
                        <E T="03">See</E>
                         Notice of Filing, 
                        <E T="03">supra</E>
                         note 5, at 15753.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">See</E>
                         Notice of Filing, 
                        <E T="03">supra</E>
                         note 5, at 15754. Because NSCC would recalculate supplemental liquidity deposits daily, NSCC will no longer need to hold deposits for the extended periods under its current Rules. 
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <P>
                    NSCC states that, under its proposed calculation, it will no longer need to estimate its liquidity need for a Provider's expected settlement activity based on the Provider's historical settlement activity.
                    <SU>28</SU>
                    <FTREF/>
                     Instead, each Provider's deposit will be calculated based on NSCC's actual liquidity need based on the Provider's daily settlement activity in the event the Provider defaulted on that day, which NSCC believes will provide both NSCC and Providers with a more reliable measure of the liquidity risks posed to NSCC.
                    <SU>29</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         
                        <E T="03">See</E>
                         Notice of Filing, 
                        <E T="03">supra</E>
                         note 5, at 15753.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <P>
                    NSCC provided the Commission with the results of an impact study comparing the proposal against the observed regulatory liquidity needs and NSCC's qualifying liquid resources available during the period from 2016 through 2020. The study assessed both pro-forma and hypothetical impacts of the proposal under various liquidity scenarios. The study also analyzed historical trends including the average composition and rankings of the top 30 Providers at NSCC during the 2016 to 2020 period. Based on the pro-forma/hypothetical impact as well analysis of the top Providers, the study's results generally indicate that the proposal would continue to allow NSCC to meet its regulatory liquidity obligations, and the largest Members would continue to be the ones affected by supplemental liquidity obligations.
                    <SU>30</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         
                        <E T="03">See id.</E>
                         NSCC further states that if its other qualifying liquid resources materially decrease, it would expect to see an increase in both number and amount of supplemental liquidity obligations that Providers would have been required to fund under the proposed rule. 
                        <E T="03">See id.</E>
                         at 15756.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Proposed Pro Rata Calculation of Supplemental Liquidity Deposits</HD>
                <P>
                    As a potential alternative to the calculation described above, NSCC proposes a discretionary pro rata calculation that could apply in the event two or more Providers each would be obligated to provide a supplemental liquidity deposit of more than $2 billion on a business day pursuant to the calculation described above.
                    <SU>31</SU>
                    <FTREF/>
                     Under the proposed alternative, NSCC will have the option to allocate, on a pro rata basis, its largest liquidity need on a business day to all Providers that are required to make a supplemental liquidity deposit on that day, thereby reducing all such Providers' obligations to NSCC on that day. NSCC's determination will be based on the market conditions at that time. For example, NSCC may determine that, in certain market conditions, this alternative approach would be appropriate to alleviate liquidity pressures on all Providers required to make a supplemental liquidity deposit on that day.
                    <SU>32</SU>
                    <FTREF/>
                     NSCC states this alternative would allow NSCC to use this pro rata calculation to sufficiently cover its liquidity exposure on that day, without requiring that all Providers fund the total amount of its calculated supplemental liquidity deposit on that day.
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         NSCC represents that it has never had two or more Providers owe more than $2 billion on a calculation date since its adoption of the supplemental liquidity deposit Rules in 2013. Therefore, NSCC believes this alternative calculation would only be available in very limited circumstances. 
                        <E T="03">See</E>
                         Notice of Filing, 
                        <E T="03">supra</E>
                         note 5, at 15754.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         
                        <E T="03">See</E>
                         Notice of Filing, 
                        <E T="03">supra</E>
                         note 5, at 15754.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">3. Proposed Intraday Supplemental Liquidity Calls</HD>
                <P>
                    NSCC also proposes to establish intraday supplemental liquidity calls, which are intended to allow NSCC to calculate and collect additional supplemental liquidity deposits on an intraday basis if a Provider's increased daily activity levels or projected settlement activity causes a NSCC liquidity shortfall during a given day.
                    <SU>33</SU>
                    <FTREF/>
                     NSCC believes the proposed intraday supplemental liquidity calls will help to mitigate increased liquidity exposures presented to NSCC on an intraday basis in specified circumstances, as discussed further below.
                    <SU>34</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         The alternative pro rata calculation described in Section II.C.2 would not apply to an intraday supplemental liquidity call.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Notice of Filing, 
                        <E T="03">supra</E>
                         note 5, at 15754.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">i. Proposed Mandatory Intraday Supplemental Liquidity Call</HD>
                <P>
                    First, NSCC proposes to establish a mandatory monthly intraday supplemental liquidity call that is calculated and collected, when applicable, on the first business day (typically a Friday) of an options expiry period.
                    <SU>35</SU>
                    <FTREF/>
                     A Provider's mandatory intraday supplemental liquidity call will be the difference between, on the one hand, NSCC's qualifying liquid resources and, on the other hand, NSCC's daily liquidity need based on the Provider's settlement activity at the start of the business day, recalculated to account for both the Provider's actual settlement activity submitted to NSCC over the course of the day, and the Provider's projected settlement activity in stock options expected to be submitted to NSCC.
                    <SU>36</SU>
                    <FTREF/>
                     Because NSCC's recalculated daily liquidity need will not factor in late day trades or other off-setting settlement activity,
                    <SU>37</SU>
                    <FTREF/>
                     NSCC proposes to adjust its re-calculated daily liquidity need using an estimated 
                    <PRTPAGE P="24992"/>
                    netting percentage based on each Provider's average percentage of netting from its off-setting settlement activity observed over the prior 24 months. NSCC states that the actual settlement activity flowing into NSCC for cash settlement of stocks underlying expiring options is typically lower than the projected settlement activity NSCC receives from OCC on the Thursday before the start of the options expiry period due to late day offsetting trades in stock options on that Friday; therefore, applying this netting percentage should more accurately reflect the actual liquidity exposures that will be presented to NSCC from the Providers.
                    <SU>38</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         NSCC will retain how it defines the duration of the options expiry periods in its Rules. 
                        <E T="03">See supra</E>
                         note 19.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Each business day, NSCC receives information regarding projected settlement activity from The Options Clearing Corporation (“OCC”) pursuant to a Stock and Futures Settlement Agreement. That agreement provides for the clearance and settlement of exercises and assignments of options on eligible securities or the maturity of eligible stock futures contracts through NSCC. 
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 81260 (July 31, 2017), 82 FR 36484 (August 4, 2017) (File Nos. SR-NSCC-2017-803; SR-OCC-2017-804). In this case, the re-calculation will be based on the data NSCC receives from OCC late Thursday.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         
                        <E T="03">See</E>
                         Notice of Filing, 
                        <E T="03">supra</E>
                         note 5, at 15754. For example, an affiliated Member may be entitled, under NSCC Rules, to liquidity credits based the trading activity of its affiliates, who are also Members, in order to determine NSCC's net liquidity exposure from the affiliated family of Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See</E>
                         Notice of Filing, 
                        <E T="03">supra</E>
                         note 5, at 15754.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">ii. Proposed Discretionary Intraday Supplemental Liquidity Call</HD>
                <P>Second, NSCC proposes to establish a discretionary intraday supplemental liquidity call on any business day other than the first business day during options expiry periods. Under this provision, NSCC will have the discretion to call for additional supplemental liquidity deposits on an intraday basis on any such business day if a Provider's increased activity levels during that day would cause a liquidity shortfall at NSCC. The amount of a Provider's intraday supplemental liquidity call, pursuant to NSCC's discretion, would be the difference between NSCC's daily liquidity need, recalculated to take into account the increase in the Provider's settlement activity during the day, and NSCC's qualifying liquid resources.</P>
                <P>
                    NSCC states that it would collect a discretionary intraday call in circumstances where NSCC believes it should accelerate the collection of a Provider's supplemental liquidity obligation because that Provider's intraday settlement activity would cause NSCC's liquidity needs to exceed its liquidity resources.
                    <SU>39</SU>
                    <FTREF/>
                     For example, NSCC may impose an intraday supplemental liquidity call on a Provider if NSCC determines that Provider is unlikely to meet its projected settlement obligations through the settlement cycle due to rapidly escalating financial stress.
                    <SU>40</SU>
                    <FTREF/>
                     NSCC will make this determination based on a variety of factors, including NSCC's assessment of the Provider's ability to meet its obligations to NSCC (
                    <E T="03">i.e.,</E>
                     an assessment of the Provider's creditworthiness on a particular business day) or estimates of settlement activity that could offset settlement exposures and are not reflected in NSCC's liquidity estimates.
                    <SU>41</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Discussion and Commission Findings</HD>
                <P>
                    Although the Clearing Supervision Act does not specify a standard of review for an advance notice, the stated purpose of the Clearing Supervision Act is instructive: To mitigate systemic risk in the financial system and promote financial stability by, among other things, promoting uniform risk management standards for SIFMUs and strengthening the liquidity of SIFMUs.
                    <SU>42</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         12 U.S.C. 5461(b).
                    </P>
                </FTNT>
                <P>
                    Section 805(a)(2) of the Clearing Supervision Act authorizes the Commission to prescribe regulations containing risk management standards for the payment, clearing, and settlement activities of designated clearing entities engaged in designated activities for which the Commission is the supervisory agency.
                    <SU>43</SU>
                    <FTREF/>
                     Section 805(b) of the Clearing Supervision Act provides the following objectives and principles for the Commission's risk management standards prescribed under Section 805(a): 
                    <SU>44</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         12 U.S.C. 5464(a)(2).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         12 U.S.C. 5464(b).
                    </P>
                </FTNT>
                <P>• To promote robust risk management;</P>
                <P>• to promote safety and soundness;</P>
                <P>• to reduce systemic risks; and</P>
                <P>• to support the stability of the broader financial system.</P>
                <P>
                    Section 805(c) provides, in addition, that the Commission's risk management standards may address such areas as risk management and default policies and procedures, among other areas.
                    <SU>45</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         12 U.S.C. 5464(c).
                    </P>
                </FTNT>
                <P>
                    The Commission has adopted risk management standards under Section 805(a)(2) of the Clearing Supervision Act and Section 17A of the Exchange Act (the “Clearing Agency Rules”).
                    <SU>46</SU>
                    <FTREF/>
                     The Clearing Agency Rules require, among other things, each covered clearing agency to establish, implement, maintain, and enforce written policies and procedures that are reasonably designed to meet certain minimum requirements for its operations and risk management practices on an ongoing basis.
                    <SU>47</SU>
                    <FTREF/>
                     As such, it is appropriate for the Commission to review advance notices against the Clearing Agency Rules and the objectives and principles of these risk management standards as described in Section 805(b) of the Clearing Supervision Act. As discussed below, the Commission finds the proposal in the Advance Notice is consistent with the objectives and principles described in Section 805(b) of the Clearing Supervision Act,
                    <SU>48</SU>
                    <FTREF/>
                     and in the Clearing Agency Rules, in particular Rule 17Ad-22(e)(7)(i) and (ii).
                    <SU>49</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         17 CFR 240.17Ad-22. 
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 68080 (October 22, 2012), 77 FR 66220 (November 2, 2012) (S7-08-11). 
                        <E T="03">See also</E>
                         Securities Exchange Act Release No. 78961 (September 28, 2016), 81 FR 70786 (October 13, 2016) (S7-03-14) (“Covered Clearing Agency Adopting Release”). NSCC is a “covered clearing agency” as defined in Rule 17Ad-22(a)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         12 U.S.C. 5464(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         17 CFR 240.17Ad-22(e)(7)(i) and (ii).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">A. Consistency With Section 805(b) of the Clearing Supervision Act</HD>
                <P>
                    The Commission finds that the Advance Notice is consistent with the stated objectives and principles of Section 805(b) of the Clearing Supervision Act.
                    <SU>50</SU>
                    <FTREF/>
                     Specifically, the Commission finds that the changes proposed in the Advance Notice are consistent with promoting robust risk management in the area of liquidity risk, promoting safety and soundness, reducing systemic risks, and supporting the broader financial system.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         12 U.S.C. 5464(b).
                    </P>
                </FTNT>
                <P>
                    The Commission finds that the changes proposed in the Advance Notice are consistent with promoting robust risk management, in particular the management of liquidity risk presented to NSCC. As a CCP and a SIFMU, it is imperative that NSCC maintains adequate resources to satisfy liquidity needs arising from its settlement obligations, including in the event of a Member default. As described above in Section II.C.1, NSCC currently may only collect supplemental liquidity deposits during monthly options expiry periods. However, NSCC can also face increased liquidity exposure from a Member's activity outside of these periods, even if unrelated to options settlement activity. The ability to calculate and collect supplemental liquidity deposits, as applicable, on a daily basis should help NSCC more accurately manage its daily liquidity exposures based on Members' actual activity, as opposed to only being able to collect additional liquidity resources from Members during monthly options expiry. Moreover, the proposal would allow NSCC to determine the amount of supplemental liquidity deposits based on Members' actual activity, providing more precise and, potentially, lower charges for Members than provided under the current methodology, which uses estimates based on a look-back period and can, on occasion, result in NSCC collecting more resources than needed to cover its exposure.
                    <PRTPAGE P="24993"/>
                </P>
                <P>Additionally, as described above in Section II.C.3, NSCC also proposes to include both mandatory and discretionary intraday supplemental liquidity calls which would allow NSCC to calculate and collect additional supplemental liquidity deposits on an intraday basis if a Provider's increased activity levels during that day or projected settlement activity causes NSCC's daily liquidity need to exceed its qualifying liquid resources. The Commission finds that the mandatory monthly intraday supplemental liquidity calls on the first business day of the monthly options expiry periods should help NSCC continue to manage the potential increased liquidity exposures that may arise from options settlement-related activity by allowing it to accelerate the collection of supplemental liquidity deposits on that day, as opposed to waiting for the proposed daily collection that would occur on the morning of the following business day. Moreover, the proposed discretionary intraday supplemental liquidity calls should collect additional supplemental liquidity deposits from Members whose activity outside of the monthly options expiry periods may cause a sudden increase in NSCC's liquidity needs on an overnight basis. Therefore, because NSCC's proposal is designed to enable NSCC to better limit its liquidity exposures that could arise in the event of a Member default, the Commission finds the changes proposed in the Advance Notice promote robust risk management, specifically in the area of liquidity risk.</P>
                <P>
                    The Commission also finds that the changes proposed in the Advance Notice are consistent with promoting safety and soundness, reducing systemic risks, and promoting the stability of the broader financial system. As described above, NSCC's proposal to calculate and collect, if applicable, supplemental liquidity deposits on a daily basis could provide NSCC with additional liquidity resources, including on days outside of monthly Options Expiration Activity Periods, in the event of a Member default. Therefore, the changes proposed would promote safety and soundness by enabling NSCC to obtain additional liquid resources to cover a liquidity gap that could arise in the event of a Member default.
                    <SU>51</SU>
                    <FTREF/>
                     By covering such a gap, the proposal bolsters NSCC's ability to meet its settlement obligations in the event of a Member default and its ability to continue to provide CCP services to its Members.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         The Commission has reviewed and considered the results of NSCC's hypothetical impact studies. 
                        <E T="03">See supra</E>
                         note 30 and accompanying text. Based on that review, the Commission concludes that the proposal could help mitigate the risks to NSCC that could arise if NSCC is unable to secure adequate default liquidity from other sources in an amount necessary to meet its liquidity needs. For example, the proposal could help mitigate the risks that could arise if investor demand for the short-term notes issued under the Commercial Paper Program weakens, there is limited investor demand for term debt issued pursuant to a Term Debt Issuance, or NSCC is unable to renew its Line of Credit at the targeted amount.
                    </P>
                </FTNT>
                <P>In addition, the proposed changes should reduce the potential procyclicality of NSCC's liquidity demands, which could reduce the potential for unexpected liquidity stress to market participants in certain situations. Because NSCC would now calculate and collect, if applicable, supplemental liquidity deposits on a daily basis, the proposal should reduce the likelihood that NSCC would have to call on its Members to contribute additional liquidity in periods of financial stress, when liquidity may be most costly. Therefore, the Commission finds that by enhancing NSCC's ability to address losses and liquidity pressures that otherwise might cause financial distress to NSCC or its Members, the Advance Notice promotes safety and soundness.</P>
                <P>
                    Maintaining adequate liquidity resources to help meet settlement obligations in the event of a Member default also enhances NSCC's ability to manage systemic risk and to support the broader financial system. NSCC's ability to obtain additional liquid resources for use in the event of a Member default should reduce the risk of loss contagion (
                    <E T="03">i.e.,</E>
                     the risk of losses arising at other NSCC Members if NSCC is unable to deliver cash or securities on the defaulting Member's behalf). Reducing the risk of loss contagion would reduce the potential transmission of financial shocks from defaulting Members to non-defaulting Members, thereby enhancing the ability of NSCC and its Members to continue to provide stability and safety to the financial markets that they serve.
                </P>
                <P>
                    Additionally, establishing an optional alternative pro rata calculation of supplemental liquidity deposits could help NSCC alleviate any unintended but significant liquidity constraints on its Members, while still enabling NSCC to meet its regulatory requirements with respect to liquidity without collecting more liquidity resources than needed. The proposed pro rata calculation would provide NSCC with a method to reduce the supplemental liquidity deposits owed by all Providers who would otherwise be obligated to provide such a deposit, which would be appropriate in light of the likely stressed market conditions that would result in two or more Providers presenting a potential supplemental liquidity deposit of over $2 billion. Likewise, because NSCC would recalculate supplemental liquidity deposit obligations each business day, NSCC will no longer need to hold supplemental liquidity deposits for the extended periods under its current Rule 4(A), which could also alleviate liquidity pressures on its Members. Accordingly, the Commission finds the proposal is consistent with reducing systemic risks, and promoting the stability of the broader financial system as contemplated in Section 805(b) of the Clearing Supervision Act.
                    <SU>52</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         12 U.S.C. 5464(b).
                    </P>
                </FTNT>
                <P>
                    For the reasons stated above, the Commission finds the changes proposed in the Advance Notice are consistent with Section 805(b) of the Clearing Supervision Act.
                    <SU>53</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         12 U.S.C. 5464(b).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Consistency With Rule 17Ad-22(e)(7)(i) and (ii)</HD>
                <P>
                    The Commission finds the changes proposed in the Advance Notice are consistent with Rules 17Ad-22(e)(7)(i) and (ii), each promulgated under the Exchange Act,
                    <SU>54</SU>
                    <FTREF/>
                     for the reasons described below.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         17 CFR 240.17Ad-22(e)(7)(i) and (ii).
                    </P>
                </FTNT>
                <P>
                    Rule 17Ad-22(e)(7)(i) under the Exchange Act requires that a covered clearing agency establish, implement, maintain and enforce written policies and procedures reasonably designed to maintain sufficient liquid resources at the minimum in all relevant currencies to effect same-day and, where appropriate, intraday and multiday settlement of payment obligations with a high degree of confidence under a wide range of foreseeable stress scenarios that includes, but is not limited to, the default of the participant family that would generate the largest aggregate payment obligation for the covered clearing agency in extreme but plausible market conditions.
                    <SU>55</SU>
                    <FTREF/>
                     Rule 17Ad-22(e)(7)(ii) under the Act requires that a cover clearing agency establish, implement, maintain and enforce written policies and procedures reasonably designed to hold qualifying liquid resources sufficient to meet the minimum liquidity resource requirement under Rule 17Ad-22(e)(7)(i) in each relevant currency for which the covered clearing agency has 
                    <PRTPAGE P="24994"/>
                    payment obligations owed to its clearing members.
                    <SU>56</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         17 CFR 240.17Ad-22(e)(7)(i).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         17 CFR 240.17Ad-22(e)(7)(ii). For purposes of Rule 17Ad-22(e)(7)(ii), “qualifying liquid resources” are defined in Rule 17Ad-22(a)(14) as including, in part, cash held either at the central bank of issue or at creditworthy commercial banks. 17 CFR 240.17Ad-22(a)(14).
                    </P>
                </FTNT>
                <P>
                    As described above, the changed proposed in the Advance Notice would help strengthen NSCC's ability to maintain sufficient liquid resources to complete end-of-day settlement in the event of the Member default by allowing NSCC to calculate and collect, when applicable, supplemental liquidity deposits every business day, or on an intraday basis, from those Members that pose the largest liquidity exposures to NSCC on that day. These resources would be available to NSCC to complete end-of-day settlement in the event of the default of a Member. Moreover, the Commission has reviewed and considered the impact study results provided by NSCC comparing the proposal against the observed regulatory liquidity needs and NSCC's qualifying liquid resources available during the period from 2016 through 2020, to assess both pro-forma and hypothetical impacts of the proposal under various liquidity scenarios,
                    <SU>57</SU>
                    <FTREF/>
                     and finds that these results generally indicated that the proposal would continue allow NSCC to meet its regulatory liquidity obligations.
                </P>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         
                        <E T="03">See supra</E>
                         note 30 and accompanying text.
                    </P>
                </FTNT>
                <P>
                    In addition, deposits made to satisfy supplemental liquidity deposit obligations are currently and will continue to be required to be made as cash deposits, which will continue to be held by NSCC at either its cash deposit account at the Federal Reserve Bank of New York, at a creditworthy commercial bank, or in other investments pursuant to NSCC's Clearing Agency Investment Policy.
                    <SU>58</SU>
                    <FTREF/>
                     Therefore, supplemental liquidity deposits would continue to be considered a qualifying liquid resource, as defined by Rule 17Ad-22(a)(14),
                    <SU>59</SU>
                    <FTREF/>
                     and would support NSCC's ability to hold qualifying liquid resources sufficient to meet the minimum liquidity resource requirement under Rule 17Ad-22(e)(7)(i),
                    <SU>60</SU>
                    <FTREF/>
                     as required by Rule 17Ad-22(e)(7)(ii).
                    <SU>61</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release Nos. 79528 (December 12, 2016), 81 FR 91232 (December 16, 2016) (File Nos. SR-DTC-2016-007, SR-FICC-2016-005, SR-NSCC-2016-003); 84949 (December 21, 2018), 83 FR 67779 (December 31, 2018) (File Nos. SR-DTC-2018-012, SR-FICC-2018-014, SR-NSCC-2018-013).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>59</SU>
                         17 CFR 240.17Ad-22(a)(14).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>60</SU>
                         17 CFR 240.17Ad-22(e)(7)(i).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>61</SU>
                         17 CFR 240.17Ad-22(e)(7)(ii).
                    </P>
                </FTNT>
                <P>
                    Accordingly, the Commission finds that implementation of the proposed amendments to supplemental liquidity deposits would be consistent with Rule 17Ad-22(e)(7)(i) and (ii) under the Exchange Act.
                    <SU>62</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>62</SU>
                         17 CFR 240.17Ad-22(e)(7).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Conclusion</HD>
                <P>
                    <E T="03">It is therefore noticed,</E>
                     pursuant to Section 806(e)(1)(I) of the Clearing Supervision Act, that the Commission 
                    <E T="03">does not object</E>
                     to Advance Notice (SR-NSCC-2021-801) and that NSCC is 
                    <E T="03">authorized</E>
                     to implement the proposed change as of the date of this notice or the date of an order by the Commission approving proposed rule change SR-NSCC-2021-002, whichever is later.
                </P>
                <SIG>
                    <P>By the Commission.</P>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09788 Filed 5-7-21; 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. 34-91753; File No. SR-MRX-2021-05]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt a Fee Schedule To Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Nasdaq MRX, LLC (“MRX” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I, II, and III, below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    The Exchange proposes to adopt a fee schedule to establish fees for Industry Members related to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in Rule General 7 (Consolidated Audit Trail Compliance) (MRX General 7 incorporates The Nasdaq Stock Market LLC General 7 by reference).
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is available on the Exchange's website at 
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/mrx/rules,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the SEC a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are MRX members in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon 
                    <PRTPAGE P="24995"/>
                    the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91555 (April 14, 2017), 86 FR 21050 (April 21, 2021) (“Proposed CAT Fee Plan Amendment”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <P>
                    While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative following Commission approval of the Join [sic] Industry Plan Amendment to the National Market System Plan Governing the Consolidated Audit Trail filed on March 31, 2021.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91555 (April 14, 2017), 86 FR 21050 (April 21, 2021) (“Proposed CAT Fee Plan Amendment”).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant quarter (“Total CAT Costs”).
                    <SU>8</SU>
                    <FTREF/>
                     The CAT Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic], 21074 [sic].
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic].
                    </P>
                </FTNT>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>10</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Proposed CAT Fee Plan Amendment at 21054-55.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) establishing fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>11</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                        <SU>12</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                        </P>
                    </FTNT>
                      
                </EXTRACT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the development and implementation of the CAT.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>14</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(B) 75%/25% Allocation Between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>15</SU>
                    <FTREF/>
                     Under the CAT Funding 
                    <PRTPAGE P="24996"/>
                    Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>16</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21055-56 [sic]. Note that, in the funding model set 
                        <PRTPAGE/>
                        forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21056-58 [sic].
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry Member based on message traffic.
                    <SU>17</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21059 [sic].
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>18</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>19</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>20</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21056-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, 
                        <E T="03">see</E>
                         CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>22</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21057-58.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>23</SU>
                    <FTREF/>
                     would have a discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>24</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>25</SU>
                    <FTREF/>
                     and (2) all message traffic for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         Section 1.1 of the CAT NMS Plan; Nasdaq General 7 Section 1(ee) defines an “Options Market Maker” as “a broker-dealer registered with an exchange for the purpose of making markets in options contracts traded on the exchange.” (MRX General 7 incorporates The Nasdaq Stock Market LLC General 7 by reference).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.</P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members 
                    <PRTPAGE P="24997"/>
                    during the relevant time period 
                    <SU>26</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>To implement the Options Market Maker discount, the Exchange proposes to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>27</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <SU>28</SU>
                    <FTREF/>
                     regardless of where the order is ultimately routed or executed.
                    <SU>29</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio. The Equity Market Maker CAT fee then would be calculated by-multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>30</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic] discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>31</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT, would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage.
                    <SU>32</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>33</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59 [sic].
                    </P>
                </FTNT>
                <PRTPAGE P="24998"/>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that</P>
                <EXTRACT>
                    <P>If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).</P>
                </EXTRACT>
                <P>Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.</P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>34</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21063.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4th of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <EXTRACT>
                    <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>35</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>36</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020-July 31, 2020) and certain costs from Period 2 of the Financial Accountability Milestones (which covered the period from August 1, 2020-December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21064-65.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4th of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.</P>
                <P>
                    To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. 
                    <PRTPAGE P="24999"/>
                    Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”
                </P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>38</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,17,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>39</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21065-66.
                    </P>
                </FTNT>
                <P>Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message by 1/4th of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.</P>
                <P>
                    The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public 
                    <PRTPAGE P="25000"/>
                    accounting firm and making the statements publicly available.
                </P>
                <P>To implement the Period 3 CAT Fee, the Exchange proposes to add proposed paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and Regulatory Utilization of Transactional Database Functionality. As discussed above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 3 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment Due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 3 CAT Costs 
                            <SU>40</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022.</ENT>
                        <ENT>1st quarter of 2023.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    (C) Period 4 CAT Fee
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>41</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21066-67.
                    </P>
                </FTNT>
                <P>Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.</P>
                <P>To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the 
                    <PRTPAGE P="25001"/>
                    requirements set forth in Section 9.2 of the CAT NMS Plan.
                </P>
                <P>The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>
                    The following chart summarizes the imposition of the Period 4 CAT Fee:
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 4 CAT Costs 
                            <SU>42</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(D) Quarterly CAT Fee—Beginning 2023</HD>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>43</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>44</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067-68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses collected will be treated as an operational reserve to offset future fees and will not be distributed to the Participants as profits.
                    <SU>45</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs 
                    <PRTPAGE P="25002"/>
                    for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>46</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (i) the Prime Rate plus 300 basis points, or (ii) the maximum rate permitted by applicable law.
                    <SU>47</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>48</SU>
                    <FTREF/>
                     which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the Act,
                    <SU>49</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act 
                    <SU>50</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>51</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>52</SU>
                    <FTREF/>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities necessary or appropriate in furtherance of the purposes of this chapter,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT 
                    <PRTPAGE P="25003"/>
                    fees equitably allocate CAT costs between Participants and Industry Members, and among Industry Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068-70.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>54</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.</P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>55</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its MRX members. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>56</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21070.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
                    <SU>57</SU>
                    <FTREF/>
                     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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         15 U.S.C. 78s(b)(3)(A)(ii).
                    </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:
                    <PRTPAGE P="25004"/>
                </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-MRX-2021-05 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-MRX-2021-05. 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. 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. All submissions should refer to File Number SR-MRX-2021-05 and should be submitted on or before June 1, 2021.
                    <FTREF/>
                </FP>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         17 CFR 200.30-3(a)(12).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>58</SU>
                    </P>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09780 Filed 5-7-21; 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. 34-91758; File No. SR-CboeEDGX-2021-024]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt a Fee Schedule To Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Cboe EDGX Exchange, Inc. (“Exchange” or “EDGX”) 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 the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    Cboe EDGX Exchange, Inc. (the “Exchange” or “Cboe EDGX”) proposes to adopt a fee schedule to establish fees for Industry Members related to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                     The text of the proposed rule change is provided in Exhibit 5.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in the CAT Compliance Rule. 
                        <E T="03">See</E>
                         Rules 4.5 through 4.17 of the Exchange's Rulebook. The Exchange and each of its affiliated exchanges (Cboe BYX Exchange, Inc., Cboe BZX Exchange, Inc., Cboe C2 Exchange, Inc., Cboe Exchange, Inc., and Cboe EDGA Exchange, Inc.) are filing to adopt the CAT fee schedule.
                    </P>
                </FTNT>
                <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/edgx/</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 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>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the Securities and Exchange Commission (“SEC” or “Commission”) a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are Members in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Rel. No. 91555 (Apr. 14, 2021), 86 FR 21050 (April 21, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant quarter (“Total CAT Costs”).
                    <SU>7</SU>
                    <FTREF/>
                     The CAT 
                    <PRTPAGE P="25005"/>
                    Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4, 56-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4.
                    </P>
                </FTNT>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>9</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Proposed CAT Fee Plan Amendment at 10-11.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) Establishing fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>10</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                </EXTRACT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                    </P>
                </FTNT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the development and implementation of the CAT.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>13</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(B) 75%/25% Allocation Between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>14</SU>
                    <FTREF/>
                     Under the CAT Funding Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>15</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 12-16. Note that, in the funding model set forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 16-20.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry Member based on message traffic.
                    <SU>16</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of 
                    <PRTPAGE P="25006"/>
                    all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21-22.
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>17</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>18</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>19</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 26-27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, 
                        <E T="03">see</E>
                         CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>21</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27-30.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>22</SU>
                    <FTREF/>
                     would have a discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>23</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>24</SU>
                    <FTREF/>
                     and (2) all message traffic for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         Section 1.1 of the CAT NMS Plan. Rule 4.5(ee) defines an “Options Market Maker” as “a broker-dealer registered with an exchange for the purpose of making markets in options contracts traded on the exchange.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 30-32.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 31.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.</P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>25</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>To implement the Options Market Maker discount, the Exchange proposes to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry 
                    <PRTPAGE P="25007"/>
                    Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>26</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <SU>27</SU>
                    <FTREF/>
                     regardless of where the order is ultimately routed or executed.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32-33.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio. The Equity Market Maker CAT fee then would be calculated by-multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>29</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 33.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic] discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>30</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT, would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 33-35.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>32</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 35-37.
                    </P>
                </FTNT>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that:</P>
                <EXTRACT>
                    <P>If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).</P>
                </EXTRACT>
                <P>
                    Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member 
                    <PRTPAGE P="25008"/>
                    CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.
                </P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>33</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 50-51.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4th of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <EXTRACT>
                    <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>34</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>35</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020-July 31, 2020) and certain costs from Period 2 of the Financial Accountability Milestones (which covered the period from August 1, 2020-December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 55-60.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4th of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.</P>
                <P>To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress 
                    <PRTPAGE P="25009"/>
                    Report,
                    <SU>36</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,17,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for
                            <LI>message traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>38</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 60-63.
                    </P>
                </FTNT>
                <P>Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message by 1/4th of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public accounting firm and making the statements publicly available.</P>
                <P>To implement the Period 3 CAT Fee, the Exchange proposes to add proposed paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and 
                    <PRTPAGE P="25010"/>
                    Regulatory Utilization of Transactional Database Functionality. As discussed above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <P>The following chart summarizes the imposition of the Period 3 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for
                            <LI>message traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 3 CAT Costs 
                            <E T="0731">39</E>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022</ENT>
                        <ENT>1st quarter of 2023.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (C) Period 4
                    <FTREF/>
                     CAT Fee
                </HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>40</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 63-65.
                    </P>
                </FTNT>
                <P>Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.</P>
                <P>To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the requirements set forth in Section 9.2 of the CAT NMS Plan.</P>
                <P>The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>
                    The following chart summarizes the imposition of the Period 4 CAT
                    <FTREF/>
                     Fee:
                </P>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <PRTPAGE P="25011"/>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for
                            <LI>message traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 4 CAT Costs 
                            <E T="0731">41</E>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(D) Quarterly CAT Fee—Beginning 2023</HD>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>42</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>43</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 65-68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 66.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses collected will be treated as an operational reserve to offset future fees and will not be distributed to the Participants as profits.
                    <SU>44</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for
                            <LI>message traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year.</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="25012"/>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>45</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (A) the Prime Rate plus 300 basis points, or (B) the maximum rate permitted by applicable law.
                    <SU>46</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 68-69.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 69.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>47</SU>
                    <FTREF/>
                     which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the Act,
                    <SU>48</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act,
                    <SU>49</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>50</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>51</SU>
                    <FTREF/>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities necessary or appropriate in furtherance of the purposes of this chapter,” 
                    <SU>52</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT fees equitably allocate CAT costs between Participants and Industry Members, and among Industry Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 70-79.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of 
                    <PRTPAGE P="25013"/>
                    CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.
                </P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>54</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its Members. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>55</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 78-79.
                    </P>
                </FTNT>
                <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>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>56</SU>
                    <FTREF/>
                     and paragraph (f) of Rule 19b-4 
                    <SU>57</SU>
                    <FTREF/>
                     thereunder. 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 will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         17 CFR 240.19b-4(f).
                    </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-CboeEDGX-2021-024 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-CboeEDGX-2021-024. 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. 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. All submissions should refer to File Number SR-CboeEDGX-2021-024 and 
                    <PRTPAGE P="25014"/>
                    should be submitted on or before
                    <FTREF/>
                     June 1, 2021.
                </FP>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         17 CFR 200.30-3(a)(12).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>58</SU>
                    </P>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09786 Filed 5-7-21; 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. 34-91766; File No. SR-Phlx-2021-27]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Expiration Date of the Temporary Amendments Concerning Video Conference Hearings</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 28, 2021, Nasdaq PHLX LLC (“Phlx” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I and II below, which Items have been substantially prepared by the Exchange. The Exchange has designated the proposed rule change as constituting a “non-controversial” rule change under paragraph (f)(6) of Rule 19b-4 under the Act,
                    <SU>3</SU>
                    <FTREF/>
                     which renders the proposal effective upon receipt of this filing by 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>
                         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>
                    The Exchange proposes to extend the expiration date of the temporary amendments in SR-Phlx-2020-53 from April 30, 2021, to August 31, 2021.
                    <SU>4</SU>
                    <FTREF/>
                     The proposed rule change would not make any changes to the text of the Exchange rules.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 90758 (Dec. 21, 2020), 85 FR 85782 (Dec. 29, 2020) (SR-Phlx-2020-53). If the Exchange seeks to provide additional temporary relief from the rule requirements identified in this proposed rule change beyond August 31, 2021, the Exchange will submit a separate rule filing to further extend the temporary extension of time. The amended Exchange rules will revert to their original form at the conclusion of the temporary relief period and any extension thereof.
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is available on the Exchange's website at 
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/phlx/rules,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    The Exchange proposes to continue to harmonize Exchange Rule General 3, Section 16 with recent changes by the Financial Industry Regulatory Authority, Inc. (“FINRA”) to its Rule 1015 in response to the COVID-19 global health crisis and the corresponding need to restrict in-person activities.
                    <SU>5</SU>
                    <FTREF/>
                     The Exchange originally filed proposed rule change SR-Phlx-2020-53, which allows the Exchange Review Council (“ERC”) to conduct hearings in connection with appeals of Membership Application Program decisions, on a temporary basis, by video conference, if warranted by the current COVID-19-related public health risks posed by an in-person hearing. While there are signs of improvement, the COVID-19 conditions necessitating the temporary amendments persist and, based on its assessment of current COVID-19 conditions and the lack of certainty as to when COVID-19-related health concerns and corresponding restrictions will meaningfully subside, the Exchange has determined that there is a continued need for this temporary relief for several months beyond April 30, 2021. Accordingly, the Exchange proposes to extend the expiration date of the temporary rule amendments in SR-Phlx-2020-53 from April 30, 2021, to August 31, 2021.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91495 (April 7, 2021), 86 FR 19306 (April 13, 2021) (SR-FINRA-2021-006) (“FINRA Filing”). The Exchange notes that the FINRA Filing also proposed to temporarily amend FINRA Rules 9261, 9524, and 9830, which govern hearings in connection with appeals of disciplinary actions, eligibility proceedings, and temporary and permanent cease and desist orders. The Exchange's Rules 9261, 9524, and 9830 incorporate by reference The Nasdaq Stock Market LLC rules, which are the subject of a separate filing. 
                        <E T="03">See</E>
                         SR-NASDAQ-2021-033 (April 28, 2021). Therefore, the Exchange is not proposing to adopt that aspect of the FINRA Filing.
                    </P>
                </FTNT>
                <P>As set forth in SR-Phlx-2020-53, the Exchange also relies on COVID-19 data and criteria to determine whether the current public health risks presented by an in-person hearing may warrant a hearing by video conference. Based on that data and criteria, the Exchange does not believe the COVID-19- related health concerns necessitating this relief will meaningfully subside by April 30, 2021, and has determined that there will be a continued need for this temporary relief for several months beyond that date. Accordingly, the Exchange proposes to extend the expiration date of the temporary rule amendments originally set forth in SR-Phlx-2020-53 from April 30, 2021, to August 31, 2021. The extension of the temporary amendments allowing for specified ERC hearings to proceed by video conference will allow the Exchange's critical adjudicatory functions to continue to operate effectively in these extraordinary circumstances—enabling the Exchange to fulfill its statutory obligations to protect investors and maintain fair and orderly markets—while also protecting the health and safety of hearing participants.</P>
                <P>The Exchange has filed the proposed rule change for immediate effectiveness and has requested that the SEC waive the requirement that the proposed rule change not become operative for 30 days after the date of the filing, so the Exchange can implement the proposed rule change immediately.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
                    <SU>6</SU>
                    <FTREF/>
                     in general, and furthers the objectives of Section 6(b)(5) of the Act,
                    <SU>7</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, by providing greater harmonization between the Exchange rules and FINRA rules of similar purpose, resulting in less burdensome and more efficient regulatory compliance.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See supra</E>
                         note 5.
                    </P>
                </FTNT>
                <PRTPAGE P="25015"/>
                <P>The proposed rule change, which extends the expiration date of the temporary amendments to the Exchange rules set forth in SR-Phlx-2020-53, will continue to aid the Exchange's efforts to timely conduct hearings in connection with its core adjudicatory functions. Given current COVID-19 conditions and the uncertainty around when those conditions will meaningfully improve, without this relief allowing ERC hearings to continue to proceed by video conference, such hearings may need to be postponed indefinitely. The Exchange must be able to perform its critical adjudicatory functions in order to fulfill its statutory obligations to protect investors and maintain fair and orderly markets. As such, this relief is essential to the Exchange's ability to fulfill its statutory obligations and allows hearing participants to avoid the serious COVID-19-related health and safety risks associated with in-person hearings.</P>
                <P>Among other things, this relief will allow the ERC to timely provide members, disqualified individuals and other applicants an approval or denial of their applications. As set forth in detail in SR-Phlx-2020-53, this temporary relief allowing ERC hearings to proceed by video conference accounts for fair process considerations and will continue to provide fair process while avoiding the COVID-19-related public health risks for hearing participants. Accordingly, the proposed rule change extending this temporary relief is in the public interest and consistent with the Act's purpose.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>The Exchange does not believe that the temporary proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. As set forth in SR-Phlx-2020-53, the proposed rule change is intended solely to extend temporary relief necessitated by the continued impacts of the COVID-19 outbreak and the related health and safety risks of conducting in-person activities. The Exchange believes that the proposed rule change will prevent unnecessary impediments to its operations, including its critical adjudicatory processes, and its ability to fulfill its statutory obligations to protect investors and maintain fair and orderly markets that would otherwise result if the temporary amendments were to expire on April 30, 2021.</P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    Because the foregoing 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)(iii) of the Act 
                    <SU>9</SU>
                    <FTREF/>
                     and subparagraph (f)(6) of Rule 19b-4 thereunder.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         15 U.S.C. 78s(b)(3)(A)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</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>11</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>12</SU>
                    <FTREF/>
                     the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Exchange has indicated that the proposed rule change to extend the expiration date will continue to prevent unnecessary impediments to its operations, including its critical adjudicatory processes, and its ability to fulfill its statutory obligations to protect investors and maintain fair and orderly markets that would otherwise result if the temporary amendments were to expire on April 30, 2021.
                    <SU>13</SU>
                    <FTREF/>
                     Importantly, extending the relief provided in Phlx-2020-53 immediately upon filing and without a 30-day operative delay will allow the Exchange to continue critical adjudicatory and review processes in a reasonable and fair manner and meet its critical investor protection goals, while also following best practices with respect to the health and safety of its employees.
                    <SU>14</SU>
                    <FTREF/>
                     The Commission also notes that this proposal extends without change the temporary relief previously provided by Phlx-2020-53,
                    <SU>15</SU>
                    <FTREF/>
                     and only during the period in which the Exchange's operations are impacted by COVID-19. As proposed, the changes would be in place through August 31, 2021 and the amended rules will revert back to their original state at the conclusion of the temporary relief period and, if applicable, any extension thereof.
                    <SU>16</SU>
                    <FTREF/>
                     For these reasons, the Commission believes that waiver of the 30-day operative delay for this proposal is consistent with the protection of investors and the public interest. Accordingly, the Commission hereby waives the 30-day operative delay and designates the proposal operative upon filing.
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         17 CFR 240.19b-4(f)(6)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See supra</E>
                         Item II.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         FINRA Filing, 86 FR at 19308 (noting the same in granting FINRA's request to waive the 30-day operative delay so that SR-FINRA-2021-006 would become operative immediately upon filing).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See supra</E>
                         note 4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See id.</E>
                         As noted above, the Exchange states that if it requires temporary relief from the rule requirements identified in this proposal beyond August 31, 2021, it may submit a separate rule filing to extend the effectiveness of the temporary relief under these rules.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         For purposes only of waiving the 30-day operative delay, the Commission has considered the proposed rule change'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-Phlx-2021-27 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>
                <PRTPAGE P="25016"/>
                <FP>
                    All submissions should refer to File Number SR-Phlx-2021-27. 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-Phlx-2021-27 and should be submitted on or before June 1, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>18</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09773 Filed 5-7-21; 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. 34-91761; File No. SR-CboeBYX-2021-011]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt a Fee Schedule to Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Cboe BYX Exchange, Inc. (“Exchange” or “BYX”) 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 the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    Cboe BYX Exchange, Inc. (the “Exchange” or “Cboe BYX”) proposes to adopt a fee schedule to establish fees for Industry Members related to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                     The text of the proposed rule change is provided in Exhibit 5.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in the CAT Compliance Rule. 
                        <E T="03">See</E>
                         Rules 4.5 through 4.17 of the Exchange's Rulebook. The Exchange and each of its affiliated exchanges (Cboe BZX Exchange, Inc., Cboe C2 Exchange, Inc., Cboe Exchange, Inc., Cboe EDGA Exchange, Inc., and Cboe EDGX Exchange, Inc.) are filing to adopt the CAT fee schedule.
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is also available on the Exchange's website (
                    <E T="03">http://markets.cboe.com/us/equities/regulation/rule_filings/byx/</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 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>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the Securities and Exchange Commission (“SEC” or “Commission”) a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are Members in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Rel. No. 91555 (Apr. 14, 2021), 86 FR 21050 (April 21, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant quarter (“Total CAT Costs”).
                    <SU>7</SU>
                    <FTREF/>
                     The CAT Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4, 56-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 4.
                    </P>
                </FTNT>
                <PRTPAGE P="25017"/>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>9</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Proposed CAT Fee Plan Amendment at 10-11.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) Establishing fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>10</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                        <SU>11</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                        </P>
                    </FTNT>
                      
                </EXTRACT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the development and implementation of the CAT.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>13</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(B) 75%/25% Allocation Between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>14</SU>
                    <FTREF/>
                     Under the CAT Funding Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>15</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 12-16. Note that, in the funding model set forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 16-20.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry Member based on message traffic.
                    <SU>16</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are 
                    <PRTPAGE P="25018"/>
                    calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21-22.
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>17</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>18</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>19</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 26-27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, 
                        <E T="03">see</E>
                         CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>21</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27-30.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>22</SU>
                    <FTREF/>
                     would have a discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>23</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>24</SU>
                    <FTREF/>
                     and (2) all message traffic for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         Section 1.1 of the CAT NMS Plan. Rule 4.5(ee) defines an “Options Market Maker” as “a broker-dealer registered with an exchange for the purpose of making markets in options contracts traded on the exchange.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 30-32.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 31.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.</P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>25</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>To implement the Options Market Maker discount, the Exchange proposes to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>26</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <FTREF/>
                    <SU>27</SU>
                      
                    <PRTPAGE P="25019"/>
                    regardless of where the order is ultimately routed or executed.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32-33.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the 
                        <PRTPAGE/>
                        Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 32.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio. The Equity Market Maker CAT fee then would be calculated by-multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>29</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 33.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic] discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>30</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT, would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage.
                    <SU>31</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 33-35.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>32</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 35-37.
                    </P>
                </FTNT>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that:</P>
                <EXTRACT>
                    <P>If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).</P>
                </EXTRACT>
                <P>Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.</P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs 
                    <PRTPAGE P="25020"/>
                    for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>33</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 50-51.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4th of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <EXTRACT>
                    <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>34</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>35</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020-July 31, 2020) and certain costs from Period 2 of the Financial Accountability Milestones (which covered the period from August 1, 2020-December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 55-60.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4th of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.</P>
                <P>To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>36</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the 
                    <PRTPAGE P="25021"/>
                    CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,12,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry 
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for message 
                            <LI>traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>38</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 60-63.
                    </P>
                </FTNT>
                <P>Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message by 1/4th of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public accounting firm and making the statements publicly available.</P>
                <P>To implement the Period 3 CAT Fee, the Exchange proposes to add proposed paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and Regulatory Utilization of Transactional Database Functionality. As discussed 
                    <PRTPAGE P="25022"/>
                    above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <P>
                    The following chart summarizes the imposition of the Period 3 CAT Fee:
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 3 CAT Costs 
                            <SU>39</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022</ENT>
                        <ENT>1st quarter of 2023.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(C) Period 4 CAT Fee</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>40</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 63-65.
                    </P>
                </FTNT>
                <P>Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.</P>
                <P>To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the requirements set forth in Section 9.2 of the CAT NMS Plan.</P>
                <P>The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>
                    The following chart summarizes the imposition of the Period 4 CAT Fee:
                    <PRTPAGE P="25023"/>
                </P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">
                            CAT data used for message traffic
                            <LI>calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 4 CAT Costs 
                            <SU>41</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (D) Quarterly CAT Fee—Beginning 2023
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>42</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>43</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 65-68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 66.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses collected will be treated as an operational reserve to offset future fees and will not be distributed to the Participants as profits.
                    <SU>44</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry 
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for
                            <LI>message traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="25024"/>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>45</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (A) the Prime Rate plus 300 basis points, or (B) the maximum rate permitted by applicable law.
                    <SU>46</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 68-69.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 69.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>47</SU>
                    <FTREF/>
                     which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the Act,
                    <SU>48</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act,
                    <SU>49</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>50</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>51</SU>
                    <FTREF/>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities necessary or appropriate in furtherance of the purposes of this chapter,” 
                    <SU>52</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT fees equitably allocate CAT costs between Participants and Industry Members, and among Industry Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the 
                    <PRTPAGE P="25025"/>
                    imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 70-79.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct
                </P>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.</P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>54</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its Members. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>55</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 78-79.
                    </P>
                </FTNT>
                <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>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>56</SU>
                    <FTREF/>
                     and paragraph (f) of Rule 19b-4 
                    <SU>57</SU>
                    <FTREF/>
                     thereunder. 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 will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         17 CFR 240.19b-4(f).
                    </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-CboeBYX-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>
                <PRTPAGE P="25026"/>
                <FP>
                    All submissions should refer to File Number SR-CboeBYX-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 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. 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. All submissions should refer to File Number SR-CboeBYX-2021-011 and should be submitted on or before June 1, 2021.
                    <FTREF/>
                </FP>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         17 CFR 200.30-3(a)(12).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>58</SU>
                    </P>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09768 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <SUBJECT>Sunshine Act Meeting; Cancellation</SUBJECT>
                <PREAMHD>
                    <HD SOURCE="HED">FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT:</HD>
                    <P> 86 FR 24059, May 5, 2021.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING:</HD>
                    <P> Friday, May 7, 2021 at 1:00 p.m.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">CHANGES IN THE MEETING:</HD>
                    <P>The Closed Meeting scheduled for Friday, May 7, 2021 at 1:00 p.m., has been cancelled.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">CONTACT PERSON FOR MORE INFORMATION:</HD>
                    <P>For further information; please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.</P>
                </PREAMHD>
                <SIG>
                    <DATED>Dated: May 6, 2021.</DATED>
                    <NAME>Vanessa A. Countryman,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09940 Filed 5-6-21; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-91767; File No. SR-CBOE-2021-029]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing of a Proposed Rule Change To Increase Position Limits for Options on Certain Exchange-Traded Funds and an Exchange-Traded Note</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Cboe Exchange, Inc. (“Exchange” or “Cboe Options”) 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 the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to increase position limits for options on certain exchange-traded funds (“ETFs”) and exchange-traded notes (“ETNs”). 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 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>Position limits are designed to address potential manipulative schemes and adverse market impacts surrounding the use of options, such as disrupting the market in the security underlying the options. While position limits should address and discourage the potential for manipulative schemes and adverse market impact, if such limits are set too low, participation in the options market may be discouraged. The Exchange believes that position limits must therefore be balanced between mitigating concerns of any potential manipulation and the cost of inhibiting potential hedging activity that could be used for legitimate economic purposes.</P>
                <P>
                    The Exchange has observed an ongoing increase in demand, for both trading and hedging purposes, in options on the following exchange-traded products (“ETPs”): (1) SPDR Gold Shares (“GLD”), (2) iShares Silver Trust (“SLV”), (3) iShares iBoxx $ Investment Grade Corporate Bond ETF (“LQD”), (4) VanEck Vectors Gold Miners ETF (“GDX”), (5) iPath S&amp;P 500 VIX Short-Term Futures ETN (“VXX”), and (6) ProShares Ultra VIX Short-Term Futures ETF (“UVXY”, and collectively, with the aforementioned ETFs, the “Underlying ETPs”). Though the demand for these options appears to have increased, position limits for options on the Underlying ETPs have remained the same. The Exchange believes these unchanged position limits may have impeded, and may continue to impede, trading activity and strategies of investors, such as use of effective hedging vehicles or income generating strategies (
                    <E T="03">e.g.,</E>
                     buy-write or put-write), and the ability of Market-Makers to make liquid markets with tighter spreads in these options resulting in the transfer of volume to over-the-counter (“OTC”) markets. OTC transactions occur through bilateral agreements, the terms of which are not publicly disclosed to the marketplace. As such, OTC transactions do not contribute to the price discovery process on a public exchange or other lit markets. Therefore, the Exchange believes that the proposed increases in 
                    <PRTPAGE P="25027"/>
                    position limits for options on the Underlying ETPs may enable liquidity providers to provide additional liquidity to the Exchange and other market participants to transfer their liquidity demands from OTC markets to the Exchange. As described in further detail below, the Exchange believes that the continuously increasing market capitalization of the Underlying ETPs, ETP component securities, as well as the highly liquid markets for those securities, reduces the concerns for potential market manipulation and/or disruption in the underlying markets upon increasing position limits, while the rising demand for trading options on the Underlying ETPs for legitimate economic purposes compels an increase in position limits.
                </P>
                <HD SOURCE="HD3">Proposed Position Limits for Options on the Underlying ETPs</HD>
                <P>
                    Position limits for options on ETPs are determined pursuant to Rule 8.30 and vary according to the number of outstanding shares and the trading volumes of the underlying stocks or ETPs over the past six months. Pursuant to Rule 8.30, the largest in capitalization and the most frequently traded stocks and ETPs have an option position limit of 250,000 contracts (with adjustments for splits, re-capitalizations, etc.) on the same side of the market; and smaller capitalization stocks and ETPs have position limits of 200,000, 75,000, 50,000 or 25,000 contracts (with adjustments for splits, re-capitalizations, etc.) on the same side of the market. Options on GLD, SLV, LQD, GDX, VXX and UVXY are currently subject to the standard position limit of 250,000 contracts as set forth in Rule 8.30. Rule 8.30.07 sets forth separate, higher position limits for options on specific ETPs. The Exchange proposes to amend Rule 8.30.07 to increase the position limits and, as a result, exercise limits, for options on each of GLD, SLV, LQD,GDX, VXX and UVXY.
                    <SU>3</SU>
                    <FTREF/>
                     The table below represents the current, and proposed, position limits for options on the ETPs subject to this proposal:
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         By virtue of [sic] 8.42.02, which is not being amended by this filing, the exercise limits for GLD, SLV, LQD, GDX, VXX and UVXY options would be similarly increased.
                    </P>
                </FTNT>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s25,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Product</CHED>
                        <CHED H="1">
                            Current 
                            <LI>position </LI>
                            <LI>limit</LI>
                        </CHED>
                        <CHED H="1">
                            Proposed 
                            <LI>position </LI>
                            <LI>limit</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">GLD</ENT>
                        <ENT>250,000</ENT>
                        <ENT>1,000,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SLV</ENT>
                        <ENT>250,000</ENT>
                        <ENT>500,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LQD</ENT>
                        <ENT>250,000</ENT>
                        <ENT>500,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GDX</ENT>
                        <ENT>250,000</ENT>
                        <ENT>500,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VXX</ENT>
                        <ENT>250,000</ENT>
                        <ENT>500,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UVXY</ENT>
                        <ENT>250,000</ENT>
                        <ENT>500,000</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    The Exchange notes that the proposed position limit for options on GLD is consistent with existing position limits for options on the iShares Russell 2000 ETF (“IWM”), the iShares MSCI Emerging Markets ETF (“EEM”), iShares China Large-Cap ETF (“FXI”) and iShares MSCI EAFE ETF (“EFA”), while the proposed limits for options on LQD, SLV and GDX are consistent with current position limits for options on the iShares MSCI Brazil Capped ETF (“EWZ”), iShares 20+ Year Treasury Bond Fund ETF (“TLT”), iShares MSCI Japan ETF (“EWJ”), iShares iBoxx High Yield Corporate Bond Fund (“HYG”) and Financial Select Sector SPDR Fund (“XLF”). The Exchange represents that the Underlying ETPs qualify for either (1) the initial listing criteria set forth in Rule 4.3.06(c) for ETFs holding non-U.S. component securities, (2) generic listing standards for series of portfolio depository receipts and index fund shares based on international or global indexes under which a comprehensive surveillance agreement (“CSA”) is not required, or (3) the initial listing criteria set forth in Rule 4.3.13(c) for ETNs (or, Index-Linked Securities), as well as the continued listing criteria in Rule 4.4 (for ETFs) 
                    <SU>4</SU>
                    <FTREF/>
                     and Rule 4.4.14 (for ETNs). In compliance with its listing rules, the Exchange also represents that non-U.S. component securities that are not subject to a comprehensive surveillance agreement (“CSA”) do not, in the aggregate, represent more than more than 50% of the weight of any of the Underlying ETPs that are ETFs.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         The Exchange notes that the initial listing criteria for options on ETFs that hold non-U.S. component securities are more stringent than the maintenance listing criteria for those same ETF options. 
                        <E T="03">See</E>
                         Rule 4.3.06(c); Rule 4.4.06.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Rule 4.3.06(c).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Composition and Growth Analysis for Underlying ETPs</HD>
                <P>
                    As stated above, position (and exercise) limits are intended to prevent the establishment of options positions that can be used to or potentially create incentives to manipulate the underlying market so as to benefit options positions. The Securities and Exchange Commission (the “Commission”) has recognized that these limits are designed to minimize the potential for mini-manipulations and for corners or squeezes of the underlying market, as well as serve to reduce the possibility for disruption of the options market itself, especially in illiquid classes.
                    <SU>6</SU>
                    <FTREF/>
                     The Underlying ETPs, as well as the ETP components, are highly liquid and are based on a broad set of highly liquid securities and other reference assets, as demonstrated through the trading statistics presented in this proposal. To support the proposed position limit increases, the Exchange considered the liquidity of the Underlying ETPs, the value of the underlying securities or index components and relevant marketplace, the share and option volume for the Underlying ETPs, and, where applicable, the availability or comparison of economically equivalent products to options on the Underlying ETPs.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 67672 (August 15, 2012), 77 FR 50750 (August 22, 2012) (SR-NYSEAmex-2012-29).
                    </P>
                </FTNT>
                <PRTPAGE P="25028"/>
                <P>The Exchange has collected the following trading statistics regarding shares of and options on the Underlying ETPs and the values of the Underlying ETPs and their component securities or index components, as applicable:</P>
                <GPOTABLE COLS="6" OPTS="L2,tp0,i1" CDEF="s25,15,15,15,15,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Product</CHED>
                        <CHED H="1">
                            ADV 
                            <SU>7</SU>
                            <LI>(ETF shares) </LI>
                            <LI>(millions)</LI>
                        </CHED>
                        <CHED H="1">
                            ADV
                            <LI>(option contracts)</LI>
                        </CHED>
                        <CHED H="1">
                            Shares 
                            <LI>outstanding </LI>
                            <LI>
                                (millions) 
                                <SU>8</SU>
                            </LI>
                        </CHED>
                        <CHED H="1">
                            Fund 
                            <LI>market cap</LI>
                            <LI>
                                (USD) (millions) 
                                <SU>9</SU>
                            </LI>
                        </CHED>
                        <CHED H="1">
                            Share value 
                            <SU>10</SU>
                             (USD)
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">GLD</ENT>
                        <ENT>12.3</ENT>
                        <ENT>257,700</ENT>
                        <ENT>354.30</ENT>
                        <ENT>70,195.7</ENT>
                        <ENT>161.71 (NAV).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SLV</ENT>
                        <ENT>33.1</ENT>
                        <ENT>376,700</ENT>
                        <ENT>619.3</ENT>
                        <ENT>14,228.4</ENT>
                        <ENT>22.57 (NAV).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">LQD</ENT>
                        <ENT>14.1</ENT>
                        <ENT>30,300</ENT>
                        <ENT>308.1</ENT>
                        <ENT>54,113.7</ENT>
                        <ENT>130.13 (NAV).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">GDX</ENT>
                        <ENT>39.4</ENT>
                        <ENT>166,000</ENT>
                        <ENT>419.8</ENT>
                        <ENT>16,170.5</ENT>
                        <ENT>33.80 (NAV).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">VXX</ENT>
                        <ENT>39.3</ENT>
                        <ENT>289,800</ENT>
                        <ENT>110.8</ENT>
                        <ENT>1,023.</ENT>
                        <ENT>10.31 (Closing Indicative Value).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">UVXY</ENT>
                        <ENT>29.3</ENT>
                        <ENT>113,500</ENT>
                        <ENT>228.7</ENT>
                        <ENT>1,580.6</ENT>
                        <ENT>4.85 (NAV).</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    The
                    <FTREF/>
                     Exchange has collected the same trading statistics, where applicable, as above regarding a sample of other ETPs, as well as the current position limits for options on such ETPs pursuant to Rule 8.30.07, to draw comparisons in support of proposed position limit increases for options on the Underlying ETPs (see further discussion below):
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Average daily volume (ADV) data for ETP shares and option contracts, as well as for ETF shares and options on the comparative ETFs presented below, are for all of 2020. Additionally, reference to ADV in ETP shares and ETP options, and indexes herein this proposal are for all of calendar year 2020, unless otherwise indicated.
                    </P>
                    <P>
                        <SU>8</SU>
                         Shares Outstanding and Net Asset Values (“NAV”), as well as for the comparative ETPs presented below, are as of April 5, 2021 for all ETPs except for VXX and UVXY, which are as of April 14, 2021.
                    </P>
                    <P>
                        <SU>9</SU>
                         Fund Market Capitalization data, as well as for the comparative ETPs presented below, are as of January 14, 2021.
                    </P>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See supra</E>
                         note 8.
                    </P>
                </FTNT>
                <GPOTABLE COLS="7" OPTS="L2,tp0,i1" CDEF="s25,12,14,12,14,r25,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Product</CHED>
                        <CHED H="1">
                            ADV
                            <LI>(ETF shares) </LI>
                            <LI>(millions)</LI>
                        </CHED>
                        <CHED H="1">
                            ADV
                            <LI>(option contracts)</LI>
                        </CHED>
                        <CHED H="1">
                            Shares 
                            <LI>outstanding </LI>
                            <LI>(millions)</LI>
                        </CHED>
                        <CHED H="1">
                            Fund 
                            <LI>market cap</LI>
                            <LI>(USD) (millions)</LI>
                        </CHED>
                        <CHED H="1">Share value (USD)</CHED>
                        <CHED H="1">
                            Current 
                            <LI>position </LI>
                            <LI>limits</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">EEM</ENT>
                        <ENT>55.9</ENT>
                        <ENT>284,700</ENT>
                        <ENT>581.4</ENT>
                        <ENT>30,262.2</ENT>
                        <ENT>53.79 (NAV)</ENT>
                        <ENT>1,000,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FXI</ENT>
                        <ENT>24.6</ENT>
                        <ENT>128,900</ENT>
                        <ENT>91.2</ENT>
                        <ENT>4,398.9</ENT>
                        <ENT>47.60 (NAV)</ENT>
                        <ENT>1,000,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EFA</ENT>
                        <ENT>29.6</ENT>
                        <ENT>130,900</ENT>
                        <ENT>719.4</ENT>
                        <ENT>53,808.1</ENT>
                        <ENT>77.02 (NAV)</ENT>
                        <ENT>1,000,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EWZ</ENT>
                        <ENT>29.2</ENT>
                        <ENT>139,400</ENT>
                        <ENT>173.8</ENT>
                        <ENT>6,506.8</ENT>
                        <ENT>33.71 (NAV)</ENT>
                        <ENT>500,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TLT</ENT>
                        <ENT>11.5</ENT>
                        <ENT>111,800</ENT>
                        <ENT>103.7</ENT>
                        <ENT>17,121.3</ENT>
                        <ENT>136.85 (NAV)</ENT>
                        <ENT>500,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EWJ</ENT>
                        <ENT>8.2</ENT>
                        <ENT>15,500</ENT>
                        <ENT>185.3</ENT>
                        <ENT>13,860.7</ENT>
                        <ENT>69.72 (NAV)</ENT>
                        <ENT>500,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">HYG</ENT>
                        <ENT>30.5</ENT>
                        <ENT>261,600</ENT>
                        <ENT>254.5</ENT>
                        <ENT>24,067.5</ENT>
                        <ENT>86.86 (NAV)</ENT>
                        <ENT>500,000</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The Exchange believes that, overall, the liquidity in the shares of the Underlying ETPs and in their overlying options, the larger market capitalizations for each of the Underlying ETPs, and the overall market landscape relevant to each of the Underlying ETPs support the proposal to increase the position limits for each option class. Given the robust liquidity in and value of the Underlying ETPs and their component securities, the Exchange does not anticipate that the proposed increase in position limits would create significant price movements as the relevant markets are large enough to adequately absorb potential price movements that may be caused by larger trades.</P>
                <P>
                    Specifically, the investment objective of GLD (also known as SPDR Gold Trust, or the “Trust”) is to track the performance of the price of gold bullion.
                    <SU>11</SU>
                    <FTREF/>
                     GLD offers investors an innovative, relatively cost efficient and secure way to access the gold market, without the necessity of taking physical delivery of gold, and to buy and sell that interest through the trading of a security on a regulated stock exchange. SPDR Gold Shares represent fractional, undivided beneficial ownership interests in the Trust, the sole assets of which are gold bullion. The spot price for gold is determined by market forces in the 24-hour global OTC market for gold including spot, forwards, and options and other derivatives, together with exchange-traded futures and options. The Net Asset Value (“NAV”) of the Trust is calculated based on the total ounces of gold owned by the Trust valued at the London Bullion Market Association (“LBMA”) Gold Price PM of that day (plus any cash held by the Trust less accrued expenses).
                    <SU>12</SU>
                    <FTREF/>
                     The Exchange has observed that the ADV in GLD shares has increased from approximately 8.7 million shares in 2019 to 12.3 million shares by the end of 2020. Similarly, the ADV in options on GLD has increased from approximately 153,900 option contracts in 2019 to 257,700 option contracts by the end of 2020. The Exchange also notes that in the first quarter of 2021, GLD options experienced an ADV of approximately 395,100 option contracts. Additionally, comparing the statistics shown in the tables above for GLD and the sample of other ETFs with a current position limit of 1,000,000 contracts, the Exchange notes that the ADV for GLD options (257,700 option contracts) are more, or just as, liquid as EEM options (284,700 option contracts), FXI options (128,900 option contracts) and EFA options (130,900 option contracts). Also, as indicated in the table above, GLD's market capitalization (approximately $70.2 billion) is higher than all three of these comparable ETFs, and, in addition to this, the Exchange notes that the NAV of GLD is higher than that of the NAV of EEM, FXI and EFA, which is indicative that the total value of its underlying components is generally higher. The Exchange believes that GLD's share and option volume, its market capitalization, and the comparatively high value of its underlying components (as indicated by its NAV) are large enough to absorb potential price movements caused by a large trade in GLD.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         SPDR Gold Shares, available at 
                        <E T="03">https://www.ssga.com/us/en/intermediary/etfs/funds/spdr-gold-shares-gld</E>
                         (January 11, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See</E>
                         State Street Global Advisors, SPDR Gold Trust GLD, FAQ (July 2020), available at 
                        <E T="03">https://www.ssga.com/library-content/products/fund-docs/etfs/us/tax-documents/gld-faq.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    Like that of GLD and spot gold, SLV seeks to reflect generally the performance of the price of silver and represents a cost-efficient alternative to investments in physical silver for 
                    <PRTPAGE P="25029"/>
                    investors not otherwise in a position to participate directly in the market for physical silver. The SLV's NAV is derived from its holdings in silver valued on the basis of the daily LBMA Silver Price.
                    <SU>13</SU>
                    <FTREF/>
                     SLV, too, has experienced a significant increase in AVD [sic] in shares and options from 2019 through 2020. It grew from approximately 13.6 million shares in 2019 to 33.1 million shares by the end of 2020, and from approximately 118,800 option contracts in 2019 to 376,700 option contracts by the end of 2020. The Exchange also notes that SLV options experienced in ADV of approximately 1.1 million option contracts in the first quarter of 2021.
                    <SU>14</SU>
                    <FTREF/>
                     Additionally, SLV generally experiences a significantly greater ADV in shares (33.1 million share) and in options (376,700 option contracts) than that of the ADV in shares and options for EWZ (29.2 million shares and 139,300 option contracts), TLT (11.5 million shares and 111,800 option contracts), EWJ (8.2 million shares and 15,500 option contracts) and HYG (30.5 million shares and 261,600 option contracts), and also has a comparable, or higher, market capitalization (approximately $14.2 billion) than EWZ, TLT and EWJ. As per the table above, options on each of these ETFs already have a position limit of 500,000 contracts — the proposed position limit for SLV options. The Exchange believes that SLV's share and option volume and its market capitalization are large enough to absorb potential price movements caused by a large trade in SLV.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See</E>
                         iShares Silver Trust, Fact Sheet as of 9/20/2020, available at 
                        <E T="03">https://www.ishares.com/us/literature/fact-sheet/slv-ishares-silver-trust-fund-fact-sheet-en-us.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         While volume in SLV options in the first quarter of 2021 experienced significantly high volume as a result of unusual market conditions, the Exchange believes that the existing possibility of such significant increases supports the proposed position limit increase.
                    </P>
                </FTNT>
                <P>
                    While the demand for options trading on GLD and SLV has evidently increased, and continues to increase, the position limits have remained the same, which the Exchange believes may be impacting the ability of Trading Permit Holders (“TPHs”) to effectively hedge against exposure to physical gold and silver. For example, a single TPH may manage groups of mutual funds (
                    <E T="03">i.e.,</E>
                     a fund complex), each of which may have different growth objectives. If one portfolio manager with a large group of funds has a relatively small exposure to spot gold or spot silver, they may hedge such exposure using GLD options or SLV options, respectively. Though relatively small, this hedge (up to 250,00 [sic] option contracts for GLD and for SLV) may utilize the TPH's entire capacity against the position limit. As a result, the TPH's other portfolio managers must look to use alternative vehicles to hedge gold or silver exposure for the funds under their management. The Exchange understands that, unlike GLD or SLV options, most of these alternatives hedging vehicles are not a perfect hedge, which creates liquidity issues and results in increased trading costs. As a result, the Exchange believes that the proposed position limit increases for both GLD and SLV options will allow TPHs to effectively hedge their total gold or silver exposure without having to seek other, less precise hedging vehicles.
                </P>
                <P>
                    LQD tracks the performance of the Markit iBoxx USD Liquid Investment Grade (“IBOXIG”) Index, which is an index designed as a subset of the broader U.S. dollar-denominated corporate bond market which can be used as a basis for tradable products, such as ETFs, and is comprised of over 8,000 bonds.
                    <SU>15</SU>
                    <FTREF/>
                     The Exchange notes that from 2019 through 2020, ADV has grown significantly in shares of LQD and in options on LQD, from approximately 9.7 million shares in 2019 to 14.1 million through 2020, and from approximately 8,200 option contracts in 2019 to 30,300 through 2020. LQD also continued to experience significant growth in ADV in the first quarter of 2021 with an ADV of approximately 140,200 option contracts. Further, LQD generally experiences higher ADV in shares than both TLT (11.5 million shares) and EWJ (8.2 million shares) and almost double the ADV in option contracts than EWJ (15,500 option contracts). Options on each EWZ, TLT and EWJ are currently subject to a position limit of 500,000 contracts—the proposed limit for options on LQD. The NAV of LQD is also higher than, or comparable to, that of the NAV of the ETFs underlying the options that are currently subject to a position limit of 500,000 option contracts (as presented in the table above), which is indicative that the total value of its underlying components is generally higher or comparable. Per the tables above, LQD's total market capitalization of approximately $54.1 billion is also higher than or comparable to the total market capitalization of the ETFs underlying the options currently subject to a position limit of 5000,000 [sic] contracts. In addition to this, the Exchange notes that, although there are currently no options listed for trading on the IBOXIG Index, the components 
                    <SU>16</SU>
                    <FTREF/>
                     of the IBOXIG Index, which can be used in creating a basket of securities that equate to the LQD ETF, are made up of over 8,000 bonds for which the outstanding face value of each must be greater than or equal to $2 billion.
                    <SU>17</SU>
                    <FTREF/>
                     The Exchange believes that the total value of the bonds in the IBOXIG Index, coupled with LQD's share and option volume, total market capitalization, and NAV price indicates that the market is large enough to absorb potential price movements caused by a large trade in LQD. Also, as evidenced above, trading volume in LQD shares has increased over the past few years and the Exchange understands that market participants' need for options have continued to grow alongside the ETF. Particularly, the Exchange notes that in the last year, market participants have sought more cost-effective hedging strategies through the use of LQD options as a result of the borrow on other fixed income ETFs, such as HYG. Therefore, the Exchange believes that because LQD options are being increasingly utilized as an alternative to similar products, such as HYG options, then it is appropriate that options on LQD be subject to the same 500,000 contract position limit that currently exists for options on HYG.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         Markit iBoxx USD Liquid Investment Grade Index, available at 
                        <E T="03">https://cdn.ihsmarkit.com/www/pdf/MKT-iBoxx-USD-Liquid-Investment-Grade-Index-factsheet.pdf</E>
                         (January 14, 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         Investment grade corporate bonds.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See supra</E>
                         note 14.
                    </P>
                </FTNT>
                <P>
                    GDX seeks to replicate as closely as possible the price and yield performance of the NYSE Arca Gold Miners (“GDMNTR”) Index, which is intended to track the overall performance of companies involved in the gold mining industry.
                    <SU>18</SU>
                    <FTREF/>
                     ADV in GDX options has increased from 2019 through 2020, with an ADV of approximately 117,400 option contracts in 2019 to an ADV of approximately 166,000 option contracts in 2020. The Exchange notes that ADV in GDX shares did not increase from 2019 to 2020. GDX options also experienced an ADV of approximately 287,800 option contracts in the first quarter of 2021. The Exchange notes that the ADV in GDX shares (39.4 million) and options on GDX (166,000 option contracts) are greater than the ADV in EWZ (29.2 million shares and 139,300 option contracts), TLT (11.5 million shares and 111,800 option contracts), EWJ (8.2 million shares and 15,500 option contracts) and HYG (30.5 million shares 
                    <PRTPAGE P="25030"/>
                    and 261,600 option contracts), each of which is currently subject to a position limit of 500,000 option contracts—the proposed limit for options on GDX. GDX also experiences a comparable, or higher, market capitalization (approximately $16.2 billion) than EWZ, TLT and EWZ. Additionally, like that of LDQ above, there is currently no index option analogue for the GDX ETF on the GDMNTR Index approved for options trading, however, the components of the GDMNTR Index, which can be used to create the GDX ETF, currently must each have a market capitalization greater than $750 million, an ADV of at least 50,000 shares, and an average daily value traded of at least $1 million in order to be eligible for inclusion in the GDMNTR Index. The Exchange believes that the GDMNTR Index component inclusion requirements, as well as GDX's share and option volume and total market capitalization, indicate that the GDX market is sufficiently large and liquid enough to absorb price movements as a result of potentially oversized trades.
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         VanEck Vectors Gold Miners ETF, available at 
                        <E T="03">https://www.vaneck.com/library/vaneck-vectors-etfs/gdx-fact-sheet-pdf/</E>
                         (January 14, 2021).
                    </P>
                </FTNT>
                <P>
                    VXX ETNs (which are unsecured debt obligations of the issuer) 
                    <SU>19</SU>
                    <FTREF/>
                     are designed to provide exposure to the S&amp;P 500 VIX Short-Term Futures Index Total Return (“SPVXSTR”). The SPVXSTR Index is designed to provide access to equity market volatility through Cboe Volatility (“VIX”) Index futures by offering exposure to a daily rolling long position in the first and second month VIX futures contracts. The SPVXSTR Index generally reflects market participants' views of the future direction of the VIX Index at the time of expiration of the VIX futures contracts comprising the index.
                    <SU>20</SU>
                    <FTREF/>
                     VXX volume has increased over the last years, growing from an ADV of approximately 28.6 million shares and 179,200 option contracts in 2019 to an ADV of approximately 39.3 million shares and 289,800 option contracts in 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Barclays Bank PLC.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See</E>
                         iPath Series B S&amp;P 500 VIX Short-Term Futures ETN, Product Summary (April 13, 2021), available at: 
                        <E T="03">https://www.ipathetn.com/US/16/en/details.app?instrumentId=341408.</E>
                    </P>
                </FTNT>
                <P>Similarly, the UVXY ETF provides leveraged exposure to the S&amp;P 500 VIX Short-Term Futures (“SPVXSPID”) Index. Like the SPVXSTR Index, the SPVXSPID Index measures the returns of a portfolio of monthly VIX futures contracts that rolls positions from first-month contracts into second-month contracts on a daily basis and maintains a weighted average of one month to expiration. UVXY volume has increased significantly from 2019 through 2020—from an ADV of approximately 12 million shares and 73,700 option contracts in 2019 to an ADV of approximately 29.3 million shares and 113,500 option contracts in 2020.</P>
                <P>
                    Both VXX and UVXY experience an ADV in shares and option contracts that is greater than, or comparable to, ADV in shares and/or option contracts for EWZ (29.2 million shares and 139,400 option contracts), TLT (11.5 million shares and 111,800 option contracts), EWJ (8.2 million shares and 15,500 option contracts), and HYG (30.5 million shares). As stated, options on EWZ, TLT, EWJ and HYG are all currently subject to the same position limit (500,000 option contracts) proposed for VXX and UVXY options. The Exchange also notes that, while VIX options share similar trading characteristics with options on VXX and UVXY, VIX options are not currently subject to position limits.
                    <SU>21</SU>
                    <FTREF/>
                     Moreover, the 2020 ADV for trading in VIX futures was approximately 192,000 contracts and VIX futures currently have a value of approximately $7.6 billion in open interest. The Exchange believes that the ADV in shares of and options on VXX and UXVY, along with the robust market that exists for the underlying index components (VIX futures) in connection with both ETPs, indicates that the market for these ETPs is sufficiently large and liquid enough to absorb price movements and large- sized trades. In addition to this, both the VXX and UVXY are used as key indicators of the health of the global volatility market. The VIX futures that comprise each product are a perfect hedge to the underlying delta risk; however, such futures are not recognized as hedges for options contract equivalent of the net delta (“OCEND”) purposes. A TPH that is not delta neutral must be hedged to the extent that the OCEND stays within the applicable position limit. The Exchange understands that due to the OCEND limitations and current position limits for options on VXX and UVXY, TPHs must hedge with options and buy or create shares of the underlying ETPs despite already having a hedge on their position via the component futures. As a result, TPHs may be unable to provide the most concise pricing to customers participating in these ETPs due to the increased costs associated with transacting in additional or alternative hedging vehicles in order to comply with the position limits currently in place. The Exchange also believes that the approximate value of open interest in VIX futures ($7.6 billion) potentially necessitates substantial hedging capacity as both ETPs provide exposure to volatility trading based on VIX futures.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Rule 8.31.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Creation and Redemption for ETPs</HD>
                <P>
                    The Exchange believes that the creation and redemption process for the ETFs and ETN subject to this proposal (VXX) will lessen the potential for manipulative activity with options on the Underlying ETPs. Regarding ETFs, when an ETF provider wants to create more shares, it looks to an Authorized Participant (generally a market maker or other large financial institution) to acquire the securities the ETF is to hold. For instance, when an ETF is designed to track the performance of an index, the Authorized Participant can purchase all the constituent securities in the exact same weight as the index, then deliver those shares to the ETF provider. In exchange, the ETF provider gives the Authorized Participant a block of equally valued ETF shares, on a one-for-one fair value basis. The price is based on the NAV, not the market value at which the ETF is trading. The creation of new ETF units can be conducted during an entire trading day and is not subject to position limits. This process works in reverse where the ETF provider seeks to decrease the number of shares that are available to trade. Regarding the process for the ETN subject to this proposal, VXX, investors may redeem VXX shares on any redemption date,
                    <SU>22</SU>
                    <FTREF/>
                     provided that the minimum amount of VXX shares redeemed is at least 25,000 shares. Investors redeeming VXX shares receive a cash payment equal to the applicable closing indicative value on the applicable valuation date (less the redemption fee). While there is no direct analogue to an ETF “creation” for an ETN, the ETN issuer may sell additional VXX shares from its inventory.
                    <SU>23</SU>
                    <FTREF/>
                     In order to redeem existing VXX shares or issue new VXX shares, the issuer may transact in VIX futures (selling VIX futures in the case of a VXX redemption, and purchasing VIX futures in the case of issuing new VXX shares) in order to hedge its exposure. The applicable creation and redemption processes for 
                    <PRTPAGE P="25031"/>
                    the Underlying ETPs creates a direct link to the underlying components of the ETF or ETN and serves to mitigate potential price impact of the ETF and ETN shares that might otherwise result from increased position limits for the options on the Underlying ETPs.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         A redemption date for each series of VXX is the third business day following each valuation date (other than the final valuation date). The final redemption date will be the third business day following the valuation date that is immediately prior to the final valuation date. If notice is provided prior to noon E.T., the applicable valuation date is the date on which notice is provided; otherwise, the applicable valuation date is the business day following the date on which notice is provided. 
                        <E T="03">See</E>
                         VXX Prospectus, available at 
                        <E T="03">https://www.ipathetn.com/US/16/en/documentation.app?instrumentId=341408&amp;contentId=7549819.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         There is currently no minimum number of additional ETNs that an issuer may sell.
                    </P>
                </FTNT>
                <P>The Exchange understands that the ETF and ETN creation and redemption processes seek to keep an ETF's or ETN's share price trading in line with the product's underlying net asset value (ETFs) or indicative value (ETNs). Because an ETF trades like a stock, its share price will fluctuate during the trading day, due to simple supply and demand. If demand to buy an ETF or ETN is high, for instance, an ETF's share price might rise above the value of its underlying securities or an ETN's share price above the value of the index components. When this happens, the Authorized Participant or issuer believes the ETF or ETN may now be overpriced, so it may buy shares of the component securities (ETF) or buy same the index component instruments (ETN) and then sell ETF or ETN shares in the open market. This may drive the ETF's or ETN's share price back toward the underlying net asset value or indicative index value. Likewise, if an ETF or ETN share price starts trading at a discount to the securities it holds or its index components, the Authorized Participant or issuer can buy shares of the ETF or ETN and redeem them for the underlying securities or index component instruments. Buying undervalued ETF or ETN shares may drive the share price of an ETF or ETN back toward fair value. This arbitrage process helps to keep an ETF's and ETN's share price in line with the value of its underlying portfolio or index components.</P>
                <HD SOURCE="HD3">Surveillance and Reporting Requirements</HD>
                <P>
                    The Exchange believes that increasing the position limits for the options on the Underlying ETPs would lead to a more liquid and competitive market environment for these options, which will benefit customers interested in trading these products. The reporting requirement for the options on the Underlying ETPs would remain unchanged. Thus, the Exchange would still require that each TPH or TPH organization that maintains positions in the options on the same side of the market, for its own account or for the account of a customer, report certain information to the Exchange. This information would include, but would not be limited to, the options' positions, whether such positions are hedged and, if so, a description of the hedge(s). Market-Makers 
                    <SU>24</SU>
                    <FTREF/>
                     (including Designated Primary Market-Makers (“DPMs”)) 
                    <SU>25</SU>
                    <FTREF/>
                     would continue to be exempt from this reporting requirement, however, the Exchange may access Market-Maker position information.
                    <SU>26</SU>
                    <FTREF/>
                     Moreover, the Exchange's requirement that TPHs file reports with the Exchange for any customer who held aggregate large long or short positions on the same side of the market of 200 or more option contracts of any single class for the previous day will remain at this level for the options subject to this proposal and will continue to serve as an important part of the Exchange's surveillance efforts.
                    <SU>27</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         A Market-Maker [sic] “Trading Permit Holder registered with the Exchange pursuant to Rule 3.52 for the purpose of making markets in option contracts traded on the Exchange and that has the rights and responsibilities set forth in Chapter 5, Section D of the Rules.” 
                        <E T="03">See</E>
                         Rule 1.1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         A Designated Primary Market-Maker “is TPH organization that is approved by the Exchange to function in allocated securities as a Market-Maker (as defined in Rule 8.1) and is subject to the obligations under Rule 5.54 or as otherwise provided under the rules of the Exchange.” 
                        <E T="03">See</E>
                         Rule 1.1.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         The Options Clearing Corporation (“OCC”) through the Large option Position Reporting (“LOPR”) system acts as a centralized service provider for TPH compliance with position reporting requirements by collecting data from each TPH or TPH organization, consolidating the information, and ultimately providing detailed listings of each TPH's report to the Exchange, as well as Financial Industry Regulatory Authority, Inc. (“FINRA”), acting as its agent pursuant to a regulatory services agreement (“RSA”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">See</E>
                         Rule 8.43 for reporting requirements.
                    </P>
                </FTNT>
                <P>
                    The Exchange believes that the existing surveillance procedures and reporting requirements at the Exchange and other SROs are capable of properly identifying disruptive and/or manipulative trading activity. The Exchange also represents that it has adequate surveillances in place to detect potential manipulation, as well as reviews in place to identify potential changes in composition of the Underlying ETPs and continued compliance with the Exchange's listing standards. These procedures utilize daily monitoring of market activity via automated surveillance techniques to identify unusual activity in both options and the underlyings, as applicable.
                    <SU>28</SU>
                    <FTREF/>
                     The Exchange also notes that large stock holdings must be disclosed to the Commission by way of Schedules 13D or 13G,
                    <SU>29</SU>
                    <FTREF/>
                     which are used to report ownership of stock which exceeds 5% of a company's total stock issue and may assist in providing information in monitoring for any potential manipulative schemes.
                </P>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         The Exchange believes these procedures have been effective for the surveillance of trading the options subject to this proposal and will continue to employ them.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         17 CFR 240.13d-1.
                    </P>
                </FTNT>
                <P>
                    The Exchange believes that the current financial requirements imposed by the Exchange and by the Commission adequately address concerns regarding potentially large, unhedged positions in the options on the Underlying ETPs. Current margin and risk-based haircut methodologies serve to limit the size of positions maintained by any one account by increasing the margin and/or capital that a TPH must maintain for a large position held by itself or by its customer.
                    <SU>30</SU>
                    <FTREF/>
                     In addition, Rule 15c3-1 
                    <SU>31</SU>
                    <FTREF/>
                     imposes a capital charge on TPHs to the extent of any margin deficiency resulting from the higher margin requirement.
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         
                        <E T="03">See</E>
                         Rule 10.3 for a description of margin requirements.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         17 CFR 240.15c3-1.
                    </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>32</SU>
                    <FTREF/>
                     Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 
                    <SU>33</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>34</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>32</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    The Exchange believes that the proposed increase in position limits for options on the Underlying ETPs will remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, protect investors and the public interest, because it will provide market participants with the ability to more effectively execute their trading and hedging activities. The proposed increases will allow market participants 
                    <PRTPAGE P="25032"/>
                    to more fully implement hedging strategies in related derivative products and to further use options to achieve investment strategies (
                    <E T="03">e.g.,</E>
                     there are other ETPs that use options on the ETFs or the ETN subject to this proposal as part of their investment strategy, and the applicable position limits as they stand today may inhibit these other ETPs in achieving their investment objectives, to the detriment of investors). Also, increasing the applicable position limits may allow Market-Makers to provide the markets for these options with more liquidity in amounts commensurate with increased consumer demand in such markets. The proposed position limit increases may also encourage other liquidity providers to shift liquidity, as well as encourage consumers to shift demand, from over the counter markets onto the Exchange, which will enhance the process of price discovery conducted on the Exchange through increased order flow.
                </P>
                <P>
                    In addition, the Exchange believes that the structure of the Underlying ETPs, the considerable market capitalization of the funds, underlying component securities, and/or indexed component securities, and the liquidity of the markets for the applicable options and underlying component securities will mitigate concerns regarding potential manipulation of the products and/or disruption of the underlying markets upon increasing the relevant position limits. As a general principle, increases in market capitalizations, active trading volume, and deep liquidity of securities do not lead to manipulation and/or disruption. This general principle applies to the recently observed increased levels of market capitalization and trading volume and liquidity in shares of and options on the Underlying ETPs (as described above), and, as a result, the Exchange does not believe that the options markets or underlying markets would become susceptible to manipulation and/or disruption as a result of the proposed position limit increases. Indeed, the Commission has previously expressed the belief that not just increasing, but removing, position and exercise limits may bring additional depth and liquidity to the options markets without increasing concerns regarding intermarket manipulation or disruption of the options or the underlying securities.
                    <SU>35</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 62147 [sic] (October 28 [sic], 2005) (SR-CBOE-2005-41), at 62149.
                    </P>
                </FTNT>
                <P>
                    Further, the Exchange notes that the proposed rule change to increase position limits for select actively traded options is not novel and the Commission has approved similar proposed rule changes by the Exchange to increase position limits for options on similar, highly liquid and actively traded ETPs.
                    <SU>36</SU>
                    <FTREF/>
                     Furthermore, the Exchange again notes that that the proposed position limits for options on GLD, SLV, LQD, GDX, VXX and UVXY are consistent with existing position limits for options on comparable ETPs in Rule 8.30.07.
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release Nos. 88768 (April 29, 2020), 85 FR 26736 (May 5, 2020) (SR-CBOE-2020-015); 83415 (June 12, 2018), 83 FR 28274 (June 18, 2018) (SR-CBOE-2018-042); 
                        <E T="03">and</E>
                         68086 (October 23, 2012), 77 FR 65600 (October 29, 2012) (SR-CBOE-2012-066).
                    </P>
                </FTNT>
                <P>The Exchange's surveillance and reporting safeguards continue to be designed to deter and detect possible manipulative behavior that might arise from increasing or eliminating position and exercise limits in certain classes. The Exchange believes that the current financial requirements imposed by the Exchange and by the Commission adequately address concerns regarding potentially large, unhedged position in the options on the Underlying ETPs, further promoting just and equitable principles of trading, the maintenance of a fair and orderly market, and the protection of investors.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because the increased position limits (and exercise limits) will be available to all market participants and apply to each in the same manner. The Exchange believes that the proposed rule change will provide additional opportunities for market participants to more efficiently achieve their investment and trading objectives of market participants.</P>
                <P>
                    The Exchange does not believe that the proposed rule change will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the Act. On the contrary, the Exchange believes the proposal promotes competition because it may attract additional order flow from the OTC market to exchanges, which would in turn compete amongst each other for those orders.
                    <SU>37</SU>
                    <FTREF/>
                     The Exchange believes market participants would benefit from being able to trade options with increased position limits in an exchange environment in several ways, including but not limited to the following: (1) Enhanced efficiency in initiating and closing out position; (2) increased market transparency; and (3) heightened contra-party creditworthiness due to the role of OCC as issuer and guarantor. The Exchange notes that other options exchanges may choose to file similar proposals with the Commission to increase position limits on options on the Underlying ETPs.
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Additionally, several other options exchanges have the same position limits as the Exchange, as they incorporate by reference to the Exchange's position limits, and as a result the position limits for options on the Underlying ETPs will increase at those exchanges. For example, Nasdaq Options position limits are determined by the position limits established by the Exchange. 
                        <E T="03">See</E>
                         Nasdaq Stock Market LLC Rules, Options 9, Sec. 13 (Position Limits).
                    </P>
                </FTNT>
                <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>
                    Within 45 days of the date of publication of this notice in the 
                    <E T="04">Federal Register</E>
                     or within such longer period up to 90 days (i) as the Commission may designate if it finds such longer period to be appropriate and publishes its reasons for so finding or (ii) as to which the Exchange consents, the Commission will:
                </P>
                <P>A. By order approve or disapprove such proposed rule change, or</P>
                <P>B. Institute proceedings to determine whether the proposed rule change should be 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-CBOE-2021-029 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>
                    • Send paper comments in triplicate to Secretary, Securities and Exchange 
                    <PRTPAGE P="25033"/>
                    Commission, 100 F Street NE, Washington, DC 20549-1090.
                </P>
                <FP>
                    All submissions should refer to File Number SR-CBOE-2021-029. 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. 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. All submissions should refer to File Number SR-CBOE-2021-029, and should be submitted on or before June 1, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>38</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09774 Filed 5-7-21; 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. 34-91764; File No. SR-GEMX-2021-04]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Expiration Date of the Temporary Amendments Concerning Video Conference Hearings</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 28, 2021, Nasdaq GEMX, LLC (“GEMX” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I and II below, which Items have been substantially prepared by the Exchange. The Exchange has designated the proposed rule change as constituting a “non-controversial” rule change under paragraph (f)(6) of Rule 19b-4 under the Act,
                    <SU>3</SU>
                    <FTREF/>
                     which renders the proposal effective upon receipt of this filing by 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>
                         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>
                    The Exchange proposes to extend the expiration date of the temporary amendments in SR-GEMX-2020-21 from April 30, 2021, to August 31, 2021.
                    <SU>4</SU>
                    <FTREF/>
                     The proposed rule change would not make any changes to the text of the Exchange rules.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 90755 (Dec. 21, 2020), 85 FR 85819 (Dec. 29, 2020) (SR-GEMX-2020-21). If the Exchange seeks to provide additional temporary relief from the rule requirements identified in this proposed rule change beyond August 31, 2021, the Exchange will submit a separate rule filing to further extend the temporary extension of time. The amended Exchange rules will revert to their original form at the conclusion of the temporary relief period and any extension thereof.
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is available on the Exchange's website at 
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/gemx/rules,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    The Exchange proposes to continue to harmonize Exchange Rule General 3, Section 2 with recent changes by the Financial Industry Regulatory Authority, Inc. (“FINRA”) to its Rule 1015 in response to the COVID-19 global health crisis and the corresponding need to restrict in-person activities.
                    <SU>5</SU>
                    <FTREF/>
                     The Exchange originally filed proposed rule change SR-GEMX-2020-21, which allows the Exchange Review Council (“ERC”) to conduct hearings in connection with appeals of Membership Application Program decisions, on a temporary basis, by video conference, if warranted by the current COVID-19-related public health risks posed by an in-person hearing. While there are signs of improvement, the COVID-19 conditions necessitating the temporary amendments persist and, based on its assessment of current COVID-19 conditions and the lack of certainty as to when COVID-19-related health concerns and corresponding restrictions will meaningfully subside, the Exchange has determined that there is a continued need for this temporary relief for several months beyond April 30, 2021. Accordingly, the Exchange proposes to extend the expiration date of the temporary rule amendments in 
                    <PRTPAGE P="25034"/>
                    SR-GEMX-2020-21 from April 30, 2021, to August 31, 2021.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91495 (April 7, 2021), 86 FR 19306 (April 13, 2021) (SR-FINRA-2021-006) (“FINRA Filing”). The Exchange notes that the FINRA Filing also proposed to temporarily amend FINRA Rules 9261, 9524, and 9830, which govern hearings in connection with appeals of disciplinary actions, eligibility proceedings, and temporary and permanent cease and desist orders. The Exchange's Rules 9261, 9524, and 9830 incorporate by reference The Nasdaq Stock Market LLC rules, which are the subject of a separate filing. 
                        <E T="03">See</E>
                         SR-NASDAQ-2021-033 (April 28, 2021). Therefore, the Exchange is not proposing to adopt that aspect of the FINRA Filing.
                    </P>
                </FTNT>
                <P>As set forth in SR-GEMX-2020-21, the Exchange also relies on COVID-19 data and criteria to determine whether the current public health risks presented by an in-person hearing may warrant a hearing by video conference. Based on that data and criteria, the Exchange does not believe the COVID-19- related health concerns necessitating this relief will meaningfully subside by April 30, 2021, and has determined that there will be a continued need for this temporary relief for several months beyond that date. Accordingly, the Exchange proposes to extend the expiration date of the temporary rule amendments originally set forth in SR-GEMX-2020-21 from April 30, 2021, to August 31, 2021. The extension of the temporary amendments allowing for specified ERC hearings to proceed by video conference will allow the Exchange's critical adjudicatory functions to continue to operate effectively in these extraordinary circumstances—enabling the Exchange to fulfill its statutory obligations to protect investors and maintain fair and orderly markets—while also protecting the health and safety of hearing participants.</P>
                <P>The Exchange has filed the proposed rule change for immediate effectiveness and has requested that the SEC waive the requirement that the proposed rule change not become operative for 30 days after the date of the filing, so the Exchange can implement the proposed rule change immediately.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
                    <SU>6</SU>
                    <FTREF/>
                     in general, and furthers the objectives of Section 6(b)(5) of the Act,
                    <SU>7</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, by providing greater harmonization between the Exchange rules and FINRA rules of similar purpose, resulting in less burdensome and more efficient regulatory compliance.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See supra</E>
                         note 5.
                    </P>
                </FTNT>
                <P>The proposed rule change, which extends the expiration date of the temporary amendments to the Exchange rules set forth in SR-GEMX-2020-21, will continue to aid the Exchange's efforts to timely conduct hearings in connection with its core adjudicatory functions. Given current COVID-19 conditions and the uncertainty around when those conditions will meaningfully improve, without this relief allowing ERC hearings to continue to proceed by video conference, such hearings may need to be postponed indefinitely. The Exchange must be able to perform its critical adjudicatory functions in order to fulfill its statutory obligations to protect investors and maintain fair and orderly markets. As such, this relief is essential to the Exchange's ability to fulfill its statutory obligations and allows hearing participants to avoid the serious COVID-19-related health and safety risks associated with in-person hearings.</P>
                <P>Among other things, this relief will allow the ERC to timely provide members, disqualified individuals and other applicants an approval or denial of their applications. As set forth in detail in SR-GEMX-2020-21, this temporary relief allowing ERC hearings to proceed by video conference accounts for fair process considerations and will continue to provide fair process while avoiding the COVID-19-related public health risks for hearing participants. Accordingly, the proposed rule change extending this temporary relief is in the public interest and consistent with the Act's purpose.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>The Exchange does not believe that the temporary proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. As set forth in SR-GEMX-2020-21, the proposed rule change is intended solely to extend temporary relief necessitated by the continued impacts of the COVID-19 outbreak and the related health and safety risks of conducting in-person activities. The Exchange believes that the proposed rule change will prevent unnecessary impediments to its operations, including its critical adjudicatory processes, and its ability to fulfill its statutory obligations to protect investors and maintain fair and orderly markets that would otherwise result if the temporary amendments were to expire on April 30, 2021.</P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    Because the foregoing 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)(iii) of the Act 
                    <SU>9</SU>
                    <FTREF/>
                     and subparagraph (f)(6) of Rule 19b-4 thereunder.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         15 U.S.C. 78s(b)(3)(A)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</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>11</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>12</SU>
                    <FTREF/>
                     the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Exchange has indicated that the proposed rule change to extend the expiration date will continue to prevent unnecessary impediments to its operations, including its critical adjudicatory processes, and its ability to fulfill its statutory obligations to protect investors and maintain fair and orderly markets that would otherwise result if the temporary amendments were to expire on April 30, 2021.
                    <SU>13</SU>
                    <FTREF/>
                     Importantly, extending the relief provided in GEMX-2020-21 immediately upon filing and without a 30-day operative delay will allow the Exchange to continue critical adjudicatory and review processes in a reasonable and fair manner and meet its critical investor protection goals, while also following best practices with respect to the health and safety of its employees.
                    <SU>14</SU>
                    <FTREF/>
                     The Commission also notes that this proposal extends without change the temporary relief previously provided by GEMX-2020-21,
                    <SU>15</SU>
                    <FTREF/>
                     and only during the period in which the Exchange's operations are impacted by 
                    <PRTPAGE P="25035"/>
                    COVID-19. As proposed, the changes would be in place through August 31, 2021 and the amended rules will revert back to their original state at the conclusion of the temporary relief period and, if applicable, any extension thereof.
                    <SU>16</SU>
                    <FTREF/>
                     For these reasons, the Commission believes that waiver of the 30-day operative delay for this proposal is consistent with the protection of investors and the public interest. Accordingly, the Commission hereby waives the 30-day operative delay and designates the proposal operative upon filing.
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         17 CFR 240.19b-4(f)(6)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See supra</E>
                         Item II.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         FINRA Filing, 86 FR at 19308 (noting the same in granting FINRA's request to waive the 30-day operative delay so that SR-FINRA-2021-006 would become operative immediately upon filing).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See supra</E>
                         note 4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See id.</E>
                         As noted above, the Exchange states that if it requires temporary relief from the rule requirements identified in this proposal beyond August 31, 2021, it may submit a separate rule filing to extend the effectiveness of the temporary relief under these rules.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         For purposes only of waiving the 30-day operative delay, the Commission has considered the proposed rule change'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-GEMX-2021-04 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-GEMX-2021-04. 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-GEMX-2021-04 and should be submitted on or before June 1, 2021.
                    <FTREF/>
                </FP>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         17 CFR 200.30-3(a)(12).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>18</SU>
                    </P>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09771 Filed 5-7-21; 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. 34-91755; File No. SR-ISE-2021-08]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt a Fee Schedule To Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Nasdaq ISE, LLC (“ISE” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I, II, and III, below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    The Exchange proposes to adopt a fee schedule to establish fees for Industry Members related to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in Rule General 7 (Consolidated Audit Trail Compliance) (ISE General 7 incorporates The Nasdaq Stock Market LLC General 7 by reference).
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is available on the Exchange's website at 
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/ise/rules,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the SEC a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed 
                    <PRTPAGE P="25036"/>
                    CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are ISE members in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91555 (April 14, 2017), 86 FR 21050 (April 21, 2021) (“Proposed CAT Fee Plan Amendment”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <P>
                    While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative following Commission approval of the Join [sic] Industry Plan Amendment to the National Market System Plan Governing the Consolidated Audit Trail filed on March 31, 2021.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91555 (April 14, 2017), 86 FR 21050 (April 21, 2021) (“Proposed CAT Fee Plan Amendment”).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant quarter (“Total CAT Costs”).
                    <SU>8</SU>
                    <FTREF/>
                     The CAT Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic], 21074 [sic].
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic].
                    </P>
                </FTNT>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>10</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Proposed CAT Fee Plan Amendment at 21054-55.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) Establishing fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>11</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>
                        The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                        <SU>12</SU>
                        <FTREF/>
                    </P>
                </EXTRACT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                    </P>
                </FTNT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the development and implementation of the CAT.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>14</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <PRTPAGE P="25037"/>
                <HD SOURCE="HD3">(B) 75%/25% Allocation Between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>15</SU>
                    <FTREF/>
                     Under the CAT Funding Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>16</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21055-56 [sic]. Note that, in the funding model set forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21056-58 [sic].
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry Member based on message traffic.
                    <SU>17</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21059 [sic].
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>18</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>19</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>20</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21056-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, 
                        <E T="03">see</E>
                         CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>22</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21057-58.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>23</SU>
                    <FTREF/>
                     would have a discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>24</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>25</SU>
                    <FTREF/>
                     and (2) all message traffic for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         Section 1.1 of the CAT NMS Plan; Nasdaq General 7 Section 1(ee) defines an “Options Market Maker” as “a broker-dealer registered with an exchange for the purpose of making markets in options contracts traded on the exchange.” (ISE General 7 incorporates The Nasdaq Stock Market LLC General 7 by reference).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>
                    The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of 
                    <PRTPAGE P="25038"/>
                    trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.
                </P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>26</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>To implement the Options Market Maker discount, the Exchange proposes to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>27</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <SU>28</SU>
                    <FTREF/>
                     regardless of where the order is ultimately routed or executed.
                    <SU>29</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio. The Equity Market Maker CAT fee then would be calculated by-multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>30</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic] discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>31</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT, would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage.
                    <SU>32</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>33</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee 
                    <PRTPAGE P="25039"/>
                    would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59 [sic].
                    </P>
                </FTNT>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that</P>
                <EXTRACT>
                    <P>If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).</P>
                </EXTRACT>
                <P>Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.</P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>34</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21063.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4th of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <EXTRACT>
                    <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>35</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>36</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020-July 31, 2020) and certain costs from Period 2 of the Financial Accountability Milestones (which covered the period from August 1, 2020-December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21064-65.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>
                    Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4th of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee 
                    <PRTPAGE P="25040"/>
                    Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.
                </P>
                <P>To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>38</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,17,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>39</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21065-66.
                    </P>
                </FTNT>
                <P>
                    Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message by 1/4th of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. 
                    <PRTPAGE P="25041"/>
                    Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.
                </P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public accounting firm and making the statements publicly available.</P>
                <P>To implement the Period 3 CAT Fee, the Exchange proposes to add proposed paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and Regulatory Utilization of Transactional Database Functionality. As discussed above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 3 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT Fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 3 CAT Costs 
                            <SU>40</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022</ENT>
                        <ENT>1st quarter of 2023.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (C) Period 4 CAT Fee
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>41</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21066-67.
                    </P>
                </FTNT>
                <P>Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.</P>
                <P>
                    To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market 
                    <PRTPAGE P="25042"/>
                    Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”
                </P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the requirements set forth in Section 9.2 of the CAT NMS Plan.</P>
                <P>The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 4 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT Fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 4 CAT Costs 
                            <SU>42</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (D) Quarterly CAT Fee—Beginning 2023
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>43</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>44</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067-68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses collected will be treated as an operational reserve to offset future fees and will not be distributed to the 
                    <PRTPAGE P="25043"/>
                    Participants as profits.
                    <SU>45</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,p7,7/8,i1" CDEF="xs90,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT Fee</CHED>
                        <CHED H="1">
                            Quarterly industry
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT data used for message 
                            <LI>traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>46</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (i) the Prime Rate plus 300 basis points, or (ii) the maximum rate permitted by applicable law.
                    <SU>47</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>48</SU>
                    <FTREF/>
                     which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the Act,
                    <SU>49</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act 
                    <SU>50</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>51</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>52</SU>
                    <FTREF/>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities necessary or appropriate in furtherance of the 
                    <PRTPAGE P="25044"/>
                    purposes of this chapter,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT fees equitably allocate CAT costs between Participants and Industry Members, and among Industry Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068-70.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>54</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.</P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>55</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its ISE members. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>56</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21070.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
                    <SU>57</SU>
                    <FTREF/>
                     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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         15 U.S.C. 78s(b)(3)(A)(ii).
                    </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 
                    <PRTPAGE P="25045"/>
                    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-ISE-2021-08 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-ISE-2021-08. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. 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. 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. All submissions should refer to File Number SR-ISE-2021-08 and should be submitted on or before June 1, 2021.
                    <FTREF/>
                </FP>
                <FTNT>
                    <P>
                        <SU>58</SU>
                         17 CFR 200.30-3(a)(12).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>58</SU>
                    </P>
                    <NAME>J. Matthew DesLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09782 Filed 5-7-21; 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. 34-91750; File No. SR-BX-2021-018]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt a Fee Schedule To Establish Fees for Industry Members Related to the National Market System Plan Governing the Consolidated Audit Trail</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 21, 2021, Nasdaq BX, Inc. (“BX” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I, II, and III, below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    The Exchange proposes to adopt a fee schedule to establish fees for Industry Members related to the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”).
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in Rule General 7 (Consolidated Audit Trail Compliance) (BX General 7 incorporates The Nasdaq Stock Market LLC General 7 by reference).
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is available on the Exchange's website at 
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/bx/rules</E>
                    , at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    Under the CAT NMS Plan, the Operating Committee of the Consolidated Audit Trail, LLC (“Company”) (“Operating Committee”) has discretion to establish funding for the Company to operate the CAT, including establishing fees that the Participants will pay, and establishing fees for Industry Members that will be implemented by the Participants.
                    <SU>4</SU>
                    <FTREF/>
                     The Operating Committee has filed with the SEC a proposal to amend the CAT NMS Plan to implement a revised funding model for the CAT (“CAT Funding Model”) and to establish a fee schedule for Participant CAT fees (“Proposed CAT Fee Plan Amendment”).
                    <SU>5</SU>
                    <FTREF/>
                     The Proposed CAT Fee Plan Amendment describes the CAT Funding Model in detail, including the proposal to charge Industry Members CAT fees. The Participants are required to file with the SEC under Section 19(b) of the Exchange Act any CAT fees applicable to Industry Members that the Operating Committee approves.
                    <SU>6</SU>
                    <FTREF/>
                     Accordingly, the purpose of this proposed rule change is to implement the required fee schedule provisions for CAT fees applicable to Industry Members that are BX members in accordance with the CAT Funding Model. The fee schedule provisions will become operative upon the SEC's approval of the Proposed CAT Fee Plan Amendment.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91555 (April 14, 2017), 86 FR 21050 (April 21, 2021) (“Proposed CAT Fee Plan Amendment”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Section 11.1(b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <P>
                    While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative following Commission approval of the Join [sic] Industry Plan Amendment to the National Market System Plan Governing the Consolidated Audit Trail filed on March 31, 2021.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91555 (April 14, 2017), 86 FR 21050 (April 21, 2021) (“Proposed CAT Fee Plan Amendment”).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(1) CAT Funding Model</HD>
                <P>
                    Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, the CAT fees applicable to Participants and Industry Members for the relevant quarter would be designed to cover the total CAT costs associated with developing, implementing and operating the CAT for the relevant 
                    <PRTPAGE P="25046"/>
                    quarter (“Total CAT Costs”).
                    <SU>8</SU>
                    <FTREF/>
                     The CAT Funding Model would implement a bifurcated funding model, where these costs would be borne by both Participants and Industry Members. Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Note that certain costs would be excluded from the Historical CAT Assessment Costs, as discussed in more detail below. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic], 21074 [sic].
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Each Industry Member and Participant CAT Reporter would be required to pay CAT fees established via the CAT Funding Model. CAT Reporting Agents acting in their role as such would not have an obligation to pay CAT fees. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21051 [sic].
                    </P>
                </FTNT>
                <P>Under the CAT Funding Model set out in the Proposed CAT Fee Plan Amendment, each Industry Member will pay a CAT fee that is calculated by multiplying each Industry Member's message traffic percentage of the total message traffic of all Industry Members during the relevant time period by the Industry Member Allocation, subject to certain market maker message traffic discounts, a Minimum Industry Member CAT Fee and a Maximum Industry Member CAT Fee. Each Industry Member that is an Options Market Maker will have a discount based on the options trade-to-quote ratio applied to its Options Market Maker message traffic when calculating that Industry Member's message traffic, and each Industry Member that is an Equity Market Maker will have a discount based on the NMS Stock trade-to-quote ratio applied to its Equity Market Maker message traffic when calculating that Industry Member's message traffic. In addition, each Industry Member will pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic. Furthermore, an Industry Member's CAT fee would be subject to the Maximum Industry Member CAT Fee. The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic. Each of these aspects of the Industry Member CAT fee are discussed in more detail below.</P>
                <HD SOURCE="HD3">(A) CAT Fees for Both Industry Members and Participants</HD>
                <P>
                    Under the CAT Funding Model, both Participants and Industry Members would contribute to the funding of the CAT by paying a CAT fee.
                    <SU>10</SU>
                    <FTREF/>
                     As permitted by Rule 613, the CAT NMS Plan requires Industry Members to pay a CAT fee. Rule 613(a)(1)(vii)(D) contemplates Industry Members contributing to the payment of CAT costs. Specifically, this provision requires the CAT NMS Plan to address “[h]ow the plan sponsors propose to fund the creation, implementation, and maintenance of the consolidated audit trail, including the proposed allocation of such estimated costs among the plan sponsors, and between the plan sponsors and members of the plan sponsors.”
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Proposed CAT Fee Plan Amendment at 21054-55.
                    </P>
                </FTNT>
                <P>
                    In addition, as approved by the SEC, the CAT NMS Plan specifically contemplates CAT fees to be paid by both Industry Members and Participants. Section 11.1(b) states that “the Operating Committee shall have discretion to establish funding for the Company, including: (i) Establishing fees that the Participants shall pay; and (ii) establishing fees for Industry Members that shall be implemented by the Participants.” 
                    <SU>11</SU>
                    <FTREF/>
                     The Commission stated in approving the CAT NMS Plan the following:
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See also</E>
                         Sections 11.1(c), 11.2(c), and 11.3(a) and (b) of the CAT NMS Plan.
                    </P>
                </FTNT>
                <P>
                    The Commission believes that the proposed funding model reflects a reasonable exercise of the Participants' funding authority to recover the Participants' costs related to the CAT. The CAT is a regulatory facility jointly owned by the Participants and, as noted above, the Exchange Act specifically permits the Participants to charge members fees to fund their self-regulatory obligations. The Commission further believes that the proposed funding model is designed to impose fees reasonably related to the Participants' self-regulatory obligations because the fees would be directly associated with the costs of establishing and maintaining the CAT, and not unrelated SRO services.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Securities Exchange Act Rel. No. 79318 (Nov. 15, 2016), 81 FR 84696, 84794 (Nov. 23, 2016) (“CAT NMS Plan Approval Order”).
                    </P>
                </FTNT>
                <P>
                    In its recent amendments to the CAT NMS Plan, the SEC reaffirmed the ability for the Participants to charge Industry Members a CAT fee. Specifically, the SEC noted that the amendments were not intended to change the basic funding structure for the CAT, which may include fees established by the Operating Committee, and implemented by the Participants, to recover from Industry Members the costs and expenses incurred by the Participants in connection with the development and implementation of the CAT.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Rel. No. 88890 (May 15, 2020), 85 FR 31322, 31329 (May 22, 2020) (“Financial Accountability Release”).
                    </P>
                </FTNT>
                <P>
                    Finally, as noted by the SEC, the CAT “substantially enhance[s] the ability of the SROs and the Commission to oversee today's securities markets,” 
                    <SU>14</SU>
                    <FTREF/>
                     thereby benefitting all market participants. As such, both Participants and Industry Members should contribute to covering the cost of the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         Securities Exchange Act Rel. No. 67457 (Jul. 18, 2012), 77 FR 45722, 45726 (Aug. 1, 2012).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(B) 75%/25% Allocation Between Industry Members and Participants</HD>
                <P>
                    The CAT NMS Plan as approved by the Commission provides the Operating Committee with discretion to establish CAT fees to be paid by Participants and Industry Members. The CAT Funding Model as set out in the Proposed CAT Fee Plan Amendment contemplates allocating CAT costs between Participants and Industry Members to permit the calculation of CAT fees based on market share for Participants and based on message traffic for Industry Members.
                    <SU>15</SU>
                    <FTREF/>
                     Under the CAT Funding Model as proposed, Industry Members as a group would pay 75% of the Total CAT Costs (the “Industry Member Allocation”), and Participants as a group would pay 25% of the Total CAT Costs (the “Participant Allocation”).
                    <SU>16</SU>
                    <FTREF/>
                     As discussed in more detail below, the Industry Member Allocation of 75% of the Total CAT Costs is included in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule for the Consolidated Audit Trail Funding Fees. In each such paragraph, the calculation of the Industry Member CAT fees is based on 75% of the Total CAT Costs.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21055-56 [sic]. Note that, in the funding model set forth in Article XI of the CAT NMS Plan (“Original Funding Model”), costs were allocated between Execution Venues and certain Industry Members, whereas the CAT Funding Model would allocate costs between Participants and Industry Members.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         For additional discussions regarding the 75%-25% allocation, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21056-58 [sic].
                    </P>
                </FTNT>
                <PRTPAGE P="25047"/>
                <HD SOURCE="HD3">(C) Message Traffic</HD>
                <P>
                    The Industry Member Allocation would be allocated to each Industry Member based on message traffic.
                    <SU>17</SU>
                    <FTREF/>
                     Each Industry Member CAT Reporter would pay a CAT fee that is calculated by multiplying each Industry Member's percentage of the total message traffic of all Industry Members each quarter by the Industry Member Allocation, subject to certain market making discounts, Minimum Industry Member CAT Fees, and Maximum Industry Member CAT Fees. To implement the use of message traffic in the calculation of Industry Member CAT fees, the Exchange proposes to describe the use of message traffic in proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule. In each such paragraph, the Industry Member CAT fees are calculated based on Industry Members' message traffic in the CAT.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         For additional discussions regarding the use of message traffic for calculating Industry Member CAT fees, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21059 [sic].
                    </P>
                </FTNT>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment,
                    <SU>18</SU>
                    <FTREF/>
                     message traffic would be calculated based on Industry Members' Reportable Events reported to the CAT as defined in the CAT Reporting Technical Specifications for Industry Members (“IM Reporting Tech Specs”) as amended from time to time.
                    <SU>19</SU>
                    <FTREF/>
                     The Reportable Events may vary over time if the IM Reporting Tech Specs are amended.
                    <SU>20</SU>
                    <FTREF/>
                     However, Reportable Events in the current IM Reporting Tech Specs that will be counted as message traffic include, but are not limited to, such events as the New Order Event, the Order Route Event and the Trade Event. In addition, message traffic will not include reporting activity related to Customer information as set forth in the CAT Reporting Customer and Account Technical Specifications for Industry Members.
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21056-57.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         The CAT Reporting Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         Due to the Phased Reporting approach, all Reportable Events will not be reported until all Industry Members are reporting all Reportable Events to the CAT. For example, Phase 2d CAT Reporting is scheduled for December 2021, and Small Industry Non-OATS Reporters are not required to report until December 2021. In addition, certain Reportable Events, such as simple options manual orders and OTC link messages, are not required to be reported until later in the Phased Reporting. For a detailed description of such Reportable Events, 
                        <E T="03">see</E>
                         CAT Reporting Technical Specifications for Industry Members (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). For the Industry Member CAT reporting timeline, 
                        <E T="03">see, e.g.,</E>
                         FINRA Rule 6895(c). CAT costs will be allocated based on the Reportable Events reported to the CAT in any relevant quarter, regardless of whether all Industry Members are reporting to the CAT or all Reportable Events are required to be reported to the CAT for a relevant quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 27.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         The CAT Reporting Customer and Account Technical Specifications for Industry Members are available at 
                        <E T="03">www.catnmsplan.com.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(D) Market Maker Discounts</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Operating Committee recognized that treating Options Market Maker message traffic and Equity Market Maker message traffic in the same way as other message traffic for purposes of calculating Industry Member CAT fees may result in an undue or inappropriate burden on competition or may lead to a reduction in market quality.
                    <SU>22</SU>
                    <FTREF/>
                     For example, charging Industry Members on the basis of message traffic may impact market makers disproportionately because of their continuous quoting obligations. Moreover, in the context of Options Market Makers, message traffic would include bids and offers for every Listed Options strikes and series. Accordingly, the Operating Committee determined to discount Options Market Maker message traffic by the trade-to-quote ratio for Listed Options when calculating message traffic for Options Market Makers, and to discount Equity Market Maker message traffic by the trade-to-quote ratio for NMS Stocks when calculating message traffic for Equity Market Makers. The message traffic of Options Market Makers and Equity Market Makers, as discounted, would be counted as part of the total message traffic for all Industry Members. The practical effect of applying such discounts for market making activity would be to lower the CAT fees for Options Market Makers and Equity Market Makers.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21057-58.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(I) Options Market Maker Discount</HD>
                <P>
                    Each Industry Member that is an Options Market Maker 
                    <SU>23</SU>
                    <FTREF/>
                     would have a discount based on the options trade-to-quote ratio applied to its options market making message traffic when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on options market making due to such message traffic.
                    <SU>24</SU>
                    <FTREF/>
                     Specifically, for each Options Market Maker, a discount would be applied to (1) all message traffic reported to the CAT by the Options Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered, regardless of where the order is ultimately routed or executed; 
                    <SU>25</SU>
                    <FTREF/>
                     and (2) all message traffic for which a “quote sent time” is reported by an Options Exchange on behalf of the given Options Market Maker.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         Section 1.1 of the CAT NMS Plan; Nasdaq General 7 Section 1(ee) defines an “Options Market Maker” as “a broker-dealer registered with an exchange for the purpose of making markets in options contracts traded on the exchange.” (BX General 7 incorporates The Nasdaq Stock Market LLC General 7 by reference).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Options Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by an Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Options Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the securities information processors (“SIP”). As an example, the trade-to-quote ratio for Listed Options for the fourth quarter of 2020 was 0.01%.</P>
                <P>
                    Accordingly, each Options Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the options trade-to-quote ratio. The Options Market Maker's CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>26</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Options Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>
                    To implement the Options Market Maker discount, the Exchange proposes to add paragraph (g)(1) to the fee schedule. Paragraph (g)(1) would state that “[w]hen calculating the message traffic of an Industry Member that is an Options Market Maker, the Options Market Maker's market making message traffic would be discounted by multiplying its Listed Options market making message traffic by the Listed Options trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message 
                    <PRTPAGE P="25048"/>
                    traffic calculation would be subject to applicable discounts for Options Market Maker message traffic for each of the four Industry Member CAT fees.
                </P>
                <HD SOURCE="HD3">(II) Equity Market Maker Discount</HD>
                <P>
                    Similarly, each Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”) would have a discount based on the NMS Stock trade-to-quote ratio applied to its market making message traffic in NMS Stocks when calculating that Industry Member's message traffic to prevent a potentially disproportionate effect on market making in NMS Stocks.
                    <SU>27</SU>
                    <FTREF/>
                     Specifically, for each Equity Market Maker, a discount would be applied to all message traffic reported to the CAT by the Equity Market Maker related to an order originated by a market maker in its market making account for a security in which it is registered,
                    <SU>28</SU>
                    <FTREF/>
                     regardless of where the order is ultimately routed or executed.
                    <SU>29</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         Note that Equity Market Makers do not have a quote sent time exemption comparable to the Options Market Maker quote sent time exemption, as discussed above.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         Under the current version of the IM Reporting Tech Specs, the discount would apply to new order messages and all related messages reported to the CAT by an Equity Market Maker with an accountHolderType = O. 
                        <E T="03">See</E>
                         CAT FAQ C5 (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ). The discount would not apply to messages by the Industry Member that are associated with any other accountHolderType. The IM Reporting Tech Specs may be amended from time to time and this designation could be changed. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>The relevant trade-to-quote ratio for the Equity Market Maker discount would be calculated each quarter based on the prior quarter's SIP Data that is included in CAT Data. The discount is calculated by dividing the adjusted trade count (that is, the total number of trades for the quarter minus the total number of trade busts) by the total number of quotes received by the SIP. As an example, the trade-to-quote ratio for NMS Stocks for the fourth quarter of 2020 was 4.77%.</P>
                <P>
                    The Equity Market Maker CAT fee would be calculated in the same manner as the Options Market Maker CAT fee. Each Equity Market Maker's discounted message traffic count would be calculated by multiplying its message traffic by the NMS Stock trade-to-quote ratio. The Equity Market Maker CAT fee then would be calculated by multiplying its discounted percentage of the total message traffic of all Industry Members during the relevant time period 
                    <SU>30</SU>
                    <FTREF/>
                     by the Industry Member Allocation, subject to the Minimum Industry Member CAT Fee and the Maximum Industry Member CAT Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         Note that the total message traffic of all Industry Members during the relevant time period will be calculated using the discounted total for all Equity Market Makers. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21058.
                    </P>
                </FTNT>
                <P>To implement the Equity Market Maker discount, the Exchanges proposes to add paragraph (g)(2) to the fee schedule. Paragraph (g)(2) would state that “[w]hen calculating the message traffic of an Industry Member that is an equity market maker in NMS Stocks (“Equity Market Maker”), the Equity Market Maker's market making message traffic would be a [sic] discounted by multiplying its market making message traffic in NMS Stocks by the NMS Stock trade-to-quote ratio.” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule would state that the message traffic calculation would be subject to applicable discounts for Equity Market Maker message traffic for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(E) Minimum Industry Member CAT Fee</HD>
                <P>
                    Each Industry Member would be required to pay a Minimum Industry Member CAT Fee of $125 per quarter if its CAT fee would be less than $125 per quarter when calculated based on message traffic.
                    <SU>31</SU>
                    <FTREF/>
                     All Industry Members required to report to the CAT, including those that have not yet begun to report to the CAT due to the phased implementation schedule for the CAT, would be subject to the Minimum Industry Member CAT Fee. If any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage.
                    <SU>32</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         For additional discussions regarding the Minimum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         Options Market Makers and Equity Market Makers will be required to pay the Minimum Industry Member CAT Fee if their quarterly CAT fee calculated with the market maker discounts is less than $125 per quarter.
                    </P>
                </FTNT>
                <P>To implement the Minimum Industry Member CAT Fee, the Exchange proposes to add paragraph (h) to the fee schedule. Proposed paragraph (h)(1) of the fee schedule would state that “[t]he Minimum Industry Member CAT Fee is $125 per quarter.” Proposed paragraph (h)(2) of the fee schedule would state that “[i]f any Industry Member is required to pay the Minimum Industry Member CAT Fee, the total additional amount paid by all such Industry Members over the amount they otherwise would have paid as a result of their message traffic calculation would be discounted from all Industry Members other than those that were subject to a Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Minimum Industry Member CAT Fee Re-Allocation”).” In addition, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) of the fee schedule describes the Minimum Industry Member CAT Fee Re-Allocation for each of the four Industry Member CAT fees.</P>
                <HD SOURCE="HD3">(F) Maximum Industry Member CAT Fee</HD>
                <P>
                    An Industry Member's CAT fee also would be subject to a Maximum Industry Member CAT Fee.
                    <SU>33</SU>
                    <FTREF/>
                     The Maximum Industry Member CAT Fee would be the fee calculated based on 8% of the total message traffic for all Industry Members. If an Industry Member's fee is subject to the Maximum Industry Member CAT Fee, any excess amount which the Industry Member would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry Members (including any Industry Members subject to the Maximum Industry Member CAT Fee and any Industry Members subject to the Minimum Industry Member CAT Fee) in accordance with each Industry Member's percentage of total message traffic.
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         For additional discussions regarding the Maximum Industry Member CAT Fee, 
                        <E T="03">see</E>
                         Proposed CAT Fee Plan Amendment at 21058-59 [sic].
                    </P>
                </FTNT>
                <P>To implement the Maximum Industry Member CAT Fee, the Exchange proposes to add proposed paragraph (f) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (f)(1) would state that “[t]he Maximum Industry Member CAT Fee for each quarter is 8% of the total CAT costs for the relevant quarter.” In addition, proposed paragraph (f)(2) would state that:</P>
                <EXTRACT>
                    <P>
                        If an Industry Member's CAT Fee that is calculated pursuant to paragraph (a)(2), (b)(2), (c)(2), (d)(2), as applicable, without reference to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation, is greater than the Maximum Industry Member CAT Fee, then the Industry Member will be subject to the Maximum Industry Member CAT Fee. If any Industry Member is subject to the Maximum Industry Member CAT Fee, then any excess amount which the Industry Member otherwise would have paid as a fee above such Maximum Industry Member CAT Fee will be re-allocated among all Industry 
                        <PRTPAGE P="25049"/>
                        Members, including any Industry Member that is subject to the Maximum Industry Member CAT Fee or subject to the Minimum Industry Member CAT Fee in accordance with their message traffic percentage (“Maximum Industry Member CAT Fee Re-Allocation”).
                    </P>
                </EXTRACT>
                <P>Furthermore, proposed paragraphs (a)(1), (b)(1), (c)(1) and (d)(1) would state that an Industry Member's CAT fee calculated pursuant to (a)(1), (b)(1), (c)(1) and (d)(1) would include any applicable Maximum Industry Member CAT Fee Re-Allocation. Finally, proposed paragraphs (a)(2), (b)(2), (c)(2) and (d)(2) would state that an Industry Member's CAT fee calculated pursuant to paragraph (a)(2), (b)(2), (c)(2) or (d)(2) is subject to the Maximum Industry Member CAT Fee and the Maximum Industry Member CAT Fee Re-Allocation.</P>
                <HD SOURCE="HD3">(G) Total CAT Costs</HD>
                <P>
                    As set out in the Proposed CAT Fee Plan Amendment, the Total CAT Costs for the year would be comprised of all fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during this period.
                    <SU>34</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21063.
                    </P>
                </FTNT>
                <P>For purposes of the Historical CAT Assessment, the Total CAT Costs would be $193,273,342, as set forth in the Proposed CAT Fee Plan Amendment. Accordingly, the quarterly CAT fee for the Historical CAT Assessment will be calculated based on costs of $36,238,752, which is 1/4th of 75% of the Total CAT Costs. This amount is set forth in proposed paragraph (b)(2) of the fee schedule.</P>
                <P>In addition, proposed paragraph (i) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule describes the Total CAT Costs to be used in calculating the Period 3 CAT Fee, the Period 4 CAT Fee and the Quarterly CAT Fees. Proposed paragraph (i)(1) of the fee schedule would state that “[t]he Period 3 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2021.” Proposed paragraph (i)(2) of the fee schedule would state that “[t]he Period 4 CAT Costs shall be the total CAT costs set forth in the year-end financial statements of the Consolidated Audit Trail, LLC for 2022.” Proposed paragraph (i)(3) of the fee schedule would state the following with regard to the Quarterly CAT Fees:</P>
                <EXTRACT>
                    <P>For purposes of the Quarterly CAT Fee, the budgeted Total CAT Costs for the relevant year shall be the total CAT costs set forth in the annual operating budget approved by the Operating Committee pursuant to Section 11.1(a) of the CAT NMS Plan for the relevant year. The budgeted Total CAT Costs for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted budgeted costs for the CAT will be used in calculating the remaining CAT fees for that year.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(2) Proposed CAT Fees</HD>
                <P>The Exchange proposes to charge its Industry Members fees related to CAT costs. To implement these CAT fees, the Exchange proposes to add a section entitled “Consolidated Audit Trail Funding Fees” to its fee schedule, and to describe the CAT fees in that section.</P>
                <HD SOURCE="HD3">(A) Historical CAT Assessment (for Pre-Period 1, Period 1 and Period 2)</HD>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee determined to charge Industry Members a historical assessment (“Historical CAT Assessment”) to recover certain CAT costs incurred prior to January 1, 2021 (“Historical CAT Assessment Costs”).
                    <SU>35</SU>
                    <FTREF/>
                     Specifically, as detailed in the Proposed CAT Fee Plan Amendment, the Historical CAT Assessment is intended to collect from Industry Members 75% of certain costs incurred through June 22, 2020, the effective date for the Financial Accountability Milestones,
                    <SU>36</SU>
                    <FTREF/>
                     certain costs from Period 1 of the Financial Accountability Milestones (which covered the period from June 22, 2020-July 31, 2020) and certain costs from Period 2 of the Financial Accountability Milestones (which covered the period from August 1, 2020-December 31, 2020). The Total CAT Costs, excluding Excluded Costs (as defined below) and certain costs related to the conclusion of the relationship with Thesys CAT, LLC is $193,273,342. The Historical CAT Assessment is designed to recover 75% of these CAT costs. Accordingly, the Historical CAT Assessment Costs would be $144,955,006.
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21064-65.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">See</E>
                         Section 11.6 of the CAT NMS Plan; and Financial Accountability Release.
                    </P>
                </FTNT>
                <P>Using the Historical CAT Assessment Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Historical CAT Assessment owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover the Historical CAT Assessment Costs over a period of four calendar quarters, commencing upon the SEC's approval of the Historical CAT Assessment. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic (subject to the market making discounts and the maximum fee). The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by $36,238,752, which is 1/4th of the Historical CAT Assessment Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation, and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Historical CAT Assessment in the first quarter after SEC approval of the Historical CAT Assessment, based on CAT Data from the quarter in which the SEC approved the CAT fees.</P>
                <P>To implement the Historical CAT Assessment, the Exchange proposes to add proposed paragraph (b) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (b) would state that “each Industry Member shall pay an Historical CAT Assessment in the amount of the greater of the following each quarter for four quarters commencing upon approval of the Historical CAT Assessment by the SEC: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by $36,238,752 (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    In accordance with Section 11.6(b) of the CAT NMS Plan and as provided in the Proposed CAT Fee Plan 
                    <PRTPAGE P="25050"/>
                    Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 1. Period 1 began on June 22, 2020, the effective date of Section 11.6 of the CAT NMS Plan, and concluded on July 31, 2020, the date of Initial Industry Member Core Equity and Options Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>37</SU>
                    <FTREF/>
                     Initial Industry Member Core Equity and Option Reporting was completed on schedule by July 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from June 22, 2020 through July 31, 2020.
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         Q3 2020 Quarterly Progress Report (Oct. 30, 2020) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, the proposed Historical CAT Assessment seeks to recover costs that are related to Post-Amendment Expenses incurred during Period 2. Period 2 began on August 1, 2020, and concluded on December 31, 2020, the date of the Full Implementation of Core Equity Reporting. As indicated by the Participants' Quarterly Progress Report,
                    <SU>38</SU>
                    <FTREF/>
                     Full Implementation of Core Equity Reporting was completed on schedule by December 31, 2020. As discussed above, the Historical CAT Assessment Costs to be recovered via the Historical CAT Assessment would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from August 1, 2020 through December 31, 2020. Accordingly, proposed paragraph (b) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Historical CAT Assessment “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         Q4 2020 Quarterly Progress Report (Jan. 29, 2021) (available at 
                        <E T="03">www.catnmsplan.com</E>
                        ).
                    </P>
                </FTNT>
                <P>The following chart summarizes the imposition of the Historical CAT Assessment:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,12,r100,r100">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly 
                            <LI>industry </LI>
                            <LI>member </LI>
                            <LI>allocation</LI>
                        </CHED>
                        <CHED H="1">CAT data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>$36,238,752</ENT>
                        <ENT>Quarter of SEC approval of Historical CAT Assessment</ENT>
                        <ENT>1st quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>1st quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>2nd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>2nd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>3rd quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>36,238,752</ENT>
                        <ENT>3rd quarter after SEC approval of Historical CAT Assessment</ENT>
                        <ENT>4th quarter after SEC approval of Industry Member CAT Fees as set forth in the CAT Fee Plan Amendment.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(B) Period 3 CAT Fee</HD>
                <P>
                    Per the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2021 through December 31, 2021, referred to as the Period 3 CAT Fee.
                    <SU>39</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2021 through December 31, 2021 (“Period 3 CAT Costs”) will be calculated at the completion of 2021. Specifically, the Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21065-66.
                    </P>
                </FTNT>
                <P>Using the Period 3 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 3 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 3 CAT Costs over a period of four calendar quarters, commencing in 2022. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message by 1/4th of 75% of the Period 3 CAT Costs traffic (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members would be required to commence paying the Period 3 CAT Fee in the second quarter of 2022, based on CAT Data from the first quarter of 2022.</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2021 the Total CAT Costs for 2021 to be used in calculating the quarterly Period 3 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. Such financial statements are required to be prepared in accordance with Section 9.2 of the CAT NMS Plan, including requirements related to compliance with GAAP, auditing by an independent public accounting firm and making the statements publicly available.</P>
                <P>
                    To implement the Period 3 CAT Fee, the Exchange proposes to add proposed paragraph (c) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (c) would state that “each Industry Member shall pay a Period 3 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2022: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic 
                    <PRTPAGE P="25051"/>
                    based on the prior quarter's message traffic by 1/4th of 75% of the Period 3 Total CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”
                </P>
                <P>Per the Proposed CAT Fee Plan Amendment, the proposed Period 3 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 3. Period 3 began on January 1, 2021 and is expected to conclude on December 31, 2021, the date of Full Availability and Regulatory Utilization of Transactional Database Functionality. As discussed above, the Period 3 CAT Costs to be recovered via the Period 3 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and operation of the CAT during the period from January 1, 2020 through December 31, 2021. The collection of the full amount of the Period 3 CAT Fee will depend upon achievement of Full Availability and Regulatory Utilization of Transaction Database Functionality by December 31, 2021; if not, the amount of the Period 3 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (c) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 3 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”</P>
                <P>The following chart summarizes the imposition of the Period 3 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="xs80,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT  fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">
                            CAT data used for message traffic 
                            <LI>calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 3 CAT Costs 
                            <SU>40</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2022</ENT>
                        <ENT>2nd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2022</ENT>
                        <ENT>3rd quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2022</ENT>
                        <ENT>4th quarter of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 3 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2022</ENT>
                        <ENT>1st quarter of 2023.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (C) Period 4 CAT Fee
                    <SU/>
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         The Period 3 CAT Costs will be the total actual costs incurred for the CAT for 2021 as set forth in the 2021 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined to charge Industry Members a quarterly fee to recover a percentage of the Total CAT Costs incurred from January 1, 2022 through December 30, 2022, referred to as the Period 4 CAT Fee.
                    <SU>41</SU>
                    <FTREF/>
                     The Total CAT Costs incurred from January 1, 2022 through December 30, 2022 (“Period 4 CAT Costs”) will be calculated at the completion of 2022. Specifically, the Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements of the Company.
                </P>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21066-67.
                    </P>
                </FTNT>
                <P>Using the Period 4 CAT Costs, as set forth in the Proposed CAT Fee Plan Amendment, the Operating Committee will calculate the Period 4 CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. Per the Proposed CAT Fee Plan Amendment, the Operating Committee plans to recover Period 4 CAT Costs over a period of four calendar quarters, commencing in 2023. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic. The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using CAT Data from the prior quarter. Industry Members will be required to commence paying the Period 4 CAT Fee in the second quarter of 2023, based on data from the first quarter of 2023.</P>
                <P>To implement the Period 4 CAT Fee, the Exchange proposes to add proposed paragraph (d) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (d) would state that “each Industry Member shall pay a Period 4 CAT Fee in the amount of the greater of the following each quarter for four quarters commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the Period 4 CAT Costs (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>The Exchange understands that the Operating Committee will announce via a CAT alert after the end of 2022 the Total CAT Costs for 2022 to be used in calculating the quarterly Period 4 CAT Fees. Such Total CAT Costs will be set forth in the year-end financial statements of the Consolidated Audit Trail, LLC. As noted above, such financial statements are required to be prepared in accordance with the requirements set forth in Section 9.2 of the CAT NMS Plan.</P>
                <P>
                    The Exchange indicates that the proposed Period 4 CAT Fee seeks to recover costs that will be related to Post-Amendment Expenses incurred during Period 4. Period 4 is expected to begin on January 1, 2022 and conclude on December 30, 2022, the date of Full Implementation of CAT NMS Plan Requirements. As discussed above, the Period 4 CAT Costs to be recovered via the Period 4 CAT Fee would include fees, costs and expenses incurred by or for the Company in connection with the development, implementation and 
                    <PRTPAGE P="25052"/>
                    operation of the CAT during the period from January 1, 2022 through December 30, 2022. The collection of the full amount of the Period 4 CAT Fee will depend upon achievement of Full Implementation of CAT NMS Plan Requirements by December 30, 2022; if not, the amount of the Period 4 CAT Fee that may be collected from the Industry Members will depend upon the fee limitations set forth in Section 11.6(a)(ii) of the CAT NMS Plan. Accordingly, proposed paragraph (e) of the “Consolidated Audit Trail Funding Fees” section of its fee schedule would state that Industry Members will be required to pay the Period 4 CAT Fee “[s]ubject to the requirements of Section 11.6 of the CAT NMS Plan.”
                </P>
                <P>The following chart summarizes the imposition of the Period 4 CAT Fee:</P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r100,r100,xs80">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">Quarterly industry member allocation</CHED>
                        <CHED H="1">CAT Data used for message traffic calculation</CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>
                            1/4th of 75% of the Period 4 CAT Costs 
                            <SU>42</SU>
                        </ENT>
                        <ENT>CAT Data from first quarter of 2023</ENT>
                        <ENT>2nd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from second quarter of 2023</ENT>
                        <ENT>3rd quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from third quarter of 2023</ENT>
                        <ENT>4th quarter of 2023.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the Period 4 CAT Costs</ENT>
                        <ENT>CAT Data from fourth quarter of 2023</ENT>
                        <ENT>1st quarter of 2024.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">
                    (D) Quarterly CAT Fee—Beginning 2023
                    <FTREF/>
                </HD>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         The Period 4 CAT Costs will be the total actual costs incurred for the CAT for 2022 as set forth in the 2022 financial statements for the Company.
                    </P>
                </FTNT>
                <P>
                    As provided in the Proposed CAT Fee Plan Amendment, to recover the costs of the CAT going forward beginning in 2023, the Operating Committee determined to charge Industry Members an ongoing quarterly CAT fee calculated based on the allocation of Total CAT Costs pursuant to the CAT Funding Model (“Quarterly CAT Fee”).
                    <SU>43</SU>
                    <FTREF/>
                     The Operating Committee will use the costs set forth in the annual operating budget as the Total CAT Costs in the calculation of the Quarterly CAT Fee. Specifically, the Total CAT Costs budgeted for the upcoming year for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. Using these estimated Total CAT Costs, the Operating Committee will calculate the Quarterly CAT Fee owed by each Industry Member in accordance with the CAT Funding Model. As provided in the Proposed CAT Fee Plan Amendment, the Operating Committee proposes to seek to recover the budgeted Total CAT Costs over the course of the year. Each quarter, each Industry Member will pay the greater of the minimum fee of $125 or the Industry Member's fee calculated based on message traffic.
                    <SU>44</SU>
                    <FTREF/>
                     The message traffic fee would be calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation). Each Industry Member's message traffic would be calculated using data from the prior calendar quarter. The Exchange proposes to commence charging this CAT fee in the second quarter of 2023, based on CAT Data from the first quarter of 2023.
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067-68.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         To the extent that any two or more of the four categories of Industry Member CAT fees (
                        <E T="03">i.e.,</E>
                         the Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and the Quarterly CAT Fee) are due during the same quarter, any Industry Member obligated to pay one or more categories of fees is required to pay each category of fee for that quarter. For example, if an Industry Member would be subject to the Minimum Industry Member CAT Fee for the Period 4 CAT Fee and the Minimum Industry Member CAT Fee for the Quarterly CAT Fee during the same quarter, the Industry Member would be required to pay two minimum $125 fees that quarter for a total of $250. As another example, suppose that an Industry Member owed a CAT fee (other than the minimum fee of $125) for both the Historical CAT Assessment and the Period 3 CAT Fee, the Industry Member would be required to pay both fees that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21067.
                    </P>
                </FTNT>
                <P>To implement the Quarterly CAT Fee, the Exchange proposes to add proposed paragraph (a) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule. Proposed paragraph (a) would state that “[e]ach Industry Member shall pay a Quarterly CAT Fee in the amount of the greater of the following each quarter commencing in the second quarter of 2023: (1) Minimum Industry Member CAT Fee (plus any applicable Maximum Industry Member CAT Fee Re-Allocation); or (2) the amount calculated by multiplying the percentage of the Industry Member's message traffic of the total Industry Member message traffic based on the prior quarter's message traffic by 1/4th of 75% of the budgeted Total CAT Costs for the relevant year (subject to applicable discounts for Options Market Maker message traffic and Equity Market Maker message traffic, the Maximum Industry Member CAT Fee, the Maximum Industry Member CAT Fee Re-Allocation and the Minimum Industry Member CAT Fee Re-Allocation).”</P>
                <P>
                    The Exchange understands the Operating Committee will announce at the beginning of the relevant year via a CAT alert the budgeted Total CAT Costs to be used in calculating the Quarterly CAT Fees for that year. The budgeted Total CAT Costs will be the costs set forth in the annual operating budget for the Company required pursuant to Section 11.1(a) of the CAT NMS Plan. As discussed above, CAT costs would include, but not be limited to, Plan Processor costs, insurance costs, third-party support costs and an operational reserve. As required by Section 11.1(c) of the CAT NMS Plan, any surpluses collected will be treated as an operational reserve to offset future fees and will not be distributed to the Participants as profits.
                    <SU>45</SU>
                    <FTREF/>
                     In addition, to address potential changes in the budget during the year, the total budgeted costs for the CAT for the relevant year may be adjusted on a quarterly basis as the Operating Committee reasonably deems appropriate for the prudent operation of the Company. To the extent that the Operating Committee adjusts the total budgeted costs for the CAT for the relevant year during its quarterly budget review, the adjusted total budgeted costs for the CAT will be used in calculating the remaining quarterly CAT fees for that year.
                </P>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         CAT NMS Plan Approval Order at 84792.
                    </P>
                </FTNT>
                <P>
                    The following chart summarizes the imposition of the Quarterly CAT Fee each year commencing in 2023 and continuing each year thereafter:
                    <PRTPAGE P="25053"/>
                </P>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="s50,r50,r50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Quarterly CAT fee</CHED>
                        <CHED H="1">
                            Quarterly industry 
                            <LI>member allocation</LI>
                        </CHED>
                        <CHED H="1">
                            CAT Data used for 
                            <LI>message traffic calculation</LI>
                        </CHED>
                        <CHED H="1">Payment due</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #1</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from first quarter of the relevant year</ENT>
                        <ENT>2nd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #2</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from second quarter of the relevant year</ENT>
                        <ENT>3rd quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #3</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from third quarter of the relevant year</ENT>
                        <ENT>4th quarter of the relevant year.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Quarterly CAT Fee #4</ENT>
                        <ENT>1/4th of 75% of the budgeted annual CAT costs for the relevant year</ENT>
                        <ENT>CAT Data from fourth quarter of the relevant year</ENT>
                        <ENT>1st quarter of year following the relevant year.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD3">(3) Time and Manner of Payment</HD>
                <P>
                    The Exchange proposes to add paragraph (e) to the “Consolidated Audit Trail Funding Fees” section of its fee schedule to describe the time and manner of the payment of the Industry Member CAT fees as provided in the Proposed CAT Fee Plan Amendment.
                    <SU>46</SU>
                    <FTREF/>
                     Proposed paragraph (e)(1) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with an invoice setting forth the Industry Member's Historical CAT Assessment, Period 3 CAT Fee, Period 4 CAT Fee and/or Quarterly CAT Fee (as applicable) (collectively, “CAT Fees”) for each payment period.” Proposed paragraph (e)(2) would state that “Consolidated Audit Trail, LLC will provide each Industry Member with one invoice each payment period for its CAT Fees as determined pursuant to paragraph (a)-(d) above, regardless of whether the Industry Member is a member of multiple self-regulatory organizations.” Proposed paragraph (e)(3) would state that “[e]ach Industry Member will pay its CAT Fees to the Consolidated Audit Trail, LLC via the centralized system for the collection of CAT Fees established by the Consolidated Audit Trail, LLC in the manner prescribed by the Consolidated Audit Trail, LLC.” Finally, proposed paragraph (e)(4) would require that Industry Members pay their CAT Fees within thirty days after receipt of an invoice or other notice indicating payment is due (unless a longer payment period is otherwise indicated). If an Industry Member fails to pay any such fee when due, such Industry Member shall pay interest on the outstanding balance from such due date until such fee is paid at a per annum rate equal to the lesser of (i) the Prime Rate plus 300 basis points, or (ii) the maximum rate permitted by applicable law.
                    <SU>47</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         CAT Reporters will be responsible for each quarterly fee in which they are a CAT Reporter. If a CAT Reporter ceases to the meet the definition of a CAT Reporter during a quarter, the CAT Reporter will still be responsible for CAT fees attributable to its message traffic (or, the minimum fee in the alternative) during that quarter. 
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the requirements of the Exchange Act. The Exchange believes that the proposed rule change is consistent with Section 6(b)(5) of the Act,
                    <SU>48</SU>
                    <FTREF/>
                     which requires, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and not designed to permit unfair discrimination between customers, issuers, brokers and dealers. The Exchange also believes that the proposed rule change is consistent with the provisions of Section 6(b)(4) of the Act,
                    <SU>49</SU>
                    <FTREF/>
                     because it provides for the equitable allocation of reasonable dues, fees and other charges among members and issuers and other persons using its facilities. The Exchange further believes that the proposed rule change is consistent with Section 6(b)(8) of the Act 
                    <SU>50</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         15 U.S.C. 78f(b)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Section 11.1(b) of the CAT NMS Plan states that “[t]he Participants shall file with the SEC under Section 19(b) of the Exchange Act any such fees on Industry Members that the Operating Committee approves.” Per Section 11.1(b) of the CAT NMS Plan, the Exchange has filed this proposed rule change to implement the Industry Member CAT fees included in the CAT Funding Model approved by the Operating Committee. The Exchange believes that this proposal is consistent with the Exchange Act because it is consistent with, and implements, the CAT Funding Model, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the CAT NMS Plan. In approving the CAT NMS Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>51</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Exchange Act.
                </P>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         CAT NMS Plan Approval Order at 84696.
                    </P>
                </FTNT>
                <P>
                    The Exchange further notes that, as provided in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed Industry Member CAT fees comply with the requirements of the Exchange Act and the CAT NMS Plan.
                    <SU>52</SU>
                    <FTREF/>
                     The Operating Committee determined that the Industry Member CAT fees provide for the “equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities necessary or appropriate in furtherance of the purposes of this chapter,” 
                    <SU>53</SU>
                    <FTREF/>
                     as required by the Exchange Act. The Operating Committee determined that the CAT fees equitably allocate CAT costs between Participants and Industry Members, and among Industry 
                    <PRTPAGE P="25054"/>
                    Members, as discussed in detailed [sic] above. For the reasons discussed above, the Operating Committee determined that the 75%-25% allocation between Industry Members and Participants in the CAT Funding Model as well as the use of message traffic for allocating costs among Industry Members provide for an equitable allocation of CAT costs among CAT Reporters. In addition, as discussed above, the Operating Committee determined that the imposition of minimum and maximum fees and market maker discounts would operate to provide for an equitable allocation of CAT costs among Industry Members.
                </P>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21068-70.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         Sections 6(b)(4) and 15A(b)(5) of the Exchange Act.
                    </P>
                </FTNT>
                <P>
                    As further provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also determined that the CAT Funding Model is “not designed to permit unfair discrimination between customers, issuers, brokers, or dealers,” 
                    <SU>54</SU>
                    <FTREF/>
                     as required by the Exchange Act, as the CAT Funding Model does not unfairly discriminate between Industry Members and Participants, or among Industry Members. In making this determination, the Operating Committee noted that all Industry Members are grouped together for the purpose of determining CAT fees, and Industry Members with similar levels of activity would pay similar fees. For example, Industry Members with higher levels of message traffic would pay higher fees, and those with lower levels of message traffic would pay lower fees. With the elimination of tiers in the Original Funding Model, fees for Industry Members are directly related to their message traffic. With tiers, the relationship between message traffic and the CAT fee would not have been as direct.
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         Sections 6(b)(5) and 15A(b)(6) of the Exchange Act.
                    </P>
                </FTNT>
                <P>In addition, as discussed in the Proposed CAT Fee Plan Amendment, where the method of fee calculation may potentially affect certain groups of CAT Reporters adversely, the Operating Committee sought to limit such adverse effects. For example, the Operating Committee proposed market maker discounts to address the high levels of message traffic generally exhibited by market makers. As discussed above, the SEC has recognized repeatedly that such favorable treatment for market makers in other contexts was not unfairly discriminatory or a burden on competition in light of its positive effects on market quality, nor was it considered to involve an inequitable allocation of fees among members.</P>
                <P>As also provided in the Proposed CAT Fee Plan Amendment, the Operating Committee also proposed the Maximum Industry Member CAT Fee to address the potential for significant fees based on outsized message traffic for certain Industry Members. The Maximum Industry Member CAT Fee would serve as a method to institute a cap on fees to fairly allocate costs to Industry Members. Such a fee would prevent Industry Members from paying significantly larger CAT fees than Participant complexes.</P>
                <P>The Proposed CAT Fee Plan Amendment notes that Operating Committee also determined that the proposed Industry Member CAT fees would promote just and equitable principles of trade, and, in general, protect investors and the public interest, as the fees would be transparent and relate specifically to CAT activity. The Operating Committee also determined that the proposed fees were reasonable because they would provide ease of calculation, ease of billing and other administrative functions. Such factors are crucial to estimating a reliable revenue stream for the Company.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    Section 6(b)(8) of the Act 
                    <SU>55</SU>
                    <FTREF/>
                     requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Exchange Act. The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule change implements provisions of the CAT NMS Plan that are subject to approval by the Commission and is designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the proposed rule changes will apply equally to all Industry Members, including its BX members. In addition, all national securities exchanges and FINRA are proposing a similar proposed fee change to implement the requirements of the CAT NMS Plan. Therefore, this is not a competitive fee filing, and, therefore, it does not raise competition issues between and among the exchanges and FINRA.
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <P>
                    Moreover, the Exchange notes that, as discussed in the Proposed CAT Fee Plan Amendment, the Operating Committee determined that the proposed fees do not impose an unnecessary or inappropriate burden on competition as they fairly and equitably allocate costs among CAT Reporters.
                    <SU>56</SU>
                    <FTREF/>
                     The Operating Committee determined that the cost allocation between Participants and Industry Members recognizes the greater number of Industry Members as compared to the Participants and the greater collective revenue of Industry Members as compared to Participants. In addition, cost allocations among Industry Members based on message traffic fairly and equitably distribute CAT costs. Furthermore, the market maker discounts and the Maximum Industry Member CAT Fee address the potential for burdens on market makers and Industry Members with outsized message traffic potentially resulting from the proposed fee calculations. Moreover, the Operating Committee determined that the Minimum Industry Member CAT Fee would not act as a barrier to entry for smaller Industry Member CAT Reporters.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         
                        <E T="03">See</E>
                         Proposed CAT Fee Plan Amendment at 21070.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
                    <SU>57</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         15 U.S.C. 78s(b)(3)(A)(ii).
                    </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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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
                    <PRTPAGE P="25055"/>
                </P>
                <P>
                    • Send an email to 
                    <E T="03">rule-comments@sec.gov</E>
                    . Please include File Number SR-BX-2021-018 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to File Number SR-BX-2021-018. 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. 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. All submissions should refer to File Number SR-BX-2021-018 and should be submitted on or before June 1, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>58</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09777 Filed 5-7-21; 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. 34-91763; File No. SR-NASDAQ-2021-033]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Expiration Date of the Temporary Amendments Concerning Video Conference Hearings</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 28, 2021, The Nasdaq Stock Market LLC (“Nasdaq” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Exchange has designated the proposed rule change as constituting a “non-controversial” rule change under paragraph (f)(6) of Rule 19b-4 under the Act,
                    <SU>3</SU>
                    <FTREF/>
                     which renders the proposal effective upon receipt of this filing by 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>
                         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>
                    The Exchange proposes to extend the expiration date of the temporary amendments in SR-NASDAQ-2020-076 from April 30, 2021, to August 31, 2021.
                    <SU>4</SU>
                    <FTREF/>
                     The proposed rule change would not make any changes to the text of the Exchange rules.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         If the Exchange seeks to provide additional temporary relief from the rule requirements identified in this proposed rule change beyond August 31, 2021, the Exchange will submit a separate rule filing to further extend the temporary extension of time. The amended Exchange rules will revert to their original form at the conclusion of the temporary relief period and any extension thereof.
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is available on the Exchange's website at 
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/nasdaq/rules,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    The Exchange proposes to continue to harmonize Exchange Rules 1015, 9261, 9524 and 9830 with recent changes by the Financial Industry Regulatory Authority, Inc. (“FINRA”) to its Rules 1015, 9261, 9524 and 9830 in response to the COVID-19 global health crisis and the corresponding need to restrict in-person activities. The Exchange originally filed proposed rule change SR-NASDAQ-2020-076, which allows the Exchange's Office of Hearing Officers (“OHO”) and the Exchange Review Council (“ERC”) to conduct hearings, on a temporary basis, by video conference, if warranted by the current COVID-19-related public health risks posed by an in-person hearing. In December 2020, the Exchange filed a proposed rule change, SR-NASDAQ-2020-092, to extend the expiration date of the temporary amendments in SR-NASDAQ-2020-076 from December 31, 2020, to April 30, 2021.
                    <SU>5</SU>
                    <FTREF/>
                     While there are signs of improvement, the COVID-19 conditions necessitating these temporary amendments persist and, based on its assessment of current COVID-19 conditions and the lack of certainty as to when COVID-19-related health concerns and corresponding restrictions will meaningfully subside, the Exchange has determined that there is a continued need for this temporary relief for several months beyond April 30, 2021. Accordingly, the Exchange proposes to extend the expiration date of the temporary rule amendments in SR-NASDAQ-2020-076 from April 30, 2021, to August 31, 2021.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 90774 (December 22, 2020), 85 FR 86614 (December 30, 2020) (Notice of Filing and Immediate Effectiveness of File No. SR-NASDAQ-2020-092).
                    </P>
                </FTNT>
                <P>
                    On November 5, 2020, the Exchange filed, and subsequently extended to 
                    <PRTPAGE P="25056"/>
                    April 30, 2021, SR-NASDAQ-2020-076, to temporarily amend Exchange Rules 1015, 9261, 9524 and 9830 to grant OHO and the ERC authority 
                    <SU>6</SU>
                    <FTREF/>
                     to conduct hearings in connection with appeals of Membership Application Program decisions, disciplinary actions, eligibility proceedings and temporary and permanent cease and desist orders by video conference, if warranted by the COVID-19-related public health risks posed by an in-person hearing.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         For OHO hearings under Exchange Rules 9261 and 9830, the proposed rule change temporarily grants authority to the Chief or Deputy Chief Hearing Officer to order that a hearing be conducted by video conference. For ERC hearings under Exchange Rules 1015 and 9524, this temporary authority is granted to the ERC or relevant Subcommittee.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 90390 (November 10, 2020), 85 FR 73302 (November 17, 2020) (Notice of Filing and Immediate Effectiveness of File No. SR-NASDAQ-2020-076); 
                        <E T="03">supra</E>
                         note 5.
                    </P>
                </FTNT>
                <P>
                    As set forth in the previous filings, the Exchange also relies on COVID-19 data and the guidance issued by public health authorities to determine whether the current public health risks presented by an in-person hearing may warrant a hearing by video conference.
                    <SU>8</SU>
                    <FTREF/>
                     Based on that data and guidance, the Exchange does not believe the COVID-19-related health concerns necessitating this relief will meaningfully subside by April 30, 2021, and has determined that there will be a continued need for this temporary relief for several months beyond that date. Accordingly, the Exchange proposes to extend the expiration date of the temporary rule amendments originally set forth in SR-NASDAQ-2020-076 from April 30, 2021, to August 31, 2021. The extension of these temporary amendments allowing for specified OHO and ERC hearings to proceed by video conference will allow the Exchange's critical adjudicatory functions to continue to operate effectively in these extraordinary circumstances—enabling the Exchange to fulfill its statutory obligations to protect investors and maintain fair and orderly markets—while also protecting the health and safety of hearing participants.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         As noted in SR-NASDAQ-2020-076, the temporary proposed rule change grants discretion to OHO and the ERC to order a video conference hearing. In deciding whether to schedule a hearing by video conference, OHO and the ERC may consider a variety of other factors in addition to COVID-19 trends.
                    </P>
                </FTNT>
                <P>The Exchange has filed the proposed rule change for immediate effectiveness and has requested that the SEC waive the requirement that the proposed rule change not become operative for 30 days after the date of the filing, so the Exchange can implement the proposed rule change immediately.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
                    <SU>9</SU>
                    <FTREF/>
                     in general, and furthers the objectives of Section 6(b)(5) of the Act,
                    <SU>10</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, by continuing to provide greater harmonization between the Exchange rules and FINRA rules of similar purpose,
                    <SU>11</SU>
                    <FTREF/>
                     resulting in less burdensome and more efficient regulatory compliance.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91495 (April 7, 2021), 86 FR 19306 (April 13, 2021) (SR-FINRA-2021-006).
                    </P>
                </FTNT>
                <P>The proposed rule change, which extends the expiration date of the temporary amendments to the Exchange rules set forth in SR-NASDAQ-2020-076, will continue to aid the Exchange's efforts to timely conduct hearings in connection with its core adjudicatory functions. Given current COVID-19 conditions and the uncertainty around when those conditions will meaningfully improve, without this relief allowing OHO and ERC hearings to continue to proceed by video conference, such hearings may need to be postponed indefinitely. The Exchange must be able to perform its critical adjudicatory functions in order to fulfill its statutory obligations to protect investors and maintain fair and orderly markets. As such, this relief is essential to the Exchange's ability to fulfill its statutory obligations and allows hearing participants to avoid the serious COVID-19-related health and safety risks associated with in-person hearings.</P>
                <P>Among other things, this relief will allow OHO to conduct temporary cease and desist proceedings by video conference so that the Exchange can take immediate action to stop ongoing customer harm and will allow the ERC to timely provide members, disqualified individuals and other applicants an approval or denial of their applications. As set forth in detail in SR-NASDAQ-2020-076, this temporary relief allowing OHO and ERC hearings to proceed by video conference accounts for fair process considerations and will continue to provide fair process while avoiding the COVID-19-related public health risks for hearing participants. Accordingly, the proposed rule change extending this temporary relief is in the public interest and consistent with the Act's purpose.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>The Exchange does not believe that the temporary proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. As set forth in SR-NASDAQ-2020-076, the proposed rule change is intended solely to extend temporary relief necessitated by the continued impacts of the COVID-19 outbreak and the related health and safety risks of conducting in-person activities. The Exchange believes that the proposed rule change will prevent unnecessary impediments to its operations, including its critical adjudicatory processes, and its ability to fulfill its statutory obligations to protect investors and maintain fair and orderly markets that would otherwise result if the temporary amendments were to expire on April 30, 2021.</P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    Because the foregoing 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)(iii) of the Act 
                    <SU>12</SU>
                    <FTREF/>
                     and subparagraph (f)(6) of Rule 19b-4 thereunder.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         15 U.S.C. 78s(b)(3)(A)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</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>14</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>15</SU>
                    <FTREF/>
                     the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has asked the 
                    <PRTPAGE P="25057"/>
                    Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Exchange has indicated that the proposed rule change to extend the expiration date will continue to prevent unnecessary impediments to its operations, including its critical adjudicatory processes, and its ability to fulfill its statutory obligations to protect investors and maintain fair and orderly markets that would otherwise result if the temporary amendments were to expire on April 30, 2021.
                    <SU>16</SU>
                    <FTREF/>
                     Importantly, extending the relief provided in NASDAQ-2020-092 immediately upon filing and without a 30-day operative delay will allow the Exchange to continue critical adjudicatory and review processes in a reasonable and fair manner and meet its critical investor protection goals, while also following best practices with respect to the health and safety of its employees.
                    <SU>17</SU>
                    <FTREF/>
                     The Commission also notes that this proposal extends without change the temporary relief previously provided by NASDAQ-2020-092,
                    <SU>18</SU>
                    <FTREF/>
                     and only during the period in which the Exchange's operations are impacted by COVID-19. As proposed, the changes would be in place through August 31, 2021 and the amended rules will revert back to their original state at the conclusion of the temporary relief period and, if applicable, any extension thereof.
                    <SU>19</SU>
                    <FTREF/>
                     For these reasons, the Commission believes that waiver of the 30-day operative delay for this proposal is consistent with the protection of investors and the public interest. Accordingly, the Commission hereby waives the 30-day operative delay and designates the proposal operative upon filing.
                    <SU>20</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         17 CFR 240.19b-4(f)(6)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See supra</E>
                         Item II.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         FINRA Filing, 86 FR 19308 (noting the same in granting FINRA's request to waive the 30-day operative delay so that SR-FINRA-2021-006 would become operative immediately upon filing).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See supra</E>
                         note 5.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See supra</E>
                         note 4. As noted above, the Exchange states that if it requires temporary relief from the rule requirements identified in this proposal beyond August 31, 2021, it may submit a separate rule filing to extend the effectiveness of the temporary relief under these rules.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         For purposes only of waiving the 30-day operative delay, the Commission has considered the proposed rule change'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-NASDAQ-2021-033 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-NASDAQ-2021-033. 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-NASDAQ-2021-033 and should be submitted on or before June 1, 2021.
                    <FTREF/>
                </FP>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         17 CFR 200.30-3(a)(12).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>21</SU>
                    </P>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09770 Filed 5-7-21; 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. 34-91765; File No. SR-MRX-2021-06]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Expiration Date of the Temporary Amendments Concerning Video Conference Hearings</SUBJECT>
                <DATE>May 4, 2021.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on April 28, 2021, Nasdaq MRX, LLC (“MRX” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change as described in Items I and II below, which Items have been substantially prepared by the Exchange. The Exchange has designated the proposed rule change as constituting a “non-controversial” rule change under paragraph (f)(6) of Rule 19b-4 under the Act,
                    <SU>3</SU>
                    <FTREF/>
                     which renders the proposal effective upon receipt of this filing by 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>
                         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>
                    The Exchange proposes to extend the expiration date of the temporary amendments in SR-MRX-2020-23 from April 30, 2021, to August 31, 2021.
                    <SU>4</SU>
                    <FTREF/>
                     The proposed rule change would not make any changes to the text of the Exchange rules.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 90757 (Dec. 21, 2020), 85 FR 85771 (Dec. 29, 2020) (SR-MRX-2020-23). If the Exchange seeks to provide additional temporary relief from the rule requirements identified in this proposed rule change beyond August 31, 2021, the Exchange will submit a separate rule filing to further extend the temporary extension of time. The amended Exchange rules will revert to their original form at the conclusion of the temporary relief period and any extension thereof.
                    </P>
                </FTNT>
                <P>
                    The text of the proposed rule change is available on the Exchange's website at 
                    <PRTPAGE P="25058"/>
                    <E T="03">https://listingcenter.nasdaq.com/rulebook/mrx/rules,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    The Exchange proposes to continue to harmonize Exchange Rule General 3, Section 2 with recent changes by the Financial Industry Regulatory Authority, Inc. (“FINRA”) to its Rule 1015 in response to the COVID-19 global health crisis and the corresponding need to restrict in-person activities.
                    <SU>5</SU>
                    <FTREF/>
                     The Exchange originally filed proposed rule change SR-MRX-2020-23, which allows the Exchange Review Council (“ERC”) to conduct hearings in connection with appeals of Membership Application Program decisions, on a temporary basis, by video conference, if warranted by the current COVID-19-related public health risks posed by an in-person hearing. While there are signs of improvement, the COVID-19 conditions necessitating the temporary amendments persist and, based on its assessment of current COVID-19 conditions and the lack of certainty as to when COVID-19-related health concerns and corresponding restrictions will meaningfully subside, the Exchange has determined that there is a continued need for this temporary relief for several months beyond April 30, 2021. Accordingly, the Exchange proposes to extend the expiration date of the temporary rule amendments in SR-MRX-2020-23 from April 30, 2021, to August 31, 2021.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 91495 (April 7, 2021), 86 FR 19306 (April 13, 2021) (SR-FINRA-2021-006) (“FINRA Filing”). The Exchange notes that the FINRA Filing also proposed to temporarily amend FINRA Rules 9261, 9524, and 9830, which govern hearings in connection with appeals of disciplinary actions, eligibility proceedings, and temporary and permanent cease and desist orders. The Exchange's Rules 9261, 9524, and 9830 incorporate by reference The Nasdaq Stock Market LLC rules, which are the subject of a separate filing. 
                        <E T="03">See</E>
                         SR-NASDAQ-2021-033 (April 28, 2021). Therefore, the Exchange is not proposing to adopt that aspect of the FINRA Filing.
                    </P>
                </FTNT>
                <P>As set forth in SR-MRX-2020-23, the Exchange also relies on COVID-19 data and criteria to determine whether the current public health risks presented by an in-person hearing may warrant a hearing by video conference. Based on that data and criteria, the Exchange does not believe the COVID-19- related health concerns necessitating this relief will meaningfully subside by April 30, 2021, and has determined that there will be a continued need for this temporary relief for several months beyond that date. Accordingly, the Exchange proposes to extend the expiration date of the temporary rule amendments originally set forth in SR-MRX-2020-23 from April 30, 2021, to August 31, 2021. The extension of the temporary amendments allowing for specified ERC hearings to proceed by video conference will allow the Exchange's critical adjudicatory functions to continue to operate effectively in these extraordinary circumstances—enabling the Exchange to fulfill its statutory obligations to protect investors and maintain fair and orderly markets—while also protecting the health and safety of hearing participants.</P>
                <P>The Exchange has filed the proposed rule change for immediate effectiveness and has requested that the SEC waive the requirement that the proposed rule change not become operative for 30 days after the date of the filing, so the Exchange can implement the proposed rule change immediately.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
                    <SU>6</SU>
                    <FTREF/>
                     in general, and furthers the objectives of Section 6(b)(5) of the Act,
                    <SU>7</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, by providing greater harmonization between the Exchange rules and FINRA rules of similar purpose, resulting in less burdensome and more efficient regulatory compliance.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See supra</E>
                         note 5.
                    </P>
                </FTNT>
                <P>The proposed rule change, which extends the expiration date of the temporary amendments to the Exchange rules set forth in SR-MRX-2020-23, will continue to aid the Exchange's efforts to timely conduct hearings in connection with its core adjudicatory functions. Given current COVID-19 conditions and the uncertainty around when those conditions will meaningfully improve, without this relief allowing ERC hearings to continue to proceed by video conference, such hearings may need to be postponed indefinitely. The Exchange must be able to perform its critical adjudicatory functions in order to fulfill its statutory obligations to protect investors and maintain fair and orderly markets. As such, this relief is essential to the Exchange's ability to fulfill its statutory obligations and allows hearing participants to avoid the serious COVID-19-related health and safety risks associated with in-person hearings.</P>
                <P>Among other things, this relief will allow the ERC to timely provide members, disqualified individuals and other applicants an approval or denial of their applications. As set forth in detail in SR-MRX-2020-23, this temporary relief allowing ERC hearings to proceed by video conference accounts for fair process considerations and will continue to provide fair process while avoiding the COVID-19-related public health risks for hearing participants. Accordingly, the proposed rule change extending this temporary relief is in the public interest and consistent with the Act's purpose.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>The Exchange does not believe that the temporary proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. As set forth in SR-MRX-2020-23, the proposed rule change is intended solely to extend temporary relief necessitated by the continued impacts of the COVID-19 outbreak and the related health and safety risks of conducting in-person activities. The Exchange believes that the proposed rule change will prevent unnecessary impediments to its operations, including its critical adjudicatory processes, and its ability to fulfill its statutory obligations to protect investors and maintain fair and orderly markets that would otherwise result if the temporary amendments were to expire on April 30, 2021.</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="25059"/>
                </P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    Because the foregoing 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)(iii) of the Act 
                    <SU>9</SU>
                    <FTREF/>
                     and subparagraph (f)(6) of Rule 19b-4 thereunder.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         15 U.S.C. 78s(b)(3)(A)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</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>11</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>12</SU>
                    <FTREF/>
                     the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. The Exchange has indicated that the proposed rule change to extend the expiration date will continue to prevent unnecessary impediments to its operations, including its critical adjudicatory processes, and its ability to fulfill its statutory obligations to protect investors and maintain fair and orderly markets that would otherwise result if the temporary amendments were to expire on April 30, 2021.
                    <SU>13</SU>
                    <FTREF/>
                     Importantly, extending the relief provided in MRX-2020-23 immediately upon filing and without a 30-day operative delay will allow the Exchange to continue critical adjudicatory and review processes in a reasonable and fair manner and meet its critical investor protection goals, while also following best practices with respect to the health and safety of its employees.
                    <SU>14</SU>
                    <FTREF/>
                     The Commission also notes that this proposal extends without change the temporary relief previously provided by MRX-2020-23,
                    <SU>15</SU>
                    <FTREF/>
                     and only during the period in which the Exchange's operations are impacted by COVID-19. As proposed, the changes would be in place through August 31, 2021 and the amended rules will revert back to their original state at the conclusion of the temporary relief period and, if applicable, any extension thereof.
                    <SU>16</SU>
                    <FTREF/>
                     For these reasons, the Commission believes that waiver of the 30-day operative delay for this proposal is consistent with the protection of investors and the public interest. Accordingly, the Commission hereby waives the 30-day operative delay and designates the proposal operative upon filing.
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         17 CFR 240.19b-4(f)(6)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See supra</E>
                         Item II.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         FINRA Filing, 86 FR at 19308 (noting the same in granting FINRA's request to waive the 30-day operative delay so that SR-FINRA-2021-006 would become operative immediately upon filing).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See supra</E>
                         note 4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See id.</E>
                         As noted above, the Exchange states that if it requires temporary relief from the rule requirements identified in this proposal beyond August 31, 2021, it may submit a separate rule filing to extend the effectiveness of the temporary relief under these rules.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         For purposes only of waiving the 30-day operative delay, the Commission has considered the proposed rule change'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-MRX-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-MRX-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 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-MRX-2021-06 and should be submitted on or before June 1, 2021.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>18</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09772 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <DEPDOC>[Disaster Declaration #16955 and #16956; MISSISSIPPI Disaster Number MS-00135]</DEPDOC>
                <SUBJECT>Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Mississippi</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Small Business Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of MISSISSIPPI (FEMA-4598-DR), dated 05/04/2021.</P>
                    <P>
                        <E T="03">Incident:</E>
                         Severe Winter Storms.
                    </P>
                    <P>
                        <E T="03">Incident Period:</E>
                         02/11/2021 through 02/19/2021.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Issued on 05/04/2021.</P>
                    <P>
                        <E T="03">Physical Loan Application Deadline Date:</E>
                         07/06/2021.
                    </P>
                    <P>
                        <E T="03">Economic Injury (EIDL) Loan Application Deadline Date:</E>
                         02/04/2022.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit completed loan applications to: U.S. Small Business 
                        <PRTPAGE P="25060"/>
                        Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Notice is hereby given that as a result of the President's major disaster declaration on 05/04/2021, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.</P>
                <P>The following areas have been determined to be adversely affected by the disaster:</P>
                <FP SOURCE="FP-2">
                    <E T="03">Primary Counties:</E>
                     Adams, Attala, Choctaw, Claiborne, Copiah, Covington, Franklin, Grenada, Hinds, Jasper, Jefferson, Jefferson Davis, Kemper, Lafayette, Lauderdale, Lawrence, Leake, Lincoln, Neshoba, Newton, Noxubee, Pike, Rankin, Scott, Simpson, Smith, Tallahatchie, Walthall, Warren, Winston, Yazoo and the Mississippi Band of Choctaw Indians.
                </FP>
                <P>The Interest Rates are:</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s25,8">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1">Percent</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="22">
                            <E T="03">For Physical Damage:</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="02">Non-Profit Organizations with Credit Available Elsewhere</ENT>
                        <ENT>2.000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="02">Non-Profit Organizations without Credit Available Elsewhere</ENT>
                        <ENT>2.000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">
                            <E T="03">For Economic Injury:</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="02">Non-Profit Organizations without Credit Available Elsewhere</ENT>
                        <ENT>2.000</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The number assigned to this disaster for physical damage is 16955 7 and for economic injury is 16956 0.</P>
                <EXTRACT>
                    <FP>(Catalog of Federal Domestic Assistance Number 59008)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>James Rivera,</NAME>
                    <TITLE>Associate Administrator for Disaster Assistance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09857 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8026-03-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <DEPDOC>[Disaster Declaration #16957 and #16958; OREGON Disaster Number OR-00119]</DEPDOC>
                <SUBJECT>Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Oregon</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Small Business Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of OREGON (FEMA-4599-DR), dated 05/04/2021.</P>
                    <P>
                        <E T="03">Incident:</E>
                         Severe Winter Storm.
                    </P>
                    <P>
                        <E T="03">Incident Period:</E>
                         02/11/2021 through 02/15/2021.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Issued on 05/04/2021.</P>
                    <P>
                        <E T="03">Physical Loan Application Deadline Date:</E>
                         07/06/2021.
                    </P>
                    <P>
                        <E T="03">Economic Injury (EIDL) Loan Application Deadline Date:</E>
                         02/04/2022.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Notice is hereby given that as a result of the President's major disaster declaration on 05/04/2021, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.</P>
                <P>The following areas have been determined to be adversely affected by the disaster:</P>
                <FP SOURCE="FP-2">
                    <E T="03">Primary Counties:</E>
                     Benton, Clackamas, Linn, Marion, Polk, Yamhill and the Confederated Tribes of Grand Ronde.
                </FP>
                <P>The Interest Rates are:</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s25,8">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1">Percent</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="22">
                            <E T="03">For Physical Damage:</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="02">Non-Profit Organizations with Credit Available Elsewhere</ENT>
                        <ENT>2.000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="02">Non-Profit Organizations without Credit Available Elsewhere</ENT>
                        <ENT>2.000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">
                            <E T="03">For Economic Injury:</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="02">Non-Profit Organizations without Credit Available Elsewhere</ENT>
                        <ENT>2.000</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The number assigned to this disaster for physical damage is 16957 7 and for economic injury is 16958 0.</P>
                <EXTRACT>
                    <FP>(Catalog of Federal Domestic Assistance Number 59008)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>James Rivera,</NAME>
                    <TITLE>Associate Administrator for Disaster Assistance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09858 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8026-03-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <SUBJECT>Notice of Funding Opportunity for Environmental Mitigation Pilot Program</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration, DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of funding opportunity.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Section 190 of the FAA Reauthorization Act of 2018 authorizes the Federal Aviation Administration (FAA) to carry out an Airport Environmental Mitigation Pilot Program. This program provides grants to sponsors of public-use airports. The pilot program is open to environmental mitigation projects that will measurably reduce or mitigate aviation impacts on noise, air quality, or water quality at the airport or within five miles of the airport. FAA may fund up to six projects at public-use airports. The purpose of this notice is to solicit pre-applications from eligible airports and consortia.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Pre-applications must be submitted by 5:00 p.m. EST on July 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You can obtain an electronic copy of this Policy and all other documents in this docket using the internet by:</P>
                    <P>
                        (1) Searching the Federal eRulemaking portal (
                        <E T="03">http://www.faa.gov/regulations/search</E>
                        );
                    </P>
                    <P>
                        (2) Visiting FAA's Regulations and Policies web page at (
                        <E T="03">http://www.faa.gov/regulations_policies</E>
                        ); or
                    </P>
                    <P>
                        (3) Accessing the Government Printing Office's web page at (
                        <E T="03">http://www.gpoaccess.gov</E>
                        ).
                    </P>
                    <P>You can also obtain a copy by sending a request to FAA, Airport Planning and Environmental Division, 800 Independence Ave. SW, Washington, DC 20591, or by calling (202) 267-3263. Make sure to identify the docket number, notice number or amendment number of this proceeding.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Jaclyn M. Johnson, Environmental Protection Specialist, Federal Aviation Administration, 800 Independence Avenue, Washington, DC 20591; email 
                        <E T="03">jaclyn.johnson@faa.gov,</E>
                         phone 202-267-9596.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Each section of this notice contains information and instructions relevant to the pre-application process for these environmental mitigation pilot program grants. Applicants should read this notice in its entirety so that they have the information they need to submit eligible and competitive applications.
                    <PRTPAGE P="25061"/>
                </P>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">A. Program Description</FP>
                    <FP SOURCE="FP-2">B. Federal Award Information</FP>
                    <FP SOURCE="FP-2">C. Eligibility Information</FP>
                    <FP SOURCE="FP-2">D. Pre-Application and Submission Information</FP>
                    <FP SOURCE="FP-2">E. Pre-Application Review Information</FP>
                    <FP SOURCE="FP-2">F. Grant Award Notice</FP>
                </EXTRACT>
                <HD SOURCE="HD1">A. Program Description</HD>
                <P>Section 190 of the FAA Reauthorization Act of 2018 (Pub. L. 115-254) creates a pilot program for environmental mitigation projects. The environmental mitigation projects should introduce new environmental mitigation techniques or technologies that have been proven in laboratory demonstrations. These projects should propose methods for efficient adaptation or integration of new concepts into airport operations. In addition, these projects must measurably reduce or mitigate aviation impacts on noise, air quality, or water quality at the airport or within five miles of the airport, and demonstrate whether new techniques or new technologies are practical to implement at or near public-use airports.</P>
                <P>FAA may establish and publish information identifying best practices for reducing or mitigating aviation impacts on noise, air quality, and water quality at airports or in the vicinity of airports based on the projects carried out under the program. The program shall terminate five years after FAA makes the first grant under the program.</P>
                <HD SOURCE="HD1">B. Federal Award Information</HD>
                <P>Per Section 190(a), FAA may fund up to six projects at public use airports. Per Section 190(k), additional projects may be carried out at a site previously, but not currently, managed by the Department of Defense (DOD) if the DOD provides funds to the FAA for funding such projects.</P>
                <P>FAA may make grants from the Airport Improvement Program's noise and environmental set-aside (49 U.S.C. 47117(e)(1)(A)). Each project is limited to not more than $2,500,000 in federal funding. The federal share of the cost of the project carried out under the program is 50 percent, and requires 50 percent in airport matching funds.</P>
                <HD SOURCE="HD1">C. Eligibility Information</HD>
                <P>The law specifies that projects must be carried out by an eligible consortium consisting of two or more of the following entities:</P>
                <P>• Businesses incorporated in the U.S.</P>
                <P>• Public or private educational or research organizations located in the U.S.</P>
                <P>• Entities of state or local governments in the U.S.</P>
                <P>• Federal laboratories.</P>
                <HD SOURCE="HD1">D. Pre-Application and Submission Information</HD>
                <P>Airport Sponsors should submit a pre-application to their local FAA Airports District Office that includes a project title and location, and identifies the entities that will carry out the project. The pre-application should include a description of the roles and responsibilities of each entity and must be signed by each entity. The pre-application should include a project description that discusses the project and anticipated benefits, the roles and responsibilities of each entity involved in the program, and how the project meets the program's goals of funding mitigation that is not widely available at airports; and could introduce a novel, applicable mitigation opportunity for airport development operations.</P>
                <P>The pre-application should also describe how environmental benefits will be measured and include a draft scope of work that describes how the entity will implement the environmental mitigation project. In addition, the pre-application should include a schedule for completion of the project within 24 months of grant award and feature quarterly reporting to the airport sponsor's Regional or Airport District Office. Last, the pre-application should include a preliminary SF-424, with estimated project cost broken out by federal and local share.</P>
                <P>In short, the pre-application should include the information necessary for FAA to determine that the project satisfies project requirements as described in Section A and C and to assess the selection criteria specified in Section E. The pre-application should be prepared with standard formatting preferences including a single-spaced document, using standard 12-point font such as Times New Roman, with 1-inch margins. The pre-application may not exceed 25 pages in length, including any attachments or appendices. If the pre-application includes information the applicant considers to be trade secret or confidential commercial or financial information, the applicant should note on the front cover that the submission “Contains Confidential Business Information” and mark each affected page. DOT protects such information from disclosure to the extent allowed under applicable law.</P>
                <P>
                    Pre-applications should be submitted by the airport sponsor, not the consortium, to the sponsor's local Regional or Airports District Office. A listing of FAA Regional Airports Divisions and Airports District Offices by State is located at 
                    <E T="03">https://www.faa.gov/about/office_org/headquarters_offices/arp/regional_offices/.</E>
                     Any questions on the program and pre-application materials should also be directed to the Regional or Airports District Office.
                </P>
                <HD SOURCE="HD1">E. Pre-Application Review Information</HD>
                <P>FAA will give priority consideration to projects that will achieve the greatest reductions in aircraft noise, airport emissions, or airport water quality impacts either on an absolute basis or on a per dollar of funds expended basis, and will be implemented by an eligible consortium.</P>
                <HD SOURCE="HD1">F. Grant Award Notice</HD>
                <P>Following the evaluation outlined in Section E, FAA will notify candidates about grant awards. If selected through the pre-application process, the local FAA Regional or Airports District Office will commence a conventional grant process (including standard application materials).</P>
                <P>This policy does not have the force and effect of law and is not meant to bind the public in any way, it is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.</P>
                <SIG>
                    <P>Issued in Washington, DC.</P>
                    <NAME>Robert John Craven,</NAME>
                    <TITLE>Director, Airport Planning and Programming.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09856 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Pipeline and Hazardous Materials Safety Administration</SUBAGY>
                <SUBJECT>Hazardous Materials: Notice of Actions on Special Permits</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of actions on special permit applications.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.
                        <PRTPAGE P="25062"/>
                    </P>
                    <P>Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington DC.</P>
                <P>This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).</P>
                <SIG>
                    <DATED>Issued in Washington, DC, on May 3, 2021.</DATED>
                    <NAME>Donald P. Burger,</NAME>
                    <TITLE>Chief, General Approvals and Permits Branch.</TITLE>
                </SIG>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="xs60,r60,r60,r100">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Application No.</CHED>
                        <CHED H="1">Applicant</CHED>
                        <CHED H="1">Regulation(s) affected</CHED>
                        <CHED H="1">Nature of the special permits thereof</CHED>
                    </BOXHD>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Special Permits Data—Granted</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">3121-M</ENT>
                        <ENT>Department of Defense US Army Military Surface Deployment &amp; Distribution Command</ENT>
                        <ENT>172.101(i)(3)</ENT>
                        <ENT>To modify the special permit to update references to military manuals referenced in the permit.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10631-M</ENT>
                        <ENT>Department of Defense US Army Military Surface Deployment &amp; Distribution Command</ENT>
                        <ENT>173.243, 173.244</ENT>
                        <ENT>To modify the special permit to remove outdated references to military programs used and to more closely align with the HMR.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10922-M</ENT>
                        <ENT>FIBA Technologies, Inc</ENT>
                        <ENT>173.302(a), 180.205, 180.207(d)(1), 172.302(c)</ENT>
                        <ENT>To modify the special permit to authorize a 10-year retest for ISO cylinders and tubes transporting certain hazardous materials.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">20499-M</ENT>
                        <ENT>Inmar Rx Solutions, Inc</ENT>
                        <ENT/>
                        <ENT>To modify the special permit to authorize cargo only aircraft as a mode of transportation.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">20584-M</ENT>
                        <ENT>Battery Solutions, LLC</ENT>
                        <ENT>173.185(f)(3), 173.185(c)(1)(iii), 173.185(c)(1)(iv), 173.185(c)(1)(v), 173.185(c)(3), 173.185(f), 173.185(f)(1)</ENT>
                        <ENT>To modify the special permit to authorize up to 400 lbs. of damaged/defective batteries in individual packaging to be shipped in a 55-gallon drum.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">20876-M</ENT>
                        <ENT>Sodastream USA Inc</ENT>
                        <ENT>178.71</ENT>
                        <ENT>To modify the special permit to remove the requirement of marking the outer package with the special permit number and removed the requirement that a copy of the permit be carried aboard each vessel or motor vehicle used to transport packages covered by the permit.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21018-M</ENT>
                        <ENT>Packaging and Crating Technologies, LLC</ENT>
                        <ENT>172.200, 172.300, 172.400, 172.600, 172.700(a), 173.185(b), 173.185(c), 173.185(f)</ENT>
                        <ENT>To modify the special permit to authorize four new package sizes.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21091-N</ENT>
                        <ENT>Air Products and Chemicals, Inc</ENT>
                        <ENT>173.301(f), 173.301(g)</ENT>
                        <ENT>To authorize the transportation in commerce of hydrogen in module assemblies containing non-DOT specification carbon fiber composite cylinders manufactured under DOT-SP 14576 without pressure relief devices.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21171-N</ENT>
                        <ENT>HDT Expeditionary Systems, Inc</ENT>
                        <ENT>172.101(j)</ENT>
                        <ENT>To authorize the transportation in commerce of lithium batteries exceeding 35 kg by cargo-only aircraft.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21182-N</ENT>
                        <ENT>LG Energy Solution, Ltd</ENT>
                        <ENT>172.101(j)</ENT>
                        <ENT>To authorize the transportation in commerce of lithium batteries exceeding 35 kg by cargo-only aircraft.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21191-N</ENT>
                        <ENT>Joyson Safety Systems Acquisition LLC</ENT>
                        <ENT>172.203(a), 172.301(c), 173.166(e)(6)</ENT>
                        <ENT>To authorize the transportation in commerce of recalled safety devices that were removed from, or were intended to be used in, motor vehicles.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21221-N</ENT>
                        <ENT>Starfire Corporation</ENT>
                        <ENT>173.56(b)</ENT>
                        <ENT>To authorize the transportation in commerce of unapproved explosives (firework components) as Division 1.1G.</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="01">21226-N</ENT>
                        <ENT>RML Group Limited</ENT>
                        <ENT>173.185(a)(1)</ENT>
                        <ENT>To authorize the transportation in commerce aboard cargo-only aircraft of prototype and low production lithium ion batteries that have not completed all U.N. tests and exceed 35 kg net weight by cargo-only aircraft.</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Special Permits Data—Denied</E>
                        </ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="21">
                            <E T="02">Special Permits Data—Withdrawn</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">21207-N</ENT>
                        <ENT>Volkswagen AG</ENT>
                        <ENT>172.101(j)</ENT>
                        <ENT>To authorize the transportation in commerce of lithium ion batteries exceeding 35 kg and contained in non-specification packaging by cargo-only aircraft.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21218-N</ENT>
                        <ENT>RML Group Limited</ENT>
                        <ENT>172.101(j)</ENT>
                        <ENT>To authorize the transportation of lithium-ion batteries which exceed the allowable weight (35 kg) by cargo aircraft.</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="25063"/>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09823 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-60-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Pipeline and Hazardous Materials Safety Administration</SUBAGY>
                <SUBJECT>Hazardous Materials: Notice of Applications for New Special Permits</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>List of applications for special permits.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before June 9, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.</P>
                    <P>Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Donald Burger, Chief, Office of Hazardous Materials Safety General Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington DC.</P>
                <P>This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).</P>
                <SIG>
                    <DATED>Issued in Washington, DC, on May 3, 2021.</DATED>
                    <NAME>Donald P. Burger,</NAME>
                    <TITLE>Chief, General Approvals and Permits Branch.</TITLE>
                </SIG>
                <GPOTABLE COLS="4" OPTS="L2,nj,p7,7/8,i1" CDEF="s25,r50,r50,r100">
                    <TTITLE>Special Permits Data</TTITLE>
                    <BOXHD>
                        <CHED H="1">Application No.</CHED>
                        <CHED H="1">Applicant</CHED>
                        <CHED H="1">Regulation(s) affected</CHED>
                        <CHED H="1">Nature of the special permits thereof</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">21210-N</ENT>
                        <ENT>Aero Micronesia Inc</ENT>
                        <ENT>172.101(j), 173.27(b)(2), 173.27(b)(3), 175.30</ENT>
                        <ENT>To authorize the transportation in commerce of Class 1 materials that are forbidden aboard cargo-only aircraft by cargo-only aircraft. (mode 4)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21212-N</ENT>
                        <ENT>The Boeing Company</ENT>
                        <ENT>178.955</ENT>
                        <ENT>To authorize the transportation in commerce of environmentally hazardous substances contained in non-DOT specification bulk packagings by motor vehicle. (mode 1)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21213-N</ENT>
                        <ENT O="xl">Space Exploration Technologies Corp</ENT>
                        <ENT>172.400, 172.500, 173.302(a)</ENT>
                        <ENT>To authorize the transportation in commerce of spacecraft containing krypton, compressed in non-DOT specification cylinders. (mode 1)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21215-N</ENT>
                        <ENT>Lord Corporation</ENT>
                        <ENT>172.203(a), 173.58(a)</ENT>
                        <ENT>To authorize the transportation in commerce of a certain explosive (quinone dioxime) as a flammable solid. (modes 1, 2, 3, 4, 5)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21216-N</ENT>
                        <ENT>Bren-tronics, Inc</ENT>
                        <ENT>172.101(j), 173.185(b)(1)</ENT>
                        <ENT>To authorize transportation in commerce of lithium ion batteries that exceed 35 kg in non-DOT specification packaging aboard cargo-only aircraft. (mode 4)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21217-N</ENT>
                        <ENT>Transport Logistics International, Inc</ENT>
                        <ENT>173.420(a)(2), 173.420(a)(3)(i)</ENT>
                        <ENT>To authorize the transportation in commerce of UF6 in repaired cylinders that no longer meet the specification required by the Hazardous Materials Regulations. (mode 1)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21219-N</ENT>
                        <ENT>FIBA Technologies, Inc</ENT>
                        <ENT>180.212(a)</ENT>
                        <ENT>To authorize the transportation in commerce of certain specification DOT 3A, DOT 3AA, DOT 3AX, DOT 3AAX, and DOT 3T cylinders and UN ISO 11120 tubes that have been repaired. (modes 1, 2, 3, 4, 5)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21222-N</ENT>
                        <ENT>Bren-Tronics, Inc</ENT>
                        <ENT>172.101(j), 173.185(b)(1)</ENT>
                        <ENT>To authorize the transportation in commerce of lithium ion batteries exceeding 35 kg in non-DOT specification packaging by cargo-only aircraft. (mode 4)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21229-N</ENT>
                        <ENT O="xl">Mercedes-Benz U.S. International, Inc</ENT>
                        <ENT>172.101(j), 173.185(b)(1)</ENT>
                        <ENT>To authorize the transportation in commerce of lithium ion batteries exceeding 35 kg net weight in non-DOT specification packaging by cargo-only aircraft. (mode 4)</ENT>
                    </ROW>
                </GPOTABLE>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09824 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-60-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Pipeline and Hazardous Materials Safety Administration</SUBAGY>
                <SUBJECT>Hazardous Materials: Notice of Applications for Modifications to Special Permit</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>List of applications for modification of special permits.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before May 25, 2021.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation Washington, DC 20590.</P>
                    <P>Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Donald Burger, Chief, Office of Hazardous Materials Safety General 
                        <PRTPAGE P="25064"/>
                        Approvals and Permits Branch, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-13, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington DC.</P>
                <P>This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).</P>
                <SIG>
                    <DATED>Issued in Washington, DC, on May 3, 2021.</DATED>
                    <NAME>Donald P. Burger,</NAME>
                    <TITLE>Chief, General Approvals and Permits Branch.</TITLE>
                </SIG>
                <GPOTABLE COLS="4" OPTS="L2,tp0,i1" CDEF="xs60,r50,r50,r100">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Application No.</CHED>
                        <CHED H="1">Applicant</CHED>
                        <CHED H="1">Regulation(s) affected</CHED>
                        <CHED H="1">Nature of the special permits thereof</CHED>
                    </BOXHD>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="21">
                            <E T="02">Special Permits Data</E>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="00">
                        <ENT I="01">10970-M</ENT>
                        <ENT>Luxfer Inc</ENT>
                        <ENT>173.302a(a)(1), 173.304a(a), 173.304a(d)</ENT>
                        <ENT>To modify the special permit to authorize additional Division 2.2 gases, to modify the safety control measures to more accurately reflect what type of fiber is used and to waive the elastic expansion requirement. (modes 1, 2, 3, 4, 5).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">12783-M</ENT>
                        <ENT>Cool Renewal, LLC</ENT>
                        <ENT>173.304a(a)(1), 173.306(a)</ENT>
                        <ENT>To modify the special permit to authorize the transportation in commerce of small units of certain compressed gas, intended for medical use as limited quantities. (modes 1, 2, 3, 4, 5).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">14661-M</ENT>
                        <ENT>FIBA Technologies, Inc</ENT>
                        <ENT>180.209(a), 180.209(a), 180.209(b)(1), 180.209(b)(1)(iv)</ENT>
                        <ENT>To modify the special permit to authorize additional Division 2.1 and 2.2 hazmat. (modes 1, 2, 3).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">15036-M</ENT>
                        <ENT>UTLX Manufacturing Incorporated</ENT>
                        <ENT>172.203(a), 172.302(c), 173.244, 173.1, 173.3, 173.314, 173.31(e), 179.102-2, 179.102-3, 179.15, 179.16</ENT>
                        <ENT>To modify the special permit to remove the requirement for visual inspection of areas needing access via cut-out ports in the support structure. (mode 2).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">20639-M</ENT>
                        <ENT>ICC The Compliance Center Inc</ENT>
                        <ENT>172.200, 172.300, 172.600, 172.700(a), 172.400, 172.500, 173.185(f)</ENT>
                        <ENT>To modify the special permit to authorize the use of EXTOVER fire suppressant material in shipments. (modes 1, 2, 3).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">20881-M</ENT>
                        <ENT>Arkema Inc</ENT>
                        <ENT>172.102(c)(7)</ENT>
                        <ENT>To modify the special permit to authorize additional tanks. (mode 1).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21136-M</ENT>
                        <ENT>Cimarron Composites, LLC</ENT>
                        <ENT>173.302(a)(1)</ENT>
                        <ENT>To modify the special permit to remove references to insulated tubes. (modes 1, 2, 3).</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">21185-M</ENT>
                        <ENT>Hach Company</ENT>
                        <ENT>172.102(b)(4), 173.36(a)</ENT>
                        <ENT>To modify the permit to authorize additional Class 8 hazmat. (Mode 1).</ENT>
                    </ROW>
                </GPOTABLE>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09822 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-60-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Bureau of Transportation Statistics</SUBAGY>
                <SUBJECT>Agency Information Collection Activities; Proposals, Submissions, and Approvals; Annual Tank Car Facility Survey</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Transportation Statistics (BTS), U. S. Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice and Request for Comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the requirements of the Paperwork Reduction Act of 1995, this notice announces the intention of the Bureau of Transportation Statistics (BTS) to request the Office of Management and Budget's (OMB) approval of an extension for an information collection from tank car facilities to obtain an estimate of tank cars projected to be modified or built to the new safer Department of Transportation (DOT) standards. A summary report of survey findings will be submitted to Congress and published by BTS on the BTS web page.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be submitted on or before June 9, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Clara Reschovsky, (202) 366-2857, Tank Car Facility Survey Project Manager, BTS, OST-R, Department of Transportation, 1200 New Jersey Ave. SE, Room E36-324, Washington, DC 20590. Office hours are from 8:30 a.m. to 5:00 p.m., E.T., Monday through Friday, except Federal holidays.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title:</E>
                     Annual Tank Car Facility Survey.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Approval for an extension of an existing information collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     There are approximately 175 tank car facilities with the capacity to manufacture or retrofit tank cars capable of carrying Class 3 flammable liquids nationwide.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Section 7308(c) of the Fixing America's Surface Transportation Act (Pub. L. 114-94; the “FAST Act”) directs the Secretary of Transportation to conduct a survey of tank car facilities to obtain an estimate of tank cars projected to be modified or built to the new safer Department of Transportation (DOT) Specification 117 or 117R. Over time, this data collection has and will continue to inform Congress as well as the Department of Transportation as to industry's progress in upgrading the nation's fleet of rail cars to be safer in the event of an incident involving tank cars carrying Class 3 Flammable liquids. BTS has been collecting and intends to continue to collect information from tank car retrofitting and manufacturing facilities on the planned and projected number of tank cars to be retrofitted or manufactured beginning the next calendar year and annually thereafter until 2029. Any facility identified with the capacity to modify or build new tank cars to the 117 or 117R specification, as described in Section 7308(c) of the FAST Act will be included in the survey identified in this notice and is requested to submit the results to the Bureau of Transportation Statistics (BTS) no later than 60 days upon request. This will be a voluntary data collection. Individual responses to the survey will be kept confidential and a summary report of aggregate findings will be provided to:
                    <PRTPAGE P="25065"/>
                </P>
                <P>(1) The Committee on Commerce, Science, and Transportation of the Senate; and</P>
                <P>(2) The Committee on Transportation and Infrastructure of the House of Representatives.</P>
                <P>In addition, this summary report will also be published to the BTS web page.</P>
                <P>
                    <E T="03">Data Confidentiality Provisions:</E>
                     The Annual Tank Car Facility Survey may collect confidential business information. The confidentiality of these data will be protected under Title V of the E-Government Act, the Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA). In accordance with this legislation, individual responses will not be disclosed in any direct or indirect manner and only aggregated statistical information will be made available through reports.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     This survey will be updated every year until 2029.
                </P>
                <P>
                    <E T="03">Estimated Average Burden per Response:</E>
                     The burden per respondent is estimated to be an average of 30 minutes. This includes the time required to gather records as well as respond to the survey.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden:</E>
                     Across the nation there are approximately 400 tank car facilities that are currently registered or certified to build or modify tank cars. However, the majority of these do not have the capacity to modify or build to the 117 or 117R Specifications. It is estimated that, at most, 175 tank car shops possess the required capacity to build or modify to these new safer requirements. The total annual burden is estimated to be 87.5 hours (that is 30 minutes per respondent for 175 respondents equals 5,250 minutes).
                </P>
                <P>
                    <E T="03">Response to Comments:</E>
                     A 60-day notice requesting public comment was issued in the 
                    <E T="04">Federal Register</E>
                     on January 11, 2021 (Volume 86, Number 6; pages 2030-2031). No comments were received.
                </P>
                <P>
                    <E T="03">Public Comments Invited:</E>
                     Interested parties are invited to send comments regarding any aspect of this information collection, including, but not limited to: (1) The necessity and utility of the information collection for the proper performance of the functions of the DOT; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, clarity and content of the collected information; and (4) ways to minimize the collection burden without reducing the quality of the collected information. Send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725-17th Street NW, Washington, DC 20503, Attention: BTS Desk Officer.
                </P>
                <SIG>
                    <DATED>Issued in Washington, DC, on this 5th day of May, 2021.</DATED>
                    <NAME>Cha-Chi Fan,</NAME>
                    <TITLE>Director, Office of Data Development and Standards, Bureau of Transportation Statistics, Office of the Assistant Secretary for Research and Technology.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09816 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-9X-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBJECT>Request for Expressions of Interest in Membership on the Advisory Committee on Risk-Sharing Mechanisms</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 Federal Insurance Office (FIO) within the Department of the Treasury invites the public to submit expressions of interest in serving as members of the Advisory Committee on Risk-Sharing Mechanisms (ACRSM). Potential candidates must meet the membership criteria set forth below. Submissions must be received by FIO no later than June 15, 2021.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Richard Ifft, Senior Insurance Regulatory Policy Analyst, Federal Insurance Office, Department of the Treasury, 1500 Pennsylvania Ave. NW, Room 1410 MT, Washington, DC 20220, at (202) 622-2922 (this is not a toll-free number). Persons who have difficulty hearing or speaking may access this number via TTY by calling the toll-free Federal Relay Service at (800) 877- 8339.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P SOURCE="NPAR">
                    <E T="03">Background.</E>
                     The ACRSM, a federal advisory committee of representatives of the affected sectors of the insurance industry that participate or desire to participate in the market for terrorism risk insurance, was established in 2015 under the Terrorism Risk Insurance Program Reauthorization Act of 2015 (the Reauthorization Act).
                    <SU>1</SU>
                    <FTREF/>
                     The ACRSM provides FIO with nonbinding advice and recommendations with respect to (1) the creation and development of non-governmental, private market risk-sharing mechanisms for protection against losses arising from acts of terrorism; and (2) FIO's administration of the Terrorism Risk Insurance Program (TRIP). Assisting the Secretary of the Treasury in the administration of TRIP is among FIO's duties and authorities as set out in Subpart A of the Federal Insurance Office Act of 2010 (31 U.S.C. 313, 
                    <E T="03">et seq.</E>
                    ), Title V of the Dodd-Frank Wall Street Reform and Consumer Protection Act, P.L. 111- 203, 12 U.S.C. 5301 
                    <E T="03">et seq.</E>
                     (July 21, 2010).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Public Law 114-1, 129 Stat. 3, § 110.
                    </P>
                </FTNT>
                <P>
                    Under the Reauthorization Act, the ACRSM “shall be composed of nine members who are directors, officers, or other employees of insurers, reinsurers, or capital market participants that are participating or that desire to participate” in the market for terrorism risk insurance, and “who are representative of the affected sectors of the insurance industry, including commercial property insurance, commercial casualty insurance, reinsurance, and alternative risk transfer industries.” 
                    <SU>2</SU>
                    <FTREF/>
                     The ACRSM's membership is balanced to include a cross-section of these individuals. More information regarding the ACRSM, including a list of its current members, prior recommendations to FIO, and its organizational documents, is available on the Treasury website.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Reauthorization Act, § 110(b)(3).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">https://home.treasury.gov/policy-issues/financial-markets-financial-institutions-and-fiscal-service/federal-insurance-office/terrorism-risk-insurance-program/advisory-committee-on-risk-sharing-mechanisms-acrsm.</E>
                         Additional information related to the ACRSM's recent activities is also available in FIO's most recent Report on the Effectiveness of the Terrorism Risk Insurance Program. 
                        <E T="03">See</E>
                         FIO, 
                        <E T="03">Report on the Effectiveness of the Terrorism Risk Insurance Program</E>
                         (2020), 79-81, 
                        <E T="03">https://home.treasury.gov/system/files/311/2020-TRIP-Effectiveness-Report.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    Individuals interested in serving as members of the ACRSM who meet the membership criteria described above should submit an expression of interest including name, organization or affiliation, and contact information (
                    <E T="03">e.g.,</E>
                     employment address, telephone number, and email address). Submissions should also include a curriculum vitae and a statement describing the individual's interest in serving and willingness to work on the issues addressed by the ACRSM. FIO and Treasury will retain the ultimate authority to appoint members to the ACRSM and will not be required to appoint any individuals submitting expressions of interest through this process.
                </P>
                <P>
                    Some members of the ACRSM may be required to adhere to the conflict of interest rules applicable to Special Government Employees as such employees are defined in 18 U.S.C. 202(a). These rules include relevant provisions in 18 U.S.C. related to criminal activity, Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR part 2635), and Executive 
                    <PRTPAGE P="25066"/>
                    Order 12674 (as modified by Executive Order 12731).
                </P>
                <P>In accordance with Department of Treasury Directive 21-03, candidates for appointment to the ACRSM are subject to a clearance process, including fingerprinting, annual tax checks, and a Federal Bureau of Investigation criminal check. All ACRSM candidates must agree to submit to these pre-appointment checks.</P>
                <P>
                    The deadline for submitting expressions of interest is June 15, 2021. Submissions may be sent by email to 
                    <E T="03">ACRSM@treasury.gov</E>
                     or by mail to: The Federal Insurance Office, Department of the Treasury, 1500 Pennsylvania Avenue NW, Washington, DC 20220-0002, Attention: ACRSM.
                </P>
                <SIG>
                    <NAME>Steven Seitz,</NAME>
                    <TITLE>Director, Federal Insurance Office.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2021-09753 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-AK-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBAGY>United States Mint</SUBAGY>
                <SUBJECT>2021 Pricing of Numismatic Gold, Commemorative Gold, Platinum, and Palladium Products Grid</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States Mint, Department of the Treasury.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The United States Mint announces 2021 revisions to include price increases for the American Eagle Gold Proof Coin, American Eagle Gold Uncirculated Coin, American Buffalo Gold Proof Coin, American Liberty Gold Coin, and Mayflower Gold Coins within the Pricing of Numismatic Gold, Commemorative Gold, Platinum, and Palladium Products Grid. An excerpt of the grid with a recent price range for the American Eagle Gold Proof coins appears below:</P>
                </SUM>
                <GPH SPAN="3" DEEP="207">
                    <GID>EN10MY21.371</GID>
                </GPH>
                <P>
                    The complete 2021 Pricing of Numismatic Gold, Commemorative Gold, Platinum, and Palladium Products Grid will be available at 
                    <E T="03">https://catalog.usmint.gov/coin-programs/american-eagle-coins.</E>
                </P>
                <P>Pricing can vary weekly dependent upon the London Bullion Market Association gold, platinum, and palladium prices weekly average. The pricing for all United States Mint numismatic gold, platinum, and palladium products is evaluated every Wednesday and modified as necessary.</P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P> Cathy Olson; Sales and Marketing Directorate; United States Mint; 801 9th Street NW; Washington, DC 20220; or call 202-354-7500.</P>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 31 U.S.C. 5111, 5112, &amp; 9701.</P>
                    </AUTH>
                    <SIG>
                        <NAME>Eric Anderson,</NAME>
                        <TITLE>Executive Secretary, United States Mint.</TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09764 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-37-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">UNIFIED CARRIER REGISTRATION PLAN</AGENCY>
                <SUBJECT>Sunshine Act Meeting; Unified Carrier Registration Plan Board Subcommittee Meeting</SUBJECT>
                <PREAMHD>
                    <HD SOURCE="HED">TIME AND DATE: </HD>
                    <P>May 13, 2021, 12:00 p.m. to 2:00 p.m., Eastern time.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">PLACE: </HD>
                    <P>
                        This meeting will be accessible via conference call and via Zoom Meeting and Screenshare. Any interested person may call (i) 1-929-205-6099 (US Toll) or 1-669-900-6833 (US Toll) or (ii) 1-877-853-5247 (US Toll Free) or 1-888-788-0099 (US Toll Free), Meeting ID: 916 0446 8270, to listen and participate in this meeting. The website to participate via Zoom Meeting and Screenshare is 
                        <E T="03">https://kellen.zoom.us/j/91604468270.</E>
                    </P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">STATUS: </HD>
                    <P>This meeting will be open to the public.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">MATTERS TO BE CONSIDERED:</HD>
                    <P>The Unified Carrier Registration Plan Finance Subcommittee (the “Subcommittee”) will continue its work in developing and implementing the Unified Carrier Registration Plan and Agreement. The subject matter of this meeting will include:</P>
                </PREAMHD>
                <HD SOURCE="HD1">Proposed Agenda</HD>
                <HD SOURCE="HD1">I. Call to Order—Subcommittee Chair</HD>
                <P>The Subcommittee Chair will welcome attendees, call the meeting to order, call roll for the Subcommittee, confirm whether a quorum is present, and facilitate self-introductions.</P>
                <HD SOURCE="HD1">II. Verification of Publication of Meeting Notice—UCR Executive Director</HD>
                <P>
                    The UCR Executive Director will verify the publication of the meeting notice on the UCR website and distribution to the UCR contact list via email followed by the subsequent publication of the notice in the 
                    <E T="04">Federal Register</E>
                    .
                    <PRTPAGE P="25067"/>
                </P>
                <HD SOURCE="HD1">III. Review and Approval of Subcommittee Agenda and Setting of Ground Rules—Subcommittee Chair</HD>
                <HD SOURCE="HD2">For Discussion and Possible Subcommittee Action</HD>
                <P>The Agenda will be reviewed, and the Subcommittee will consider adoption.</P>
                <HD SOURCE="HD3">Ground Rules</HD>
                <P>➢ Subcommittee action only to be taken in designated areas on agenda</P>
                <HD SOURCE="HD1">IV. Review and Approval of Minutes From April 1, 2021 Meeting—Subcommittee Chair</HD>
                <HD SOURCE="HD2">For Discussion and Possible Subcommittee Action</HD>
                <P>Draft minutes from the April 1, 2021 Subcommittee meeting via teleconference will be reviewed. The Subcommittee will consider action to approve.</P>
                <HD SOURCE="HD1">V. 2023 Fee Change Recommendation—Calculation Methodology—Subcommittee Chair and UCR Depository Manager</HD>
                <HD SOURCE="HD2">For Discussion and Possible Subcommittee Action</HD>
                <P>The Subcommittee Chair and the UCR Depository Manager will lead a discussion regarding the merits of using an “average collections” method for estimating the remaining fees collected before the end of the registration year on September 30, 2022 versus the “minimum collections” method used for estimating fee collections over the same period. The Subcommittee may take action to make a recommendation to the UCR Board of Directors regarding the most appropriate method to use.</P>
                <HD SOURCE="HD1">VI. 2023 Fee Change Recommendation—Initial Estimate—UCR Depository Manager</HD>
                <P>The UCR Depository Manager will present the initial fee calculations for the 2023 registration year. This will be an initial review to the Subcommittee and most likely will not be the final fees recommended to the UCR Board from the Subcommittee for the 2023 registration year. This will be a forward-looking analysis, and no reliance should be placed on whether these figures will be the fees that will be recommended for the 2023 registration year because they are very preliminary and subject to change prior to the Subcommittee's final fee recommendation to the Board to be made at the Subcommittee's July meeting.</P>
                <HD SOURCE="HD1">VII. 2019 Registration Year Closure—UCR Depository Manager</HD>
                <HD SOURCE="HD2">For Discussion and Possible Subcommittee Action</HD>
                <P>The UCR Depository Manager will present to the Subcommittee the results of the final closure of the Depository for the 2019 registration year.</P>
                <HD SOURCE="HD1">VIII. Other Business—Subcommittee Chair</HD>
                <P>The Subcommittee Chair will call for any other items Subcommittee members would like to discuss.</P>
                <HD SOURCE="HD1">IX. Adjournment—Subcommittee Chair</HD>
                <P>The Subcommittee Chair will adjourn the meeting.</P>
                <P>
                    The agenda will be available no later than 5:00 p.m. Eastern time, May 5, 2021 at: 
                    <E T="03">https://plan.ucr.gov.</E>
                </P>
                <PREAMHD>
                    <HD SOURCE="HED">CONTACT PERSON FOR MORE INFORMATION:</HD>
                    <P>
                         Elizabeth Leaman, Chair, Unified Carrier Registration Plan Board of Directors, (617) 305-3783, 
                        <E T="03">eleaman@board.ucr.gov.</E>
                    </P>
                </PREAMHD>
                <SIG>
                    <NAME>Alex B. Leath,</NAME>
                    <TITLE>Chief Legal Officer, Unified Carrier Registration Plan.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2021-09924 Filed 5-6-21; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-YL-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF VETERANS AFFAIRS</AGENCY>
                <DEPDOC>[OMB Control No. 2900-0668]</DEPDOC>
                <SUBJECT>Agency Information Collection Activity Under OMB Review: Supplemental Income Questionnaire (for Philippine Claims Only)</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, 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 search function. Refer to “OMB Control No. 2900-0668”.
                    </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. 2900-0668” in any correspondence.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Authority:</E>
                     38 U.S.C. 5101,107, 1521, 1541, and 1542; 38 CFR 3.262 and 3.272.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Supplemental Income Questionnaire (for Philippine Claims Only) (VA Form 21P-0784).
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2900-0668.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Reinstatement of a previously approved collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     VBA administers Pension Benefits, which is a needs-based benefit program for wartime Veterans, who are aged 65 or older or have a permanent and total 
                    <E T="03">non-service-connected</E>
                     disability and limited income and net worth. Eligibility is determined based on the income of and asset amounts for the Veteran and their spouse. Claimants residing in the Philippines complete the 21P-0784 
                    <E T="03">Supplemental Income Questionnaire (for Philippine Claims Only)</E>
                     to report their countable family income and net worth.
                </P>
                <P>VBA uses the information to determine the claimant's entitlement to pension benefits. In an effort to safeguard Veterans and their beneficiaries from financial exploitation, the instructions on this form were amended to include information regarding VA-accredited attorneys or agents charging fees in connection with a proceeding before the Department of Veterans Affairs with respect to a claim.</P>
                <PRTPAGE P="25068"/>
                <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 
                    <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 34 on February 23, 2021, page 11056.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or Households.
                </P>
                <P>
                    <E T="03">Estimated Annual Burden:</E>
                     30 hours.
                </P>
                <P>
                    <E T="03">Estimated Average Burden Per Respondent:</E>
                     15 minutes.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     One time.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     120.
                </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. 2021-09870 Filed 5-7-21; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8320-01-P</BILCOD>
        </NOTICE>
    </NOTICES>
    <VOL>86</VOL>
    <NO>88</NO>
    <DATE>Monday, May 10, 2021</DATE>
    <UNITNAME>Presidential Documents</UNITNAME>
    <PRESDOCS>
        <PRESDOCU>
            <PROCLA>
                <TITLE3>Title 3—</TITLE3>
                <PRES>
                    The President
                    <PRTPAGE P="24697"/>
                </PRES>
                <PROC>Proclamation 10203 of May 5, 2021</PROC>
                <HD SOURCE="HED">National Day of Prayer, 2021</HD>
                <PRES>By the President of the United States of America</PRES>
                <PROC>A Proclamation</PROC>
                <FP>Throughout our history, Americans of many religions and belief systems have turned to prayer for strength, hope, and guidance. Prayer has nourished countless souls and powered moral movements—including essential fights against racial injustice, child labor, and infringement on the rights of disabled Americans. Prayer is also a daily practice for many, whether it is to ask for help or strength, or to give thanks over blessings bestowed.</FP>
                <FP>The First Amendment to our Constitution protects the rights of free speech and religious liberty, including the right of all Americans to pray. These freedoms have helped us to create and sustain a Nation of remarkable religious vitality and diversity across the generations.</FP>
                <FP>Today, we remember and celebrate the role that the healing balm of prayer can play in our lives and in the life of our Nation. As we continue to confront the crises and challenges of our time—from a deadly pandemic, to the loss of lives and livelihoods in its wake, to a reckoning on racial justice, to the existential threat of climate change—Americans of faith can call upon the power of prayer to provide hope and uplift us for the work ahead. As the late Congressman John Lewis once said, “Nothing can stop the power of a committed and determined people to make a difference in our society. Why? Because human beings are the most dynamic link to the divine on this planet.”</FP>
                <FP>On this National Day of Prayer, we unite with purpose and resolve, and recommit ourselves to the core freedoms that helped define and guide our Nation from its earliest days. We celebrate our incredible good fortune that, as Americans, we can exercise our convictions freely—no matter our faith or beliefs. Let us find in our prayers, however they are delivered, the determination to overcome adversity, rise above our differences, and come together as one Nation to meet this moment in history.</FP>
                <FP>The Congress, by Public Law 100-307, as amended, has called on the President to issue each year a proclamation designating the first Thursday in May as a “National Day of Prayer.”</FP>
                <FP>NOW, THEREFORE, I, JOSEPH R. BIDEN JR., President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim May 6, 2021, as a National Day of Prayer. I invite the citizens of our Nation to give thanks, in accordance with their own faiths and consciences, for our many freedoms and blessings, and I join all people of faith in prayers for spiritual guidance, mercy, and protection.</FP>
                <PRTPAGE P="24698"/>
                <FP>IN WITNESS WHEREOF, I have hereunto set my hand this fifth day of May, in the year of our Lord two thousand twenty-one, and of the Independence of the United States of America the two hundred and forty-fifth.</FP>
                <GPH SPAN="1" DEEP="80" HTYPE="RIGHT">
                    <GID>BIDEN.EPS</GID>
                </GPH>
                <PSIG> </PSIG>
                <FRDOC>[FR Doc. 2021-09946 </FRDOC>
                <FILED>Filed 5-7-21; 8:45 am]</FILED>
                <BILCOD>Billing code 3295-F1-P</BILCOD>
            </PROCLA>
        </PRESDOCU>
    </PRESDOCS>
    <VOL>86</VOL>
    <NO>88</NO>
    <DATE>Monday, May 10, 2021</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <NEWBOOKT>
            <PRTPAGE P="25069"/>
            <PARTNO>Part II</PARTNO>
            <BOOK>Book 2 of 2 Books</BOOK>
            <PGS>Pages 25069-26798</PGS>
            <AGENCY TYPE="P">Department of Health and Human Services</AGENCY>
            <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
            <HRULE/>
            <CFR>42 CFR Parts 412, 413, 425, et al.</CFR>
            <TITLE>Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes to the Medicare Shared Savings Program; Proposed Rule</TITLE>
        </NEWBOOKT>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="25070"/>
                    <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                    <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                    <CFR>42 CFR Parts 412, 413, 425, 455, and 495</CFR>
                    <DEPDOC>[CMS-1752-P]</DEPDOC>
                    <RIN>RIN 0938-AU44</RIN>
                    <SUBJECT>Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Proposed Changes to Medicaid Provider Enrollment; and Proposed Changes to the Medicare Shared Savings Program</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Centers for Medicare &amp; Medicaid Services (CMS), HHS.</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Proposed rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2022 and to implement certain recent legislation. In addition, we are proposing to rebase and revise the hospital market baskets for acute care hospitals, update the labor-related share, and provide the market basket update that would apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2022. We are also proposing policies relating to Medicare graduate medical education (GME) for teaching hospitals to implement certain recent legislation. The proposed rule would also update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2022. In this FY 2022 IPPS/LTCH PPS proposed rule, we are proposing to extend New COVID-19 Treatments Add-on Payment (NCTAP) for certain eligible products through the end of the fiscal year in which the PHE ends and to discontinue the NCTAP for discharges on or after October 1, 2021 for a product that is approved for new technology add-on payments beginning FY 2022. We are also proposing to repeal the collection of market-based rate information on the Medicare cost report and the market-based MS-DRG relative weight methodology, as finalized in the FY 2021 IPPS/LTCH PPS final rule.</P>
                        <P>We are proposing to establish new requirements and revise existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare Promoting Interoperability Program. We are also providing estimated and newly established performance standards for the Hospital Value-Based Purchasing (VBP) Program, and proposing updated policies for the Hospital Readmissions Reduction Program, Hospital Inpatient Quality Reporting (IQR) Program, Hospital VBP Program, Hospital-Acquired Condition (HAC) Reduction Program, and the PPS-Exempt Cancer Hospital Reporting (PCHQR) Program, and the Long-Term Care Hospital Quality Reporting Program (LTCH QRP). Additionally, due to the impact of the COVID-19 PHE on measure data used in our value-based purchasing programs, we are proposing to suppress several measures in the Hospital VBP, HAC Reduction, and Hospital Readmissions Reduction Programs. In connection with our measure suppression proposals for the FY 2022 Hospital VBP Program, we are also proposing to revise the scoring and payment methodology for the FY 2022 program year such that hospitals will not be scored using quality measure data that are distorted by the effects of the COVID-19 public health emergency (PHE) and will not receive Total Performance Scores or adjustments to their payments as a result. Similarly, we are proposing to suppress affected measures for the FY 2022 HAC Reduction Program such that hospitals will not be scored using distorted quality measure data and will not receive Total HAC Scores based on those data. For the Hospital Readmissions Reduction Program, we are proposing to suppress one affected measure under the proposed measure suppression policy for the FY 2023 applicable period such that hospitals will not be assessed using distorted quality measure data and will not receive payment reductions based on those data.</P>
                        <P>In addition, we are proposing to change, clarify, and codify Medicare organ acquisition payment policies relative to organ procurement organizations (OPOs), transplant hospitals, and donor community hospitals. Also, we are proposing to add regulation requiring that state Medicaid agencies accept valid enrollments from all Medicare-enrolled providers and suppliers for purposes of processing claims for Medicare cost-sharing liability for services furnished to Medicare-Medicaid dually eligible individuals in order to alleviate a long-standing problem related to claiming Medicare bad debt.</P>
                        <P>Additionally, we are proposing to amend the Medicare Shared Savings Program regulations to allow eligible accountable care organizations (ACOs) participating in the BASIC track's glide path the opportunity to maintain their current level of participation for performance year (PY) 2022.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>
                            To be assured consideration, comments must be received at one of the addresses provided in the 
                            <E T="02">ADDRESSES</E>
                             section, no later than 5 p.m. EDT on June 28, 2021.
                        </P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>In commenting, please refer to file code CMS-1752-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.</P>
                        <P>Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):</P>
                        <P>
                            1. 
                            <E T="03">Electronically.</E>
                             You may (and we encourage you to) submit electronic comments on this regulation to 
                            <E T="03">http://www.regulations.gov</E>
                            . Follow the instructions under the “submit a comment” tab.
                        </P>
                        <P>
                            2. 
                            <E T="03">By regular mail.</E>
                             You may mail written comments to the following address ONLY: Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services, Attention: CMS-1752-P, P.O. Box 8013, Baltimore, MD 21244-1850.
                        </P>
                        <P>Please allow sufficient time for mailed comments to be received before the close of the comment period.</P>
                        <P>
                            3. 
                            <E T="03">By express or overnight mail.</E>
                             You may send written comments via express or overnight mail to the following address ONLY: Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services, Attention: CMS-1752-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
                        </P>
                        <P>
                            For information on viewing public comments, we refer readers to the beginning of the 
                            <E T="02">SUPPLEMENTARY INFORMATION</E>
                             section.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P/>
                        <P>
                            Donald Thompson, (410) 786-4487, and Michele Hudson, (410) 786-4487, Operating Prospective Payment, MS-DRG Relative Weights, Wage Index, Hospital Geographic Reclassifications, Graduate Medical Education, Capital Prospective Payment, Excluded Hospitals, Medicare Disproportionate Share Hospital (DSH) Payment 
                            <PRTPAGE P="25071"/>
                            Adjustment, Sole Community Hospitals (SCHs), Medicare-Dependent Small Rural Hospital (MDH) Program, Low-Volume Hospital Payment Adjustment, and Critical Access Hospital (CAH) Issues.
                        </P>
                        <P>Emily Lipkin, (410) 786-3633 and Jim Mildenberger, (410) 786-4551, Long-Term Care Hospital Prospective Payment System and MS-LTC-DRG Relative Weights Issues.</P>
                        <P>Emily Forrest, (202) 205-1922, Market-Based Data Collection and Market-Based MS-DRG Relative Weight Methodology Issues.</P>
                        <P>Allison Pompey, (410) 786-2348, New Technology Add On Payments and New COVID-19 Treatments Add-on Payments Issues.</P>
                        <P>Mady Hue, (410) 786-4510, and Andrea Hazeley, (410) 786-3543, MS-DRG Classifications Issues.</P>
                        <P>Mollie Knight, (410) 786-7948, and Bridget Dickensheets, (410) 786-8670, Rebasing and Revising the Hospital Market Baskets Issues.</P>
                        <P>Siddhartha Mazumdar, (410) 786-6673, Rural Community Hospital Demonstration Program Issues.</P>
                        <P>Jeris Smith, (410) 786-0110, Frontier Community Health Integration Project Demonstration Issues.</P>
                        <P>
                            Pamela Brown, 
                            <E T="03">pamela.brown@cms.hhs.gov</E>
                            , Hospital Readmissions Reduction Program—Administration Issues.
                        </P>
                        <P>
                            Jim Poyer, 
                            <E T="03">james.poyer@cms.hhs.gov</E>
                            , Hospital Readmissions Reduction Program—Readmissions—Measures Issues.
                        </P>
                        <P>
                            Jennifer Tate, 
                            <E T="03">jennifer.tate@cms.hhs.gov</E>
                            , Hospital-Acquired Condition Reduction Program—Administration Issues.
                        </P>
                        <P>Yuling Li, (410) 786-8421, Hospital-Acquired Condition Reduction Program—Measures Issues.</P>
                        <P>
                            Julia Venanzi, 
                            <E T="03">julia.venanzi@cms.hhs.gov</E>
                            , Hospital Inpatient Quality Reporting and Hospital Value-Based Purchasing Programs—Administration Issues.
                        </P>
                        <P>
                            Katrina Hoadley, 
                            <E T="03">katrina.hoadley@cms.hhs.gov</E>
                            , Hospital Inpatient Quality Reporting and Hospital Value-Based Purchasing Programs—Measures Issues Except Hospital Consumer Assessment of Healthcare Providers and Systems Issues.
                        </P>
                        <P>Elizabeth Goldstein, (410) 786-6665, Hospital Inpatient Quality Reporting and Hospital Value-Based Purchasing—Hospital Consumer Assessment of Healthcare Providers and Systems Measures Issues.</P>
                        <P>
                            Annie Hollis, 
                            <E T="03">annie.hollis@cms.hhs.gov</E>
                            , PPS-Exempt Cancer Hospital Quality Reporting—Administration Issues.
                        </P>
                        <P>
                            Katrina Hoadley, 
                            <E T="03">katrina.hoadley@cms.hhs.gov</E>
                            , PPS-Exempt Cancer Hospital Quality Reporting Program-Measure Issues.
                        </P>
                        <P>Christy Hughes, (410) 786-5662, Long-Term Care Hospital Quality Reporting Program—Data Reporting Issues.</P>
                        <P>
                            Jessica Warren, 
                            <E T="03">jessica.warren@cms.hhs.gov</E>
                            , Dylan Podson, 
                            <E T="03">dylan.podson3@cms.hhs.gov</E>
                            , and Elizabeth Holland, 
                            <E T="03">elizabeth.holland@cms.hhs.gov</E>
                            , Promoting Interoperability Programs.
                        </P>
                        <P>Candace Anderson, (410) 786-1553, Medicaid Enrollment of Medicare Providers and Suppliers for Purposes of Processing Claims for Cost-Sharing for Services Furnished to Dually Eligible Beneficiaries.</P>
                        <P>Katie Lucas, (410) 786-7723, Amanda Michael, (410) 786-5834, and Kellie Shannon (410) 786-0416, Organ Acquisition Payment Issues.</P>
                        <P>
                            Naseem Tarmohamed, (410) 786-0814, or 
                            <E T="03">SharedSavingsProgram@cms.hhs.gov</E>
                            , for issues related to the Shared Savings Program.
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P/>
                    <P>
                        <E T="03">Inspection of Public Comments:</E>
                         All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: 
                        <E T="03">http://www.regulations.gov/</E>
                        . Follow the search instructions on that website to view public comments.
                    </P>
                    <HD SOURCE="HD1">Tables Available Through the Internet on the CMS Website</HD>
                    <P>
                        The IPPS tables for this FY 2022 proposed rule are available through the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                        . Click on the link on the left side of the screen titled, “FY 2022 IPPS Proposed rule Home Page” or “Acute Inpatient—Files for Download.” The LTCH PPS tables for this FY 2022 proposed rule are available through the internet on the CMS website at: 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/LongTermCareHospitalPPS/index.html</E>
                         under the list item for Regulation Number CMS-1752-P. For further details on the contents of the tables referenced in this proposed rule, we refer readers to section VI. of the Addendum to this FY 2022 IPPS/LTCH PPS proposed rule.
                    </P>
                    <P>Readers who experience any problems accessing any of the tables that are posted on the CMS websites, as previously identified, should contact Michael Treitel at (410) 786-4552.</P>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. Executive Summary and Background</FP>
                        <FP SOURCE="FP1-2">A. Executive Summary</FP>
                        <FP SOURCE="FP1-2">B. Background Summary</FP>
                        <FP SOURCE="FP1-2">C. Summary of Provisions of Recent Legislation That Would Be Implemented in This Proposed Rule</FP>
                        <FP SOURCE="FP1-2">D. Summary of the Provisions of This Proposed Rule</FP>
                        <FP SOURCE="FP1-2">E. Advancing Health Information Exchange</FP>
                        <FP SOURCE="FP1-2">F. Use of FY 2020 or FY 2019 Data in the FY 2022 IPPS and LTCH PPS Ratesetting</FP>
                        <FP SOURCE="FP-2">II. Proposed Changes to Medicare Severity Diagnosis-Related Group (MS-DRG) Classifications and Relative Weights</FP>
                        <FP SOURCE="FP1-2">A. Background</FP>
                        <FP SOURCE="FP1-2">B. Adoption of the MS-DRGs and MS-DRG Reclassifications</FP>
                        <FP SOURCE="FP1-2">C. Proposed FY 2022 MS-DRG Documentation and Coding Adjustment</FP>
                        <FP SOURCE="FP1-2">D. Proposed Changes to Specific MS-DRG Classifications</FP>
                        <FP SOURCE="FP1-2">E. Recalibration of the FY 2022 MS-DRG Relative Weights</FP>
                        <FP SOURCE="FP1-2">F. Proposed Add-On Payments for New Services and Technologies for FY 2022</FP>
                        <FP SOURCE="FP-2">III. Proposed Changes to the Hospital Wage Index for Acute Care Hospitals</FP>
                        <FP SOURCE="FP1-2">A. Background</FP>
                        <FP SOURCE="FP1-2">B. Worksheet S-3 Wage Data for the Proposed FY 2022 Wage Index</FP>
                        <FP SOURCE="FP1-2">C. Verification of Worksheet S-3 Wage Data</FP>
                        <FP SOURCE="FP1-2">D. Method for Computing the Proposed FY 2022 Unadjusted Wage Index</FP>
                        <FP SOURCE="FP1-2">E. Proposed Occupational Mix Adjustment to the FY 2022 Wage Index</FP>
                        <FP SOURCE="FP1-2">F. Analysis and Implementation of the Proposed Occupational Mix Adjustment and the Proposed FY 2022 Occupational Mix Adjusted Wage Index</FP>
                        <FP SOURCE="FP1-2">G. Application of the Rural Floor, Application of the State Frontier Floor, and Continuation of the Low Wage Index Hospital Policy, and Proposed Budget Neutrality Adjustment</FP>
                        <FP SOURCE="FP1-2">H. Proposed FY 2022 Wage Index Tables</FP>
                        <FP SOURCE="FP1-2">I. Proposed Revisions to the Wage Index Based on Hospital Redesignations and Reclassifications</FP>
                        <FP SOURCE="FP1-2">J. Proposed Out-Migration Adjustment Based on Commuting Patterns of Hospital Employees</FP>
                        <FP SOURCE="FP1-2">K. Reclassification From Urban to Rural Under Section 1886(d)(8)(E) of the Act Implemented at 42 CFR 412.103</FP>
                        <FP SOURCE="FP1-2">L. Process for Requests for Wage Index Data Corrections</FP>
                        <FP SOURCE="FP1-2">M. Proposed Labor-Related Share for the FY 2022 Wage Index</FP>
                        <FP SOURCE="FP-2">IV. Proposed Rebasing and Revising of the Hospital Market Baskets for Acute Care Hospitals</FP>
                        <FP SOURCE="FP1-2">A. Background</FP>
                        <FP SOURCE="FP1-2">B. Rebasing and Revising the IPPS Market Basket</FP>
                        <FP SOURCE="FP1-2">C. Market Basket for Certain Hospitals Presently Excluded From the IPPS</FP>
                        <FP SOURCE="FP1-2">D. Rebasing and Revising the Capital Input Price Index (CIPI)</FP>
                        <FP SOURCE="FP-2">
                            V. Other Decisions and Changes to the IPPS for Operating System
                            <PRTPAGE P="25072"/>
                        </FP>
                        <FP SOURCE="FP1-2">A. Proposed Changes in the Inpatient Hospital Updates for FY 2021 (§ 412.64(d))</FP>
                        <FP SOURCE="FP1-2">B. Rural Referral Centers (RRCs)—Proposed Annual Updates to Case-Mix Index and Discharge Criteria (§ 412.96)</FP>
                        <FP SOURCE="FP1-2">C. Proposed Payment Adjustment for Low-Volume Hospitals (§ 412.101)</FP>
                        <FP SOURCE="FP1-2">D. Proposed Indirect Medical Education (IME) Payment Adjustment Factor (§ 412.105)</FP>
                        <FP SOURCE="FP1-2">E. Proposed Payment Adjustment for Medicare Disproportionate Share Hospitals (DSHs) for FY 2022 (§ 412.106)</FP>
                        <FP SOURCE="FP1-2">F. Counting Days Associated With Section 1115 Demonstration Projects in the Medicaid Fraction</FP>
                        <FP SOURCE="FP1-2">G. Hospital Readmissions Reduction Program: Proposed Updates and Changes (§§ 412.150 Through 412.154)</FP>
                        <FP SOURCE="FP1-2">H. Hospital Value-Based Purchasing (VBP) Program: Proposed Updates and Changes (§§ 412.160 Through 412.167)</FP>
                        <FP SOURCE="FP1-2">I. Hospital-Acquired Conditions (HAC) Reduction Program: Proposed Updates and Changes (§ 412.170)</FP>
                        <FP SOURCE="FP1-2">J. Proposed Payments for Indirect and Direct Graduate Medical Education Costs (§§ 412.105 and 413.75 through 413.83)</FP>
                        <FP SOURCE="FP1-2">K. Rural Community Hospital Demonstration Program</FP>
                        <FP SOURCE="FP1-2">L. Market-Based MS-DRG Relative Weight—Proposed Policy Changes (§ 413.20)</FP>
                        <FP SOURCE="FP1-2">M. Payment Adjustment for CAR T-cell Clinical Trial and Expanded Use for Immunotherapy Cases (§§ 412.85 and 412.312)</FP>
                        <FP SOURCE="FP-2">VI. Proposed Changes to the IPPS for Capital-Related Costs</FP>
                        <FP SOURCE="FP1-2">A. Overview</FP>
                        <FP SOURCE="FP1-2">B. Additional Provisions</FP>
                        <FP SOURCE="FP1-2">C. Proposed Annual Update for FY 2022</FP>
                        <FP SOURCE="FP-2">VII. Proposed Changes for Hospitals Excluded From the IPPS</FP>
                        <FP SOURCE="FP1-2">A. Proposed Rate-of-Increase in Payments to Excluded Hospitals for FY 2022</FP>
                        <FP SOURCE="FP1-2">B. Critical Access Hospitals (CAHs)</FP>
                        <FP SOURCE="FP-2">VIII. Proposed Changes to the Long-Term Care Hospital Prospective Payment System (LTCH PPS) for FY 2022</FP>
                        <FP SOURCE="FP1-2">A. Background of the LTCH PPS</FP>
                        <FP SOURCE="FP1-2">B. Medicare Severity Long-Term Care Diagnosis-Related Group (MS-LTC-DRG) Classifications and Relative Weights for FY 2021</FP>
                        <FP SOURCE="FP1-2">C. Proposed Changes to the LTCH PPS Payment Rates and Other Proposed Changes to the LTCH PPS for FY 2022</FP>
                        <FP SOURCE="FP-2">IX. Proposed Quality Data Reporting Requirements for Specific Providers and Suppliers</FP>
                        <FP SOURCE="FP1-2">A. Advancing to Digital Quality Measurement and the Use of Fast Healthcare Interoperability Resources (FHIR) in Hospital Quality Programs—Request for Information</FP>
                        <FP SOURCE="FP1-2">B. Closing the Health Equity Gap in CMS Hospital Quality Programs—Request For Information</FP>
                        <FP SOURCE="FP1-2">C. Hospital Inpatient Quality Reporting (IQR) Program</FP>
                        <FP SOURCE="FP1-2">D. Changes to the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program</FP>
                        <FP SOURCE="FP1-2">E. Long-Term Care Hospital Quality Reporting Program (LTCH QRP)</FP>
                        <FP SOURCE="FP1-2">F. Proposed Changes to the Medicare Promoting Interoperability Programs</FP>
                        <FP SOURCE="FP-2">X. Proposed Changes for Hospitals and Other Providers and Suppliers</FP>
                        <FP SOURCE="FP1-2">A. Medicaid Enrollment of Medicare Providers and Suppliers for Purposes of Processing Claims for Cost-Sharing for Services Furnished to Dually Eligible Beneficiaries—Proposed Policy Changes (§ 455.410)</FP>
                        <FP SOURCE="FP1-2">B. Organ Acquisition Payment—Proposed Policy Changes (Part 413, Subpart L)</FP>
                        <FP SOURCE="FP1-2">C. Medicare Shared Savings Program—Proposed Policy Changes (§ 425.600)</FP>
                        <FP SOURCE="FP-2">XI. MedPAC Recommendations</FP>
                        <FP SOURCE="FP-2">XII. Other Required Information</FP>
                        <FP SOURCE="FP1-2">A. Publicly Available Files</FP>
                        <FP SOURCE="FP1-2">B. Collection of Information Requirements</FP>
                        <FP SOURCE="FP1-2">C. Response to Public Comments</FP>
                        <FP SOURCE="FP-2">Regulation Text</FP>
                        <FP SOURCE="FP-2">Addendum—Schedule of Standardized Amounts, Update Factors, and Rate-of-Increase Percentages Effective With Cost Reporting Periods Beginning on or After October 1, 2021 and Payment Rates for LTCHs Effective for Discharges Occurring on or After October 1, 2021</FP>
                        <FP SOURCE="FP-2">I. Summary and Background</FP>
                        <FP SOURCE="FP-2">II. Proposed Changes to Prospective Payment Rates for Hospital Inpatient Operating Costs for Acute Care Hospitals for FY 2022</FP>
                        <FP SOURCE="FP1-2">A. Calculation of the Proposed Adjusted Standardized Amount</FP>
                        <FP SOURCE="FP1-2">B. Proposed Adjustments for Area Wage Levels and Cost-of-Living</FP>
                        <FP SOURCE="FP1-2">C. Calculation of the Proposed Prospective Payment Rates</FP>
                        <FP SOURCE="FP-2">III. Proposed Changes to Payment Rates for Acute Care Hospital Inpatient Capital-Related Costs for FY 2022</FP>
                        <FP SOURCE="FP1-2">A. Determination of the Proposed Federal Hospital Inpatient Capital-Related Prospective Payment Rate Update for FY 2022</FP>
                        <FP SOURCE="FP1-2">B. Calculation of the Proposed Inpatient Capital-Related Prospective Payments for FY 2022</FP>
                        <FP SOURCE="FP1-2">C. Capital Input Price Index</FP>
                        <FP SOURCE="FP-2">IV. Proposed Changes to Payment Rates for Excluded Hospitals: Rate-of-Increase Percentages for FY 2022</FP>
                        <FP SOURCE="FP-2">V. Proposed Changes to the Payment Rates for the LTCH PPS for FY 2022</FP>
                        <FP SOURCE="FP1-2">A. Proposed LTCH PPS Standard Federal Payment Rate for FY 2022</FP>
                        <FP SOURCE="FP1-2">B. Proposed Adjustment for Area Wage Levels Under the LTCH PPS for FY 2022</FP>
                        <FP SOURCE="FP1-2">C. Proposed Cost-of-Living Adjustment (COLA) for LTCHs Located in Alaska and Hawaii</FP>
                        <FP SOURCE="FP1-2">D. Proposed Adjustment for LTCH PPS High-Cost Outlier (HCO) Cases</FP>
                        <FP SOURCE="FP1-2">E. Proposed Update to the IPPS Comparable/Equivalent Amounts to Reflect the Statutory Changes to the IPPS DSH Payment Adjustment Methodology</FP>
                        <FP SOURCE="FP1-2">F. Computing the Proposed Adjusted LTCH PPS Federal Prospective Payments for FY 2022</FP>
                        <FP SOURCE="FP-2">VI. Tables Referenced in This Proposed Rule Generally Available Through the Internet on the CMS Website</FP>
                        <FP SOURCE="FP-2">Appendix A—Economic Analyses</FP>
                        <FP SOURCE="FP-2">I. Regulatory Impact Analysis</FP>
                        <FP SOURCE="FP1-2">A. Statement of Need</FP>
                        <FP SOURCE="FP1-2">B. Overall Impact</FP>
                        <FP SOURCE="FP1-2">C. Objectives of the IPPS and the LTCH PPS</FP>
                        <FP SOURCE="FP1-2">D. Limitations of Our Analysis</FP>
                        <FP SOURCE="FP1-2">E. Hospitals Included in and Excluded From the IPPS</FP>
                        <FP SOURCE="FP1-2">F. Effects on Hospitals and Hospital Units Excluded From the IPPS</FP>
                        <FP SOURCE="FP1-2">G. Quantitative Effects of the Policy Changes Under the IPPS for Operating Costs</FP>
                        <FP SOURCE="FP1-2">H. Effects of Other Proposed Policy Changes</FP>
                        <FP SOURCE="FP1-2">I. Effects of Proposed Changes in the Capital IPPS</FP>
                        <FP SOURCE="FP1-2">J. Effects of Proposed Payment Rate Changes and Policy Changes Under the LTCH PPS</FP>
                        <FP SOURCE="FP1-2">K. Effects of Proposed Requirements for Hospital Inpatient Quality Reporting (IQR) Program</FP>
                        <FP SOURCE="FP1-2">L. Effects of Proposed Requirements for the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program</FP>
                        <FP SOURCE="FP1-2">M. Effects of Proposed Requirements for the Long-Term Care Hospital Quality Reporting Program (LTCH QRP)</FP>
                        <FP SOURCE="FP1-2">N. Effects of Proposed Requirements Regarding the Promoting Interoperability Program</FP>
                        <FP SOURCE="FP1-2">O. Alternatives Considered</FP>
                        <FP SOURCE="FP1-2">P. Overall Conclusion</FP>
                        <FP SOURCE="FP1-2">Q. Regulatory Review Costs</FP>
                        <FP SOURCE="FP-2">II. Accounting Statements and Tables</FP>
                        <FP SOURCE="FP1-2">A. Acute Care Hospitals</FP>
                        <FP SOURCE="FP1-2">B. LTCHs</FP>
                        <FP SOURCE="FP-2">III. Regulatory Flexibility Act (RFA) Analysis</FP>
                        <FP SOURCE="FP-2">IV. Impact on Small Rural Hospitals</FP>
                        <FP SOURCE="FP-2">V. Unfunded Mandate Reform Act (UMRA) Analysis</FP>
                        <FP SOURCE="FP-2">VI. Executive Order 13175</FP>
                        <FP SOURCE="FP-2">VII. Executive Order 12866</FP>
                        <FP SOURCE="FP-2">Appendix B: Recommendation of Update Factors for Operating Cost Rates of Payment for Inpatient Hospital Services</FP>
                        <FP SOURCE="FP-2">I. Background</FP>
                        <FP SOURCE="FP-2">II. Inpatient Hospital Update for FY 2022</FP>
                        <FP SOURCE="FP1-2">A. Proposed FY 2022 Inpatient Hospital Update</FP>
                        <FP SOURCE="FP1-2">B. Proposed Update for SCHs and MDHs for FY 2022</FP>
                        <FP SOURCE="FP1-2">C. Proposed FY 2022 Puerto Rico Hospital Update</FP>
                        <FP SOURCE="FP1-2">D. Proposed Update for Hospitals Excluded From the IPPS for FY 2022</FP>
                        <FP SOURCE="FP1-2">E. Proposed Update for LTCHs for FY 2022</FP>
                        <FP SOURCE="FP-2">III. Secretary's Recommendation</FP>
                        <FP SOURCE="FP-2">IV. MedPAC Recommendation for Assessing Payment Adequacy and Updating Payments in Traditional Medicare</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Executive Summary and Background</HD>
                    <HD SOURCE="HD2">A. Executive Summary</HD>
                    <HD SOURCE="HD3">1. Purpose and Legal Authority</HD>
                    <P>
                        This FY 2022 IPPS/LTCH PPS proposed rule would make payment and policy changes under the Medicare inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals as well as for certain hospitals and hospital units excluded from the IPPS. In addition, it would make payment and policy changes for inpatient hospital services 
                        <PRTPAGE P="25073"/>
                        provided by long-term care hospitals (LTCHs) under the long-term care hospital prospective payment system (LTCH PPS). This proposed rule also would make policy changes to programs associated with Medicare IPPS hospitals, IPPS-excluded hospitals, and LTCHs. In this FY 2022 proposed rule, we are continuing policies to address wage index disparities impacting low wage index hospitals; including a proposal to implement the imputed floor wage index provision of the American Rescue Plan Act of 2021; including proposals related to new technology add-on payments; and proposing to repeal the collection of market-based rate information on the Medicare cost report and the market-based MS-DRG relative weight methodology, as finalized in the FY 2021 IPPS/LTCH PPS final rule. This proposed rule also includes proposals to implement provisions of the Consolidated Appropriations Act of 2021 relating to payments to hospitals for direct graduate medical education (GME) and indirect medical education (IME) costs.
                    </P>
                    <P>We are proposing to establish new requirements and revise existing requirements for eligible hospitals and CAHs participating in the Medicare Promoting Interoperability Program.</P>
                    <P>We are providing estimated and newly established performance standards for the Hospital Value-Based Purchasing (VBP) Program, and proposing updated policies for the Hospital Readmissions Reduction Program, Hospital Inpatient Quality Reporting (IQR) Program, Hospital VBP Program, Hospital-Acquired Condition (HAC) Reduction Program, Long Term Care Hospital Quality Reporting Program (LTCH QRP), and the PPS-Exempt Cancer Hospital Reporting (PCHQR) Program. Additionally, due to the impact of the COVID-19 PHE on measure data used in our value-based purchasing programs, we are proposing to suppress several measures in the Hospital VBP, HAC Reduction, and Hospital Readmissions Reduction Programs. As a result of these measure suppressions for the Hospital VBP Program we are also proposing a special scoring methodology for FY 2022 that results in a value-based incentive payment amount that matches the 2 percent reduction to the base operating DRG payment amount.</P>
                    <P>Under various statutory authorities, we either discuss continued program implementation or are proposing to make changes to the Medicare IPPS, to the LTCH PPS, other related payment methodologies and programs for FY 2022 and subsequent fiscal years, and other policies and provisions included in this rule. These statutory authorities include, but are not limited to, the following:</P>
                    <P>• Section 1886(d) of the Social Security Act (the Act), which sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. Section 1886(g) of the Act requires that, instead of paying for capital-related costs of inpatient hospital services on a reasonable cost basis, the Secretary use a prospective payment system (PPS).</P>
                    <P>• Section 1886(d)(1)(B) of the Act, which specifies that certain hospitals and hospital units are excluded from the IPPS. These hospitals and units are: Rehabilitation hospitals and units; LTCHs; psychiatric hospitals and units; children's hospitals; cancer hospitals; extended neoplastic disease care hospitals, and hospitals located outside the 50 States, the District of Columbia, and Puerto Rico (that is, hospitals located in the U.S. Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa). Religious nonmedical health care institutions (RNHCIs) are also excluded from the IPPS.</P>
                    <P>• Sections 123(a) and (c) of the BBRA (Public Law (Pub. L.) 106-113) and section 307(b)(1) of the BIPA (Pub. L. 106-554) (as codified under section 1886(m)(1) of the Act), which provide for the development and implementation of a prospective payment system for payment for inpatient hospital services of LTCHs described in section 1886(d)(1)(B)(iv) of the Act.</P>
                    <P>• Sections 1814(l), 1820, and 1834(g) of the Act, which specify that payments are made to critical access hospitals (CAHs) (that is, rural hospitals or facilities that meet certain statutory requirements) for inpatient and outpatient services and that these payments are generally based on 101 percent of reasonable cost.</P>
                    <P>• Section 1886(a)(4) of the Act, which specifies that costs of approved educational activities are excluded from the operating costs of inpatient hospital services. Hospitals with approved graduate medical education (GME) programs are paid for the direct costs of GME in accordance with section 1886(h) of the Act.</P>
                    <P>• Section 1886(b)(3)(B)(viii) of the Act, which requires the Secretary to reduce the applicable percentage increase that would otherwise apply to the standardized amount applicable to a subsection (d) hospital for discharges occurring in a fiscal year if the hospital does not submit data on measures in a form and manner, and at a time, specified by the Secretary.</P>
                    <P>• Section 1866(k) of the Act, which provides for the establishment of a quality reporting program for hospitals described in section 1886(d)(1)(B)(v) of the Act, referred to as “PPS-exempt cancer hospitals.”</P>
                    <P>• Section 1886(o) of the Act, which requires the Secretary to establish a Hospital Value-Based Purchasing (VBP) Program, under which value-based incentive payments are made in a fiscal year to hospitals meeting performance standards established for a performance period for such fiscal year.</P>
                    <P>• Section 1886(p) of the Act, which establishes a Hospital-Acquired Condition (HAC) Reduction Program, under which payments to applicable hospitals are adjusted to provide an incentive to reduce hospital-acquired conditions.</P>
                    <P>• Section 1886(q) of the Act, as amended by section 15002 of the 21st Century Cures Act, which establishes the Hospital Readmissions Reduction Program. Under the program, payments for discharges from an applicable hospital as defined under section 1886(d) of the Act will be reduced to account for certain excess readmissions. Section 15002 of the 21st Century Cures Act directs the Secretary to compare hospitals with respect to the number of their Medicare-Medicaid dual-eligible beneficiaries (dual-eligibles) in determining the extent of excess readmissions.</P>
                    <P>
                        • Section 1886(r) of the Act, as added by section 3133 of the Affordable Care Act, which provides for a reduction to disproportionate share hospital (DSH) payments under section 1886(d)(5)(F) of the Act and for a new uncompensated care payment to eligible hospitals. Specifically, section 1886(r) of the Act requires that, for fiscal year 2014 and each subsequent fiscal year, subsection (d) hospitals that would otherwise receive a DSH payment made under section 1886(d)(5)(F) of the Act will receive two separate payments: (1) 25 percent of the amount they previously would have received under section 1886(d)(5)(F) of the Act for DSH (“the empirically justified amount”), and (2) an additional payment for the DSH hospital's proportion of uncompensated care, determined as the product of three factors. These three factors are: (1) 75 percent of the payments that would otherwise be made under section 1886(d)(5)(F) of the Act; (2) 1 minus the percent change in the percent of individuals who are uninsured; and (3) a hospital's uncompensated care amount relative to the uncompensated 
                        <PRTPAGE P="25074"/>
                        care amount of all DSH hospitals expressed as a percentage.
                    </P>
                    <P>• Section 1886(m)(5) of the Act, which requires the Secretary to reduce by two percentage points the annual update to the standard Federal rate for discharges for a long-term care hospital (LTCH) during the rate year for LTCHs that do not submit data in the form, manner, and at a time, specified by the Secretary.</P>
                    <P>• Section 1886(m)(6) of the Act, as added by section 1206(a)(1) of the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013 (Pub. L. 113-67) and amended by section 51005(a) of the Bipartisan Budget Act of 2018 (Pub. L. 115-123), which provided for the establishment of site neutral payment rate criteria under the LTCH PPS, with implementation beginning in FY 2016. Section 51005(b) of the Bipartisan Budget Act of 2018 amended section 1886(m)(6)(B) by adding new clause (iv), which specifies that the IPPS comparable amount defined in clause (ii)(I) shall be reduced by 4.6 percent for FYs 2018 through 2026.</P>
                    <P>• Section 1899B of the Act, as added by section 2(a) of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185), which provides for the establishment of standardized data reporting for certain post-acute care providers, including LTCHs.</P>
                    <P>• Section 1899 of the Act which established the Medicare Shared Savings Program (Shared Savings Program) to facilitate coordination and cooperation among providers and suppliers to improve the quality of care for Medicare fee-for-service (FFS) beneficiaries and reduce the rate of growth in expenditures under Medicare Parts A and B.</P>
                    <P>• Section 1902(a)(23) of the Act, which specifies Medicaid provider enrollment requirements. States may set reasonable standards relating to the qualifications of providers but may not restrict the right of beneficiaries to obtain services from any person or entity that is both qualified and willing to furnish such services.</P>
                    <HD SOURCE="HD3">2. Summary of the Major Provisions</HD>
                    <P>The following is a summary of the major provisions in this proposed rule. In general, these major provisions are being proposed as part of the annual update to the payment policies and payment rates, consistent with the applicable statutory provisions. A general summary of the proposed changes in this proposed rule is presented in section I.D. of the preamble of this proposed rule.</P>
                    <HD SOURCE="HD3">a. Proposed MS-DRG Documentation and Coding Adjustment</HD>
                    <P>Section 631 of the American Taxpayer Relief Act of 2012 (ATRA, Pub. L. 112- 240) amended section 7(b)(1)(B) of Public Law 110-90 to require the Secretary to make a recoupment adjustment to the standardized amount of Medicare payments to acute care hospitals to account for changes in MS-DRG documentation and coding that do not reflect real changes in case-mix, totaling $11 billion over a 4-year period of FYs 2014, 2015, 2016, and 2017. The FY 2014 through FY 2017 adjustments represented the amount of the increase in aggregate payments as a result of not completing the prospective adjustment authorized under section 7(b)(1)(A) of Public Law 110-90 until FY 2013. Prior to the ATRA, this amount could not have been recovered under Public Law 110 90. Section 414 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) replaced the single positive adjustment we intended to make in FY 2018 with a 0.5 percent positive adjustment to the standardized amount of Medicare payments to acute care hospitals for FYs 2018 through 2023. (The FY 2018 adjustment was subsequently adjusted to 0.4588 percent by section 15005 of the 21st Century Cures Act.) Therefore, for FY 2022, we are proposing to make an adjustment of +0.5 percent to the standardized amount.</P>
                    <HD SOURCE="HD3">b. Proposed Changes to the New COVID-19 Treatments Add-On Payment (NCTAP)</HD>
                    <P>In response to the COVID-19 PHE, we established the New COVID-19 Treatments Add-on Payment (NCTAP) under the IPPS for COVID-19 cases that meet certain criteria (85 FR 71157 and 71158). We believe that as drugs and biological products become available and are authorized for emergency use or approved by Food and Drug Administration (FDA) for the treatment of COVID-19 in the inpatient setting, it is appropriate to increase the current IPPS payment amounts to mitigate any potential financial disincentives for hospitals to provide new COVID-19 treatments during the PHE. Therefore, effective for discharges occurring on or after November 2, 2020 and until the end of the PHE for COVID-19, CMS established the NCTAP.</P>
                    <P>We anticipate that there might be inpatient cases of COVID-19, beyond the end of the PHE, for which payment based on the assigned MS-DRG may not adequately reflect the additional cost of new COVID-19 treatments. In order to continue to mitigate potential financial disincentives for hospitals to provide these new treatments, and to minimize any potential payment disruption immediately following the end of the PHE, we believe that the NCTAP should remain available for cases involving eligible treatments for the remainder of the fiscal year in which the PHE ends (for example, until September 30, 2022). At the same time, we also believe that any new technology add-on payments that may be approved for a COVID-19 treatment would also serve to mitigate any potential financial disincentives for hospitals to provide that new COVID-19 treatment, such that the NCTAP would no longer be needed for that same product.</P>
                    <P>Therefore, we are proposing to extend NCTAP for eligible products that are not approved for new technology add-on payments through the end of the fiscal year in which the PHE ends (for example, September 30, 2022). We also are proposing to discontinue the NCTAP for discharges on or after October 1, 2021 for a product that is approved for new technology add-on payments beginning FY 2022.</P>
                    <HD SOURCE="HD3">c. Use of FY 2020 or FY 2019 Data in the FY 2022 IPPS and LTCH PPS Ratesetting</HD>
                    <P>For the IPPS and LTCH PPS ratesetting, our longstanding goal is always to use the best available data overall. In section I.F. of the preamble of this proposed rule we discuss our analysis of the best available data for use in the development of this FY 2022 IPPS/LTCH PPS proposed rule given the potential impact of the public health emergency (PHE) for the Coronavirus Disease (COVID-19). As discussed in section I.F of the preamble of this proposed rule, we are proposing to use the FY 2019 data, such as the FY 2019 MedPAR file, for the FY 2022 ratesetting for circumstances where the FY 2020 data is significantly impacted by the COVID-19 PHE, primarily in that the utilization of inpatient services reflect generally markedly different utilization for certain types of services in FY 2020 than would have been expected in the absence of the PHE. In section I.O. of Appendix A of this proposed rule, we are also considering, as an alternative to this proposal, the use of the same FY 2020 data that we would ordinarily use for purposes of FY 2022 ratesetting, and which we may consider finalizing based on consideration of comments received.</P>
                    <HD SOURCE="HD3">d. Proposed Continuation of the Low Wage Index Hospital Policy</HD>
                    <P>
                        To help mitigate wage index disparities between high wage and low hospitals, in the FY 2020 IPPS/LTCH 
                        <PRTPAGE P="25075"/>
                        PPS rule (84 FR 42326 through 42332), we adopted a policy to increase the wage index values for certain hospitals with low wage index values (the low wage index hospital policy). This policy was adopted in a budget neutral manner through an adjustment applied to the standardized amounts for all hospitals. We also indicated that this policy would be effective for at least 4 years, beginning in FY 2020, in order to allow employee compensation increases implemented by these hospitals sufficient time to be reflected in the wage index calculation. Therefore, for FY 2022, we are continuing the low wage index hospital policy, and are also proposing to apply this policy in a budget neutral manner by applying an adjustment to the standardized amounts.
                    </P>
                    <HD SOURCE="HD3">e. Proposed Implementation of Section 9831 of the American Rescue Plan Act of 2021 (Pub. L. 117-2) Imputed Floor Wage Index Policy for All-Urban States</HD>
                    <P>Section 9831 of the American Rescue Plan Act of 2021 (Pub. L. 117-2) amended section 1886(d)(3)(E) of the Act (42 U.S.C. 1395ww(d)(3)(E)) to establish a minimum area wage index for hospitals in all-urban States. Specifically, section 1886(d)(3)(E)(iv) of the Act (as added by section 9831(a)(2) of Pub. L. 117-2) reinstates the imputed floor wage index policy for all-urban states effective for discharges on or after October 1, 2021 (FY 2022) with no expiration date using the methodology described in 42 CFR 412.64(h)(4)(vi) as in effect for FY 2018. Furthermore, section 1886(d)(3)(E)(iv)(III) of the Act provides that the imputed floor wage index shall not be applied in a budget neutral manner. We refer readers to section III.G.2. of this proposed rule for a summary of the provisions of section 9831 of Public Law 117-2 that we are proposing to implement in this proposed rule.</P>
                    <HD SOURCE="HD3">f. Proposed DSH Payment Adjustment and Additional Payment for Uncompensated Care</HD>
                    <P>Section 3133 of the Affordable Care Act modified the Medicare disproportionate share hospital (DSH) payment methodology beginning in FY 2014. Under section 1886(r) of the Act, which was added by section 3133 of the Affordable Care Act, starting in FY 2014, FY 2014, Medicare DSHs receive 25 percent of the amount they previously would have received under the statutory formula for Medicare DSH payments in section 1886(d)(5)(F) of the Act. The remaining amount, equal to 75 percent of the amount that otherwise would have been paid as Medicare DSH payments, is paid as additional payments after the amount is reduced for changes in the percentage of individuals that are uninsured. Each Medicare DSH will receive an additional payment based on its share of the total amount of uncompensated care for all Medicare DSHs for a given time period.</P>
                    <P>In this proposed rule, we are proposing to update our estimates of the three factors used to determine uncompensated care payments for FY 2022. We are also proposing to continue to use uninsured estimates produced by CMS' Office of the Actuary (OACT) as part of the development of the National Health Expenditure Accounts (NHEA) in the calculation of Factor 2. Consistent with the policy adopted in the FY 2021 IPPS/LTCH PPS final rule for FY 2022 and subsequent fiscal years, we are using a single year of data on uncompensated care costs from Worksheet S-10 of the FY 2018 cost reports to calculate Factor 3 in the FY 2022 methodology for all eligible hospitals with the exception of Indian Health Service (IHS) and Tribal hospitals and Puerto Rico hospitals. For IHS and Tribal hospitals and Puerto Rico hospitals we are proposing to continue to use the low-income insured days proxy to calculate Factor 3 for these hospitals for FY 2022. We are proposing certain methodological changes for calculating Factor 3 for FY 2022.</P>
                    <P>Additionally, we are proposing to revise our regulation governing the calculation of the Medicaid fraction of the DSH calculation. Under this proposal, patient days of individuals receiving benefits under a section 1115 waiver program would be counted in the numerator of the Medicaid fraction only if the patient directly receives inpatient hospital insurance coverage on that day under a waiver authorized under section 1115(a)(2) of the Act.</P>
                    <HD SOURCE="HD3">g. Reduction of Hospital Payments for Excess Readmissions</HD>
                    <P>We are proposing to make changes to policies for the Hospital Readmissions Reduction Program, which was established under section 1886(q) of the Act, as amended by section 15002 of the 21st Century Cures Act. The Hospital Readmissions Reduction Program requires a reduction to a hospital's base operating DRG payment to account for excess readmissions of selected applicable conditions. For FY 2017 and subsequent years, the reduction is based on a hospital's risk-adjusted readmission rate during a 3-year period for acute myocardial infarction (AMI), heart failure (HF), pneumonia, chronic obstructive pulmonary disease (COPD), elective primary total hip arthroplasty/total knee arthroplasty (THA/TKA), and coronary artery bypass graft (CABG) surgery. In this FY 2022 IPPS/LTCH PPS proposed rule, we are proposing the following policies: (1) To adopt a cross-program measure suppression policy; (2) to suppress the Hospital 30-Day, All-Cause, Risk-Standardized Readmission Rate (RSRR) following Pneumonia Hospitalization measure (NQF #0506) for the FY 2023 program year; (3) to modify the remaining five condition-specific readmission measures to exclude COVID-19 diagnosed patients from the measure denominators, beginning with the FY 2023 program year; (4) to use the MedPAR data that aligns with the applicable period for FY 2022; (5) to automatically adopt the use of MedPAR data corresponding to the applicable period beginning with the FY 2023 program year and all subsequent program years, unless otherwise specified by the Secretary; and (6) to update the regulatory text to reflect that our Hospital Compare website has been renamed and is now referred to as Care Compare. We are clarifying our Extraordinary Circumstances Exceptions (ECE) policy, and we are also requesting public comment on opportunities to advance health equity through possible future stratification of results by race and ethnicity for condition/procedure-specific readmission measures and by expansion of standardized data collection to additional social factors, such as language preference and disability status. We are also seeking comment on mechanisms of incorporating other demographic characteristics into analyses that address and advance health equity, such as the potential to include administrative and self-reported data to measure co-occurring disability status.</P>
                    <HD SOURCE="HD3">h. Hospital Value-Based Purchasing (VBP) Program</HD>
                    <P>
                        Section 1886(o) of the Act requires the Secretary to establish a Hospital VBP Program under which value-based incentive payments are made in a fiscal year to hospitals based on their performance on measures established for a performance period for such fiscal year. In this proposed rule, we are proposing to: (1) Establish a measure suppression policy for the duration of the public health emergency for COVID-19; (2) suppress the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), Medicare Spending Per Beneficiary (MSPB), and five Healthcare-Associated Infection (HAI) measures, for the FY 2022 Program year; and (3) suppress the Hospital 30-Day, 
                        <PRTPAGE P="25076"/>
                        All-Cause, Risk-Standardized Mortality Rate Following Pneumonia (PN) Hospitalization (MORT-30-PN) measure for the FY 2023 program year. We are also proposing to revise the scoring and payment methodology for the FY 2022 program year such that hospitals' Total Performance Scores will not include calculations based on these measures. We believe that awarding a TPS to any hospital based off the remaining measures that are not suppressed would not result in a fair national comparison and, as a result, are proposing not to award a TPS to any hospital for the FY 2022 program year. Instead, we are proposing to award each hospital a payment incentive multiplier that results in a value-based incentive payment that is equal to the amount withheld for the fiscal year (2 percent). We are proposing to remove the CMS Patient Safety and Adverse Events Composite (PSI 90) measure beginning with FY 2023 because the costs associated with the measure outweigh the benefit of its use in the program. We are also proposing to update the baseline periods for certain measures affected by the ECE granted in response to the COVID-19 PHE and to make a technical update to our terminology used in the Hospital VBP Program regulations.
                    </P>
                    <HD SOURCE="HD3">i. Hospital-Acquired Condition (HAC) Reduction Program</HD>
                    <P>
                        Section 1886(p) of the Act establishes an incentive to hospitals to reduce the incidence of hospital-acquired conditions by requiring the Secretary to make an adjustment to payments to applicable hospitals, effective for discharges beginning on October 1, 2014. This 1-percent payment reduction applies to hospitals that rank in the worst-performing quartile (25 percent) of all applicable hospitals, relative to the national average, of conditions acquired during the applicable period and on all of the hospital's discharges for the specified fiscal year. In this FY 2022 IPPS/LTCH PPS proposed rule, we are proposing to: (1) Clarify our ECE policy; (2) adopt a cross-program measure suppression policy; (3) apply that measure suppression policy to suppress certain program data; and (4) update the regulatory text to reflect that our 
                        <E T="03">Hospital Compare</E>
                         website has been renamed and is now referred to as 
                        <E T="03">Care Compare.</E>
                    </P>
                    <HD SOURCE="HD3">j. Hospital Inpatient Quality Reporting (IQR) Program</HD>
                    <P>Under section 1886(b)(3)(B)(viii) of the Act, subsection (d) hospitals are required to report data on measures selected by the Secretary for a fiscal year in order to receive the full annual percentage increase that would otherwise apply to the standardized amount applicable to discharges occurring in that fiscal year.</P>
                    <P>In this FY 2022 IPPS/LTCH PPS proposed rule, we are proposing to make several changes. We are proposing to adopt five new measures: (1) A new structural measure—Maternal Morbidity Structural Measure—beginning with a shortened reporting period from October 1, 2021 through December 31, 2021 affecting the CY 2021 reporting period/FY 2023 payment determination; (2) the Hybrid Hospital-Wide All-Cause Risk Standardized Mortality (Hybrid HWM) measure in a stepwise fashion, beginning with a voluntary reporting period from July 1, 2022 through June 30, 2023, and followed by mandatory reporting from July 1, 2023 through June 30, 2024, affecting the FY 2026 payment determination and for subsequent years; (3) the COVID-19 Vaccination Coverage Among Health Care Personnel (HCP) measure beginning with a shortened reporting period from October 1, 2021 through December 31, 2021, affecting the CY 2021 reporting period/FY 2023 payment determination and with quarterly reporting beginning with the FY 2024 payment determination and for subsequent years; and two medication-related adverse event eCQMs beginning with the CY 2023 reporting period/FY 2025 payment determination; (4) Hospital Harm-Severe Hypoglycemia eCQM (NQF #3503e); and (5) Hospital Harm-Severe Hyperglycemia eCQM (NQF #3533e).</P>
                    <P>We are also proposing to remove five measures: (1) Death Among Surgical Inpatients with Serious Treatable Complications (CMS PSI-04) beginning with the FY 2023 payment determination; (2) Exclusive Breast Milk Feeding (PC-05) (NQF #0480) beginning with the FY 2026 payment determination; (3) Admit Decision Time to ED Departure Time for Admitted Patients (ED-2) (NQF #0497) beginning with the FY 2026 payment determination; and two stroke-related eCQMs beginning with the FY 2026 payment determination; (4) Anticoagulation Therapy for Atrial Fibrillation/Flutter eCQM (STK-03) (NQF #0436); and (5) Discharged on Statin Medication eCQM (STK-06) (NQF #0439).</P>
                    <P>We are requesting comment from stakeholders on the potential future development and inclusion of two measures: (1) A mortality measure for patients admitted with COVID-19; and (2) a patient-reported outcomes measure following elective total hip and/or total knee arthroplasty (THA/TKA). We are also requesting comment from stakeholders on ways we can leverage measures to address gaps in existing health equity generally as well as comment on: (1) Potential future confidential stratified reporting for the Hospital-Wide All-Cause Unplanned Readmission (HWR) measure using both dual eligibility and race/ethnicity; and (2) potential future reporting of a structural measure to assess the degree of hospital leadership engagement in health equity performance data. In this proposed rule, we are also requesting feedback across programs on potential actions and priority areas that would enable the continued transformation of our quality measurement toward greater digital capture of data and use of the FHIR standard.</P>
                    <P>
                        In addition, beginning with the CY 2023 reporting period/FY 2025 payment determination, we are proposing to require hospitals to use certified technology that has been updated consistent with the 2015 Edition Cures Update and clarifying that certified technology must support the reporting requirements for all available eCQMs. We also are proposing that hybrid measures comply with the same certification requirements as eCQMs, specifically that EHR technology must be certified to the 2015 Edition Cures Update. We are proposing an update to revise 42 CFR 412.140(a)(2) and 42 CFR 412.140(e)(2)(iii) replacing the terms “Security Administrator” and “System Administrator” with the term “security official” in alignment with other CMS quality programs. Due to an updated URL for the QualityNet website from 
                        <E T="03">QualityNet.org</E>
                         to 
                        <E T="03">QualityNet.cms.gov</E>
                        , we are also proposing to revise Hospital IQR Program regulations at 42 CFR 412.140(a)(1) and 42 CFR 412.140(c)(2)(i) to reflect updates to the QualityNet website. Lastly, we are proposing to extend the effects of the educational review process for chart-abstracted measures beginning with validations affecting the FY 2024 payment determination.
                    </P>
                    <HD SOURCE="HD3">k. PPS-Exempt Cancer Hospital Quality Reporting Program</HD>
                    <P>Section 1866(k)(1) of the Act requires, for purposes of FY 2014 and each subsequent fiscal year, that a hospital described in section 1886(d)(1)(B)(v) of the Act (a PPS-exempt cancer hospital, or a PCH) submit data in accordance with section 1866(k)(2) of the Act with respect to such fiscal year. There is no financial impact to PCH Medicare payment if a PCH does not participate.</P>
                    <P>
                        In this proposed rule, we are proposing to remove the Oncology: Plan of Care for Pain—Medical Oncology and 
                        <PRTPAGE P="25077"/>
                        Radiation Oncology (NQF #0383) (PCH-15) measure beginning with the FY 2024 program year, adopt the COVID-19 Vaccination Coverage Among Healthcare Personnel measure beginning with the FY 2023 program year, make a technical update to the terminology we use in the program, and codify existing PCHQR Program policies in our regulations.
                    </P>
                    <HD SOURCE="HD3">l. Medicare Promoting Interoperability Program</HD>
                    <P>For purposes of reducing the burden on eligible hospitals and CAHs, we are proposing several changes to the Medicare Promoting Interoperability Program. Specifically, we are proposing: (1) To continue the EHR reporting period of a minimum of any continuous 90-day period for new and returning eligible hospitals and CAHs for CY 2023 and to increase the EHR reporting period to a minimum of any continuous 180-day period for new and returning eligible hospitals and CAHs for CY 2024; (2) to maintain the Electronic Prescribing Objective's Query of PDMP measure as optional while increasing its available bonus from five points to 10 points for the EHR reporting period in CY 2022; (3) to modify the Provide Patient's Electronic Access to Their Health Information measure to establish a data availability requirement beginning with encounters with a date of service on or after January 1, 2016, beginning with the EHR reporting period in CY 2022; (4) to add a new Health Information Exchange (HIE) Bi-Directional Exchange measure as a yes/no attestation, to the HIE objective as an optional alternative to the two existing measures beginning with the EHR reporting period in CY 2022; (5) to require reporting a “yes” on four of the existing Public Health and Clinical Data Exchange Objective measures (Syndromic Surveillance Reporting, Immunization Registry Reporting, Electronic Case Reporting, and Electronic Reportable Laboratory Result Reporting) or requesting the applicable exclusion(s); (6) adding a new measure to the Protect Patient Health Information objective that requires eligible hospitals and CAHs to attest to having completed an annual assessment of SAFER Guides beginning with the EHR reporting period in CY 2022; (7) to remove attestation statements 2 and 3 from the Promoting Interoperability Program's prevention of information blocking requirement; (8) to increase the minimum required score for the objectives and measures from 50 points to 60 points (out of 100 points) in order to be considered a meaningful EHR user; and (9) to adopt two new eCQMs to the Medicare Promoting Interoperability Program's eCQM measure set beginning with the reporting period in CY 2023, in addition to removing four eCQMs from the measure set beginning with the reporting period in CY 2024 which is in alignment with the proposals for the Hospital IQR Program. We are amending our regulation texts as necessary to incorporate several of these proposed changes.</P>
                    <HD SOURCE="HD3">m. Proposed Repeal of Market-Based Data Collection and Market-Based MS-DRG Relative Weight Methodology</HD>
                    <P>As discussed in section V.L. of the preamble of this proposed rule, we are proposing to repeal the requirement that a hospital report on the Medicare cost report the median payer-specific negotiated charge that the hospital has negotiated with all of its MA organization payers, by MS-DRG, for cost reporting periods ending on or after January 1, 2021. We are also proposing to repeal the market-based MS-DRG relative weight methodology adopted for calculating the MS-DRG relative weights effective in FY 2024, and to continue using the existing cost-based methodology for calculating the MS-DRG relative weights for FY 2024 and subsequent fiscal years. Lastly, we are soliciting comment on alternative approaches or data sources that could be used in Medicare fee-for-service (FFS) ratesetting. The proposed repeal of these policies would result in a reduction of 63,780 annual burden hours for all hospitals.</P>
                    <HD SOURCE="HD3">n. Proposed Implementation of Sections 126, 127 and 131 of the Consolidated Appropriations Act (CAA) of 2021</HD>
                    <P>In this proposed rule, we are including proposals to implement sections 126, 127 and 131 of the Consolidated Appropriations Act (CAA) of 2021. Section 126(a) of the CAA amended section 1886(h) of the Act by adding a new section 1886(h)(9) of the Act requiring the distribution of additional residency positions to qualifying hospitals. Section 127 of the CAA amended section 1886(h)(4)(H)(iv) of the Act to specify that in the case of a hospital not located in a rural area that established or establishes a medical residency training program (or rural track) in a rural area, the hospital, and each such hospital located in a rural area that participates in such a training, is allowed to receive an adjustment to its full-time equivalent (FTE) resident limit. Section 131 of the CAA amended section 1886(h)(2)(F) of the Act to provide an opportunity to hospitals with such extremely low or $0 per resident amounts (PRAs) that meet certain criteria to reset and establish new PRAs if the hospital trains resident(s) in a cost reporting period beginning on or after enactment [December 27, 2020] and before the date that is 5 years after enactment [December 26, 2025]. Section 131 also amended section 1886(h)(4)(H)(i) of the Act to provide an opportunity for hospitals that meet certain criteria and that have very small FTE resident caps to replace those caps if the Secretary determines the hospital begins training residents in a new program beginning on or after enactment (December 27, 2020) and before 5 years after enactment (December 26, 2025). We refer readers to section V.J.2. of this proposed rule for rule for a summary of the provisions of sections 126, 127, and 131 of the CAA that we are proposing to implement in this proposed rule.</P>
                    <HD SOURCE="HD3">o. Proposed Changes to Organ Acquisition Payment Policy</HD>
                    <P>In section X.B.2.h. of the preamble of this proposed rule, we are proposing to revise and codify the Medicare usable organ counting policy to count only organs transplanted into Medicare beneficiaries so that Medicare more accurately records and pays its share of organ acquisition costs.</P>
                    <HD SOURCE="HD3">p. Medicare Shared Savings Program</HD>
                    <P>We are proposing to make changes to policies for the Shared Savings Program, which was established under section 1899 of the Act, to allow eligible ACOs participating in the BASIC track's glide path the option to elect to forgo automatic advancement along the glide path's increasing levels of risk and potential reward for performance year (PY) 2022. Under this proposal, prior to the automatic advancement for PY 2022, an eligible ACO may elect to remain in the same level of the BASIC track's glide path in which it participated during PY 2021. For PY 2023, an ACO that elects this advancement deferral option would be automatically advanced to the level of the BASIC track's glide path in which it would have participated during PY 2023 if it had advanced automatically to the required level for PY 2022 (unless the ACO elects to advance more quickly before the start of PY 2023).</P>
                    <HD SOURCE="HD3">3. Summary of Costs and Benefits</HD>
                    <P>The following table provides a summary of the costs, savings, benefits associated with the major provisions described in section I.A.3. of the preamble of this proposed rule.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25078"/>
                        <GID>EP10MY21.000</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25079"/>
                        <GID>EP10MY21.001</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25080"/>
                        <GID>EP10MY21.002</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25081"/>
                        <GID>EP10MY21.003</GID>
                    </GPH>
                    <PRTPAGE P="25082"/>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">B. Background Summary</HD>
                    <HD SOURCE="HD3">1. Acute Care Hospital Inpatient Prospective Payment System (IPPS)</HD>
                    <P>Section 1886(d) of the Act sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. Section 1886(g) of the Act requires the Secretary to use a prospective payment system (PPS) to pay for the capital-related costs of inpatient hospital services for these “subsection (d) hospitals.” Under these PPSs, Medicare payment for hospital inpatient operating and capital-related costs is made at predetermined, specific rates for each hospital discharge. Discharges are classified according to a list of diagnosis-related groups (DRGs).</P>
                    <P>The base payment rate is comprised of a standardized amount that is divided into a labor-related share and a nonlabor-related share. The labor-related share is adjusted by the wage index applicable to the area where the hospital is located. If the hospital is located in Alaska or Hawaii, the nonlabor-related share is adjusted by a cost-of-living adjustment factor. This base payment rate is multiplied by the DRG relative weight.</P>
                    <P>If the hospital treats a high percentage of certain low-income patients, it receives a percentage add-on payment applied to the DRG-adjusted base payment rate. This add-on payment, known as the disproportionate share hospital (DSH) adjustment, provides for a percentage increase in Medicare payments to hospitals that qualify under either of two statutory formulas designed to identify hospitals that serve a disproportionate share of low-income patients. For qualifying hospitals, the amount of this adjustment varies based on the outcome of the statutory calculations. The Affordable Care Act revised the Medicare DSH payment methodology and provides for a new additional Medicare payment beginning on October 1, 2013, that considers the amount of uncompensated care furnished by the hospital relative to all other qualifying hospitals.</P>
                    <P>If the hospital is training residents in an approved residency program(s), it receives a percentage add-on payment for each case paid under the IPPS, known as the indirect medical education (IME) adjustment. This percentage varies, depending on the ratio of residents to beds.</P>
                    <P>Additional payments may be made for cases that involve new technologies or medical services that have been approved for special add-on payments. In general, to qualify, a new technology or medical service must demonstrate that it is a substantial clinical improvement over technologies or services otherwise available, and that, absent an add-on payment, it would be inadequately paid under the regular DRG payment. In addition, certain transformative new devices and certain antimicrobial products may qualify under an alternative inpatient new technology add-on payment pathway by demonstrating that, absent an add-on payment, they would be inadequately paid under the regular DRG payment.</P>
                    <P>The costs incurred by the hospital for a case are evaluated to determine whether the hospital is eligible for an additional payment as an outlier case. This additional payment is designed to protect the hospital from large financial losses due to unusually expensive cases. Any eligible outlier payment is added to the DRG-adjusted base payment rate, plus any DSH, IME, and new technology or medical service add-on adjustments.</P>
                    <P>Although payments to most hospitals under the IPPS are made on the basis of the standardized amounts, some categories of hospitals are paid in whole or in part based on their hospital-specific rate, which is determined from their costs in a base year. For example, sole community hospitals (SCHs) receive the higher of a hospital-specific rate based on their costs in a base year (the highest of FY 1982, FY 1987, FY 1996, or FY 2006) or the IPPS Federal rate based on the standardized amount. SCHs are the sole source of care in their areas. Specifically, section 1886(d)(5)(D)(iii) of the Act defines an SCH as a hospital that is located more than 35 road miles from another hospital or that, by reason of factors such as an isolated location, weather conditions, travel conditions, or absence of other like hospitals (as determined by the Secretary), is the sole source of hospital inpatient services reasonably available to Medicare beneficiaries. In addition, certain rural hospitals previously designated by the Secretary as essential access community hospitals are considered SCHs.</P>
                    <P>Under current law, the Medicare-dependent, small rural hospital (MDH) program is effective through FY 2022. For discharges occurring on or after October 1, 2007, but before October 1, 2022, an MDH receives the higher of the Federal rate or the Federal rate plus 75 percent of the amount by which the Federal rate is exceeded by the highest of its FY 1982, FY 1987, or FY 2002 hospital-specific rate. MDHs are a major source of care for Medicare beneficiaries in their areas. Section 1886(d)(5)(G)(iv) of the Act defines an MDH as a hospital that is located in a rural area (or, as amended by the Bipartisan Budget Act of 2018, a hospital located in a State with no rural area that meets certain statutory criteria), has not more than 100 beds, is not an SCH, and has a high percentage of Medicare discharges (not less than 60 percent of its inpatient days or discharges in its cost reporting year beginning in FY 1987 or in two of its three most recently settled Medicare cost reporting years).</P>
                    <P>Section 1886(g) of the Act requires the Secretary to pay for the capital-related costs of inpatient hospital services in accordance with a prospective payment system established by the Secretary. The basic methodology for determining capital prospective payments is set forth in our regulations at 42 CFR 412.308 and 412.312. Under the capital IPPS, payments are adjusted by the same DRG for the case as they are under the operating IPPS. Capital IPPS payments are also adjusted for IME and DSH, similar to the adjustments made under the operating IPPS. In addition, hospitals may receive outlier payments for those cases that have unusually high costs.</P>
                    <P>The existing regulations governing payments to hospitals under the IPPS are located in 42 CFR part 412, subparts A through M.</P>
                    <HD SOURCE="HD3">2. Hospitals and Hospital Units Excluded From the IPPS</HD>
                    <P>
                        Under section 1886(d)(1)(B) of the Act, as amended, certain hospitals and hospital units are excluded from the IPPS. These hospitals and units are: Inpatient rehabilitation facility (IRF) hospitals and units; long-term care hospitals (LTCHs); psychiatric hospitals and units; children's hospitals; cancer hospitals; extended neoplastic disease care hospitals, and hospitals located outside the 50 States, the District of Columbia, and Puerto Rico (that is, hospitals located in the U.S. Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa). Religious nonmedical health care institutions (RNHCIs) are also excluded from the IPPS. Various sections of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), the Medicare, Medicaid and SCHIP [State Children's Health Insurance Program] Balanced Budget Refinement Act of 1999 (BBRA, Pub. L. 106-113), and the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA, Pub. L. 106-554) provide for the implementation of PPSs for IRF hospitals and units, LTCHs, and psychiatric hospitals and units (referred to as inpatient psychiatric facilities (IPFs)). (We note that the annual 
                        <PRTPAGE P="25083"/>
                        updates to the LTCH PPS are included along with the IPPS annual update in this document. Updates to the IRF PPS and IPF PPS are issued as separate documents.) Children's hospitals, cancer hospitals, hospitals located outside the 50 States, the District of Columbia, and Puerto Rico (that is, hospitals located in the U.S. Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa), and RNHCIs continue to be paid solely under a reasonable cost-based system, subject to a rate-of-increase ceiling on inpatient operating costs. Similarly, extended neoplastic disease care hospitals are paid on a reasonable cost basis, subject to a rate-of-increase ceiling on inpatient operating costs.
                    </P>
                    <P>The existing regulations governing payments to excluded hospitals and hospital units are located in 42 CFR parts 412 and 413.</P>
                    <HD SOURCE="HD3">3. Long-Term Care Hospital Prospective Payment System (LTCH PPS)</HD>
                    <P>The Medicare prospective payment system (PPS) for LTCHs applies to hospitals described in section 1886(d)(1)(B)(iv) of the Act, effective for cost reporting periods beginning on or after October 1, 2002. The LTCH PPS was established under the authority of sections 123 of the BBRA and section 307(b) of the BIPA (as codified under section 1886(m)(1) of the Act). Section 1206(a) of the Pathway for SGR Reform Act of 2013 (Pub. L. 113-67) established the site neutral payment rate under the LTCH PPS, which made the LTCH PPS a dual rate payment system beginning in FY 2016. Under this statute, effective for LTCH's cost reporting periods beginning in FY 2016 cost reporting period, LTCHs are generally paid for discharges at the site neutral payment rate unless the discharge meets the patient criteria for payment at the LTCH PPS standard Federal payment rate. The existing regulations governing payment under the LTCH PPS are located in 42 CFR part 412, subpart O. Beginning October 1, 2009, we issue the annual updates to the LTCH PPS in the same documents that update the IPPS.</P>
                    <HD SOURCE="HD3">4. Critical Access Hospitals (CAHs)</HD>
                    <P>Under sections 1814(l), 1820, and 1834(g) of the Act, payments made to critical access hospitals (CAHs) (that is, rural hospitals or facilities that meet certain statutory requirements) for inpatient and outpatient services are generally based on 101 percent of reasonable cost. Reasonable cost is determined under the provisions of section 1861(v) of the Act and existing regulations under 42 CFR part 413.</P>
                    <HD SOURCE="HD3">5. Payments for Graduate Medical Education (GME)</HD>
                    <P>Under section 1886(a)(4) of the Act, costs of approved educational activities are excluded from the operating costs of inpatient hospital services. Hospitals with approved graduate medical education (GME) programs are paid for the direct costs of GME in accordance with section 1886(h) of the Act. The amount of payment for direct GME costs for a cost reporting period is based on the hospital's number of residents in that period and the hospital's costs per resident in a base year. The existing regulations governing payments to the various types of hospitals are located in 42 CFR part 413.</P>
                    <HD SOURCE="HD2">C. Summary of Provisions of Recent Legislation That Would Be Implemented in This Proposed Rule</HD>
                    <HD SOURCE="HD3">1. The Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10)</HD>
                    <P>Section 414 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA, Pub. L. 114-10) specifies a 0.5 percent positive adjustment to the standardized amount of Medicare payments to acute care hospitals for FYs 2018 through 2023. These adjustments follow the recoupment adjustment to the standardized amounts under section 1886(d) of the Act based upon the Secretary's estimates for discharges occurring from FYs 2014 through 2017 to fully offset $11 billion, in accordance with section 631 of the ATRA. The FY 2018 adjustment was subsequently adjusted to 0.4588 percent by section 15005 of the 21st Century Cures Act.</P>
                    <HD SOURCE="HD3">2. Consolidated Appropriations Act, 2021 (Pub. L. 116-260)</HD>
                    <P>Sections 126, 127 and 131 of the Consolidated Appropriations Act, 2021 made a number of changes to various sections of the Act relating to payment for direct GME and IME costs to hospitals.</P>
                    <HD SOURCE="HD3">a. Section 126 of the Consolidated Appropriations Act, 2021</HD>
                    <P>Section 126 amended section 1886(h) of the Act by adding a new section 1886(h)(9) requiring the distribution of additional residency positions to qualifying hospitals. Section 1886(h)(9)(A) requires that for FY 2023, and for each succeeding fiscal year until the aggregate number of full-time equivalent residency positions distributed is equal to 1,000, the Secretary shall initiate separate rounds of applications from hospitals for these additional residency positions. The Secretary is required, subject to certain provisions in the law, to increase the otherwise applicable resident limit for each qualifying hospital that submits a timely application by the number of positions that may be approved by the Secretary for that hospital. The Secretary is required to notify hospitals of the number of positions distributed to them by January 31 of the fiscal year of the increase, and the increase is effective beginning July 1 of that fiscal year. Section 1886(h)(9)(A) also limits the aggregate number of such positions made available in a single fiscal year across all hospitals to no more than 200.</P>
                    <P>In determining the qualifying hospitals for which an increase is provided, section 1886(h)(9)(B) requires the Secretary to take into account the demonstrated likelihood of the hospital filling the positions made available within the first 5 training years beginning after the date the increase would be effective, as determined by the Secretary.</P>
                    <P>Section 1886(h)(9)(B) of the Act also requires a minimum distribution for certain categories of hospitals. Specifically, the Secretary is required to distribute at least 10 percent of the aggregate number of total residency positions available to each of four categories of hospitals. Stated briefly, and discussed in greater detail in later in this proposed rule, the categories are as follows: (1) Hospitals located in rural areas or that are treated as being located in a rural area; (2) hospitals in which the reference resident level of the hospital is greater than the otherwise applicable resident limit; (3) hospitals in states with new medical schools or additional locations and branches of existing medical schools; and (4) hospitals that serve areas designated as Health Professional Shortage Areas (HPSAs). Additionally, section 1886(h)(9)(F)(ii) of the Act defines a qualifying hospital as a hospital in one of these four categories.</P>
                    <P>Section 1886(h)(9)(C) of the Act places certain limitations on the distribution of the residency positions. First, a hospital may not receive more than 25 additional full-time equivalent residency positions. Second, no increase in the otherwise applicable resident limit of a hospital may be made unless the hospital agrees to increase the total number of full-time equivalent residency positions under the approved medical residency training program of the hospital by the number of positions made available to that hospital.</P>
                    <HD SOURCE="HD3">b. Section 127 of the Consolidated Appropriations Act, 2021</HD>
                    <P>
                        Section 127 of the CAA amended section 1886(h)(4)(H)(iv) of the Act to 
                        <PRTPAGE P="25084"/>
                        specify that in the case of a hospital not located in a rural area that established or establishes a medical residency training program (or rural tracks) in a rural area, the hospital, and each such hospital located in a rural areas that participates in such a training, is allowed to receive an adjustment to its full-time equivalent (FTE) resident limit.
                    </P>
                    <HD SOURCE="HD3">c. Sections 131 of the Consolidated Appropriations Act, 2021</HD>
                    <P>Section 131 of the CAA amended section 1886(h)(2)(F) of the Act to provide an opportunity to hospitals with such extremely low or $0 per resident amounts (PRAs) that meet certain criteria to reset and establish new PRAs if the hospital trains resident(s) in a cost reporting period beginning on or after enactment [December 27, 2020] and before the date that is 5 years after enactment [December 26, 2025]. Section 131 of the CAA also amended section 1886(h)(4)(H)(i) of the Act to provide an opportunity for hospitals that meet certain criteria and that have very small FTE resident caps to replace those caps if the Secretary determines the hospital begins training residents in a program year beginning on or after enactment (December 27, 2020) and before 5 years after enactment (December 26, 2025).</P>
                    <HD SOURCE="HD2">D. Summary of the Provisions of This Proposed Rule</HD>
                    <P>In this proposed rule, we set forth proposed payment and policy changes to the Medicare IPPS for FY 2022 operating costs and capital-related costs of acute care hospitals and certain hospitals and hospital units that are excluded from IPPS. In addition, we set forth proposed changes to the payment rates, factors, and other payment and policy-related changes to programs associated with payment rate policies under the LTCH PPS for FY 2022.</P>
                    <P>The following is a general summary of the changes that we are proposing to make in this proposed rule.</P>
                    <HD SOURCE="HD3">1. Proposed Changes to MS-DRG Classifications and Recalibrations of Relative Weights</HD>
                    <P>In section II. of the preamble of this proposed rule, we include—</P>
                    <P>• Proposed changes to MS-DRG classifications based on our yearly review for FY 2022.</P>
                    <P>• Proposed adjustment to the standardized amounts under section 1886(d) of the Act for FY 2022 in accordance with the amendments made to section 7(b)(1)(B) of Public Law 110-90 by section 414 of the MACRA.</P>
                    <P>• Proposed recalibration of the MS-DRG relative weights.</P>
                    <P>• A discussion of the proposed FY 2022 status of new technologies approved for add-on payments for FY 2022, a presentation of our evaluation and analysis of the FY 2022 applicants for add-on payments for high-cost new medical services and technologies (including public input, as directed by Public Law 108-173, obtained in a town hall meeting) for applications not submitted under an alternative pathway, and a discussion of the proposed status of FY 2022 new technology applicants under the alternative pathways for certain medical devices and certain antimicrobial products.</P>
                    <P>• A proposal to extend the New COVID-19 Treatments Add-on Payment (NCTAP) through the end of the fiscal year in which the PHE ends for certain products and discontinue NCTAP for products approved for new technology add-on payments in FY 2022.</P>
                    <HD SOURCE="HD3">2. Proposed Changes to the Hospital Wage Index for Acute Care Hospitals</HD>
                    <P>In section III. of the preamble of this proposed rule we are proposing to make revisions to the wage index for acute care hospitals and the annual update of the wage data. Specific issues addressed include, but were not limited to, the following:</P>
                    <P>• The proposed FY 2022 wage index update using wage data from cost reporting periods beginning in FY 2018.</P>
                    <P>• Calculation, analysis, and implementation of the proposed occupational mix adjustment to the wage index for acute care hospitals for FY 2022 based on the 2019 Occupational Mix Survey.</P>
                    <P>• Proposed application of the rural floor and the frontier State floor, and continuation of the low wage index hospital policy.</P>
                    <P>• Proposed implementation of the imputed floor wage index policy for all-urban states under section 9831 of the American Rescue Plan Act of 2021 (Pub. L. 117-2).</P>
                    <P>• Proposed revisions to the wage index for acute care hospitals, based on hospital redesignations and reclassifications under sections 1886(d)(8)(B), (d)(8)(E), and (d)(10) of the Act.</P>
                    <P>• Proposed revisions to the regulations at § 412.278 regarding the Administrator's Review of MGCRB decisions.</P>
                    <P>• Proposed changes to rural reclassification cancellation requirements at § 412.103(g).</P>
                    <P>• Proposed adjustment to the wage index for acute care hospitals for FY 2022 based on commuting patterns of hospital employees who reside in a county and work in a different area with a higher wage index.</P>
                    <P>• Proposed labor-related share for the proposed FY 2022 wage index.</P>
                    <HD SOURCE="HD3">3. Proposed Rebasing and Revising of the Hospital Market Baskets</HD>
                    <P>In section IV. of the preamble of this proposed rule, we are proposing to rebase and revise the hospital market baskets for acute care hospitals and update the labor-related share.</P>
                    <HD SOURCE="HD3">4. Other Decisions and Proposed Changes to the IPPS for Operating Costs</HD>
                    <P>In section V. of the preamble of this proposed rule, we discuss proposed changes or clarifications of a number of the provisions of the regulations in 42 CFR parts 412 and 413, including the following:</P>
                    <P>• Proposed inpatient hospital update for FY 2022.</P>
                    <P>• Proposed updated national and regional case-mix values and discharges for purposes of determining RRC status.</P>
                    <P>• The statutorily required IME adjustment factor for FY 2022.</P>
                    <P>• Proposed changes to the methodologies for determining Medicare DSH payments and the additional payments for uncompensated care.</P>
                    <P>• Proposed requirements for payment adjustments under the Hospital Readmissions Reduction Program for FY 2022.</P>
                    <P>• The provision of estimated and newly established performance standards for the calculation of value-based incentive payments, as well as a proposal to suppress multiple measures and provide net-neutral payment adjustments under the Hospital Value-Based Purchasing Program.</P>
                    <P>• Proposed requirements for payment adjustments to hospitals under the HAC Reduction Program for FY 2022.</P>
                    <P>• Discussion of and proposed changes relating to the implementation of the Rural Community Hospital Demonstration Program in FY 2022.</P>
                    <P>• Proposed revisions to the regulations regarding the counting of days associated with section 1115 demonstration projects in the Medicaid fraction.</P>
                    <P>• Proposals to implement provisions of the Consolidated Appropriations Act relating to payments to hospitals for direct graduate medical education (GME) and indirect medical education (IME) costs.</P>
                    <P>
                        • Proposed repeal of the market-based data collection requirement and market-based MS-DRG relative weight methodology.
                        <PRTPAGE P="25085"/>
                    </P>
                    <HD SOURCE="HD3">5. Proposed FY 2022 Policy Governing the IPPS for Capital-Related Costs</HD>
                    <P>In section VI. of the preamble to this proposed rule, we discuss the proposed payment policy requirements for capital-related costs and capital payments to hospitals for FY 2022.</P>
                    <HD SOURCE="HD3">6. Proposed Changes to the Payment Rates for Certain Excluded Hospitals: Rate-of-Increase Percentages</HD>
                    <P>In section VII. of the preamble of this proposed rule, we discuss—</P>
                    <P>• Proposed changes to payments to certain excluded hospitals for FY 2022.</P>
                    <P>• Proposed continued implementation of the Frontier Community Health Integration Project (FCHIP) Demonstration.</P>
                    <HD SOURCE="HD3">7. Proposed Changes to the LTCH PPS</HD>
                    <P>In section VIII. of the preamble of this proposed rule, we set forth proposed changes to the LTCH PPS Federal payment rates, factors, and other payment rate policies under the LTCH PPS for FY 2022.</P>
                    <HD SOURCE="HD3">8. Proposed Changes Relating to Quality Data Reporting for Specific Providers and Suppliers</HD>
                    <P>In section IX. of the preamble of this proposed rule, we address the following:</P>
                    <P>• Proposed requirements for the Hospital Inpatient Quality Reporting (IQR) Program.</P>
                    <P>• Proposed changes to the requirements for the quality reporting program for PPS-exempt cancer hospitals (PCHQR Program).</P>
                    <P>• Proposed changes to the requirements under the LTCH Quality Reporting Program (QRP). We are also seeking information on CMS's future plans to define digital quality measures (dQMs) for the LTCH QRP and on CMS' continued efforts to close the health equity gap.</P>
                    <P>• Proposed changes to requirements pertaining to eligible hospitals and CAHs participating in the Medicare Promoting Interoperability Program.</P>
                    <HD SOURCE="HD3">9. Other Proposals Included in This Proposed Rule</HD>
                    <P>Section X. of the preamble to this proposed rule includes the following proposals:</P>
                    <P>• Proposed changes pertaining to Medicaid enrollment of Medicare-enrolled providers and suppliers to 42 CFR part 455.410 and request for comment on provider experiences where state Medicaid agencies apply the Medicaid payment and coverage rules to a claim for a Medicare service rather than adjudicating the claim for Medicare cost-sharing liability.</P>
                    <P>• Proposed changes pertaining to Medicare's share of organ acquisition costs transplanted into Medicare beneficiaries and the charges for services provided to cadaveric organ donors by donor community hospitals and transplants hospitals.</P>
                    <P>• Proposed changes pertaining to the Shared Savings Program that would allow eligible ACOs participating in the BASIC track's glide path to maintain their current level of participation for PY 2022.</P>
                    <HD SOURCE="HD3">10. Other Provisions of This Proposed Rule</HD>
                    <P>Section XI. of the preamble to this proposed rule includes our discussion of the MedPAC Recommendations.</P>
                    <P>Section XII. of the preamble to this proposed rule includes the following:</P>
                    <P>• A descriptive listing of the public use files associated with the proposed rule.</P>
                    <P>• The collection of information requirements for entities based on our proposals.</P>
                    <P>• Information regarding our responses to public comments.</P>
                    <HD SOURCE="HD3">11. Determining Prospective Payment Operating and Capital Rates and Rate-of-Increase Limits for Acute Care Hospitals</HD>
                    <P>In sections II. and III. of the Addendum to this proposed rule, we set forth proposed changes to the amounts and factors for determining the proposed FY 2022 prospective payment rates for operating costs and capital-related costs for acute care hospitals. We proposed to establish the threshold amounts for outlier cases. In addition, in section IV. of the Addendum to this proposed rule, we address the proposed update factors for determining the rate-of-increase limits for cost reporting periods beginning in FY 2022 for certain hospitals excluded from the IPPS.</P>
                    <HD SOURCE="HD3">12. Determining Prospective Payment Rates for LTCHs</HD>
                    <P>In section V. of the Addendum to the proposed rule, we set forth proposed changes to the amounts and factors for determining the proposed FY 2022 LTCH PPS standard Federal payment rate and other factors used to determine LTCH PPS payments under both the LTCH PPS standard Federal payment rate and the site neutral payment rate in FY 2022. We are proposing to establish the adjustments for the wage index, labor-related share, the cost-of-living adjustment, and high-cost outliers, including the applicable fixed-loss amounts and the LTCH cost-to-charge ratios (CCRs) for both payment rates.</P>
                    <HD SOURCE="HD3">13. Impact Analysis</HD>
                    <P>In Appendix A of the proposed rule, we set forth an analysis of the impact the proposed changes would have on affected acute care hospitals, CAHs, LTCHs, PCHs and other entities.</P>
                    <HD SOURCE="HD3">14. Recommendation of Update Factors for Operating Cost Rates of Payment for Hospital Inpatient Services</HD>
                    <P>In Appendix B of the proposed rule, as required by sections 1886(e)(4) and (e)(5) of the Act, we provide our recommendations of the appropriate percentage changes for FY 2022 for the following:</P>
                    <P>• A single average standardized amount for all areas for hospital inpatient services paid under the IPPS for operating costs of acute care hospitals (and hospital-specific rates applicable to SCHs and MDHs).</P>
                    <P>• Target rate-of-increase limits to the allowable operating costs of hospital inpatient services furnished by certain hospitals excluded from the IPPS.</P>
                    <P>• The LTCH PPS standard Federal payment rate and the site neutral payment rate for hospital inpatient services provided for LTCH PPS discharges.</P>
                    <HD SOURCE="HD3">15. Discussion of Medicare Payment Advisory Commission Recommendations</HD>
                    <P>
                        Under section 1805(b) of the Act, MedPAC is required to submit a report to Congress, no later than March 15 of each year, in which MedPAC reviews and makes recommendations on Medicare payment policies. MedPAC's March 2021 recommendations concerning hospital inpatient payment policies address the update factor for hospital inpatient operating costs and capital-related costs for hospitals under the IPPS. We address these recommendations in Appendix B of this proposed rule. For further information relating specifically to the MedPAC March 2021 report or to obtain a copy of the report, contact MedPAC at (202) 220-3700 or visit MedPAC's website at: 
                        <E T="03">http://www.medpac.gov</E>
                        .
                    </P>
                    <HD SOURCE="HD2">E. Advancing Health Information Exchange</HD>
                    <P>The Department of Health and Human Services (HHS) has a number of initiatives designed to encourage and support the adoption of interoperable health information technology and to promote nationwide health information exchange to improve health care and patient access to their health information.</P>
                    <P>
                        To further interoperability in post-acute care settings, CMS and the Office of the National Coordinator for Health 
                        <PRTPAGE P="25086"/>
                        Information Technology (ONC) participate inin the Post-Acute Care Interoperability Workgroup (PACIO 
                        <E T="03">http://pacioproject.org/</E>
                        ) to facilitate collaboration with industry stakeholders to develop FHIR standards. These standards could support the exchange and reuse of patient assessment data derived from the Minimum Data Set (MDS), Inpatient Rehabilitation Facility-Patient Assessment Instrument (IRF-PAI), LTCH Continuity Assessment Record and Evaluation (CARE Data Set (LCDS), Outcome and Assessment Information Set (OASIS), and other sources. The PACIO Project has focused on FHIR implementation guides for functional status, cognitive status and new use cases on advance directives and speech language pathology. We encourage post-acute care (PAC) provider and health information technology (IT) vendor participation as the efforts advance.
                    </P>
                    <P>
                        The CMS Data Element Library (DEL) continues to be updated and serves as the authoritative resource for PAC assessment data elements and their associated mappings to health IT standards, such as Logical Observation Identifiers Names and Codes (LOINC) and Systematized Nomenclature of Medicine Clinical Terms (SNOMED). The DEL furthers CMS' goal of data standardization and interoperability. These interoperable data elements can reduce provider burden by allowing the use and exchange of healthcare data; supporting provider exchange of electronic health information for care coordination, person-centered care; and supporting real-time, data driven, clinical decision-making. Standards in the Data Element Library (
                        <E T="03">https://del.cms.gov/DELWeb/pubHome</E>
                        )can be referenced on the CMS website and in the ONC Interoperability Standards Advisory (ISA). The 2021 ISA is available at 
                        <E T="03">https://www.healthit.gov/isa</E>
                        .
                    </P>
                    <P>
                        The 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted December 13, 2016) requires HHS to take new steps to enable the electronic sharing of health information ensuring interoperability for providers and settings across the care continuum. The Cures Act includes a trusted exchange framework and common agreement (TEFCA) provision 
                        <SU>1</SU>
                        <FTREF/>
                         that will enable the nationwide exchange of electronic health information across health information networks and provide an important way to enable bi-directional health information exchange in the future. For more information on current developments related to TEFCA, we refer readers to 
                        <E T="03">https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement</E>
                         and 
                        <E T="03">https://rce.sequoiaproject.org/</E>
                        .
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             ONC, 
                            <E T="03">Draft 2 Trusted Exchange Framework and Common Agreement,</E>
                              
                            <E T="03">https://www.healthit.gov/sites/default/files/page/2019-04/FINALTEFCAQTF41719508version.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        The ONC final rule entitled “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program” (85 FR 25642) published in the May 1, 2020 
                        <E T="04">Federal Register</E>
                        , (hereinafter referred to as “ONC Cures Act Final Rule”) implemented policies related to information blocking as authorized under section 4004 of the 21st Century Cures Act. Information blocking is generally defined as a practice by a health IT developer of certified health IT, health information network, health information exchange, or health care provider that, except as required by law or specified by the HHS Secretary as a reasonable and necessary activity, is likely to interfere with access, exchange, or use of electronic health information. For a health care provider (as defined in 45 CFR 171.102), the definition of information blocking (see 45 CFR 171.103) specifies that the provider knows that the practice is unreasonable, as well as likely to interfere with access, exchange, or use of electronic health information.
                        <SU>2</SU>
                        <FTREF/>
                         To deter information blocking, health IT developers of certified health IT, health information networks and health information exchanges whom the HHS Inspector General determines, following an investigation, have committed information blocking, are subject to civil monetary penalties of up to $1 million per violation. Appropriate disincentives for health care providers need to be established by the Secretary through rulemaking. Stakeholders can learn more about information blocking at 
                        <E T="03">https://www.healthit.gov/curesrule/final-rule-policy/information-blocking</E>
                        . ONC has posted information resources including fact sheets (
                        <E T="03">https://www.healthit.gov/curesrule/resources/fact-sheets</E>
                        ), frequently asked questions (
                        <E T="03">https://www.healthit.gov/curesrule/resources/information-blocking-faqs</E>
                        ), and recorded webinars (
                        <E T="03">https://www.healthit.gov/curesrule/resources/webinars</E>
                        ).
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             For other types of actors (health IT developers of certified health IT and health information network or health information exchange, as defined in 45 CFR 171.102), the definition of “information blocking” (see 45 CFR 171.103) specifies that the actor “knows, or should know, that such practice is likely to interfere with access, exchange, or use of electronic health information.”
                        </P>
                    </FTNT>
                    <P>We invite providers to learn more about these important developments and how they are likely to affect LTCHs.</P>
                    <HD SOURCE="HD2">F. Use of FY 2020 or FY 2019 Data in the FY 2022 IPPS and LTCH PPS Ratesetting</HD>
                    <P>We primarily use two data sources in the IPPS and LTCH PPS ratesetting: Claims data and cost report data. The claims data source is the MedPAR file, which includes fully coded diagnostic and procedure data for all Medicare inpatient hospital bills for discharges in a fiscal year. Our goal is always to use the best available data overall for ratesetting. Ordinarily, the best available MedPAR data would be the most recent MedPAR file that contains claims from discharges for the fiscal year that is 2 years prior to the fiscal year that is the subject of the rulemaking. For FY 2022 ratesetting, under ordinary circumstances, the best available data would be the FY 2020 MedPAR file. The cost report data source is the Medicare hospital cost report data files from the most recent quarterly HCRIS release. For example, ordinarily, the best available cost report data used in relative weight calculations would be based on the cost reports beginning 3 fiscal years prior to the fiscal year that is the subject of the rulemaking. For the FY 2022 ratesetting, under ordinary circumstances, that would be the FY 2019 cost report data from HCRIS, which would contain many cost reports ending in FY 2020 based on each hospital's cost reporting period.</P>
                    <P>
                        The FY 2020 MedPAR claims file and the FY 2019 HCRIS dataset both contain data significantly impacted by the COVID-19 PHE, primarily in that the utilization of inpatient services was generally markedly different for certain types of services in FY 2020 than would have been expected in the absence of the PHE, as we discuss in this section. Accordingly, we question whether these data sources are the best available data to use for the FY 2022 ratesetting. One factor in assessing whether these data sources represent the best available data is to what extent the FY 2019 data from before the COVID-19 PHE is a better overall approximation of FY 2022 inpatient experience (for example, whether the share of total inpatient utilization for elective surgeries will be more similar to FY 2019 than to FY 2020), or alternatively, to what extent the FY 2020 data which include the COVID-19 PHE time period is a better overall approximation of FY 2022 inpatient experience (for example, whether the share of total inpatient utilization for respiratory infections will be more similar to FY 2020 than to FY 
                        <PRTPAGE P="25087"/>
                        2019). Another factor is to what extent the decision to use the FY 2019 or FY 2020 data differentially impacts the FY 2022 IPPS ratesetting.
                    </P>
                    <P>
                        In order to help assess likely inpatient utilization in FY 2022, we examined the trend in the number of COVID-19 vaccinations in the United States as reported to the Centers for Disease Control (CDC) (see 
                        <E T="03">https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html</E>
                        , accessed April 16, 2021).
                    </P>
                    <P>
                        The U.S. COVID-19 Vaccination Program began December 14, 2020. As of April 15, 2021, 198.3 million vaccine doses have been administered. Overall, about 125.8 million people, or 37.9 percent of the U.S. population, have received at least one dose of vaccine as of this date. About 78.5 million people, or 23.6 percent of the U.S. population have been fully vaccinated.
                        <SU>3</SU>
                        <FTREF/>
                         As of April 15, the 7-day average number of administered vaccine doses reported to CDC per day was 3.3 million, a 10.3 percent increase from the previous week. As of April 15, 80 percent of people 65 or older have received at least one dose of vaccine; 63.7 percent are fully vaccinated. Nearly one-half (48.3 percent) of people 18 or older have received at least one dose of vaccine; 30.3 percent are fully vaccinated. Nationally, COVID-19-related emergency department visits as well as both hospital admissions and current hospitalizations have risen among patients ages 18 to 64 years in recent weeks, but emergency department visits and hospitalizations among people ages 65 years and older have decreased, likely demonstrating the important role vaccination plays in protecting against COVID-19.
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             People who are fully vaccinated (formerly receiving 2 doses) represents the number of people who have received the second dose in a two-dose COVID-19 vaccine series or one dose of the single-dose J&amp;J/Janssen COVID-19 vaccine.
                        </P>
                    </FTNT>
                    <P>
                        As indicated by the CDC, COVID-19 vaccines are effective at preventing COVID-19.
                        <SU>4</SU>
                        <FTREF/>
                         For example, a recent CDC report on the effectiveness of the Pfizer-BioNTech and Moderna COVID-19 vaccines when administered in real-world conditions found that after being fully vaccinated with either of these vaccines a person's risk of infection is reduced by up to 90 percent. With respect to inpatient utilization in FY 2020, we believe that COVID-19 and the risk of disease were drivers of the different utilization patterns observed. Therefore, the continuing rapid increase in vaccinations coupled with the overall effectiveness of the vaccines leads us to conclude based on the information available to us at this time that there will be significantly lower risk of COVID-19 in FY 2022 and fewer hospitalizations for COVID-19 for Medicare beneficiaries in FY 2022 than there were in FY 2020. This calls into question the applicability of inpatient data from FY 2020 to the FY 2022 time period for hospitals paid under the IPPS and LTCH PPS.
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers—Eight U.S. Locations, December 2020-March 2021, available at 
                            <E T="03">https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm?s_cid=mm7013e3_e&amp;ACSTrackingID=USCDC_921-DM53321&amp;ACSTrackingLabel=MMWR%20Early%20Release%20-%20Vol.%2070%2C%20March%2029%2C%202021&amp;deliveryName=USCDC_921-DM53321</E>
                            , accessed April 2, 2021).
                        </P>
                    </FTNT>
                    <P>
                        We also reviewed CDC guidance to healthcare facilities during the COVID-19 PHE (see 
                        <E T="03">https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-hcf.html</E>
                        ). In its most recent guidance, the CDC described how the COVID-19 pandemic has changed how health care is delivered in the United States and has affected the operations of healthcare facilities. Effects cited by the CDC include increases in patients seeking care for respiratory illnesses, patients deferring and delaying non-COVID-19 care, disruptions in supply chains, fluctuations in facilities' occupancy, absenteeism among staff because of illness or caregiving responsibilities, and increases in mental health concerns.
                    </P>
                    <P>In order to investigate the effects cited by the CDC, we examined the claims data from the FY 2020 MedPAR compared to the FY 2019 MedPAR. Overall, in FY 2020, inpatient admissions under the IPPS dropped by approximately 14 percent compared to FY 2019. Elective surgeries declined significantly, and the share of admissions for MS-DRGs associated with the treatment of COVID-19 increased. For example, the number of inpatient admissions for MS-DRG 470 (Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity without MCC) dropped by 40 percent in FY 2020. Its share of inpatient admissions dropped from 4.0 percent in FY 2019 to 2.8 percent in FY 2020. The number of inpatient admissions for MS-DRG 177 (Respiratory Infections and Inflammations with MCC) increased by +133 percent. Its share of inpatient admissions increased from 0.8 percent in FY 2019 to 2.2 percent in FY 2020. This data analysis is consistent with the observations in the CDC's guidance that COVID-19 increased the number of patients seeking care for respiratory illnesses, and caused patients to defer and delay non-COVID-19 care. We note that these observed changes in the claims data also extend to the cost reports submitted by hospitals that include the COVID-19 PHE time period, since those cost reports that extend into the COVID-19 PHE are based in part on the discharges that occurred during that time.</P>
                    <P>The effects noted by the CDC are specific to the pandemic and to the extent that the effects on healthcare facilities noted by the CDC are not expected to continue into FY 2022, it would suggest that the inpatient data from FY 2020 impacted by the COVID-19 PHE may be less suitable for use in the FY 2022 ratesetting.</P>
                    <P>
                        We also considered the analysis of 2020 IPPS real case-mix included in the notice titled “CY 2021 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts” that appeared in the 
                        <E T="04">Federal Register</E>
                         on November 12, 2020 (85 FR 71916). Section 1813(b) of the Act prescribes the method for computing the amount of the inpatient hospital deductible. The inpatient hospital deductible is an amount equal to the inpatient hospital deductible for the preceding CY, adjusted by the best estimate of the payment-weighted average of the applicable percentage increases used for updating the payment rates to hospitals, and adjusted to reflect changes in real case-mix.
                    </P>
                    <P>To develop the adjustment to reflect changes in real case-mix, we first calculated an average case-mix for each hospital that reflected the relative costliness of that hospital's mix of cases compared to those of other hospitals. We then computed the change in average case-mix for hospitals paid under the IPPS in FY 2020 compared to FY 2019, using Medicare bills from IPPS hospitals received as of July 2020. Those bills represented a total of about 6.1 million Medicare discharges for FY 2020 and provided the most recent case-mix data available at the time of that analysis. Based on these bills, the change in average case-mix in FY 2020 was 2.8 percent. Based on these bills and past experience, we expected the overall case-mix change to be 3.8 percent as the year progressed and more FY 2020 data became available.</P>
                    <P>
                        Real case-mix is that portion of case-mix that is due to changes in the mix of cases in the hospital and not due to coding optimization. As stated in the November 2020 notice, COVID-19 has complicated the determination of real case-mix increase. COVID-19 cases typically group to higher-weighted MS-DRGs, and hospitals have experienced a concurrent reduction in cases that group 
                        <PRTPAGE P="25088"/>
                        to lower weighted MS-DRGs. Both of these factors cause a real increase in case-mix. We compared the average case-mix for February 2020 through July 2020 (COVID-19 period) with average case-mix for October 2019 through January 2020 (pre-COVID-19 period). Since this increase applies for only a portion of CY 2020, we allocated this increase by the estimated discharges over the 2 periods—a 2.5 percent increase for FY 2020. The 1.3-percent residual case-mix increase is a mixture of real case-mix and coding optimization. Over the past several years, we have observed total case-mix increases of about 0.5 percent per year and have assumed that they are real. Thus, based on the information available, we expect that 0.5 percent of the residual 1.3 percent change in average case-mix for FY 2020 will be real. The combination of the 2.5 percent COVID-19 effect and the remaining residual 0.5-percent real case-mix increase results in an estimated 3.0 percent increase in real case-mix for FY 2020.
                    </P>
                    <P>
                        Because this analysis was based on Medicare bills from IPPS hospitals received as of July 2020, for this proposed rule, we calculated case-mix values for FY 2019 and FY 2020 based on the full year FY 2019 and FY 2020 MedPAR files to help assess the change in case-mix based on more complete data. For FY 2019 we calculated a case-mix value of 1.813 and for FY 2020 we calculated a case-mix value of 1.883, an increase in total case-mix of 3.9 percent. These were calculated using the MS-DRG relative weights in effect for those time periods.
                        <SU>5</SU>
                        <FTREF/>
                         This is consistent with the estimate in the Notice of the CY 2021 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts that the change in total case-mix for FY 2020 would be 3.8 percent when more complete data was available.
                    </P>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             Section 3710 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act directs the Secretary of HHS to increase the weighting factor of the assigned DRG by 20 percent for an individual diagnosed with COVID-19 discharged during the COVID-19 PHE period. In order to make the case-mix values more comparable, the 20 percent increase is not included.
                        </P>
                    </FTNT>
                    <P>The increases in patients seeking care for respiratory illnesses and patients deferring and delaying non-COVID-19 care during FY 2020, the increasing number of vaccinations for COVID-19, and the high estimate of FY 2020 real case-mix growth all lead us to believe that FY 2020 is not the best overall approximation of inpatient experience in FY 2022. We believe that FY 2019 as the most recent complete FY prior to the COVID-19 PHE is a better approximation of FY 2022 inpatient experience.</P>
                    <P>As we indicated earlier, whether the data is a better overall approximation of FY 2022 inpatient experience is one factor in assessing which data source represents the best available data for the FY 2022 rulemaking. Another factor is to what extent the decision to use the FY 2019 or FY 2020 data differentially impacts the FY 2022 ratesetting. One way to assess this factor is to model the change in the total case-mix, which is a driver of spending, if our assumption regarding the FY 2022 inpatient experience used in calculating the MS-DRG relative weights turns out to be less accurate based on actual FY 2022 experience. We estimated the difference in the total case-mix if we calculated the MS-DRG relative weights based on the FY 2019 claims data and the actual utilization is ultimately more similar to the FY 2020 data, as compared to if we calculated the MS-DRG relative weights based on the FY 2020 data and the actual utilization is ultimately more similar to the FY 2019 data.</P>
                    <P>We first calculated a set of MS-DRG relative weights using an assumption that the FY 2022 inpatient experience would be similar to the FY 2019 data. Specifically, we used the proposed version 39 GROUPER (which would be applicable to discharges occurring in FY 2022) and the FY 2019 MedPAR data to calculate MS-DRG relative weights. We refer to these MS-DRG relative weights as the FY 2019-based weights.</P>
                    <P>We next calculated a set of MS-DRG relative weights using an assumption that the FY 2022 inpatient experience would be more similar to the FY 2020 data. Specifically, we used the proposed version 39 GROUPER and the FY 2020 MedPAR data to calculate MS-DRG relative weights. This is how we would ordinarily calculate the proposed FY 2022 MS-DRG relative weights. We refer to these MS-DRG relative weights as the FY 2020-based weights.</P>
                    <P>We then estimated the difference in case-mix under the FY 2019-based weights and the FY 2020-based weights if the FY 2022 inpatient experience ended up being the reverse of the assumption made when calculating that set of relative weights. In other words, we compared estimated case-mix calculated under four different scenarios. For the FY 2019-based weights, we calculated the case-mix using claims from the FY 2019 MedPAR as an approximation of the actual FY 2022 experience (Scenario A), and using claims from the FY 2020 MedPAR as an approximation of the actual FY 2022 experience (Scenario B). For the FY 2020-based weights, we calculated the case-mix using claims from the FY 2020 MedPAR as an approximation of the actual FY 2022 experience (Scenario C), and using claims from the FY 2019 MedPAR as an approximation of the actual FY 2022 experience (Scenario D).</P>
                    <P>The results are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="165">
                        <GID>EP10MY21.004</GID>
                    </GPH>
                    <PRTPAGE P="25089"/>
                    <P>In Scenario A and Scenario C, there is by definition no differential impact on total case-mix due to a less accurate assumption made when the MS-DRG relative weights were calculated: The FY 2022 inpatient experience matches the assumption used when the MS-DRG relative weights were calculated. In Scenario B and Scenario D, it is the reverse of the assumption used when the MS-DRG relative weights were calculated.</P>
                    <P>In Scenario B, when the FY 2019-based weights were used, but the FY 2022 inpatient experience turns out to be more similar to FY 2020 data, the less accurate assumption does not differentially impact the modelled case-mix. This can be seen by comparing the modelled case-mix under Scenario B (1.885) with the modelled case-mix under Scenario C (also 1.885). In other words, if the FY 2019-based weights and inpatient experience turn out to be more similar to the FY 2020 data, then the modelled case-mix is approximately the same as if we had used the FY 2020-based weights. The results show that use of the FY 2019-based weights did not impact the modelled case-mix compared to using the FY 2020-based weights.</P>
                    <P>The same conclusion is not true of Scenario D where the FY 2020-based weights were used, but the FY 2022 inpatient experience turns out to be more similar to FY 2019 data. Here the less accurate assumption does differentially impact the modelled case-mix, by −0.2 percent. This can be seen by comparing the modelled case-mix under Scenario D (1.816) with the modelled case-mix under Scenario A (1.820). In other words, if we use the FY 2020-based weights, and FY 2022 inpatient experience turns out to be more similar to FY 2019 data, the modelled case-mix is −0.2 percent lower than if we had used the FY 2019-based weights. This shows that use of the FY 2020-based weights does impact the modelled case-mix compared to a result from using the FY 2019-based weights.</P>
                    <P>Putting aside that we believe FY 2019 is a more likely approximation of the FY 2022 inpatient experience for the reasons discussed earlier, the previous analysis indicates that the differential effect of the FY 2022 MS-DRG relative weights is more limited if the FY 2019-based weights are used than it is if the FY 2020-based weights are used, should the FY 2022 inpatient experience not match the assumption used to calculate the MS-DRG relative weights.</P>
                    <P>
                        Another payment factor that is impacted by the use of the FY 2019 or FY 2020 data in the FY 2022 ratesetting is the outlier fixed-loss threshold. As discussed in section II.A.4.j. of this proposed rule, section 1886(d)(5)(A) of the Act provides for payments in addition to the basic prospective payments for “outlier” cases involving extraordinarily high costs. To qualify for outlier payments, a case must have costs greater than the sum of certain payments and the “outlier threshold” or “fixed-loss” amount (a dollar amount by which the costs of a case must exceed payments in order to qualify for an outlier payment). In accordance with section 1886(d)(5)(A)(iv) of the Act, outlier payments for any year are projected to be not less than 5 percent nor more than 6 percent of total operating DRG payments plus outlier payments. We target 5.1 percent within this range. Section 1886(d)(3)(B) of the Act requires the Secretary to reduce the average standardized amount by a factor to account for the estimated proportion of total DRG payments made to outlier cases. In other words, outlier payments are prospectively estimated to be budget neutral overall under the IPPS.
                        <SU>6</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             More information on outlier payments may be found on the CMS website at: 
                            <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/AcuteInpatientPPS/outlier.html</E>
                            .
                        </P>
                    </FTNT>
                    <P>Under an assumption that the FY 2022 inpatient experience will be more similar to FY 2019 data, we estimate an outlier fixed-loss amount of $30,967. Under an assumption that FY 2022 inpatient experience will be more similar to FY 2020 data, we estimate an outlier fixed-loss amount of $36,843, a difference of $5,876 or approximately 20 percent higher. Again, putting aside that we believe FY 2019 is a better approximation of the FY 2022 inpatient experience for the reasons discussed earlier, the difference between the two estimated outlier fixed-loss amounts means there is a consequence to making a decision as to the best available data for estimating the FY 2022 outlier fixed-loss amount in the form of potentially exceeding or falling short of the targeted 5.1 percent of total operating DRG payments plus outlier payments.</P>
                    <P>In summary, we have highlighted two factors in the decision regarding the best available data to use in the FY 2022 ratesetting. The first factor is to what extent the FY 2019 data from before the COVID-19 PHE is a better overall approximation of FY 2022 inpatient experience, or alternatively, to what extent the FY 2020 data including the COVID-19 PHE time period is a better overall approximation of FY 2022 inpatient experience. After analyzing this issue and for the reasons discussed, we believe for purposes of this proposed rule that FY 2019 is generally a better overall approximation of FY 2022. The second factor is to what extent the decision to use the FY 2019 or FY 2020 data differentially impacts the FY 2022 IPPS ratesetting. After analyzing this issue, and as discussed previously, we have determined that the decision does differentially impact the overall FY 2022 IPPS ratesetting in two primary ways. First, a decision to base the MS-DRG relative weights on the FY 2020 data has an impact of −0.2 percent if the FY 2022 inpatient experience is more like FY 2019 data. Second, the decision to use the FY 2019 or FY 2020 data results in an approximately 20 percent difference in the estimate of the outlier fixed-loss amount.</P>
                    <P>Taking these factors into account, we are proposing to use the FY 2019 data for the FY 2022 ratesetting for circumstances where the FY 2020 data is significantly impacted by the COVID-19 PHE, primarily in that the data reflect generally markedly different utilization for certain types of services in FY 2020 than would have been expected in the absence of the PHE, as discussed previously. For example, we are proposing to use the FY 2019 MedPAR claims data for purposes where we ordinarily would have used the FY 2020 MedPAR claims data, such as in our analysis of changes to MS-DRG classifications (as discussed in greater detail section II.D. of the preamble of this proposed rule). Similarly, we are proposing to use cost report data from the FY 2018 HCRIS file for purposes where we ordinarily would have used the FY 2019 HCRIS file, such as in determining the proposed FY 2022 IPPS MS-DRG relative weights (as discussed in greater detail section II.E. of the preamble of this proposed rule). (As noted previously, the FY 2019 HCRIS data would contain many cost reports ending in FY 2020 based on each hospital's cost reporting period.) We note that MedPAR claims data and cost report data from the HCRIS file are examples of the data sources for which we discuss the proposed use of the FY 2019 data for the FY 2022 ratesetting in this proposed rule. We have clearly identified throughout this proposed rule where and how we are proposing to use alternative data than what ordinarily would be used for the proposed FY 2022 IPPS and LTCH PPS ratesetting, including certain provider specific information.</P>
                    <P>
                        As discussed in section I.O. of Appendix A of this proposed rule, we are also considering, as an alternative to this proposal, the use of the same FY 2020 data that we would ordinarily use for purposes of FY 2022 ratesetting, and 
                        <PRTPAGE P="25090"/>
                        which we may consider finalizing based on consideration of comments received. To facilitate comment on this alternative for FY 2022, we are making available the FY 2020 MedPAR file and the FY 2019 HCRIS file that we would ordinarily have provided in conjunction with this proposed rule. We are also making available the MS-DRG and MS-LTC-DRG relative weighting factors and length of stay information calculated using the FY 2020 data we would have ordinarily used. We are providing a file comparing the budget neutrality and other ratesetting adjustments calculated under our proposal with those adjustments calculated under this alternative approach. Finally, we are making available other proposed rule supporting data files based on the use of the FY 2020 data that we ordinarily would have provided, including: The IPPS and LTCH PPS Impact Files; the AOR/BOR File; the Case Mix Index File; and, the Standardizing File. We refer the reader to section I.O. of Appendix A of this proposed rule for more information on where these supplemental files may be found.
                    </P>
                    <HD SOURCE="HD1">II. Proposed Changes to Medicare Severity Diagnosis-Related Group (MS-DRG) Classifications and Relative Weights</HD>
                    <HD SOURCE="HD2">A. Background</HD>
                    <P>Section 1886(d) of the Act specifies that the Secretary shall establish a classification system (referred to as diagnosis-related groups (DRGs) for inpatient discharges and adjust payments under the IPPS based on appropriate weighting factors assigned to each DRG. Therefore, under the IPPS, Medicare pays for inpatient hospital services on a rate per discharge basis that varies according to the DRG to which a beneficiary's stay is assigned. The formula used to calculate payment for a specific case multiplies an individual hospital's payment rate per case by the weight of the DRG to which the case is assigned. Each DRG weight represents the average resources required to care for cases in that particular DRG, relative to the average resources used to treat cases in all DRGs.</P>
                    <P>Section 1886(d)(4)(C) of the Act requires that the Secretary adjust the DRG classifications and relative weights at least annually to account for changes in resource consumption. These adjustments are made to reflect changes in treatment patterns, technology, and any other factors that may change the relative use of hospital resources.</P>
                    <HD SOURCE="HD2">B. Adoption of the MS-DRGs and MS-DRG Reclassifications</HD>
                    <P>For information on the adoption of the MS-DRGs in FY 2008, we refer readers to the FY 2008 IPPS final rule with comment period (72 FR 47140 through 47189).</P>
                    <P>For general information about the MS-DRG system, including yearly reviews and changes to the MS-DRGs, we refer readers to the previous discussions in the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR 43764 through 43766) and the FYs 2011 through 2021 IPPS/LTCH PPS final rules (75 FR 50053 through 50055; 76 FR 51485 through 51487; 77 FR 53273; 78 FR 50512; 79 FR 49871; 80 FR 49342; 81 FR 56787 through 56872; 82 FR 38010 through 38085, 83 FR 41158 through 41258, 84 FR 42058 through 42165, and 85 FR 58445 through 58596 respectively).</P>
                    <HD SOURCE="HD2">C. Proposed FY 2022 MS-DRG Documentation and Coding Adjustment</HD>
                    <HD SOURCE="HD3">1. Background on the Prospective MS-DRG Documentation and Coding Adjustments for FY 2008 and FY 2009 Authorized by Public Law 110-90 and the Recoupment or Repayment Adjustment Authorized by Section 631 of the American Taxpayer Relief Act of 2012 (ATRA)</HD>
                    <P>In the FY 2008 IPPS final rule with comment period (72 FR 47140 through 47189), we adopted the MS-DRG patient classification system for the IPPS, effective October 1, 2007, to better recognize severity of illness in Medicare payment rates for acute care hospitals. The adoption of the MS-DRG system resulted in the expansion of the number of DRGs from 538 in FY 2007 to 745 in FY 2008. By increasing the number of MS-DRGs and more fully taking into account patient severity of illness in Medicare payment rates for acute care hospitals, MS-DRGs encourage hospitals to improve their documentation and coding of patient diagnoses.</P>
                    <P>In the FY 2008 IPPS final rule with comment period (72 FR 47175 through 47186), we indicated that the adoption of the MS-DRGs had the potential to lead to increases in aggregate payments without a corresponding increase in actual patient severity of illness due to the incentives for additional documentation and coding. In that final rule with comment period, we exercised our authority under section 1886(d)(3)(A)(vi) of the Act, which authorizes us to maintain budget neutrality by adjusting the national standardized amount, to eliminate the estimated effect of changes in coding or classification that do not reflect real changes in case-mix. Our actuaries estimated that maintaining budget neutrality required an adjustment of −4.8 percentage points to the national standardized amount. We provided for phasing in this −4.8 percentage point adjustment over 3 years. Specifically, we established prospective documentation and coding adjustments of −1.2 percentage points for FY 2008, −1.8 percentage points for FY 2009, and −1.8 percentage points for FY 2010.</P>
                    <P>On September 29, 2007, Congress enacted the TMA [Transitional Medical Assistance], Abstinence Education, and QI [Qualifying Individuals] Programs Extension Act of 2007 (Pub. L. 110-90). Section 7(a) of Public Law 110-90 reduced the documentation and coding adjustment made as a result of the MS-DRG system that we adopted in the FY 2008 IPPS final rule with comment period to −0.6 percentage point for FY 2008 and −0.9 percentage point for FY 2009.</P>
                    <P>As discussed in prior year rulemakings, and most recently in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56780 through 56782), we implemented a series of adjustments required under sections 7(b)(1)(A) and 7(b)(1)(B) of Public Law 110-90, based on a retrospective review of FY 2008 and FY 2009 claims data. We completed these adjustments in FY 2013 but indicated in the FY 2013 IPPS/LTCH PPS final rule (77 FR 53274 through 53275) that delaying full implementation of the adjustment required under section 7(b)(1)(A) of Public Law 110-90 until FY 2013 resulted in payments in FY 2010 through FY 2012 being overstated, and that these overpayments could not be recovered under Public Law 110-90.</P>
                    <P>
                        In addition, as discussed in prior rulemakings and most recently in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38008 through 38009), section 631 of the American Taxpayer Relief Act of 2012 (ATRA) amended section 7(b)(1)(B) of Public Law 110-90 to require the Secretary to make a recoupment adjustment or adjustments totaling $11 billion by FY 2017. This adjustment represented the amount of the increase in aggregate payments as a result of not completing the prospective adjustment authorized under section 7(b)(1)(A) of Public Law 110-90 until FY 2013.
                        <PRTPAGE P="25091"/>
                    </P>
                    <HD SOURCE="HD3">2. Adjustments Made for FYs 2018, 2019, 2020 and 2021 as Required Under Section 414 of Public Law 114-10 (MACRA) and Section 15005 of Public Law 114-255</HD>
                    <P>As stated in the FY 2017 IPPS/LTCH PPS final rule (81 FR 56785), once the recoupment required under section 631 of the ATRA was complete, we had anticipated making a single positive adjustment in FY 2018 to offset the reductions required to recoup the $11 billion under section 631 of the ATRA. However, section 414 of the MACRA (which was enacted on April 16, 2015) replaced the single positive adjustment we intended to make in FY 2018 with a 0.5 percentage point positive adjustment for each of FYs 2018 through 2023. In the FY 2017 rulemaking, we indicated that we would address the adjustments for FY 2018 and later fiscal years in future rulemaking. Section 15005 of the 21st Century Cures Act (Pub. L. 114-255), which was enacted on December 13, 2016, amended section 7(b)(1)(B) of the TMA, as amended by section 631 of the ATRA and section 414 of the MACRA, to reduce the adjustment for FY 2018 from a 0.5 percentage point positive adjustment to a 0.4588 percentage point positive adjustment. As we discussed in the FY 2018 rulemaking, we believe the directive under section 15005 of Public Law 114-255 is clear. Therefore, in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38009) for FY 2018, we implemented the required +0.4588 percentage point adjustment to the standardized amount. In the FY 2019 IPPS/LTCH PPS final rule (83 FR 41157), the FY 2020 IPPS/LTCH PPS final rule (84 FR 42057), and the FY 2021 IPPS/LTCH PPS final rule (85 FR 58444-58445), consistent with the requirements of section 414 of the MACRA, we implemented 0.5 percentage point positive adjustments to the standardized amount for FY 2019, FY 2020, and FY 2021, respectively. We indicated the FY 2018, FY 2019, FY 2020, and FY 2021 adjustments were permanent adjustments to payment rates. We also stated that we plan to propose future adjustments required under section 414 of the MACRA for FYs 2022 and 2023 in future rulemaking.</P>
                    <HD SOURCE="HD3">3. Proposed Adjustment for FY 2022</HD>
                    <P>Consistent with the requirements of section 414 of the MACRA, we are proposing to implement a 0.5 percentage point positive adjustment to the standardized amount for FY 2022. This would constitute a permanent adjustment to payment rates. We plan to propose the final adjustment required under section 414 of the MACRA for FY 2023 in future rulemaking.</P>
                    <HD SOURCE="HD2">D. Proposed Changes to Specific MS-DRG Classifications</HD>
                    <HD SOURCE="HD3">1. Discussion of Changes to Coding System and Basis for Proposed FY 2022 MS-DRG Updates</HD>
                    <HD SOURCE="HD3">a. Conversion of MS-DRGs to the International Classification of Diseases, 10th Revision (ICD-10)</HD>
                    <P>As of October 1, 2015, providers use the International Classification of Diseases, 10th Revision (ICD-10) coding system to report diagnoses and procedures for Medicare hospital inpatient services under the MS-DRG system instead of the ICD-9-CM coding system, which was used through September 30, 2015. The ICD-10 coding system includes the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, as well as the ICD-10-CM and ICD-10-PCS Official Guidelines for Coding and Reporting. For a detailed discussion of the conversion of the MS-DRGs to ICD-10, we refer readers to the FY 2017 IPPS/LTCH PPS final rule (81 FR 56787 through 56789).</P>
                    <HD SOURCE="HD3">b. Basis for Proposed FY 2022 MS-DRG Updates</HD>
                    <P>Given the need for more time to carefully evaluate requests and propose updates, as discussed in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38010), we changed the deadline to request updates to the MS-DRGs to November 1 of each year, which provided an additional five weeks for the data analysis and review process. In the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32472), we stated that with the continued increase in the number and complexity of the requested changes to the MS-DRG classifications since the adoption of ICD-10 MS-DRGs, and in order to consider as many requests as possible, more time is needed to carefully evaluate the requested changes, analyze claims data, and consider any proposed updates. We further stated we were changing the deadline to request changes to the MS-DRGs to October 20 of each year to allow for additional time for the review and consideration of any proposed updates. However, in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58445), due to the unique circumstances for the FY 2021 IPPS/LTCH PPS final rule for which we waived the delayed effective date, we maintained the deadline of November 1, 2020 for FY 2022 MS-DRG classification change requests. We also noted that we expected to reconsider a change in the deadline beginning with comments and suggestions submitted for FY 2023. While we continue to believe that a change in the deadline from November 1 to October 20 will provide hospitals sufficient time to assess potential impacts and inform future MS-DRG recommendations, we are maintaining the deadline of November 1 for FY 2023 MS-DRG classification change requests.</P>
                    <P>
                        As noted, interested parties had to submit MS-DRG classification change requests for FY 2022 by November 1, 2020, and the comments that were submitted in a timely manner for FY 2022 are discussed in this section of the preamble of this proposed rule. As we discuss in the sections that follow, we may not be able to fully consider all of the requests that we receive for the upcoming fiscal year. We have found that, with the implementation of ICD-10, some types of requested changes to the MS-DRG classifications require more extensive research to identify and analyze all of the data that are relevant to evaluating the potential change. We note in the discussion that follows those topics for which further research and analysis are required, and which we will continue to consider in connection with future rulemaking. Interested parties should continue to submit any comments and suggestions for FY 2023 by November 1, 2021 via the CMS MS-DRG Classification Change Request Mailbox located at: 
                        <E T="03">MSDRGClassificationChange@cms.hhs.gov</E>
                        .
                    </P>
                    <P>
                        As we did for the FY 2021 IPPS/LTCH PPS proposed rule, for this FY 2022 IPPS/LTCH PPS proposed rule we are providing a test version of the ICD-10 MS-DRG GROUPER Software, Version 39, so that the public can better analyze and understand the impact of the proposals included in this proposed rule. We note that this test software reflects the proposed GROUPER logic for FY 2022. Therefore, it includes the new diagnosis and procedure codes that are effective for FY 2022 as reflected in Table 6A.—New Diagnosis Codes—FY 2022 and Table 6B.—New Procedure Codes—FY 2022 associated with this proposed rule and does not include the diagnosis codes that are invalid beginning in FY 2022 as reflected in Table 6C.—Invalid Diagnosis Codes—FY 2022 and Table 6D.—Invalid Procedure Codes—FY 2022 associated with this proposed rule. These tables are not published in the Addendum to this proposed rule, but are available via the 
                        <PRTPAGE P="25092"/>
                        internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                         as described in section VI. of the Addendum to this proposed rule. Because the diagnosis and procedure codes no longer valid for FY 2022 are not reflected in the test software, we are making available a supplemental file in Table 6P.1a that includes the mapped Version 39 FY 2022 ICD-10-CM codes and the deleted Version 38 FY 2021 ICD-10-CM codes that should be used for testing purposes with users' available claims data. In addition, we are making available a supplemental file in Table 6P.1b that includes the mapped Version 39 FY 2022 ICD-10-PCS codes and the deleted Version 38 FY 2021 ICD-10-PCS codes that should be used for testing purposes with users' available claims data. Therefore, users will have access to the test software allowing them to build case examples that reflect the proposals included in this proposed rule. In addition, users will be able to view the draft version of the ICD-10 MS-DRG Definitions Manual, Version 39.
                    </P>
                    <P>
                        The test version of the ICD-10 MS-DRG GROUPER Software, Version 39, the draft version of the ICD-10 MS-DRG Definitions Manual, Version 39, and the supplemental mapping files in Table 6P.1a and Table 6P.1b of the FY 2021 and FY 2022 ICD-10-CM diagnosis and ICD-10-PCS procedure codes are available at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software</E>
                        .
                    </P>
                    <P>Following are the changes that we are proposing to the MS-DRGs for FY 2022. We are inviting public comments on each of the MS-DRG classification proposed changes, as well as our proposals to maintain certain existing MS-DRG classifications discussed in this proposed rule. In some cases, we are proposing changes to the MS-DRG classifications based on our analysis of claims data and consultation with our clinical advisors. In other cases, we are proposing to maintain the existing MS-DRG classifications based on our analysis of claims data and consultation with our clinical advisors. As discussed in section I.F of the preamble of this proposed rule, we are proposing to use claims data from the March 2020 update of the FY 2019 MedPAR file in our analysis of proposed MS-DRG classification changes for FY 2022, consistent with our goal of using the best available data overall for ratesetting. Alternatively, we are also providing the results of our analysis of proposed MS-DRG classification changes using claims data from the September 2020 update of the FY 2020 MedPAR file. As a result, for this FY 2022 IPPS/LTCH PPS proposed rule, our MS-DRG analysis was based on ICD-10 claims data from the March 2020 update of the FY 2019 MedPAR file, which contains hospital bills received from October 1, 2018 through March 31, 2020, for discharges occurring through September 30, 2019. In addition, we also analyzed ICD-10 claims data from the September 2020 update of the FY 2020 MedPAR file, which contains hospital bills received from October 1, 2019 through September 30, 2020, for discharges occurring through September 30, 2020. In our discussion of the proposed MS-DRG reclassification changes, we refer to these claims data as the “March 2020 update of the FY 2019 MedPAR file” and “the September 2020 update of the FY 2020 MedPAR file.”</P>
                    <P>As explained in previous rulemaking (76 FR 51487), in deciding whether to propose to make further modifications to the MS-DRGs for particular circumstances brought to our attention, we consider whether the resource consumption and clinical characteristics of the patients with a given set of conditions are significantly different than the remaining patients represented in the MS-DRG. We evaluate patient care costs using average costs and lengths of stay and rely on the judgment of our clinical advisors to determine whether patients are clinically distinct or similar to other patients represented in the MS-DRG. In evaluating resource costs, we consider both the absolute and percentage differences in average costs between the cases we select for review and the remainder of cases in the MS-DRG. We also consider variation in costs within these groups; that is, whether observed average differences are consistent across patients or attributable to cases that are extreme in terms of costs or length of stay, or both. Further, we consider the number of patients who will have a given set of characteristics and generally prefer not to create a new MS-DRG unless it would include a substantial number of cases.</P>
                    <P>In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58448), we finalized our proposal to expand our existing criteria to create a new complication or comorbidity (CC) or major complication or comorbidity (MCC) subgroup within a base MS-DRG. Specifically, we finalized the expansion of the criteria to include the NonCC subgroup for a three-way severity level split. We stated we believed that applying these criteria to the NonCC subgroup would better reflect resource stratification as well as promote stability in the relative weights by avoiding low volume counts for the NonCC level MS-DRGs. We noted that in our analysis of MS-DRG classification requests for FY 2021 that were received by November 1, 2019, as well as any additional analyses that were conducted in connection with those requests, we applied these criteria to each of the MCC, CC, and NonCC subgroups. We also noted that the application of the NonCC subgroup criteria going forward may result in modifications to certain MS-DRGs that are currently split into three severity levels and result in MS-DRGs that are split into two severity levels. We stated that any proposed modifications to the MS-DRGs would be addressed in future rulemaking consistent with our annual process and reflected in Table 5—Proposed List of Medicare Severity Diagnosis Related Groups (MS-DRGs), Relative Weighting Factors, and Geometric and Arithmetic Mean Length of Stay for the applicable fiscal year.</P>
                    <P>In our analysis of the MS-DRG classification requests for FY 2022 that we received by November 1, 2020, as well as any additional analyses that were conducted in connection with those requests, we applied these criteria to each of the MCC, CC, and NonCC subgroups, as described in the following table.</P>
                    <GPH SPAN="3" DEEP="355">
                        <PRTPAGE P="25093"/>
                        <GID>EP10MY21.005</GID>
                    </GPH>
                    <P>In general, once the decision has been made to propose to make further modifications to the MS-DRGs as described previously, such as creating a new base MS-DRG, or in our evaluation of a specific MS-DRG classification request to split (or subdivide) an existing base MS-DRG into severity levels, all five criteria must be met for the base MS-DRG to be split (or subdivided) by a CC subgroup. We note that in our analysis of requests to create a new MS-DRG, we typically evaluate the most recent year of MedPAR claims data available. For example, we stated earlier that for this FY 2022 IPPS/LTCH PPS proposed rule, our MS-DRG analysis was based on ICD-10 claims data from both the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file. However, in our evaluation of requests to split an existing base MS-DRG into severity levels, as noted in prior rulemaking (80 FR 49368), we typically analyze the most recent two years of data. This analysis includes 2 years of MedPAR claims data to compare the data results from 1 year to the next to avoid making determinations about whether additional severity levels are warranted based on an isolated year's data fluctuation and also, to validate that the established severity levels within a base MS-DRG are supported. The first step in our process of evaluating if the creation of a new CC subgroup within a base MS-DRG is warranted is to determine if all the criteria is satisfied for a three way split. If the criteria fail, the next step is to determine if the criteria are satisfied for a two way split. If the criteria for both of the two way splits fail, then a split (or CC subgroup) would generally not be warranted for that base MS-DRG. If the three way split fails on any one of the five criteria and all five criteria for both two way splits (1_23 and 12_3) are met, we would apply the two way split with the highest R2 value. We note that if the request to split (or subdivide) an existing base MS-DRG into severity levels specifies the request is for either one of the two way splits (1_23 or 12_3), in response to the specific request, we will evaluate the criteria for both of the two way splits, however we do not also evaluate the criteria for a three way split.</P>
                    <P>
                        For this FY 2022 IPPS/LTCH PPS proposed rule, using the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file, we also analyzed how applying the NonCC subgroup criteria to all MS-DRGs currently split into three severity levels would affect the MS-DRG structure beginning in FY 2022. Findings from our analysis indicated that approximately 32 MS-DRGs would be subject to change based on the three-way severity level split criterion finalized in FY 2021. Specifically, we found that applying the NonCC subgroup criteria to all MS-DRGs currently split into three severity levels would result in the deletion of 96 MS-DRGs (32 MS-DRGs × 3 severity levels = 96) and the creation of 58 new MS-DRGs. These updates would also involve a redistribution of cases, which would impact the relative weights, and, thus, the payment rates proposed for particular types of cases. We refer the reader to Table 6P.1c for the list of the 96 MS-DRGs that would be subject to deletion and the list of the 58 new MS-DRGs that would be proposed for creation for FY 2022 under this policy if the NonCC subgroup criteria were applied.
                        <PRTPAGE P="25094"/>
                    </P>
                    <P>In light of the public health emergency (PHE), we have concerns about the impact of implementing this volume of MS-DRG changes at this time, and believe it may be appropriate to delay application of the NonCC subgroup criteria to existing MS-DRGs in order to maintain more stability in the current MS-DRG structure. Therefore, we are proposing to delay the application of the NonCC subgroup criteria to existing MS-DRGs with a three-way severity level split until FY 2023, and proposing for FY 2022 to maintain the current structure of the 32 MS-DRGs that currently have a three-way severity level split (total of 96 MS-DRGs) that would otherwise be subject to these criteria.</P>
                    <HD SOURCE="HD3">2. Pre-MDC: MS-DRG 018 Chimeric Antigen Receptor (CAR) T-Cell Therapy</HD>
                    <P>In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58451 through 58453), we finalized our proposal to create Pre-MDC MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell Immunotherapy) and to reassign cases reporting ICD-10-PCS procedure codes XW033C3 (Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 3) or XW043C3 (Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into central vein, percutaneous approach, new technology group 3) from Pre-MDC MS-DRG 016 (Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy), to new Pre-MDC MS-DRG 018 effective with discharges on and after October 1, 2020. We also finalized our proposal to revise the title for MS-DRG 016 from “Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy” to “Autologous Bone Marrow Transplant with CC/MCC” to reflect these changes.</P>
                    <P>Additionally, in the FY 2021 IPPS/LTCH PPS final rule in response to public comments expressing concern that Pre-MDC MS-DRG 018 is specific to one mechanistic approach to cellular therapy, and in response to commenters who sought clarification on how future CAR T-cell and non-CAR T-cell therapy products would be assigned, we stated that if additional cellular therapies should become available, we would use our established process to determine the MS-DRG assignment. The commenters requested that CMS provide flexibility for future cellular therapies, as they are made available and not restrict Pre-MDC MS-DRG 018 to CAR T-cell therapies alone. In this section of this rule, we discuss the assignment of these therapies in more detail.</P>
                    <P>
                        During the September 8-9, 2020 ICD-10 Coordination and Maintenance Committee meeting, several topics involving requests for new procedure codes related to CAR T-cell therapies, non-CAR T-cell therapies and other immunotherapies were discussed. We refer the reader to the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Coding/ICD10/C-and-M-Meeting-Materials</E>
                         for additional detailed information regarding these requests for new procedure codes. As noted in prior rulemaking (85 FR 32543), for new procedure codes that have been finalized through the ICD-10 Coordination and Maintenance Committee meeting process and are proposed to be classified as O.R. procedures or non-O.R. procedures affecting the MS-DRG, our clinical advisors recommend the MS-DRG assignment which is then made available in association with the proposed rule (Table 6B.—New Procedure Codes) and subject to public comment. These proposed assignments are generally based on the assignment of predecessor codes or the assignment of similar codes. As discussed in section II.D.13 of the preamble of this proposed rule, Table 6B.—New Procedure Codes, lists the new procedure codes that have been approved to date that will be effective with discharges on and after October 1, 2021. Included in Table 6B are the following new procedure codes that describe the administration of CAR T-cell and non-CAR T-cell therapies and other immunotherapies. Consistent with our established process, we examined the MS-DRG assignment for the predecessor codes to determine the most appropriate MS-DRG assignment and, consistent with the assignment of those predecessor codes, we are proposing to classify the following new procedure codes as non-O.R. procedures affecting Pre-MDC MS-DRG 018, as shown in Table 6B.—New Procedure Codes associated with this proposed rule and available via the internet on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index/</E>
                        .
                    </P>
                    <GPH SPAN="3" DEEP="534">
                        <PRTPAGE P="25095"/>
                        <GID>EP10MY21.006</GID>
                    </GPH>
                    <P>In connection with our proposed assignment of the listed procedure codes to Pre-MDC MS-DRG 018, we are also proposing to revise the title for Pre-MDC MS-DRG 018 “Chimeric Antigen Receptor (CAR) T-cell Immunotherapy” to “Chimeric Antigen Receptor (CAR) T-cell and Other Immunotherapies” to better reflect the cases reporting the administration of non-CAR T-cell therapies and other immunotherapies that would also be assigned to this MS-DRG (for example, Introduction of lifileucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7), in addition to CAR T-cell therapies.</P>
                    <HD SOURCE="HD3">3. MDC 03 (Diseases and Disorders of Ear, Nose and Throat)</HD>
                    <P>
                        In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58462 through 58471), we finalized our proposal to create two new base MS-DRGs, 140 and 143, with a three-way severity level split for new MS-DRGs 140, 141, and 142 (Major Head and Neck Procedures with MCC, with CC, and without CC/MCC, respectively) and new MS-DRGs 143, 144, and 145 (Other Ear, Nose, Mouth And Throat O.R. Procedures with MCC, with CC, and without CC/MCC, respectively). We provided the list of procedure codes that were finalized to define the logic for the new MS-DRGs in Tables 6P.2a, 6P.2b, and 6P.2c associated with the final rule and available via the internet on the CMS website at 
                        <E T="03">
                            https://www.cms.gov/
                            <PRTPAGE P="25096"/>
                            Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index/
                        </E>
                        . We received two separate but related requests to review and reconsider the MS-DRG assignments for a subset of the procedure codes listed in Table 6P.2a (procedure codes assigned to MS-DRGs 140, 141, and 142) and Table 6P.2b (procedure codes assigned to MS-DRGs 143, 144, and 145). In this section of this proposed rule, we discuss each of these separate, but related requests.
                    </P>
                    <HD SOURCE="HD3">a. Major Head and Neck Procedures</HD>
                    <P>The requestor provided the following procedure codes from Table 6P.2a associated with the FY 2021 IPPS/LTCH PPS final rule for CMS to examine.</P>
                    <GPH SPAN="3" DEEP="143">
                        <GID>EP10MY21.368</GID>
                    </GPH>
                    <P>The requestor stated that the listed procedure codes do not appear appropriately assigned to MS-DRGs 140, 141, and 142. According to the requestor, if any one of the five procedure codes describing a procedure performed on the cranial cavity (0W9100Z, 0W910ZZ, 0WC10ZZ, 0WC13ZZ, or 0WX14ZZ) is assigned in conjunction with a principal diagnosis from MDC 03 (Diseases and Disorders of Ear, Nose, Mouth, and Throat), it appears more appropriate that cases reporting the diagnosis and procedure combination would group to MS-DRGs 25, 26, and 27 (Craniotomy and Endovascular Intracranial Procedures with MCC, with CC, and without CC/MCC, respectively) (for example, “craniotomy” MS-DRGs) in MDC 01 (Diseases and Disorders of the Central Nervous System) or to MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively). The requestor stated that drainage and extirpation from the cranial cavity always involves drilling or cutting through the skull regardless of the approach, therefore the five procedure codes identified warrant assignment to the “craniotomy” MS-DRGs. For the three procedure codes describing excision of subcutaneous tissue of chest, back, or abdomen (0JB60ZZ, 0JB70ZZ, and 0JB80ZZ), the requestor stated those codes should group to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) because they are not pertinent to the ear, nose, mouth, or throat.</P>
                    <P>
                        We reviewed this request and note that the five procedure codes describing procedures performed on the cranial cavity are already assigned to MDC 01 and group to the “craniotomy” MS-DRGs (25, 26, and 27) when reported with a principal diagnosis from MDC 01, and are also currently classified as Extensive O.R. procedures, resulting in assignment to MS-DRGs 981, 982, and 983 when any one of the five procedure codes is reported on the claim and is unrelated to the MDC to which the case was assigned based on the principal diagnosis. We also note that in addition to MS-DRGs 25, 26, and 27, MS-DRG 23 (Craniotomy with Major Device Implant or Acute Complex CNS Principal Diagnosis with MCC or Chemotherapy Implant or Epilepsy with Neurostimulator) and MS-DRG 24 (Craniotomy with Major Device Implant or Acute Complex CNS Principal Diagnosis without MCC) include procedures performed on structures located within the cranial cavity, are included in the range of MS-DRGs known as the “craniotomy” MS-DRGs in MDC 01, and the five procedure codes submitted by the requestor describing procedures performed on the cranial cavity are also assigned to these MS-DRGs. We refer the requestor to Appendix E of the ICD-10 MS-DRG Definitions Manual for further discussion of how each procedure code may be assigned to multiple MDCs and MS-DRGs under the IPPS. The ICD-10 MS-DRG Definitions Manual is located on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software</E>
                        . We also note that these five procedure codes were previously assigned to MS-DRGs 131 and 132 (Cranial and Facial Procedures with and without CC/MCC, respectively) in MDC 03 under version 37 of the ICD-10 MS-DRGs prior to the restructuring that was finalized effective FY 2021 for MS-DRG 129 (Major Head and Neck Procedures with CC/MCC or Major Device) and MS-DRG 130 (Major Head and Neck Procedures without CC/MCC), MS-DRGs 131 and 132, and MS-DRGs 133 and 134 (Other Ear, Nose, Mouth and Throat O.R. Procedures with and without CC/MCC, respectively).
                    </P>
                    <P>With regard to the three procedure codes describing excision of subcutaneous tissue of chest, back, or abdomen (0JB60ZZ, 0JB70ZZ, and 0JB80ZZ), the requestor suggested that the codes should group to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) specifically because they are not pertinent to the ear, nose, mouth, or throat, however, it is unclear if the requestor was concerned more broadly that the three procedure codes should not group to any MS-DRGs in MDC 03 (Diseases and Disorders of Ear, Nose and Throat), given the stated rationale for the request.</P>
                    <P>
                        Upon our review, we believe that the three procedure codes describing excision of subcutaneous tissue of chest, back, and abdomen (0JB60ZZ, 0JB70ZZ, and 0JB80ZZ), which do not describe major head and neck procedures, were inadvertently included in Table 6P.2a for assignment to MS-DRGs 140, 141, and 142. However, we also believe that the codes are appropriate for assignment 
                        <PRTPAGE P="25097"/>
                        in MDC 03 and note that the three procedure codes were previously assigned to MS-DRGs 133 and 134 (Other Ear, Nose, Mouth and Throat O.R. Procedures with and without CC/MCC, respectively) in MDC 03 prior to the restructuring that was finalized effective FY 2021 for MS-DRGs 129, 130, 131, 132, 133, and 134. We also provided the following clarification in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58470), as stated in the ICD-10 MS-DRG Definitions Manual, “In each MDC there is usually a medical and a surgical class referred to as “other medical diseases” and “other surgical procedures,” respectively. The “other” medical and surgical classes are not as precisely defined from a clinical perspective. The other classes would include diagnoses or procedures, which were infrequently encountered or not well defined clinically. For example, the “other” medical class for the Respiratory System MDC would contain the diagnoses “other somatoform disorders” and “congenital malformation of the respiratory system,” while the “other” surgical class for the female reproductive MDC would contain the surgical procedures “excision of liver” (liver biopsy in ICD-9-CM) and “inspection of peritoneal cavity” (exploratory laparotomy in ICD-9-CM). The “other” surgical category contains surgical procedures which, while infrequent, could still reasonably be expected to be performed for a patient in the particular MDC.”
                    </P>
                    <P>During our review of procedure codes 0JB60ZZ, 0JB70ZZ, and 0JB80ZZ (describing excision of subcutaneous tissue of chest, back, and abdomen, respectively) we also confirmed that these procedures are currently designated as Extensive O.R. procedures. Consistent with other procedure codes on the Non-extensive procedure code list, we do not believe the procedures described by these procedure codes necessarily utilize the resources or have the level of technical complexity as the procedures on the Extensive O.R. procedures list. Therefore, we agree that the procedure codes describing these procedures would be more appropriately designated as Non-extensive procedures and group to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) when any one of the three procedure codes is reported on a claim and is unrelated to the MDC to which the case was assigned based on the principal diagnosis. We refer the reader to section II.D.10. of the preamble of this proposed rule for further discussion regarding our proposal to reassign these procedure codes from MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) for FY 2022.</P>
                    <P>Therefore, we are proposing to reassign the three procedure codes describing excision of subcutaneous tissue of chest, back, or abdomen (0JB60ZZ, 0JB70ZZ, and 0JB80ZZ) from MS-DRGs 140, 141, and 142 (Major Head and Neck Procedures with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 143, 144, and 145 (Other Ear, Nose, Mouth And Throat O.R. Procedures with MCC, with CC, and without CC/MCC, respectively) in MDC 03 for FY 2022. We refer the reader to section II.D.10. of the preamble of this proposed rule for further discussion regarding the designation of these codes as Extensive O.R. procedures versus Non-extensive O.R. procedures and our proposed reassignment of these codes from MS-DRGs 981, 982, and 983 to MS-DRGs 987, 988, and 989 for FY 2022.</P>
                    <HD SOURCE="HD3">b. Other Ear, Nose, Mouth and Throat O.R. Procedures</HD>
                    <P>As stated earlier, we received two separate but related requests to review and reconsider the MS-DRG assignments for a subset of the procedure codes listed in Table 6P.2a and Table 6P.2b. In this section of this proposed rule, we discuss the second request related to procedure codes listed in Table 6P.2b associated with the FY 2021 IPPS/LTCH PPS final rule and currently assigned to MS-DRGs 143, 144 and 145.</P>
                    <P>
                        The requestor provided a list of 82 procedure codes from Table 6P.2b associated with the FY 2021 IPPS/LTCH PPS final rule for CMS to examine. We refer the reader to Table 6P.1d associated with this FY 2022 IPPS/LTCH PPS proposed rule and available via the internet at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index/</E>
                         for the list of procedure codes that were provided by the requestor. According to the requestor, if any one of the 82 procedure codes is assigned in conjunction with a principal diagnosis code from MDC 03, it appears more appropriate that cases reporting the diagnosis and procedure code combination would group to MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) or to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) versus MS-DRGs 143, 144, and 145 (Other Ear, Nose, Mouth And Throat O.R. Procedures with MCC, with CC, and without CC/MCC, respectively). However, the requestor also stated that of the 82 procedure codes, the following three procedure codes describing control of bleeding in the cranial cavity warrant grouping to MS-DRGs 25, 26, and 27 (for example, “craniotomy” MS-DRGs) in MDC 01, for the same reasons previously described in the prior section pertaining to the five other procedures performed on the cranial cavity.
                    </P>
                    <GPH SPAN="3" DEEP="82">
                        <GID>EP10MY21.007</GID>
                    </GPH>
                    <P>
                        We reviewed this request and similar to the discussion in the prior section for the separate but related request, we note that the “other” surgical category contains surgical procedures which, while infrequent, could still reasonably be expected to be performed for a patient in the particular MDC. We continue to believe that the 82 
                        <PRTPAGE P="25098"/>
                        procedure codes provided by the requestor are appropriately assigned to MS-DRGs 143, 144, and 145 in MDC 03. With regard to the requestor's assertion that cases reporting any one of the 82 procedure codes would more appropriately group to the MS-DRGs for Extensive O.R. procedures or Non-extensive O.R. procedures when reported in conjunction with a principal diagnosis from MDC 03, we note that, as shown in Table 6P.2b associated with the FY 2021 IPPS/LTCH PPS final rule, the procedure codes that were finalized for assignment to MS-DRGs 143, 144, and 145 were previously assigned to MS-DRGs 129 and 130, 131 and 132, or 133 and 134 in MDC 03. We also note that, as discussed in prior rulemaking, cases that contain O.R. procedures will map to MS-DRG 981, 982, or 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) or MS-DRG 987, 988, or 989 (Non-Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) when they do not contain a principal diagnosis that corresponds to one of the MDCs to which that procedure is assigned. For these reasons, we are proposing to maintain the current structure for MS-DRGs 143, 144, and 145 for FY 2022.
                    </P>
                    <P>With regard to the three procedure codes describing control of bleeding in the cranial cavity (0W310ZZ, 0W313ZZ, and 0W314ZZ), and the requestor's suggestion that the codes should group to MS-DRGs 25, 26, and 27 in MDC 01, we consulted with our clinical advisors who stated these procedures are consistent with the existing procedure codes included in the logic for case assignment to MS-DRGs 25, 26, and 27. We refer the reader to section II.D.10. of the preamble of this proposed rule for further discussion of this request, as well as our proposed assignment of these codes to MS-DRGs 23, 24, 25, 26, and 27 for FY 2022.</P>
                    <HD SOURCE="HD3">4. MDC 04 (Diseases and Disorders of the Respiratory System)</HD>
                    <HD SOURCE="HD3">a. Bronchiectasis</HD>
                    <P>We received a request to reassign cases reporting diagnosis codes describing bronchiectasis from MS-DRGs 190, 191, and 192 (Chronic Obstructive Pulmonary Disease with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 177, 178, and 179 (Respiratory Infections and Inflammation with MCC, with CC, and without CC/MCC, respectively). Bronchiectasis is described by the following diagnosis codes</P>
                    <GPH SPAN="3" DEEP="86">
                        <GID>EP10MY21.008</GID>
                    </GPH>
                    <P>According to the requestor, the underlying pathophysiology of bronchiectasis is more similar to cystic fibrosis than it is to chronic obstructive pulmonary disease (COPD). The requestor stated that in bronchiectasis, there is an inciting event that creates scarring in the lung which prevents the lung from clearing out mucous like it normally would. The accumulation of abnormal mucous results in an environment conducive to bacterial growth and commonly found bacteria in this setting is very similar to those of cystic fibrosis with staphylococcus aureus, pseudomonas aeruginosa, and non-tuberculous mycobacterium. The requestor reported that when patients develop an exacerbation of bronchiectasis, this is because of a buildup of mucous compounded by overwhelming growth of the previously mentioned bacteria. The requestor also stated that patients admitted to the hospital for bronchiectasis exacerbation are treated aggressively with intravenous (IV) antibiotics to suppress the bacterial infection in combination with airway clearance therapies. The requestor further stated that, unlike in an acute COPD exacerbation, these patients do not always require steroids as there is not necessarily airway reactivity.</P>
                    <P>The requestor maintained that the underlying reason for admission to the hospital for these patients is the bacterial infection component of the exacerbation, with the standard course of treatment for these pulmonary bacterial infections averaging a minimum of 10-14 days due to the slow growing nature of the bacteria commonly encountered in these patients.</P>
                    <P>We reviewed this request and believe that bronchiectasis is appropriately assigned to MS-DRGs 190, 191, and 192 (Chronic Obstructive Pulmonary Disease with MCC, with CC, and without CC/MCC, respectively) because bronchiectasis, like COPD, is a chronic condition. With respect to the requestor's comments, cystic fibrosis, a genetic disease that affects mucous producing cells resulting in recurring lung infections, can lead to bronchiectasis. However, our clinical advisors indicated that the cause of bronchiectasis can be multifactorial or even remain undefined. Regardless of the cause, when present, bronchiectasis is an irreversible chronic pulmonary condition due to abnormal change to or destruction of normal pulmonary anatomy (the major bronchi and bronchiole walls), resulting in impaired air movement in and out of the lungs. COPD, regardless of the cause (smoking, pollution, other exposures), is a chronic pulmonary condition due to change/destruction of normal pulmonary anatomy, resulting in impaired air movement in and out of the lungs. Both bronchiectasis and COPD patients have abnormal pulmonary function tests and abnormal anatomic findings on chest x-ray and/or chest CT. Therefore, for these reasons, we are proposing to maintain the structure of MS-DRGs 190, 191, and 192 for FY 2022.</P>
                    <HD SOURCE="HD3">b. Major Chest Procedures</HD>
                    <P>
                        In the FY 2020 IPPS/LTCH PPS proposed (84 FR 19234) and final rules (84 FR 42148), we stated that in review of the procedures that are currently assigned to MS-DRGs 163, 164, and 165 (Major Chest Procedures with MCC, with CC and without CC/MCC, respectively) and 166, 167, and 168 (Other Respiratory System O.R. Procedures with MCC, with CC, and without CC/MCC, respectively), that further refinement of these MS-DRGs may be warranted. In this section of this proposed rule, we discuss our review of the procedures and our proposal for 
                        <PRTPAGE P="25099"/>
                        restructuring these MS-DRGs for FY 2022.
                    </P>
                    <P>
                        We began our review of MS-DRGs 163, 164, 165, 166, 167, and 168 by first examining all the procedures currently assigned to these MS-DRGs. We refer the reader to the ICD-10 MS-DRG Definitions Manual Version 38.1, which is available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS</E>
                         for complete documentation of the GROUPER logic for MS-DRGs 163, 164, 165, 166, 167, and 168.
                    </P>
                    <P>In our review of the procedures currently assigned to MS-DRGs 163, 164, 165, 166, 167, and 168, we found 17 procedure codes in MS-DRGs 163, 164, and 165 describing laser interstitial thermal therapy (LITT) of body parts that do not describe areas within the respiratory system, which would not be clinically appropriate to maintain in the logic. These procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="272">
                        <GID>EP10MY21.009</GID>
                    </GPH>
                    <P>
                        During our review of these 17 procedure codes, we identified additional MDCs and MS-DRG assignments that are also not clinically appropriate to maintain in the logic because the body parts described by the codes are not consistent with the organ system, etiology or clinical specialty of the MDC to which the procedure code is currently assigned. For example, 16 of the 17 procedure codes (all except procedure code DVY0KZZ) are included in the logic for case assignment to MDC 12 (Diseases and Disorders of the Male Reproductive System) in MS-DRGs 715 and 716 (Other Male Reproductive System O.R. Procedures for Malignancy with and without CC/MCC, respectively) and MS-DRGs 717 and 718 (Other Male Reproductive System O.R. Procedures Except Malignancy with and without CC/MCC, respectively) which is not clinically appropriate. Therefore, we are proposing to reassign these 17 procedure codes from their current MS-DRG assignments in MDC 04, and from the additional MDCs and MS-DRGs identified during our review that were found to be clinically inappropriate, to their clinically appropriate MDC and MS-DRGs as shown in Table 6P.2b associated with this proposed rule (which is available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS</E>
                        ).
                    </P>
                    <P>During our review of the procedure codes describing LITT of various body parts we also confirmed that these procedures are currently designated as Extensive O.R. procedures. We do not believe the procedures described by these procedure codes necessarily utilize the resources or have the level of technical complexity as the other procedures on the Extensive O.R. procedures list. We believe that the procedure codes describing these procedures would be more appropriately designated as Non-extensive procedures and group to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) when any one of the procedure codes is reported on a claim and is unrelated to the MDC to which the case was assigned based on the principal diagnosis. We refer the reader to section II.D.10. of the preamble of this proposed rule for further discussion regarding our proposal to reassign these procedure codes from MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) for FY 2022.</P>
                    <P>
                        We also identified five procedure codes describing repair of the esophagus procedures currently assigned to MS-DRGs 163, 164, and 165 that would not be clinically appropriate to maintain in the logic. The procedure codes are 0DQ50ZZ (Repair esophagus, open approach), 0DQ53ZZ (Repair esophagus, percutaneous approach), 0DQ54ZZ (Repair esophagus, percutaneous 
                        <PRTPAGE P="25100"/>
                        endoscopic approach), 0DQ57ZZ (Repair esophagus, via natural or artificial opening), and 0DQ58ZZ (Repair esophagus, via natural or artificial opening endoscopic), and are currently assigned to the following MDCs and MS-DRGs.
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25101"/>
                        <GID>EP10MY21.010</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="275">
                        <PRTPAGE P="25102"/>
                        <GID>EP10MY21.011</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>The five procedure codes describing repair of esophagus procedures are not clinically coherent with the other procedures in MS-DRGs 163, 164, and 165 that describe procedures performed on major chest structures. Therefore, we are proposing to remove procedure codes 0DQ50ZZ, 0DQ53ZZ, 0DQ54ZZ, 0DQ57ZZ, and 0DQ58ZZ from the logic in MDC 04 for FY 2022.</P>
                    <P>During our review of procedure codes 0DQ50ZZ, 0DQ53ZZ, 0DQ54ZZ, 0DQ57ZZ, and 0DQ58ZZ (describing repair of esophagus procedures) we also confirmed that these procedures are currently designated as Extensive O.R. procedures. We do not believe the procedures described by procedure codes 0DQ53ZZ, 0DQ57ZZ, and 0DQ58ZZ necessarily utilize the resources or have the level of technical complexity as the other procedures on the Extensive O.R. procedures list. We believe that the procedure codes describing these procedures would be more appropriately designated as Non-extensive procedures and group to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) when any one of the three procedure codes is reported on a claim and is unrelated to the MDC to which the case was assigned based on the principal diagnosis. We refer the reader to section II.D.10. of the preamble of this proposed rule for further discussion regarding our proposal to reassign these procedure codes from MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) for FY 2022.</P>
                    <P>Next, we examined claims data from the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file for all cases in MS-DRGs 163, 164, 165, 166, 167, and 168. Our findings are shown in the following tables.</P>
                    <GPH SPAN="3" DEEP="129">
                        <GID>EP10MY21.012</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="129">
                        <PRTPAGE P="25103"/>
                        <GID>EP10MY21.013</GID>
                    </GPH>
                    <P>As shown in the tables, there were a higher number of cases reported in MS-DRGs 163, 164, 165, 166, 167, and 168 from the March 2020 update of the FY 2019 MedPAR file in comparison to the September 2020 update of the FY 2020 MedPAR file and overall, the cases reported have comparable average lengths of stay and comparable average costs for both fiscal years.</P>
                    <P>
                        We then examined claims data from both the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file for MS-DRGs 163, 164, 165, 166, 167, and 168 to compare costs, complexity of service and clinical coherence for each procedure code currently assigned to these MS-DRGs to assess any potential reassignment of the procedures. We refer the reader to Table 6P.1e and Table 6P.1f associated with this proposed rule (which is available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS</E>
                        ) for the detailed claims data analysis. Table 6P.1e contains the data analysis findings of procedure codes currently assigned to MS-DRGs 163, 164, 165, 166, 167, and 168 from the March 2020 update of the FY 2019 MedPAR file and Table 6P.1f contains the data analysis findings of procedure codes currently assigned to MS-DRGs 163, 164, 165, 166, 167, and 168 from the September 2020 update of the FY 2020 MedPAR file. We note that if a procedure code that is currently assigned to MS-DRGs 163, 164, 165, 166, 167, or 168 is not displayed, it is because there were no cases found reporting that code in the assigned MS-DRG.
                    </P>
                    <P>As shown in Table 6P.1e and Table 6P.1f associated with this proposed rule, in our examination of the claims data from both the March 2020 update of the FY 2019 MedPAR file and September 2020 update of the FY 2020 MedPAR file, we found there is wide variation in the volume, length of stay, and average costs for the procedures currently assigned to MS-DRGs 163, 164, 165, 166, 167, and 168. There were several instances in which only one occurrence of a procedure was reported with a procedure code from MS-DRGs 163, 164, 165, 166, 167, or 168, and the average length of stay for these specific cases ranged from 1 day to 97 days. For example, in the analysis of claims data from the March 2020 update of the FY 2019 MedPAR file, during our review of MS-DRG 163, we found 153 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 2 days to 65 days and the average costs ranging from $3,760 to $195,447 for these cases. For MS-DRG 164, we found 145 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 1 day to 28 days and the average costs ranging from $1,886 to $137,810 for these cases. For MS-DRG 165, we found 111 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 1 day to 23 days and the average costs ranging from $2,656 to $73,092 for these cases. For MS-DRG 166, we found 150 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 1 day to 61 days and the average costs ranging from $3,230 to $246,679 for these cases. For MS-DRG 167, we found 110 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 1 day to 23 days and the average costs ranging from $2,058 to $149,220 for these cases. For MS-DRG 168, we found 68 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 1 day to 18 days and the average costs ranging from $2,033 to $35,576 for these cases.</P>
                    <P>Our analysis of the claims data from the September 2020 update of the FY 2020 MedPAR file resulted in similar findings to those from the March 2020 update of the FY 2019 MedPAR file; there were several instances in which only one occurrence of a procedure was reported with a procedure code from MS-DRGs 163, 164, 165, 166, 167, or 168. During our review of MS-DRG 163, we found 139 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 2 days to 97 days and the average costs ranging from $5,697 to $205,696 for these cases. For MS-DRG 164, we found 122 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 1 day to 35 days and the average costs ranging from $3,204 to $120,128 for these cases. For MS-DRG 165, we found 92 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 1 day to 16 days and the average costs ranging from $2,682 to $164,014 for these cases. For MS-DRG 166, we found 141 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 1 day to 45 days and the average costs ranging from $3,230 to $246,679 for these cases. For MS-DRG 167, we found 105 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 1 day to 22 days and the average costs ranging from $2,150 to $112,465 for these cases. For MS-DRG 168, we found 72 procedures for which only one occurrence of the procedure was reported with the average length of stay ranging from 1 day to 9 days and the average costs ranging from $1,563 to $76,061 for these cases.</P>
                    <P>
                        Our clinical advisors reviewed the procedures currently assigned to MS-DRGs 163, 164, 165, 166, 167, and 168 to identify the patient attributes that currently define each of these procedures and to group them with respect to complexity of service and resource intensity. This process included separating the procedures according to the surgical approach (open, percutaneous, percutaneous endoscopic, via natural or artificial opening, via natural or artificial opening endoscopic, and external).
                        <PRTPAGE P="25104"/>
                    </P>
                    <P>We also considered the claims data from the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file for MS-DRGs 163, 164, 165, 166, 167, and 168 to further analyze the average length of stay and average costs for the cases reporting procedures assigned to any one of these MS-DRGs as well as clinical coherence for these cases. For example, procedures that we believe represent greater treatment difficulty and reflect a class of patients who are similar clinically with regard to consumption of hospital resources were grouped separately from procedures that we believe to be less complex but still reflect patients who are similar clinically with regard to consumption of hospital resources. This approach differentiated the more complex procedures, such as procedures performed on the sternum and ribs (for example, major chest) from the less complex procedures such as bypass procedures performed on peripheral vessels or diagnostic biopsies.</P>
                    <P>As an initial step in our proposed restructuring of these MS-DRGs, we identified the following 26 procedure codes that are currently assigned to MS-DRGs 166, 167, and 168 that we believe represent procedures performed on structures that align more appropriately with the procedures assigned to MS-DRGs 163, 164, and 165 that describe major chest procedures.</P>
                    <GPH SPAN="3" DEEP="458">
                        <GID>EP10MY21.014</GID>
                    </GPH>
                    <P>We analyzed claims data from the March 2020 update of the FY 2019 MedPAR file for the listed procedure codes in MS-DRGs 166, 167, and 168. We note that if a listed procedure code is not displayed, it is because there were no cases found reporting that code among MS-DRGs 166, 167, and 168. Our findings are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="312">
                        <PRTPAGE P="25105"/>
                        <GID>EP10MY21.015</GID>
                    </GPH>
                    <P>We then analyzed claims data from the September 2020 update of the FY 2020 MedPAR file for the listed procedure codes in MS-DRGs 166, 167, and 168. We note that if a listed procedure code is not displayed, it is because there were no cases found reporting that code among MS-DRGs 166, 167, and 168. Our findings are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="239">
                        <GID>EP10MY21.016</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="258">
                        <PRTPAGE P="25106"/>
                        <GID>EP10MY21.017</GID>
                    </GPH>
                    <P>We refer the reader to Tables 6P.1e and 6P.1f for detailed claims data for the previously listed procedures in MS-DRGs 163, 164, 165, 166, 167, and 168 from the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file, respectively, and note that while some of the 26 listed procedure codes identified in MS-DRGs 166, 167, and 168 may not have been reported in either year's MedPAR claims data or only had one occurrence in which the procedure was reported, we believe these procedures described by the listed 26 procedure codes are clinically coherent with the other procedures that are currently assigned to MS-DRGs 163, 164, and 165. For example, in our analysis of the March 2020 update of the FY 2019 MedPAR file, as shown in the table, we found procedure code 02QW0ZZ reported with one occurrence with an average length of stay of 15 days and average costs of $46,829. Despite finding only one case, we believe procedures described by this procedure code, as well as related procedure codes describing procedures performed on the great vessels, are more clinically coherent with the procedures assigned to MS-DRGs 163, 164, and 165 and align more appropriately with the average length of stay and average costs of those MS-DRGs. Similarly, in our analysis of the September 2020 update of the FY 2020 MedPAR file, as shown in the table, we found procedure code 0PS204Z reported with 344 occurrences with an average length of stay of 9.6 days and average costs of $48,340. We believe procedures described by this procedure code, as well as related procedure codes describing procedures performed to repair or resect the ribs, are more clinically coherent with the procedures assigned to MS-DRGs 163, 164, and 165 and also align more appropriately with the average length of stay and average costs of those MS-DRGs.</P>
                    <P>As a result of our preliminary review of MS-DRGs 163, 164, 165, 166, 167, and 168, for FY 2022 we are proposing the reassignment of the listed 26 procedure codes (9 procedure codes describing repair of pulmonary or thoracic structures, and 17 procedure codes describing procedures performed on the sternum or ribs) from MS-DRGs 166, 167, and 168 to MS-DRGs 163, 164, and 165 in MDC 04. Our data analysis shows that for the cases reporting any one of the 26 procedure codes, generally, they have an average length of stay and average costs that appear more consistent with the average length of stay and average costs of cases in MS-DRGs 163, 164, and 165. Our clinical advisors also agree that these procedures clinically align with the other procedures that are currently assigned to MS-DRGs 163, 164, and 165. We refer the reader to Table 6P.2c associated with this proposed rule for the list of procedure codes we are proposing for reassignment from MS-DRGs 166, 167, and 168 to MS-DRGs 163, 164, and 165 in MDC 04.</P>
                    <P>After this initial review of all the procedures currently assigned to MS-DRGs 163, 164, 165, 166, 167, and 168, in combination with the results of the data analysis as reflected in Tables 6P.1e and 6P.1f, our clinical advisors support a phased restructuring of these MS-DRGs. We believe further analysis of the procedures assigned to these MS-DRGs is warranted based on the creation of new procedure codes that have been assigned to these MS-DRGs in recent years for which claims data are not yet available and the need for additional time to examine the procedures currently assigned to those MS-DRGs by clinical intensity, complexity of service and resource utilization. We will continue to evaluate the procedures assigned to these MS-DRGs as additional claims data become available.</P>
                    <HD SOURCE="HD3">5. MDC 05 (Diseases and Disorders of the Circulatory System)</HD>
                    <HD SOURCE="HD3">a. Short-Term External Heart Assist Device</HD>
                    <P>
                        Impella® Ventricular Support Systems are temporary heart assist devices intended to support blood pressure and provide increased blood flow to critical organs in patients with cardiogenic shock, by drawing blood out of the heart and pumping it into the aorta, partially or fully bypassing the left ventricle to provide adequate circulation of blood (replace or supplement left ventricle pumping) while also allowing damaged heart muscle the opportunity to rest and recover in patients who need short-term support for up to 6 days. The ICD-10-PCS codes that describe the insertion of Impella® heart assist devices are 
                        <PRTPAGE P="25107"/>
                        currently assigned to MS-DRG 215 (Other Heart Assist System Implant). We refer the reader to the ICD-10 MS-DRG Definitions Manual Version 38.1, which is available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software</E>
                         for complete documentation of the GROUPER logic for MS-DRG 215.
                    </P>
                    <P>In the FY 2019 IPPS/LTCH PPS final rule (83 FR 41159 through 41170), we discussed public comments that recommended that CMS continue to monitor the data in MS-DRG 215 for future consideration of distinctions (for example, different approaches and evolving technologies) that may impact the clinical and resource use of procedures utilizing heart assist devices. Our data analysis showed a wide range in the average length of stay and the average costs for cases reporting procedures that involve a biventricular short-term external heart assist system versus a short-term external heart assist system. We noted we were aware that the AHA published Coding Clinic advice that clarified coding and reporting for certain external heart assist devices due to the technology being approved for new indications but the claims data current at that time did not yet reflect that updated guidance. We also noted that there had been recent updates to the descriptions of the codes for heart assist devices. The qualifier “intraoperative” was added effective October 1, 2017 (FY 2018) to the procedure codes describing the insertion of short-term external heart assist system procedures to distinguish between procedures where the device was only used intraoperatively and was removed at the conclusion of the procedure versus procedures where the device was not removed at the conclusion of the procedure and for which that qualifier would not be reported. We agreed with the commenters that continued monitoring of the data and further analysis was necessary prior to proposing any modifications to MS-DRG 215 and finalized our proposal to maintain the current structure of MS-DRG 215 for FY 2019.</P>
                    <P>In the FY 2020 IPPS/LTCH PPS final rule (84 FR 42167) we discussed public comments on our proposals related to recalibration of the FY 2020 relative weights and the changes in relative weights from FY 2019. Several commenters expressed concern about significant reductions to the relative weight for MS-DRG 215. Commenters stated that the reduction in the proposed relative weight was 29 percent, the largest decrease of any MS-DRG; commenters also noted that the cumulative decrease to the relative weight for MS-DRG 215 would be 43 percent since FY 2017. Commenters stated that the proposed relative weights would result in significant underpayments to facilities, which would in turn limit access to heart assist devices. After reviewing the comments received and the data used in our ratesetting calculations, we acknowledged an outlier circumstance where the weight for a MS-DRG was seeing a significant reduction for each of the 3 years since CMS began using the ICD-10 data in calculating the relative weights. Therefore, for the reasons discussed in the FY 2020 final rule, we adopted a temporary one-time measure for FY 2020 where the FY 2020 relative weight was set equal to the FY 2019 relative weight, which in turn had been set equal to the FY 2018 relative weight.</P>
                    <P>In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58598) we again acknowledged an outlier circumstance where the weight for MS-DRG 215 was seeing a significant reduction for each of the 4 years since CMS began using the ICD-10 data in calculating the relative weights. We stated while we would ordinarily consider this weight change to be appropriately driven by the underlying data, given the comments received, and in an abundance of caution because this may be the MS-DRG assigned when a hospital provides temporary right ventricular support for up to 14 days in critical care patients for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including pulmonary embolism, we adopted a temporary one-time measure for FY 2021 for MS-DRG 215. Specifically, we set the 2021 relative weight for MS-DRG 215 equal to the average of the FY 2020 relative weight and the otherwise applicable FY 2021 weight.</P>
                    <P>For this FY 2022 IPPS/LTCH PPS proposed rule, we received a request to reassign certain cases reporting procedure codes describing the insertion of a percutaneous short-term external heart assist device from MS-DRG 215 to MS-DRGs 216, 217, and 218 (Cardiac Valve and Other Major Cardiothoracic Procedures with Cardiac Catheterization with MCC, with CC, and without CC/MCC, respectively). According to the requestor, there are two distinct clinical populations within MS-DRG 215: High-risk Percutaneous Coronary Intervention (PCI) patients receiving short term “intraoperative” external heart assist systems where the device is only used intraoperatively and is removed at the conclusion of the procedure, and those patients in or at risk of cardiogenic shock requiring longer heart pump support and ICU stays. The requestor stated that cases in which short-term external heart assist systems are placed intraoperatively require fewer resources. The requestor suggested that moving the less resource intensive cases that report a procedure code that describes the intraoperative insertion of short-term external heart assist systems from MS-DRG 215 into MS-DRG 216, 217, and 218, will clinically align the two distinctly different patient populations, and consequently will address the potential decrease in the relative weight of MS-DRG 215.</P>
                    <P>The requestor stated it performed its own analysis of claims in MS-DRG 215 that involve the intraoperative insertion of a short-term external heart assist device (as identified by the presence of ICD-10-PCS codes 02HA3RJ (Insertion of short-term external heart assist system into heart, intraoperative, percutaneous approach) and 5A0221D (Assistance with cardiac output using impeller pump, continuous). The requestor stated that its analysis found that if procedures involving intraoperative placement of a short-term external heart assist device were moved into MS-DRGs 216, 217 and 218, it would result in an increase in the average costs and average lengths of stay for the cases that would remain to be assigned to MS-DRG 215.</P>
                    <P>
                        During our review of this issue, we noted that when a patient is admitted and has an Impella® external heart assist device inserted two ICD-10-PCS codes are assigned: A code that describes the insertion of the device and code 5A0221D that describes assistance with an impeller pump. Therefore, our analysis included procedure code 02HA3RJ as identified by the requestor as well as similar procedure codes 02HA0RJ (Insertion of short-term external heart assist system into heart, intraoperative, open approach) and 02HA4RJ (Insertion of short-term external heart assist system into heart, intraoperative, percutaneous endoscopic approach) that also describe the intraoperative insertion of a short-term heart assist device, differing only in approach. Because the assistance with an Impella® is coded with ICD-10-PCS code 5A0221D whether the device is used only intraoperatively or in instances where the device is left in place at the conclusion of the procedure, we did not include this code in our analysis. We also note that the requestor suggested that the cases reporting a procedure code describing 
                        <PRTPAGE P="25108"/>
                        the intraoperative insertion of a short-term external heart assist device be moved to MS-DRGs 216, 217 and 218 but these MS-DRGs are defined by the performance of cardiac catheterization. Therefore, we expanded our analysis to also include MS-DRGs 219, 220 and 221 (Cardiac Valve and Other Major Cardiothoracic Procedures without Cardiac Catheterization with MCC, with CC, and without CC/MCC, respectively).
                    </P>
                    <P>First, we examined claims data from the March 2020 update of the FY 2019 MedPAR file for MS-DRG 215 to identify cases reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ and a procedure code describing the performance of a cardiac catheterization. Our findings are shown in the following table:</P>
                    <GPH SPAN="3" DEEP="187">
                        <GID>EP10MY21.018</GID>
                    </GPH>
                    <P>As shown in the table, we identified a total of 7,741 cases within MS-DRG 215 with an average length of stay of 7.8 days and average costs of $68,234. Of these 7,741 cases, there are 2,943 cases that include both a procedure code describing the intraoperative insertion of a short-term external heart assist device and a procedure code describing the performance of a cardiac catheterization with an average length of stay of 7.1 days and average costs of $60,449. Of these 2,943 cases, there are 23 cases reporting a procedure code describing the open intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization with an average length of stay of 8.9 days and average costs of $85,806. There are 2,904 cases reporting a procedure code describing a percutaneous intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization with an average length of stay of 7.1 days and average costs of $60,227. There are 16 cases reporting a procedure code describing a percutaneous endoscopic intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization approach with an average length of stay of 6.4 days and average costs of $64,217. The data analysis shows that for the cases in MS-DRG 215 reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ with a procedure code describing the performance of a cardiac catheterization, generally, the average length of stay is shorter and the average costs are lower than the average length of stay and average costs (with the exception of the average costs and length of stay for the 23 cases reporting a procedure code describing the open intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization which are higher) compared to all cases in that MS-DRG.</P>
                    <P>We also examined claims data from the March 2020 update of the FY 2019 MedPAR file for MS-DRGs 216, 217 and 218. Our findings are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="085">
                        <GID>EP10MY21.019</GID>
                    </GPH>
                    <P>Because MS-DRG 215 is a base DRG and there is a three-way split within MS-DRGs 216, 217, and 218, we also analyzed the cases reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization for the presence or absence of a secondary diagnosis designated as a complication or comorbidity (CC) or a major complication or comorbidity (MCC).</P>
                    <GPH SPAN="3" DEEP="171">
                        <PRTPAGE P="25109"/>
                        <GID>EP10MY21.020</GID>
                    </GPH>
                    <P>This data analysis shows the cases in MS-DRG 215 reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ with a procedure code describing the performance of a cardiac catheterization when distributed based on the presence or absence of a secondary diagnosis designated as a complication or comorbidity (CC) or a major complication or comorbidity (MCC) have average costs generally more similar to the average costs in the FY 2019 MedPAR file for MS-DRGs 216, 217 and 218 respectively, while the average lengths of stay are shorter. While the cases from MS-DRG 215 reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization “with CC” and “without CC/MCC” have higher average costs than the average costs of MS-DRGs 217 and 218, these costs are closer to the average costs of those MS-DRGs than they are to the average costs of MS-DRG 215. The average costs of the cases from MS-DRG 215 reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization “with MCC” are lower than the average costs of both MS-DRGs 215 and 216.</P>
                    <P>Next, we examined claims data from the March 2020 update of the FY 2019 MedPAR file for MS-DRG 215 to identify cases reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ without a procedure code describing the performance of a cardiac catheterization. Our findings are shown in the following table:</P>
                    <GPH SPAN="3" DEEP="187">
                        <GID>EP10MY21.021</GID>
                    </GPH>
                    <P>
                        As shown in the table, of the 7,741 cases within MS-DRG 215, there are 432 cases that include a procedure code describing the intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization with an average length of stay of 4.8 days and average costs of $53,607. Of these 432 cases, there are eight cases reporting a procedure code describing the open intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization with an average length of stay of 8.8 days and average costs of $141,242. There are 423 cases reporting a procedure code describing a percutaneous intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization with an average length of stay of 4.7 days and average costs of $51,964. There is one case reporting a procedure code describing a percutaneous endoscopic intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization approach with a length of stay of 2 days and costs of $47,289. The data analysis shows that for the cases in MS-DRG 215 reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ without a 
                        <PRTPAGE P="25110"/>
                        procedure code describing the performance of a cardiac catheterization, generally, the average length of stay is shorter and the average costs are lower than the average length of stay and average costs (with the exception of the average costs and length of stay for the eight cases describing the open intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization which are higher) compared to all cases in that MS-DRG.
                    </P>
                    <P>We also examined claims data from the March 2020 update of the FY 2019 MedPAR file for MS-DRGs 219, 220 and 221. Our findings are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="085">
                        <GID>EP10MY21.022</GID>
                    </GPH>
                    <P>Similarly, because MS-DRG 215 is a base DRG and there is a three-way split within MS-DRGs 219, 220 and 221, we also analyzed the cases reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization for the presence or absence of a secondary diagnosis designated as a complication or comorbidity (CC) or a major complication or comorbidity (MCC).</P>
                    <GPH SPAN="3" DEEP="171">
                        <GID>EP10MY21.023</GID>
                    </GPH>
                    <P>This data analysis shows the cases in MS-DRG 215 reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ without a procedure code describing the performance of a cardiac catheterization when distributed based on the presence or absence of a secondary diagnosis designated as a complication or comorbidity (CC) or a major complication or comorbidity (MCC) have average costs generally more similar to the average costs in the FY 2019 MedPAR file for MS-DRGs 219, 220 and 221 respectively, while the average lengths of stay are shorter. While the cases from MS-DRG 215 reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device, without a procedure code describing the performance of a cardiac catheterization “with MCC”, “with CC” and “without CC/MCC” have higher average costs than the average costs MS-DRGs 219, 220 and 221, respectively, these costs are closer to the average costs of those MS-DRGs than they are to the average costs of MS-DRG 215.</P>
                    <P>We also examined claims data from the September 2020 update of the FY 2020 MedPAR file for MS-DRG 215 to identify cases reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ with a procedure code describing the performance of a cardiac catheterization. Our findings are shown in the following table:</P>
                    <GPH SPAN="3" DEEP="187">
                        <PRTPAGE P="25111"/>
                        <GID>EP10MY21.024</GID>
                    </GPH>
                    <P>As shown in the table, we identified a total of 6,275 cases within MS-DRG 215 with an average length of stay of 7.9 days and average costs of $72,144. Of these 6,275 cases, there are 2,395 cases that include both a procedure code describing the intraoperative insertion of a short-term external heart assist device and a procedure code describing the performance of a cardiac catheterization with an average length of stay of 6.8 days and average costs of $62,260. Of these 2,395 cases, there were 25 cases reporting a procedure code describing the open intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization with an average length of stay of 8.2 days and average costs of $85,954. There are 2,360 cases reporting a procedure code describing a percutaneous intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization with an average length of stay of 6.8 days and average costs of $61,965. There are 10 cases reporting a procedure code describing a percutaneous endoscopic intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization approach with an average length of stay of 6.9 days and average costs of $72,564. The data analysis shows that for the cases in MS-DRG 215 reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ with a procedure code describing the performance of a cardiac catheterization, when examined collectively, the average length of stay is shorter (6.8 days versus 7.9 days) and the average costs are lower ($62,260 versus $72,144) than the average length of stay and average costs (of all cases in that MS-DRG). There were some differences noted in cases reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization when examined by operative approach. For the 25 cases reporting a procedure code describing the open intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization, the average costs were higher ($85,954 versus $72,144) and average length of stay was slightly longer (8.2 days versus 7.9 days) when compared to all cases in that MS-DRG. For the 10 cases reporting a procedure code describing the percutaneous endoscopic intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization, the average costs were nearly equal ($72,564 versus $72,144) and average length of stay was shorter (6.9 days versus 7.9 days) when compared to all cases in that MS-DRG.</P>
                    <P>We also examined claims data from the September 2020 update of the FY 2020 MedPAR file for MS-DRGs 216, 217 and 218. Our findings are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="085">
                        <GID>EP10MY21.025</GID>
                    </GPH>
                    <P>Because MS-DRG 215 is a base DRG and there is a three-way split within MS-DRGs 216, 217, and 218, we also analyzed the cases reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization for the presence or absence of a secondary diagnosis designated as a complication or comorbidity (CC) or a major complication or comorbidity (MCC).</P>
                    <GPH SPAN="3" DEEP="171">
                        <PRTPAGE P="25112"/>
                        <GID>EP10MY21.026</GID>
                    </GPH>
                    <P>This data analysis shows the cases in MS-DRG 215 reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ with a procedure code describing the performance of a cardiac catheterization when distributed based on the presence or absence of a secondary diagnosis designated as a complication or comorbidity (CC) or a major complication or comorbidity (MCC) have average costs generally more similar to the average costs in the FY 2020 MedPAR file for MS-DRGs 216, 217 and 218 respectively, while the average lengths of stay are shorter. While the cases from MS-DRG 215 reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization “with CC” and “without CC/MCC” have higher average costs than the average costs of MS-DRGs 217 and 218, these costs are closer to the average costs of those MS-DRGs than they are to the average costs of MS-DRG 215. The average costs of the cases from MS-DRG 215 reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device with a procedure code describing the performance of a cardiac catheterization “with MCC” are lower than the average costs of both MS-DRGs 215 and 216.</P>
                    <P>Next, we examined claims data from the September 2020 update of the FY 2020 MedPAR file for MS-DRG 215 to identify cases reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ without a procedure code describing the performance of a cardiac catheterization. Our findings are shown in the following table:</P>
                    <GPH SPAN="3" DEEP="187">
                        <GID>EP10MY21.027</GID>
                    </GPH>
                    <P>
                        As shown in the table, of the 6,275 cases within MS-DRG 215, there are 331 cases that include a procedure code describing the intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization with an average length of stay of 4.5 days and average costs of $52,181. Of these 331 cases, there are eight cases reporting a procedure code describing the open intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization with an average length of stay of 8.9 days and average costs of $80,314. There are 332 cases reporting a procedure code describing a percutaneous intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization with an average length of stay of 4.4 days and average costs of $51,569. There is one case reporting a procedure code describing a percutaneous endoscopic intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization approach with a length of stay of 2 days and costs of $24,379. The data analysis shows that for the cases in MS-DRG 215 reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ without a 
                        <PRTPAGE P="25113"/>
                        procedure code describing the performance of a cardiac catheterization, generally, the average length of stay is shorter and the average costs are lower than the average length of stay and average costs (with the exception of the average costs and length of stay for the eight cases reporting a procedure code describing the open intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization which are higher) compared to all cases in that MS-DRG.
                    </P>
                    <P>We also examined claims data from the September 2020 update of the FY 2020 MedPAR file for MS-DRGs 219, 220 and 221. Our findings are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="084">
                        <GID>EP10MY21.028</GID>
                    </GPH>
                    <P>Similarly, because MS-DRG 215 is a base DRG and there is a three-way split within MS-DRGs 219, 220 and 221, we also analyzed the 331 cases reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization for the presence or absence of a secondary diagnosis designated as a complication or comorbidity (CC) or a major complication or comorbidity (MCC).</P>
                    <GPH SPAN="3" DEEP="171">
                        <GID>EP10MY21.029</GID>
                    </GPH>
                    <P>This data analysis shows the cases in MS-DRG 215 reporting ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ without a procedure code describing the performance of a cardiac catheterization when distributed based on the presence or absence of a secondary diagnosis designated as a complication or comorbidity (CC) or a major complication or comorbidity (MCC) have average costs generally more similar to the average costs in the FY 2020 MedPAR file for MS-DRGs 219, 220 and 221 respectively, while the average lengths of stay are shorter. While the cases from MS-DRG 215 reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization “with CC” and “without CC/MCC” have higher average costs than the average costs of MS-DRGs 220 and 221, these costs are closer to the average costs of those MS-DRGs than they are to the average costs of MS-DRG 215. The average costs of the cases from MS-DRG 215 reporting a procedure code describing the intraoperative insertion of a short-term external heart assist device without a procedure code describing the performance of a cardiac catheterization “with MCC” are lower than the average costs of both MS-DRGs 215 and 219.</P>
                    <P>
                        Our clinical advisors reviewed the clinical issues and the claims data and agreed that cases reporting a procedure code that describes the intraoperative insertion of a short-term external heart assist device are generally less resource intensive and are clinically distinct from other cases reporting procedure codes describing the insertion of other types of heart assist devices currently assigned to MS-DRG 215. Our clinical advisors state that critically ill patients who are experiencing or at risk for cardiogenic shock from an emergent event such as heart attack or virus that impacts the functioning of the heart and requires longer heart pump support are different from those patients who require intraoperative support only. Patients receiving a short-term external heart assist device intraoperatively during coronary interventions often have an underlying disease pathology such as heart failure related to occluded coronary vessels that is broadly similar in kind to other patients also receiving these interventions without the need for an insertion of a short-term external heart assist device. In the post-operative period, these patients can recover and can be sufficiently rehabilitated prior to discharge. For these reasons, our clinical advisors support reassigning 
                        <PRTPAGE P="25114"/>
                        ICD-10-PCS codes 02HA0RJ, 02HA3RJ, and 02HA4RJ that describe the intraoperative insertion of a short-term external heart assist device to MS-DRGs 216, 217, 218, 219, 220 and 221 in MDC 05. They stated this reassignment would improve clinical coherence in these MS-DRGs.
                    </P>
                    <P>To compare and analyze the impact of our suggested modifications, we ran a simulation using the Version 38.1 ICD-10 MS-DRG GROUPER and the claims data from the March 2020 update of the FY 2019 MedPAR file. The following table reflects our simulation for ICD-10-PCS procedure codes 02HA0RJ, 02HA3RJ or 02HA4RJ that describe the intraoperative insertion of a short-term external heart assist device if they were moved to MS-DRGS 216, 217, 218, 219, 220 and 221.</P>
                    <GPH SPAN="3" DEEP="268">
                        <GID>EP10MY21.030</GID>
                    </GPH>
                    <P>We believe the resulting proposed MS-DRG assignments would be more clinically homogeneous, coherent and better reflect hospital resource use while at the same time addressing concerns related to the relative weight of MS-DRG 215. A review of this simulation shows that this distribution of ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ that describe the intraoperative insertion of a short-term external heart assist device if moved to MS-DRGs 216, 217, 218, 219, 220 and 221, increases the average costs of the cases remaining in MS-DRG 215 by over $4,500, while generally having a more limited effect on the average costs of MS-DRGs 216, 217, 218, 219, 220 and 221.</P>
                    <P>We also ran a simulation using the Version 38.1 ICD-10 MS-DRG GROUPER and the claims data from the September 2020 update of the FY 2020 MedPAR file. The following table reflects our simulation for ICD-10-PCS procedure codes 02HA0RJ, 02HA3RJ or 02HA4RJ that describe the intraoperative insertion of a short-term external heart assist device if they were moved to MS-DRGS 216, 217, 218, 219, 220 and 221.</P>
                    <GPH SPAN="3" DEEP="268">
                        <PRTPAGE P="25115"/>
                        <GID>EP10MY21.031</GID>
                    </GPH>
                    <P>As with our simulation based on the March 2020 update of the FY 2019 MedPAR file, we believe that this simulation supports that the resulting proposed MS-DRG assignments would be more clinically homogeneous, coherent and better reflect hospital resource use while at the same time addressing concerns related to the relative weight of MS-DRG 215. A review of this simulation shows that this distribution of ICD-10-PCS codes 02HA0RJ, 02HA3RJ or 02HA4RJ that describe the intraoperative insertion of a short-term external heart assist device if moved to MS-DRGs 216, 217, 218, 219, 220 and 221, increases the average costs of the cases remaining in MS-DRG 215 by over $6,000, while generally having a more limited effect on the average costs of MS-DRGS 216, 217, 218, 219, 220 and 221.</P>
                    <P>Therefore, for FY 2022, we are proposing to reassign ICD-10-PCS codes 02HA0RJ, 02HA3RJ, and 02HA4RJ from MDC 05 in MS-DRG 215 to MS-DRGs 216, 217, 218, 219, 220 and 221 in MDC 05.</P>
                    <HD SOURCE="HD3">b. Type II Myocardial Infarction</HD>
                    <P>We received a request to review the MS-DRG assignment of ICD-10-CM diagnosis code I21.A1 (Myocardial infarction type 2). The requestor stated that when a type 2 myocardial infarction is documented, per coding guidelines, it is to be coded as a secondary diagnosis since it is due to an underlying cause. This requestor also noted that when a type 2 myocardial infarction is coded with a principal diagnosis in MDC 05 (Diseases and Disorders of the Circulatory System), the GROUPER logic assigns MS-DRGs 280 through 282 (Acute Myocardial Infarction, Discharged Alive with MCC, with CC, and without CC/MCC, respectively). The requestor questioned if this GROUPER logic was correct or if the logic should be changed so that a type 2 myocardial infarction, coded as a secondary diagnosis, does not result in the assignment of a MS-DRG that describes an acute myocardial infarction.</P>
                    <P>To begin our analysis, we reviewed the GROUPER logic. The requestor is correct that when diagnosis code I21.A1 is reported as a secondary diagnosis in combination with a principal diagnosis in MDC 05, the case currently groups to medical MS-DRGs 280 through 282 in the absence of a surgical procedure, when the patient is discharged alive. We note that if the patient expires, GROUPER logic instead will assign MS-DRGs 283 through 285 (Acute Myocardial Infarction, Expired with MCC, with CC, and without CC/MCC, respectively) when diagnosis code I21.A1 is reported as a secondary diagnosis in combination with a principal diagnosis in MDC 05.</P>
                    <P>According to the Universal Definition of Myocardial Infarction (MI), developed by a global task force that included the European Society of Cardiology, the American College of Cardiology, the American Heart Association and the World Heart Federation (WHF), the diagnosis of MI requires the rise and/or fall of cardiac biomarkers with clinical evidence of ischemia in which there is evidence of myocardial injury or necrosis, defined by symptoms, electrocardiographic (ECG) changes, or new regional wall motion abnormalities. Since 2007, this definition further classifies myocardial infarctions into five distinct subtypes. While a type 1 MI is defined as a MI due to an acute coronary syndrome, type 2 MI is defined as a mismatch in myocardial oxygen supply and demand due to other causes such as coronary dissection, vasospasm, emboli, or hypotension that is not attributed to unstable coronary artery disease (CAD).</P>
                    <P>
                        Our clinical advisors reviewed this issue and do not recommend changing the current MS-DRG assignment of ICD-10-CM diagnosis code I21.A1. As noted by the requestor, the ICD-10-CM Official Guidelines for Coding and Reporting state “Type 2 myocardial infarction, (myocardial infarction due to demand ischemia or secondary to ischemic imbalance) is assigned to code I21.A1, Myocardial infarction type 2 with a code for the underlying cause coded first.” Our clinical advisors believe that cases reporting diagnosis code I21.A1 as a secondary diagnosis are associated with a severity of illness on par with cases reporting a principal diagnosis of another type myocardial infarction. They state the diagnosis of myocardial infarction describes myocardial cell death due to inadequate 
                        <PRTPAGE P="25116"/>
                        oxygen supply to the myocardium for a prolonged period, regardless of the subtype. Our clinical advisors state, for clinical consistency, it is more appropriate to maintain the current assignment of ICD-10-CM diagnosis code I21.A1 with the other codes that describe myocardial infarction. Therefore, we are not proposing to reassign diagnosis code I21.A1 from MS-DRGs 280 through 285.
                    </P>
                    <P>
                        During our review of this issue we noted that code I21.A1 (Myocardial infarction type 2) is currently one of the listed principal diagnoses in the GROUPER logic for MS-DRGs 222 and 223 (Cardiac Defibrillator Implant with Cardiac Catheterization with AMI, HF or Shock with and without MCC, respectively). However, code I21.A1 is not currently recognized in these same MS-DRGs when coded as a secondary diagnosis. As a result, when coded as a secondary diagnosis in combination with a principal diagnosis in MDC 05, MS-DRGs 224 and 225 (Cardiac Defibrillator Implant with Cardiac Catheterization without AMI, HF, or Shock with and without MCC, respectively) are instead assigned when reported with a listed procedure code. We refer the reader to the ICD-10 MS-DRG Definitions Manual Version 38.1, which is available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software</E>
                         for complete documentation of the GROUPER logic for MS-DRGs 222, 223, 224, and 225.
                    </P>
                    <P>Acknowledging that coding guidelines instruct to code I21.A1 after the diagnosis code that describes the underlying cause, our clinical advisors recommend adding special logic in MS-DRGs 222 and 223 to have code I21.A1 also qualify when coded as a secondary diagnosis in combination with a principal diagnosis in MDC 05 since these diagnosis code combinations also describe acute myocardial infarctions.</P>
                    <P>As a result, we are proposing modifications to the GROUPER logic to allow cases reporting diagnosis code I21.A1 (Myocardial infarction type 2) as a secondary diagnosis to group to MS-DRGs 222 and 223 when reported with a listed procedure code for clinical consistency with the other MS-DRGs describing acute myocardial infarction.</P>
                    <P>A diagnosis code may define the logic for a specific MS-DRG assignment in three different ways. The diagnosis code may be listed as principal or as any one of the secondary diagnoses, as a secondary diagnosis, or only as a secondary diagnosis as noted in more detail in this proposed rule.</P>
                    <P>
                        • 
                        <E T="03">Principal or secondary diagnoses.</E>
                         Indicates that a specific set of diagnoses are used in the definition of the MS-DRG. The diagnoses may be listed as principal or as any one of the secondary diagnoses. A special case of this condition is MS-DRG 008 in which two diagnoses (for example, renal and diabetic) must both be present somewhere in the list of diagnoses in order to be assigned to MS-DRG 008.
                    </P>
                    <P>
                        • 
                        <E T="03">Secondary diagnoses.</E>
                         Indicates that a specific set of secondary diagnoses are used in the definition of the MS-DRG. For example, a secondary diagnosis of acute leukemia with chemotherapy is used to define MS-DRG 839.
                    </P>
                    <P>
                        • 
                        <E T="03">Only secondary diagnoses.</E>
                         Indicates that in order to be assigned to the specified MS-DRG no secondary diagnoses other than those in the specified list may appear on the patient's record. For example, in order to be assigned to MS-DRG 795, only secondary diagnoses from the specified list may appear on the patient's record.
                    </P>
                    <P>We note that whenever there is a secondary diagnosis component to the MS-DRG logic, the diagnosis code can either be used in the logic for assignment to the MS-DRG or to act as a CC/MCC. For this specific scenario, we propose that code I21.A1, as a secondary diagnosis, be used in the definition of the logic for assignment to MS-DRGs 222 and 223, similar to the example described previously, where a secondary diagnosis of acute leukemia with chemotherapy is used to define MS-DRG 839, and therefore will not act as a MCC in these MS-DRGs.</P>
                    <P>In summary, for FY 2022, we are proposing to maintain the current structure of MS-DRGs 280 through 285. We are also proposing to modify the GROUPER logic to allow cases reporting diagnosis code I21.A1 (Myocardial infarction type 2) as a secondary diagnosis to group to MS-DRGs 222 and 223 when reported with qualifying procedures.</P>
                    <HD SOURCE="HD3">c. Viral Cardiomyopathy</HD>
                    <P>We received three separate but related requests to add ICD-10-CM diagnosis code B33.24 (Viral cardiomyopathy) to the list of principal diagnoses for MS-DRGs 314, 315, and 316 (Other Circulatory System Diagnoses with MCC, with CC, and without CC/MCC, respectively) in MDC 05. The requestors noted that a discontinuity exists in the current MDC assignment of diagnosis codes in ICD-10-CM subcategory B33.2. The list of the five ICD-10-CM diagnosis codes in subcategory B33.2, as well as their current MDC assignments, is found in the following table.</P>
                    <GPH SPAN="3" DEEP="86">
                        <GID>EP10MY21.369</GID>
                    </GPH>
                    <P>
                        A requestor noted ICD-10-CM codes B33.20, B33.21, B33.22, and B33.23 are assigned to MDC 05 (Diseases and Disorders of the Circulatory System), while code B33.24 is assigned to MDC 18 (Infectious and Parasitic Diseases, Systemic or Unspecified Sites). The requestor stated that the placement of ICD-10-CM diagnosis code B33.24 within subcategory B33.2 is clinically appropriate, as all the diagnoses within this subcategory share a common etiology, involve the heart and supporting structures, and require the same intensity of hospital care. However, the assignment of code B33.24 to a different MDC is clinically incongruous with the placement of the other codes in the subcategory. According to the requestor, all of the conditions share similar etiology, anatomic location, and needs for care, therefore the five codes should all be assigned to MDC 05. This requestor also stated that reassigning code B33.24 to MDC 05 would ensure both clinical continuity and coding consistency within the B33.2 subcategory. Another requestor stated MDC 05 surgical MS-DRGs should be assigned when 
                        <PRTPAGE P="25117"/>
                        procedures such as cardiac catheterization or coronary angioplasty are performed for a principal diagnosis of viral cardiomyopathy.
                    </P>
                    <P>To begin our analysis, we reviewed the GROUPER logic. Currently, cases reporting ICD-10-CM diagnosis code B33.24 as a principal diagnosis group to medical MS-DRGs 865 and 866 (Viral Illness with and without MCC, respectively) in MDC 18 in the absence of a surgical procedure. Our clinical advisors reviewed this issue and noted viral cardiac infections may present as endocarditis (inflammation of the heart's inner lining), myocarditis (inflammation of the middle layer of the heart), pericarditis (inflammation of the pericardium), or cardiomyopathy (disease of the heart muscle). The infection usually begins somewhere other than the heart, often in the nose, lungs, or stomach. As the infection progresses, and the microbe multiplies and gets into the bloodstream, it can infiltrate the heart muscle. The growth and replication of viruses inside the heart can endanger the heart by destroying heart cells. The management of viral cardiomyopathy is similar to the management of other viral cardiac infections and can include bed rest, control of pain with non-steroidal anti-inflammatory agents and anti-microbial therapy to avoid permanent myocardial damage, cardiomegaly, and/or congestive cardiac failure.</P>
                    <P>Our clinical advisors agree that the diagnosis of viral cardiomyopathy is clinically related to the other diagnoses in ICD-10-CM subcategory B33.2. They believe it is clinically appropriate for all five diagnoses in subcategory B33.2 to group to MDC 05 (Diseases and Disorders of the Circulatory System) as these conditions describe circulatory system conditions and complications and that this modification will improve clinical coherence. Therefore, we are proposing to reassign ICD-10-CM diagnosis code B33.24 from MDC 18 in MS DRGs 865 and 866 (Viral Illness with and without MCC, respectively) to MDC 05 in MS DRGs 314, 315, and 316 (Other Circulatory System Diagnoses with MCC, with CC, and without CC/MCC, respectively). Under this proposal, cases reporting procedure codes from MDC 05 in conjunction with principal diagnosis B33.24, would group to MS-DRGs in MDC 05.</P>
                    <HD SOURCE="HD3">d. Left Atrial Appendage Closure (LAAC)</HD>
                    <P>In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58471 through 58477), we identified nine ICD-10-PCS procedure codes that describe Left Atrial Appendage Closure (LAAC) procedures and noted their corresponding MS-DRG assignments in the ICD-10 MS-DRGs Version 37 as listed in the following table.</P>
                    <GPH SPAN="3" DEEP="203">
                        <GID>EP10MY21.032</GID>
                    </GPH>
                    <P>As discussed in the FY 2021 IPPS/LTCH PPS final rule, we examined claims data from the September 2019 update of the FY 2019 MedPAR file for cases reporting LAAC procedures with an open approach in MS-DRGs 250 and 251 (Percutaneous Cardiovascular Procedures without Coronary Artery Stent with and without MCC, respectively). Our analysis showed that the cases reporting a LAAC procedure with an open approach in MS-DRGs 250 and 251 had higher average costs and longer average length of stay compared to all cases in MS-DRGs 250 and 251. We also stated our clinical advisors believed that ICD-10-PCS codes 02L70CK, 02L70DK, and 02L70ZK that describe a LAAC procedure with an open approach were more suitably grouped to MS-DRGs 273 and 274 (Percutaneous Intracardiac Procedures with and without MCC, respectfully). Therefore, we finalized our proposal to reassign ICD-10-PCS procedure codes 02L70CK, 02L70DK, and 02L70ZK from MS-DRGs 250 and 251 to MS-DRGs 273 and 274. We also finalized a revision to the titles for MS-DRG 273 and 274 to Percutaneous and Other Intracardiac Procedures with and without MCC, respectively to reflect this reassignment for FY 2021.</P>
                    <P>In response to this final policy, for this FY 2022 IPPS/LTCH PPS proposed rule, we received a request to again review the MS-DRG assignment of cases involving LAAC procedures with an open approach. The requestor disagreed with CMS's FY 2021 IPPS/LTCH PPS final rule decision to move the three procedure codes describing the open occlusion of left atrial appendage to MS-DRGs 273 and 274 (Percutaneous and Other Intracardiac Procedures with and without MCC, respectively). The requestor stated they believe that MS-DRGs 228 and 229 (Other Cardiothoracic Procedures with and without MCC, respectively), would more appropriately correspond with the open procedural resources and longer length of stay expected with open heart procedures.</P>
                    <P>
                        Our clinical advisors reviewed this request and continue to support the reassignment of ICD-10-PCS procedure 
                        <PRTPAGE P="25118"/>
                        codes 02L70CK, 02L70DK, and 02L70ZK from MS-DRGs 250 and 251 to MS-DRGs 273 and 274 because it allows all LAAC procedures to be grouped together under the same MS-DRGs and improves clinical coherence. Our clinical advisors state open LAAC procedures are primarily performed in the absence of another O.R. procedure and generally are not performed with a more intensive open chest procedure. When performed as standalone procedures, open LAAC procedures share similar factors such as complexity and resource utilization with all other LAAC procedures. Our clinical advisors continue to state our FY 2021 final policy results in MS-DRG assignments that are more clinically homogeneous and better reflect hospital resource use. Therefore, we are proposing to maintain the assignment of codes 02L70CK, 02L70DK, and 02L70ZK that describe the open occlusion of the left atrial appendage in MS-DRGs 273 and 274.
                    </P>
                    <HD SOURCE="HD3">e. Surgical Ablation</HD>
                    <P>We received a two-part request to review the MS-DRG assignments for cases involving the surgical ablation procedure for atrial fibrillation. Atrial fibrillation (AF) is an irregular and often rapid heart rate that occurs when the two upper chambers of the heart experience chaotic electrical signals. AF presents as either paroxysmal (lasting &lt;7 days), persistent (lasting &gt;7 days, but less than 1 year), or long standing persistent (chronic) (lasting &gt;1 year) based on time duration and can increase the risk for stroke, heart failure, and mortality. Management of AF has two primary goals: Optimizing cardiac output through rhythm or rate control, and decreasing the risk of cerebral and systemic thromboembolism. Patients that worsen in symptomology or fail to respond to pharmacological treatment or other interventions may be referred for surgical ablation to treat their AF. Surgical ablation is a procedure that works by burning or freezing tissue on the inside of the heart to disrupt faulty electrical signals causing the arrhythmia, which can help the heart maintain a normal heart rhythm.</P>
                    <P>The first part of this request was to create a new classification of surgical ablation MS-DRGs to better accommodate the costs of open concomitant surgical ablations. According to the requestor, patients undergoing surgical ablation are treated under two potential scenarios: (1) Open concomitant (combination) surgical ablation, meaning open surgical ablation performed during another open-heart surgical procedure such as mitral valve repair or replacement (MVR), aortic valve repair or replacement (AVR), or coronary artery bypass grafting (CABG) and (2) minimally invasive, percutaneous endoscopic, standalone surgical ablation as the sole therapeutic procedure performed. According to the requestor, open concomitant surgical ablation is an efficient procedure, as it allows treatment of AF and another clinical pathology in one procedure thereby decreasing the risk of future readmits, need for future repeat catheter ablation procedures, and patient mortality.</P>
                    <P>The requestor identified the following potential procedure combinations that would comprise an “open concomitant surgical ablation” procedure.</P>
                    <FP SOURCE="FP-1">• Open CABG + open surgical ablation</FP>
                    <FP SOURCE="FP-1">• Open MVR + open surgical ablation</FP>
                    <FP SOURCE="FP-1">• Open AVR + open surgical ablation</FP>
                    <FP SOURCE="FP-1">• Open MVR + open AVR + open surgical ablation</FP>
                    <FP SOURCE="FP-1">• Open MVR + open CABG + open surgical ablation</FP>
                    <FP SOURCE="FP-1">• Open MVR + open AVR + open CABG + open surgical ablation</FP>
                    <FP SOURCE="FP-1">• Open AVR + open CABG + open surgical ablation</FP>
                    <P>The requestor performed its own analysis of these procedure code combinations and stated that it found the average costs for open concomitant surgical ablation procedures were consistently higher compared to the average costs within their respective MS-DRGs, which could limit beneficiary access to these procedures.</P>
                    <P>The requestor suggested that the following four MS-DRGs be created to address the differences in average costs and average lengths of stay it found in its data analysis:</P>
                    <P>• Suggested New MS-DRG XXX—Open Surgical Ablation with or without Other Cardiothoracic Procedure with Cardiac Catheterization with MCC;</P>
                    <P>• Suggested New MS-DRG XXX—Open Surgical Ablation with or without Other Cardiothoracic Procedure with Cardiac Catheterization without MCC;</P>
                    <P>• Suggested New MS-DRG XXX—Open Surgical Ablation with or without Other Cardiothoracic Procedure without Cardiac Catheterization with MCC; and</P>
                    <P>• Suggested New MS-DRG XXX—Open Surgical Ablation with or without Other Cardiothoracic Procedure without Cardiac Catheterization without MCC.</P>
                    <P>In reviewing this request, we identified nine ICD-10-PCS codes that describe open surgical ablation. These codes and their corresponding MDC and MS-DRG assignments are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="249">
                        <PRTPAGE P="25119"/>
                        <GID>EP10MY21.033</GID>
                    </GPH>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, for open concomitant surgical ablation procedures, the GROUPER logic assigns MS-DRGs 228 and 229 (Other Cardiothoracic Procedures with and without MCC, respectively) in most instances because MS-DRGs 228 and 229 are high in the surgical hierarchy GROUPER logic of MDC 05 (Diseases and Disorders of the Circulatory System). Since patients can have multiple procedures reported with a principal diagnosis during a particular hospital stay, and a patient can be assigned to only one MS-DRG, the surgical hierarchy GROUPER logic provides a hierarchical order of surgical classes from the most resource-intensive to the least resource-intensive. Patients with multiple procedures are generally assigned to the MS-DRG that correlates to the most resource-intensive surgical class.</P>
                    <P>Our clinical advisors reviewed this grouping issue and noted in open concomitant surgical ablation procedures, the CABG, MVR, and/or AVR components of the procedure are more technically complex than the open surgical ablation procedure. Our clinical advisors stated that in open concomitant surgical ablation procedures, the MS-DRG assigned should be based on the most resource-intensive procedure performed. Therefore, we believe this request would be better addressed by proposing to revise the surgical hierarchy in MDC 05 rather than creating four new MS-DRGs. For FY 2022, we are proposing to revise the surgical hierarchy for the MS-DRGs in MDC 05 to sequence MS-DRGs 231-236 (Coronary Bypass) above MS-DRGs 228 and 229 to enable more appropriate MS-DRG assignment for these types of cases. Under this proposal, if a procedure code describing a CABG and a procedure code describing an open surgical ablation are present, the GROUPER logic would assign the CABG surgical class because a CABG would be sequenced higher in the hierarchy than an open surgical ablation. We refer the reader to section II.D.15. of the preamble of this proposed rule for the discussion of the surgical hierarchy and the complete list of our proposed modifications to the surgical hierarchy in MDC 05.</P>
                    <P>As mentioned earlier in this section, this request involved two parts. The second part of the request was to reassign cases describing standalone percutaneous endoscopic surgical ablation. According to the requestor, standalone, percutaneous endoscopic surgical ablation is a rapidly growing therapy, indicated for highly symptomatic patients that have already failed medical management and/or percutaneous catheter ablation procedures. The requestor identified nine ICD-10-PCS codes that they stated describe percutaneous endoscopic surgical ablation. These codes and their corresponding MDC and MS-DRG assignments are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="254">
                        <PRTPAGE P="25120"/>
                        <GID>EP10MY21.034</GID>
                    </GPH>
                    <P>The requestor performed its own analysis and stated that it found the most common MS-DRG assignment for cases describing standalone percutaneous endoscopic surgical ablation was MS-DRGs 228 and 229 (Other Cardiothoracic Procedures with and without MCC, respectively) and that in those MS-DRGs, the standalone surgical ablation procedures cost more than all the procedures in their currently assigned MS-DRGs 228 and 229. Therefore, the requestor recommended CMS reassign these procedures to higher weighted MS-DRGs 219 and 220 (Cardiac Valve and Other Major Cardiothoracic Procedures without Cardiac Catheterization with MCC and with CC, respectively).</P>
                    <P>We examined claims data from the March 2020 update of the FY 2019 MedPAR file for all cases in MS-DRGs 228 and 229 and compared the results to cases with a procedure code describing a standalone percutaneous endoscopic surgical ablation procedure. Our findings are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="156">
                        <GID>EP10MY21.035</GID>
                    </GPH>
                    <P>As shown in the table, the data analysis performed indicates that the 99 cases in MS-DRG 228 reporting a procedure code that describes percutaneous endoscopic surgical ablation have an average length of stay that is shorter than the average length of stay for all the cases in MS-DRG 228 (7.1 days versus 10.7 days) and higher average costs when compared to all the cases in MS-DRG 228 ($48,281 versus $45,772). The 497 cases in MS-DRG 229 reporting a procedure code that describes percutaneous endoscopic surgical ablation have an average length of stay that is shorter than the average length of stay for all the cases in MS-DRG 229 (3.7 days versus 5.8 days) and higher average costs when compared to all the cases in MS-DRG 229 ($35,516 versus $29,454).</P>
                    <P>We then examined the claims data from the March 2020 update of the FY 2019 MedPAR file to identify the average length of stay and average costs for all cases in MS-DRGs 219 and 220. Our findings are shown in the table.</P>
                    <GPH SPAN="3" DEEP="57">
                        <PRTPAGE P="25121"/>
                        <GID>EP10MY21.036</GID>
                    </GPH>
                    <P>As shown in the table, for MS-DRG 219, there were a total of 15,597 cases with an average length of stay of 10.9 days and average costs of $57,845. For MS-DRG 220, there were a total of 15,074 cases with an average length of stay of 6.5 days and average costs of $39,565.</P>
                    <P>We also examined claims data from the September 2020 update of the FY 2020 MedPAR file for all cases in MS-DRGs 228 and 229 and compared the results to cases with a procedure code describing a standalone percutaneous endoscopic surgical ablation procedure. Our findings are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="156">
                        <GID>EP10MY21.037</GID>
                    </GPH>
                    <P>As shown in the table, the data analysis performed indicates that the 84 cases in MS-DRG 228 reporting a procedure code that describes percutaneous endoscopic surgical ablation have an average length of stay that is shorter than the average length of stay for all the cases in MS-DRG 228 (6.9 days versus 10.2 days) and lower average costs when compared to all the cases in MS-DRG 228 ($44,710 versus $46,508). The 393 cases in MS-DRG 229 reporting a procedure code that describes percutaneous endoscopic surgical ablation have an average length of stay that is shorter than the average length of stay for all the cases in MS-DRG 229 (3.4 days versus 4.9 days) and higher average costs when compared to all the cases in MS-DRG 229 ($34,237 versus $29,885).</P>
                    <P>We then examined the claims data from the September 2020 update of the FY 2020 MedPAR file to identify the average length of stay and average costs for all cases in MS-DRGs 219 and 220. Our findings are shown in the table.</P>
                    <GPH SPAN="3" DEEP="57">
                        <GID>EP10MY21.038</GID>
                    </GPH>
                    <P>As shown in the table, for MS-DRG 219, there were a total of 11,863 cases with an average length of stay of 10.9 days and average costs of $61,934. For MS-DRG 220, there were a total of 10,072 cases with an average length of stay of 6.5 days and average costs of $41,800.</P>
                    <P>Our analysis indicates that MS-DRGs 219 and 220 generally have much higher average costs and longer average lengths of stay than the cases with a procedure code describing a standalone percutaneous endoscopic surgical ablation procedure currently assigned to MS-DRGs 228 and 229. Instead, the average costs and average length of stay for cases reporting a standalone percutaneous endoscopic surgical ablation appear to be generally more aligned with the average costs and average length of stay for all cases in MS-DRGs 228 and 229, where they are currently assigned. Our clinical advisors reviewed this issue and do not recommend changing the assignment of procedure codes describing percutaneous endoscopic surgical ablation. Therefore, for these reasons, we are proposing to maintain the current structure of MS-DRGs 219 and 220.</P>
                    <HD SOURCE="HD3">f. Drug-Eluting Stents</HD>
                    <P>
                        We received a request to review the MS-DRG assignments of claims involving the insertion of coronary stents in percutaneous coronary interventions. The requestor suggested that CMS eliminate the distinction between drug-eluting and bare-metal coronary stents in the MS-DRG classification. According to the requestor, coated stents have a clinical performance comparable to drug-eluting stents however they are grouped with bare-metal stents because they do not contain a drug. The requestor asserted that this comingling muddies the 
                        <PRTPAGE P="25122"/>
                        clinical coherence of the MS-DRG structure, as one cannot infer distinctions in clinical performance or benefits among the groups and potentially creates a barrier (based on hospital decision-making) to patient access to modern coated stents.
                    </P>
                    <P>The requestor listed the following MS-DRGs in its request.</P>
                    <P>• MS-DRG 246 (Percutaneous Cardiovascular Procedures with Drug-Eluting Stent with MCC or 4+ Arteries or Stents);</P>
                    <P>• MS-DRG 247 (Percutaneous Cardiovascular Procedures with Drug-Eluting Stent without MCC);</P>
                    <P>• MS-DRG 248 (Percutaneous Cardiovascular Procedures with Non-Drug-Eluting Stent with MCC or 4+ Arteries or Stents); and</P>
                    <P>• MS-DRG 249 (Percutaneous Cardiovascular Procedures with Non-Drug-Eluting Stent without MCC).</P>
                    <P>According to the requestor, the non-drug-eluting stent MS-DRGs have outlived their usefulness in the stent market. The requestor performed its own analysis of MedPAR data from FY 2015 through FY 2019 and stated that it found the volume of cases describing non-drug-eluting coronary stents has declined since 2015, culminating in FY 2019, with drug-eluting stents accounting for 96.1% of all stent cases within the Medicare program, while non-drug-eluting stents accounted for only 3.9% that year. The requestor asserted that the assignment of coated stents to the non-drug-eluting stent category creates a market distortion as this newer technology is being comingled with very old technology at a payment disadvantage large enough to influence hospitals' willingness to prescribe, while at the same time acknowledging that the separation in average charges and costs between the non-drug-eluting stent category and the drug-eluting stent category is minimal in their analysis of the claims data.</P>
                    <P>Based on a review of the procedure codes that are currently assigned to MS-DRGs 246, 247, 248 and 249, our clinical advisors agree that further refinement of these MS-DRGs may be warranted. However, in ICD-10-PCS, a stent is considered an intraluminal device. The distinction between drug-eluting and non-drug eluting intraluminal devices is found elsewhere in the ICD-10-PCS procedure code classification and evaluating this request requires a more extensive analysis to assess potential impacts across the MS-DRGs. For these reasons, at this time, our clinical advisors recommend that rather than evaluating the procedure codes assigned to MS-DRGs 246, 247, 248 and 249 in isolation, additional analysis should be performed for this subset of procedure codes across the MS-DRGs, as part of the comprehensive procedure code review described in section II.D.11. of the preamble of this proposed rule. Therefore, we believe it would be more appropriate to consider this request further during our comprehensive procedure code review in future rulemaking.</P>
                    <HD SOURCE="HD3">6. MDC 08 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue)</HD>
                    <HD SOURCE="HD3">a. Knee Joint Procedures</HD>
                    <P>We received a request to examine the procedure code combinations for procedures describing a right knee joint removal and replacement and procedures describing a left knee joint removal and replacement in MS-DRGs 466, 467, and 468 (Revision of Hip or Knee Replacement with MCC, with CC, and without CC/MCC, respectively). According to the requestor, when using the MS-DRG GROUPER software version 37, the left knee joint procedure combinations group correctly to MS-DRG 468, while the exact same right knee procedure code combinations group incorrectly to MS-DRG 465 (Wound Debridement and Skin Graft Except Hand for Musculoskeletal and Connective Tissue Disorders without CC/MCC).</P>
                    <P>The requestor provided the following procedure codes that describe the procedure code combinations for the left knee joint removal and replacement procedures currently assigned to MS-DRGs 466, 467, and 468.</P>
                    <GPH SPAN="3" DEEP="237">
                        <GID>EP10MY21.039</GID>
                    </GPH>
                    <P>The requestor also provided the following procedure codes that describe the procedure code combinations for right knee joint removal and replacement procedures for CMS's review and consideration.</P>
                    <GPH SPAN="3" DEEP="252">
                        <PRTPAGE P="25123"/>
                        <GID>EP10MY21.040</GID>
                    </GPH>
                    <P>We reviewed the procedure code combinations listed and agree with the requestor that the procedure codes that describe the procedure code combinations for right knee joint removal and replacement procedures were inadvertently excluded from the logic for MS-DRGs 466, 467, and 468.</P>
                    <P>During our review of the previously listed procedure code combinations describing removal and replacement of the right and left knee joints, we identified additional MS-DRGs in which the listed procedure code combinations for the left knee joint are in the logic, however, the listed procedure code combinations for the right knee joint were inadvertently excluded from the logic. Specifically, the listed procedure code combinations describing removal and replacement of the left knee joint are also included in the logic for case assignment to MS-DRGs 461 and 462 (Bilateral or Multiple Major Joint Procedures of Lower Extremity with and without MCC, respectively) in MDC 08 and in the logic for case assignment to MS-DRGs 628, 629, and 630 (Other Endocrine, Nutritional and Metabolic O.R. Procedures with MCC, with CC, and without CC/MCC, respectively) in MDC 10 (Endocrine, Nutritional and Metabolic Diseases and Disorders). Our clinical advisors stated that the procedure code combinations describing removal and replacement of the right knee joint should be added to MS-DRGs 461, 462, 466, 467, and 468 in MDC 08 and MS-DRGs 628, 629, and 630 in MDC 10 for consistency with the procedure code combinations describing removal and replacement of the left knee joint that are currently assigned to those MS-DRGs. Adding these procedure codes will improve clinical coherence and ensure more appropriate MS-DRG assignment for these cases.</P>
                    <P>Therefore, for FY 2022, we are proposing to add the three procedure code combinations listed previously describing removal and replacement of the right knee joint that were inadvertently omitted from the logic to MS-DRGs 461, 462, 466, 467, and 468 in MDC 08 and MS-DRGs 628, 629, and 630 in MDC 10.</P>
                    <HD SOURCE="HD3">b. Pelvic Trauma With Internal Fixation</HD>
                    <P>We received a request to reassign cases reporting a diagnosis code describing a pelvic fracture in combination with a procedure code describing repair of a pelvic fracture with internal fixation, from the lower (NonCC) severity level MS-DRG of its current base MS-DRG assignment to the higher (MCC) severity level MS-DRG of its current base MS-DRG assignment. According to the requestor, there has been steady growth in the volume of internal fixation procedures performed for pelvic fractures since 2008. The requestor stated that due to this growth rate and the anticipated increase in utilization of these internal fixation devices in these procedures in the future that CMS should reconsider the payment structure for these cases it referred to as “internal fixation for pelvic trauma”.</P>
                    <P>The requestor provided data for the Healthcare Common Procedural Coding System (HCPCS) code G0413 (Percutaneous skeletal fixation of posterior pelvic bone fracture and/or dislocation, for fracture patterns which disrupt the pelvic ring, unilateral or bilateral, (includes ileum, sacroiliac joint and/or sacrum) and current procedural terminology (CPT) code 22848 (Pelvic fixation (attachment of caudal end of instrumentation to pelvic bony structures) other than sacrum) from 2008 through 2018 that it crosswalked to ICD-10-PCS procedure codes. The requestor stated that this CPT coded data indicated that physicians have used pelvic fracture fixation, and pelvic instrumentation, for an increasing number of trauma/fracture repair cases, demonstrating expanded use of these devices in the pelvic area overall.</P>
                    <P>
                        The requestor reported that sacral fractures are often underdiagnosed and once the diagnosis is made, bedrest is common, although prolonged bedrest is not recommended for the elderly. In addition, the requestor stated that pelvic fractures may be isolated or they may be associated with surrounding structures. For example, the requester reported that the sacroiliac joint is involved in approximately 30 to 35% of pelvic fracture cases. According to the requestor, the standard of care has also transitioned, from bedrest-only to surgery, and current medical practice has evolved to lower the threshold for fracture repair surgery. For instance, the requestor stated that smaller 5mm 
                        <PRTPAGE P="25124"/>
                        fractures that were once left untreated now have standard treatment protocols involving the use of pelvic instrumentation. As a result, the requestor asserted that there will be greater utilization of internal fixation devices to treat these smaller pelvic fractures.
                    </P>
                    <P>The requestor provided the following procedure codes that it stated describe procedures involving the use of internal fixation devices for pelvic fracture repair.</P>
                    <GPH SPAN="3" DEEP="143">
                        <GID>EP10MY21.041</GID>
                    </GPH>
                    <P>The requestor also provided the following diagnosis code subcategories that it stated identify diagnoses describing pelvic fracture.</P>
                    <GPH SPAN="3" DEEP="72">
                        <GID>EP10MY21.042</GID>
                    </GPH>
                    <P>The requestor performed its own analysis of claims data and reported findings for cases reporting a combination of the diagnosis codes found in the listed diagnosis code subcategories and the listed procedure codes (internal fixation for pelvic trauma) for MS-DRGs 515, 516, and 517 (Other Musculoskeletal System and Connective Tissue O.R. Procedures with MCC, with CC, and without CC/MCC, respectively); MS-DRGs 907, 908, and 909 (Other O.R. Procedures for Injuries with MCC, with CC, and without CC/MCC, respectively); and MS-DRGs 957, 958, and 959 (Other O.R. Procedures for Multiple Significant Trauma with MCC, with CC, and without CC/MCC, respectively). According to the requestor, its findings support reassignment of these internal fixation for pelvic trauma cases from the lower severity level MS-DRG 517 to the higher severity level MS-DRG 515, from the lower severity level MS-DRG 909 to the higher severity level 907, and from the lower severity level MS-DRG 959 to the higher severity level 957. The requestor suggested that approximately 2,000 cases would be impacted by its recommendation to reassign internal fixation for pelvic trauma cases. The requestor also stated that these internal fixation for pelvic trauma cases currently result in a high rate of CMS outlier payments to institutions that perform a high volume of these procedures. Finally, the requestor stated that there is precedent for reassignment of cases from the lower severity level MS-DRGs to the higher severity level MS-DRG for cases involving the use of a device in orthopedic surgery. The requestor provided the examples of total ankle replacement procedures, spinal disc replacement procedures and neurostimulator implantation procedures to demonstrate how CMS has previously reassigned cases from the lower severity level MS-DRG to the higher severity level MS-DRG.</P>
                    <P>We first examined the claims data from the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file for all cases in MS-DRGs 515, 516, and 517; MS-DRGs 907, 908, and 909; and MS-DRGs 957, 958, and 959. Our findings are shown in the following tables.</P>
                    <GPH SPAN="3" DEEP="186">
                        <PRTPAGE P="25125"/>
                        <GID>EP10MY21.043</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="186">
                        <GID>EP10MY21.044</GID>
                    </GPH>
                    <P>We then examined claims data from the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file for cases reporting any combination of the diagnosis and procedure codes that the requestor provided to identify internal fixation for pelvic trauma cases in MS-DRGs 515, 516, and 517; MS-DRGs 907, 908, and 909; and MS-DRGs 957, 958, and 959.</P>
                    <P>
                        We note that our analysis identified two types of cases in which the combination of a diagnosis code and a procedure code (that the requestor provided to identify internal fixation for pelvic trauma cases) was reported. The first type of case consisted of a diagnosis code describing a pelvic fracture reported in combination with a single procedure code describing repair of a pelvic fracture with internal fixation on a claim, and the second type of case consisted of a diagnosis code describing a pelvic fracture reported in combination with two procedure codes describing repair of a pelvic fracture with internal fixation (for example, one for the right side and one for the left side) on a claim. These cases are described as single and bilateral internal fixation procedures for pelvic trauma, respectively. We refer the reader to Tables 6P.1h and 6P.1i associated with this proposed rule (which are available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS</E>
                        ) for the list of diagnosis and procedure code combinations reflecting single internal fixation for pelvic trauma procedures reported by case ID in each MS-DRG, by fiscal year, along with the detailed claims analysis. We refer the reader to Tables 6P.1j and 6P.1k associated with this proposed rule (which are available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS</E>
                        ) for the list of diagnosis and procedure code combinations reflecting bilateral internal fixation for pelvic trauma procedures reported by case ID in each MS-DRG, by fiscal year, along with the detailed claims analysis. For example, Table 6P.1h shows the claims data analysis findings from the March 2020 update of the FY 2019 MedPAR file. Line 2 identifies the section for single cases reported in MS-DRG 515, line 13 identifies the section for single cases reported in MS-DRG 516, and line 42 identifies the single cases reported in MS-DRG 517. The following table summarizes the information found in each column of the tables.
                    </P>
                    <GPH SPAN="3" DEEP="366">
                        <PRTPAGE P="25126"/>
                        <GID>EP10MY21.045</GID>
                    </GPH>
                    <P>As shown in Table 6P.1h, line 4, column A, displays the Case ID “Single-A” for the first case; column B displays MS-DRG 515; column C displays the diagnosis code S32.111A; column D displays the description of the diagnosis code (Minimally displaced Zone 1 fracture of sacrum, initial encounter for closed fracture); column E displays the procedure code 0QS234Z; column F displays the description of the procedure code (Reposition right pelvic bone with internal fixation device, percutaneous approach); column G displays the case count 1; column H displays an average length of stay of 3.0 days; column I displays average costs of $8,433 for the case; column J displays the frequency of the procedure reported was one (1) occurrence; column K displays a 3.0 day length of stay for the case; and column L displays $8,433 for the cost of the case.</P>
                    <P>In our analysis of the claims data from the March 2020 update of the FY 2019 MedPAR file, we found that there were no cases reporting any combination of the diagnosis codes and procedure codes previously listed in MS-DRGs 907, 908, and 909 or MS-DRGs 957, 958, and 959. Our findings are shown in the following table for any cases found to report a diagnosis code describing a pelvic trauma in combination with a procedure code describing single internal fixation in MS-DRGs 515, 516, and 517.</P>
                    <GPH SPAN="3" DEEP="143">
                        <GID>EP10MY21.046</GID>
                    </GPH>
                    <PRTPAGE P="25127"/>
                    <P>As shown in the table, there were only three cases found in MS-DRG 517 reporting single internal fixation for pelvic trauma procedures, with an average length of stay of 5.33 days and average costs of $12,147. The average length of stay is longer and the average costs of these three cases higher compared to the average length of stay and the average costs for all cases in MS-DRG 517 (5.33 days versus 2.6 days and $12,147 versus $10,316, respectively); however, overall, we believe the data findings are comparable. Our clinical advisors did not support reassignment of the three cases from MS-DRG 517 to MS-DRG 515 based on the claims data analysis and also stated it would not be appropriate to reassign these cases into the higher severity level MS-DRG in the absence of a MCC and noted that the cases would not be clinically coherent with regard to resource utilization.</P>
                    <P>
                        In our analysis of the claims data from the March 2020 update of the FY 2019 MedPAR file for cases in which a bilateral internal fixation for pelvic trauma procedure was performed, we identified one case in MS-DRG 517. As shown in Table 6P.1j, the average length of stay for this case was 4.0 days and the average costs were $24,258, which is longer than the average length of stay and greater than the average costs for all cases in MS-DRG 517 (2.6 days and $10,316, respectively). We also identified cases reporting various code combinations for MS-DRGs 515 and 516, and provide the details in Table 6P.1j associated with this proposed rule (which is available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS</E>
                        ).
                    </P>
                    <P>In our analysis of the claims data from the September 2020 update of the FY 2020 MedPAR file we found that there were no cases reporting any combination of the diagnosis codes and procedure codes previously listed in MS-DRG 909 or in MS-DRGs 957, 958, and 959. Our findings are shown in the following table for any cases found to report a diagnosis code describing a pelvic trauma in combination with a procedure code describing single internal fixation in MS-DRGs 515, 516, 517, 907, and 908.</P>
                    <GPH SPAN="3" DEEP="203">
                        <GID>EP10MY21.047</GID>
                    </GPH>
                    <P>As shown in the table, there were only four cases found in MS-DRG 517 reporting single internal fixation for pelvic trauma procedures, with an average length of stay of 2.5 days and average costs of $10,136. For the same reasons described previously based on the FY 2019 analysis, our clinical advisors did not support reassignment of the cases in the lower severity level MS-DRG 517 to the higher severity level MS-DRG 515. In addition, the average length of stay and average costs for these four cases reporting single internal fixation for pelvic trauma procedures are less than the average length of stay and average costs for all the cases in MS-DRG 517 (2.5 days versus 2.6 days and $10,136 versus $11,301, respectively)); however, overall, we believe the data findings are comparable.</P>
                    <P>
                        In our analysis of the claims data from the September 2020 update of the FY 2020 MedPAR file for cases in which a bilateral internal fixation for pelvic trauma procedure was performed, we identified one case in MS-DRG 517. As shown in Table 6P.1k, the average length of stay for this case was 2.0 days and the average costs were $10,103, which is shorter than the average length of stay and less than the average costs for all cases in MS-DRG 517 (2.6 days and $11,301, respectively). We also identified cases reporting various combinations for MS-DRGs 515, 516 and MS-DRG 907, and provide the details in Table 6P.1k associated with this proposed rule (which is available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS</E>
                        ).
                    </P>
                    <P>
                        We believe further analyses of these internal fixation for pelvic trauma cases in the claims data is warranted. We note that our analysis for both the single and bilateral cases was centered on the reporting of a principal diagnosis code describing a pelvic trauma (fracture) in combination with a procedure code describing internal fixation based on the codes provided by the requestor. However, we also identified cases in the claims data in which a pelvic trauma diagnosis code was reported as a secondary diagnosis code in combination with a procedure code describing internal fixation and believe these cases require further evaluation. In addition, during our review of the diagnosis and procedure codes that the requestor provided, we identified diagnosis codes that we believe do not warrant consideration for purposes of this request and additional procedure codes that describe internal fixation for pelvic trauma procedures, which we believe do warrant further analysis. For example, as previously noted, the requestor provided the subcategories for 
                        <PRTPAGE P="25128"/>
                        the diagnosis codes that it requested we consider for analysis. We do not agree that diagnosis codes describing a pelvic fracture that include the term “sequela” should be considered in the analysis to examine this request because, in the ICD-10-CM classification, the term sequela is defined as the residual effect (condition produced) after the acute phase of an illness or injury has terminated.
                    </P>
                    <P>We refer the reader to Table 6P.1g for the list of diagnosis codes that are included in the diagnosis subcategories provided by the requestor and the list of procedure codes provided by the requestor, which also contains the procedure codes we identified. Additional time is needed for data analysis given the volume of these code combinations and corresponding data. We also believe that additional time is needed to allow for further analysis of the claims data to determine the causes of the fractures and other possible contributing factors with respect to the length of stay and costs of these cases, as well as the rate of outlier payments as identified by the requestor. Our clinical advisors also believe that future data findings may demonstrate additional variance in resource utilization for this patient population. We further note that, as discussed in the FY 2021 IPPS/LTCH PPS final rule, we finalized the addition of 161 procedure codes to MS-DRGs 957, 958, and 959 in MDC 24 (Multiple Significant Trauma) that include the insertion of internal fixation devices. We believe it would be beneficial to examine future claims data to determine if there is a change in the volume of cases in those specific MS-DRGs as a result of that update. For these reasons, we are proposing to maintain the structure of MS-DRGs 515, 516, and 517; MS-DRGs 907, 908, and 909; and MS-DRGs 957, 958, and 959 for FY 2022.</P>
                    <HD SOURCE="HD3">7. MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract): Chronic Renal Replacement Therapy (CRRT)</HD>
                    <P>We received a request to create new MS-DRGs for cases where the patient receives continuous renal replacement therapy (CRRT) during the inpatient stay. According to the requestor, hospitals incur higher costs related to CRRT and current MS-DRG definitions do not adequately account for the clinical and resource requirements of CRRT. The requestor stated Medicare reimbursement is insufficient to cover the costs of administering CRRT, creating a disincentive in offering this dialysis modality and is a barrier to further adoption of CRRT. The requestor suggested that the following two new MS-DRGs be created:</P>
                    <P>• Suggested New MS-DRG XXX—Continuous Renal Replacement Therapy with CC/MCC; and</P>
                    <P>• Suggested New MS-DRG XXX—Continuous Renal Replacement Therapy without CC/MCC.</P>
                    <P>Renal replacement therapy (RRT) replaces kidney function by exchanging solute and removing fluid from the blood as a means to prevent or treat renal failure in patients with acute kidney injury (AKI). Modalities of renal support include CRRT, conventional intermittent hemodialysis (IHD), and prolonged intermittent renal replacement therapies (PIRRTs), which are a hybrid of CRRT and IHD. IHD provides solute clearance and filtration during relatively brief treatment sessions, generally lasting from three to five hours. CRRT provides gradual fluid removal and solute clearance over prolonged treatment times, typically over a 24-hour period, mimicking the natural function of the kidney to allow for the continuous removal or replacement of fluid. The most common CRRT modalities are continuous venovenous hemofiltration, continuous venovenous hemodialysis, and continuous venovenous hemodiafiltration.</P>
                    <P>According to the requestor, CRRT is used primarily to treat critically ill, hospitalized patients who experience AKI requiring more intensive and continuous treatment than other dialysis modalities. The requestor stated that CRRT offers fluid balance and convective clearance that may be precisely adjusted for each patient, and has been associated with a higher likelihood of kidney recovery as compared to other modalities of RRT. The requestor asserted that IHD may worsen the neurological status of patients with acute brain injury or other causes of increased intracranial pressure by compromising their cerebral perfusion by raising intracranial pressure. The ongoing modulation of fluid balance and targeted fluid management capabilities of CRRT enables its use in situations other than renal failure. According to the requestor, CRRT, a slow continuous therapy, is preferred for patients who are hemodynamically unstable because it helps prevent the hemodynamic fluctuations common with the more rapid IHD. In light of the COVID-19 pandemic, the requestor noted the National Institutes of Health's Coronavirus Disease 2019 (COVID-19) Treatment Guidelines and The American Society of Nephrology recommend CRRT as the preferred renal replacement therapy for critically ill, COVID-19 patients experiencing AKI, who develop indications for renal replacement therapy, due to the hemodynamic instability often experienced in this condition.</P>
                    <P>The requestor acknowledged that under the current MS-DRG definitions, Medicare cases with beneficiaries receiving CRRT are assigned to more than 300 MS-DRGs. Although these beneficiaries are clinically similar in that they are critically ill patients who experience AKI requiring more intensive and continuous treatment than other dialysis modalities, the principal diagnoses for their inpatient stays vary. The requestor stated their analysis of the variability in principal diagnosis of the cases examined with beneficiaries receiving CRRT indicated that, in general, IHD tends to be used more for patients with chronic illnesses, and CRRT tends to be used for more acute injuries and end of life scenarios. Therefore, the requestor suggested that CMS create new MS-DRGs specific to CRRT, without regard to principal diagnosis, in order to group the resource intensive, clinically coherent, CRRT cases together in contrast to the existing GROUPER definitions.</P>
                    <P>According to the requestor, continuing to assign CRRT to existing MS-DRGs would be clinically inappropriate and remain financially devastating to providers even when treating the most routine, uncomplicated CRRT patients. The requestor performed its own data analysis and stated hospitals lose over $22,000 per CRRT case on average, even when outliers are considered, which they state is a shortfall of more than 30 percent. The requestor asserted these losses create a disincentive for providers to offer CRRT despite its clinical benefits. The requestor also asserted the magnitude of financial losses associated with the provision of CRRT at the current level of MS-DRG payment could force many hospitals to examine the capacity and scope of their CRRT programs if facilities continue to determine that the financial burden of treating Medicare beneficiaries with CRRT is more than the facility can sustain. As COVID-19 continues to strain hospital resources, the requestor asserts the availability of CRRT should not be impeded by inadequate MS-DRG payments related to CRRT.</P>
                    <P>The following ICD-10-PCS procedure code identifies the performance of CRRT.</P>
                    <GPH SPAN="3" DEEP="62">
                        <PRTPAGE P="25129"/>
                        <GID>EP10MY21.048</GID>
                    </GPH>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure code 5A1D90Z is currently recognized as a non-O.R. procedure that affects the MS-DRG to which it is assigned. Our clinical advisors agree that the principal diagnosis assigned for inpatient admissions where continuous renal replacement of therapy is utilized can vary. To examine the impact of the use of CRRT, we examined claims data from the March 2020 update of the FY 2019 MedPAR file for the top ten MS-DRGs reporting the use of CRRT. Our findings are reflected in the following table:</P>
                    <GPH SPAN="3" DEEP="325">
                        <GID>EP10MY21.049</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="199">
                        <PRTPAGE P="25130"/>
                        <GID>EP10MY21.050</GID>
                    </GPH>
                    <P>As shown in this table, our data findings demonstrate the average lengths of stay were longer and the average costs were higher for the cases reporting the use of CRRT when compared to all cases in their respective MS-DRG. We note that the claims data demonstrate that the MS-DRG with the largest number of cases reporting CRRT is MS-DRG 871 with 2,912 cases. Of the top 10 MS-DRGs reporting CRRT, the MS-DRG with the smallest number of cases is MS-DRG 682 with 401 cases. The average length of stay of this subset of cases ranges from a high of 35.5 days in MS-DRG 004 to a low of 7.9 days in MS-DRG 871 for cases reporting the use of CRRT. The average costs of this subset of cases ranges from a high of $174,085 in MS-DRG 003 to a low of $27,681 in MS-DRG 871 for cases reporting the use of CRRT.</P>
                    <P>We also examined claims data from the September 2020 update of the FY 2020 MedPAR file for the top ten MS-DRGs reporting the use of CRRT. Our similar findings are reflected in the following table:</P>
                    <GPH SPAN="3" DEEP="460">
                        <PRTPAGE P="25131"/>
                        <GID>EP10MY21.051</GID>
                    </GPH>
                    <P>As shown in this table, our data findings show that the average lengths of stay were longer and the average costs were higher for the cases reporting the use of CRRT when compared to all cases in their respective MS-DRG. We note that the claims data demonstrate that the MS-DRG with the largest number of cases reporting CRRT is MS-DRG 871 with 3,023 cases. Of the top 10 MS-DRGs reporting CRRT, the MS-DRG with the smallest number of cases is MS-DRG 219 with 374 cases. The average length of stay of this subset of cases ranges from a high of 34.9 days in MS-DRG 004 to a low of 7.9 days in MS-DRG 871 for cases reporting the use of CRRT. The average costs of this subset of cases ranges from a high of $182,952 in MS-DRG 003 to a low of $29,248 in MS-DRG 871 for cases reporting the use of CRRT.</P>
                    <P>While the results of the claims analysis indicate that the average costs and average lengths of stay for cases reporting the use of CRRT are higher compared to the average costs for all cases in their assigned MS-DRG, we are unable to ascertain from the claims data the resource use specifically attributable to CRRT during a hospital stay. There is large variability in the differences in average costs from MS-DRG to MS-DRG, indicating there may have been other factors contributing to the higher costs. When reviewing consumption of hospital resources for this subset of cases, the claims data clearly demonstrate the patients typically have a major complication or co-morbid (MCC) condition reported based on the MS-DRGs assigned. The claims data also reflects, based on the top ten MS-DRGS, that the procedure frequently occurs in cases with other procedures with higher than average resource use such as mechanical ventilation, tracheostomy, extracorporeal membrane oxygenation (ECMO) and other major cardiovascular procedures that also may be contributing to the higher average costs for these cases.</P>
                    <P>
                        To further examine the variability in cases reporting the use of CRRT, we also reviewed the claims data to identify the number (frequency) and types of principal diagnoses that were reported to determine what factors may also be contributing to the higher average costs for these cases.
                        <PRTPAGE P="25132"/>
                    </P>
                    <P>Our findings for the top 10 principal diagnoses that were reported within the claims data from the March 2020 update of the FY 2019 MedPAR file for this subset of cases is shown in the following table:</P>
                    <GPH SPAN="3" DEEP="255">
                        <GID>EP10MY21.052</GID>
                    </GPH>
                    <P>The claims data in this table reflects a wide variance with regard to the frequency and types of principal diagnoses that were reported along with the procedure code describing the use of CRRT. We note that the claims data demonstrate that the diagnosis with the largest number of cases reporting CRRT is A41.9 (Sepsis, unspecified organism) with 4,226 cases. Of the top 10 principal diagnoses reporting CRRT, the diagnosis with the smallest number of cases is A41.01 (Sepsis due to Methicillin susceptible Staphylococcus aureus) with 271 cases. The average length of stay of this subset of cases ranges from a high of 20 days with a diagnosis of I13.0 (Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease) to a low of 12.6 days with a diagnosis of A41.9 (Sepsis, unspecified organism) for cases reporting the use of CRRT. The average costs of this subset of cases ranges from a high of $85,557 with a diagnosis of I21.4 (Non-ST elevation (NSTEMI) myocardial infarction) to a low of $40,908 with a diagnosis of N17.9 (Acute kidney failure, unspecified) for cases reporting the use of CRRT.</P>
                    <P>Our findings for the top 10 principal diagnoses that were reported within the claims data from the September 2020 update of the FY 2020 MedPAR file for this subset of cases is shown in the following table:</P>
                    <GPH SPAN="3" DEEP="255">
                        <PRTPAGE P="25133"/>
                        <GID>EP10MY21.053</GID>
                    </GPH>
                    <P>The claims data in this table also reflects a wide variance with regard to the frequency and types of principal diagnoses that were reported along with the procedure code describing the use of CRRT. As shown, the claims data demonstrate that the diagnosis with the largest number of cases reporting CRRT is A41.9 (Sepsis, unspecified organism) with 4,128 cases. Of the top 10 principal diagnoses reporting CRRT, the diagnosis with the smallest number of cases is N17.0 (Acute kidney failure with tubular necrosis) with 270 cases. The average length of stay of this subset of cases ranges from a high of 21.4 days with a diagnosis of U07.1 (COVID-19) to a low of 11.8 days with a diagnosis of J96.01 (Acute respiratory failure with hypoxia) for cases reporting the use of CRRT. The average costs of this subset of cases ranges from a high of $ 86,717 with a diagnosis of I21.4 (Non-ST elevation (NSTEMI) myocardial infarction) to a low of $ 48,882 with a diagnosis of J96.01 (Acute respiratory failure with hypoxia) for cases reporting the use of CRRT.</P>
                    <P>To evaluate the frequency with which the use of CRRT is reported for different clinical scenarios, we examined claims from the March 2020 update of the FY 2019 MedPAR file across each of the 25 MDCs to determine the number of cases reporting the use of CRRT. Our findings are shown in this table.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="590">
                        <PRTPAGE P="25134"/>
                        <GID>EP10MY21.054</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="581">
                        <PRTPAGE P="25135"/>
                        <GID>EP10MY21.055</GID>
                    </GPH>
                    <P>As shown in the table, the top five MDCs with the largest number of cases reporting CRRT are MDC 18, with 6,761 cases; MDC 05, with 6,027 cases; MDC 04, with 1,370 cases; MDC 11, with 1,134 cases; and MDC 06, with 987 cases. The top five MDCs with the highest average costs for cases reporting the use of CRRT were MDC 13, with average costs of $131,252; MDC 22, with average costs of $104,749; MDC 17, with average costs of $95,309; MDC 07, with average costs of $87,272; and MDC 05, with average costs of $86,024. The claims data indicate that the average length of stay ranges from a high of 47.3 days in MDC 13 to a low of 8 days in MDC 14 for cases reporting the use of CRRT across each of the 25 MDCs.</P>
                    <P>
                        We also examined claims from the September 2020 update of the FY 2020 MedPAR file across each of the 25 MDCs to determine the number of cases 
                        <PRTPAGE P="25136"/>
                        reporting the use of CRRT. Our findings are shown in this table.
                    </P>
                    <GPH SPAN="3" DEEP="475">
                        <GID>EP10MY21.056</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25137"/>
                        <GID>EP10MY21.057</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        As shown in the table, the top five MDCs with the largest number of cases reporting CRRT are MDC 18, with 7,678 cases; MDC 05, with 5,516 cases; MDC 
                        <PRTPAGE P="25138"/>
                        04, with 2,191 cases; MDC 11, with 1,066 cases; and MDC 06, with 838 cases. The top five MDCs with the highest average costs for cases reporting the use of CRRT were MDC 22, with average costs of $139,244; MDC 17, with average costs of $88,182; MDC 05, with average costs of $87,875; MDC 07, with average costs of $86,894; and MDC 08, with average costs of $ 77,515. The claims data indicate that the average length of stay ranges from a high of 26.7 days in MDC 22 to a low of 11 days in MDC 20 for cases reporting the use of CRRT across each of the 25 MDCs.
                    </P>
                    <P>Our clinical advisors reviewed the clinical issues and the claims data, and did not support creating new MS-DRGs for CRRT without regard to principal diagnosis. Our clinical advisors noted that more than one modality for RRT can be utilized for managing patients with AKI given the needs of the patient. For example, a patient may initially start on CRRT when they are hemodynamically unstable, but transition to IHD as their condition is managed during the admission. While patients requiring CRRT can be more resource intensive, it would not be practical to create new MS-DRGs specifically for this subset of patients given the various clinical presentations for which CRRT may be utilized, and the variation of costs in their assigned MS-DRGs. We believe that additional analysis and efforts toward a broader approach to refining the MS-DRGs for cases of patients requiring renal replacement therapy would be needed to address the concerns expressed by the requestor. These data do show cases reporting the use of CRRT can present greater treatment difficulty. However, when reviewing consumption of hospital resources for this subset of cases, the claims data also suggest that the increased costs may be attributable to the severity of illness of the patient and other circumstances of the admission.</P>
                    <P>In summary, the claims data reflect a wide variance with regard to the frequency and average costs for cases reporting the use of CRRT. Depending on the number of cases in each MS-DRG, it is difficult to detect patterns of complexity and resource intensity. We believe the creation of new MS-DRGs for cases with procedure codes reporting the use of CRRT has the potential for creating instability in the relative weights and disrupting the integrity of the MS-DRG system. Therefore, we are not proposing to create new MS-DRGs for cases reporting the use of continuous renal replacement therapy.</P>
                    <HD SOURCE="HD3">8. MDC 16 (Diseases and Disorders of Blood, Blood Forming Organs and Immunologic Disorders)</HD>
                    <HD SOURCE="HD3">a. ANDEXXA® (Coagulation Factor Xa (Recombinant), Inactivated-zhzo)</HD>
                    <P>ANDEXXA® (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant decoy protein that rapidly reverses the anticoagulant effects of two direct oral anticoagulants, apixaban and rivaroxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding in indications such as intracranial hemorrhages (ICHs) and gastrointestinal bleeds (GIBs). ANDEXXA® received FDA approval on May 3, 2018. When administered as a bolus followed by continuous infusion, ANDEXXA® blocks the anticoagulants ability to inhibit FXa. ANDEXXA® was approved for new technology add on payments in FY 2019 (83 FR 41362). We refer readers to section II.H.5.j. of the preamble of the FY 2019 IPPS/LTCH PPS final rule (83 FR 41355 through 41362), and section II.H.4.k. of the preamble of the FY 2020 IPPS/LTCH PPS final rule (84 FR 42193 through 42194) for a complete discussion of the new technology add on payment application and payment amount for ANDEXXA® for FY 2019 and FY 2020.</P>
                    <P>In section II.H.4.i. of the preamble of the FY 2021 IPPS/LTCH PPS final rule (85 FR 58614 through 58615), we noted the 3-year anniversary date of the entry of ANDEXXA® onto the U.S. market (May 3, 2021) will occur in the second half of FY 2021. We stated in general, we extend new technology add-on payments for an additional year only if the 3-year anniversary date of the product's entry onto the U.S. market occurs in the latter half of the upcoming fiscal year. After consideration of the public comments received, we finalized our proposal to continue new technology add-on payments for this technology for FY 2021.</P>
                    <P>We received a request from the manufacturer to review potential access issues in the inpatient setting for this drug in the future. The requestor acknowledged that CMS approved the new technology add-on payment for ANDEXXA® beginning in FY 2019 and noted that FY 2021 will be the last year before the add-on payments expire. According to the requestor, ANDEXXA® is the only indicated factor Xa inhibitor reversal agent, and the requestor stated a concern for the future of access to ANDEXXA® for patients experiencing uncontrolled bleeds caused by factor Xa inhibitors. The requestor stated their claims modeling showed a significant drop in hospital payment for cases involving use of ANDEXXA® following the expiration of new technology add-on payments. Specifically, after new technology add-on payments expire, the requestor stated their model projects that approximately 59% of cases are likely to be paid less than the wholesale acquisition costs for ANDEXXA®.</P>
                    <P>The following ICD-10-PCS procedure codes identify the intravenous administration of ANDEXXA®.</P>
                    <GPH SPAN="3" DEEP="115">
                        <GID>EP10MY21.058</GID>
                    </GPH>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure codes XW03372 and XW04372 are designated as non-O.R. procedures for purposes of MS-DRG assignment. Our clinical advisors agree that the principal diagnosis assigned for inpatient admissions where the intravenous administration of ANDEXXA® is indicated can vary.</P>
                    <P>
                        To evaluate the frequency with which the intravenous administration of 
                        <PRTPAGE P="25139"/>
                        ANDEXXA® is reported for different clinical scenarios, we examined claims data from the March 2020 update of the FY 2019 MedPAR file across the Pre-MDC category, each of the 25 MDCs and the surgical class referred to as “unrelated operating room procedures” to determine the number of cases reporting the use of ANDEXXA®. Our findings are shown in the following table.
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="534">
                        <GID>EP10MY21.059</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="464">
                        <PRTPAGE P="25140"/>
                        <GID>EP10MY21.060</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>As shown in the table, there were 461 cases reporting the intravenous administration of ANDEXXA® with procedure codes XW03372 or XW04372. The top five MDCs with the largest number of cases reporting ANDEXXA® are MDC 01, with 250 cases; MDC 06 with 53 cases; MDC 05, with 33 cases; MDC 18, with 25 cases; and the Pre-MDC category, with 16 cases. The claims data indicate that the average costs range from a high of $107,741 in the Pre-MDC category to a low of $22,242 in MDC 09 for cases reporting the use of ANDEXXA® across the claims data. The claims data also indicates that the average length of stay ranges from a high of 19.9 days in the Pre-MDC category to a low of 4 days in MDC 09 for cases reporting the use of ANDEXXA®.</P>
                    <P>We also examined claims data from the September 2020 update of the FY 2020 MedPAR file across the Pre-MDC category, each of the 25 MDCs and the surgical class referred to as “unrelated operating room procedures” to determine the number of cases reporting the use of ANDEXXA®. Our findings are shown in the following table.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="490">
                        <PRTPAGE P="25141"/>
                        <GID>EP10MY21.061</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="618">
                        <PRTPAGE P="25142"/>
                        <GID>EP10MY21.062</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        As shown in the table, there were 719 cases reporting the intravenous administration of ANDEXXA® with procedure codes XW03372 or XW04372. The top five MDCs with the largest number of cases reporting ANDEXXA® are MDC 01, with 364 cases; MDC 06 with 98 cases; MDC 18, with 52 cases; MDC 05, with 50 cases; and MDC 24, with 30 cases. The claims data indicate that the average costs range from a high 
                        <PRTPAGE P="25143"/>
                        of $123,750 in the Pre-MDC category to a low of $27,922 in MDC 09 for cases reporting the use of ANDEXXA® across the claims data. The claims data also indicates that the average length of stay ranges from a high of 25 days in the Pre-MDC category to a low of 4.2 days in MDC 21 for cases reporting the use of ANDEXXA® across the claims data.
                    </P>
                    <P>To further examine the impact of the intravenous administration of ANDEXXA®, we examined claims data from the March 2020 update of the FY 2019 MedPAR file for the top ten MS-DRGs reporting procedure codes XW03372 or XW04372. Our findings are reflected in the following table:</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="363">
                        <GID>EP10MY21.063</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="300">
                        <PRTPAGE P="25144"/>
                        <GID>EP10MY21.064</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>As shown in this table, the claims data demonstrate that the MS-DRG with the largest number of cases reporting ANDEXXA® is MS-DRG 064 with 78 cases. Of the top 10 MS-DRGs reporting ANDEXXA®, the MS-DRG with the smallest number of cases is MS-DRG 003 with 13 cases. The average length of stay of this subset of cases ranges from a high of 21.5 days in MS-DRG 003 to a low of 4.2 days in MS-DRG 086 for cases reporting the use of ANDEXXA®. The average costs of this subset of cases ranges from a high of $117,265 in MS-DRG 003 to a low of $26,992 in MS-DRG 083 for cases reporting the use of ANDEXXA®. We note while our data findings demonstrate the average costs were higher for the cases reporting the intravenous administration of ANDEXXA® when compared to all cases in their respective MS-DRG, these cases represent a very small percentage of the total number of cases reported in these MS-DRGs. We also note that the top 10 MS-DRGs identified only account for 239 of the 461 cases in total that were identified in the March 2020 update of the FY 2019 MedPAR file reporting ICD-10-PCS codes XW03372 or XW04372. The remainder of the cases are distributed in small numbers across the MS-DRGs.</P>
                    <P>We also examined claims data from the September 2020 update of the FY 2020 MedPAR file for the top ten MS-DRGs reporting procedure codes XW03372 or XW04372. Our findings are reflected in the following table:</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="600">
                        <PRTPAGE P="25145"/>
                        <GID>EP10MY21.065</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        As shown in this table, the claims data demonstrate that the MS-DRG with the largest number of cases reporting ANDEXXA® is MS-DRG 064 with 111 cases. Of the top 10 MS-DRGs reporting ANDEXXA®, the MS-DRG with the smallest number of cases is MS-DRG 083 with 23 cases. The average length of stay of this subset of cases ranges from a high of 10 days in MS-DRG 023 to a low of 3.5 days in MS-DRG 378 for cases reporting the use of ANDEXXA®. The average costs of this subset of cases ranges from a high of $59,478 in MS-DRG 025 to a low of $24,348 in MS-DRG 378 for cases reporting the use of ANDEXXA®. As with our analysis of the 
                        <PRTPAGE P="25146"/>
                        FY 2019 claims data, while these data findings demonstrate the average costs were higher for the cases reporting the intravenous administration of ANDEXXA® when compared to all cases in their respective MS-DRG, these cases represent a very small percentage of the total number of cases reported in these MS-DRGs. We also note that the top 10 MS-DRGs identified only account for 385 of the 719 cases in total that were identified in the September 2020 update of the FY 2020 MedPAR file reporting ICD-10-PCS codes XW03372 or XW04372. The remainder of the cases are distributed in small numbers across the MS-DRGs.
                    </P>
                    <P>After reviewing the claims data, we believe it is premature to consider a proposal for cases involving ANDEXXA® therapy for FY 2022. While the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file do contain claims reporting the procedure codes identifying the intravenous administration of ANDEXXA®, the number of cases is small across the MDCs and MS-DRGs. The claims data also reflect a wide variance with regard to the frequency and average costs for these cases reporting the use of ANDEXXA®. Moreover, we were unable to identify another MS-DRG that would be a more appropriate MS-DRG assignment for these cases based on the indication for this therapeutic drug. As noted previously, ANDEXXA® reverses the anticoagulant effects of apixaban and rivaroxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The underlying cause of the life-threatening or uncontrolled bleeding can vary which means the principal diagnosis assigned for inpatient admissions where ANDEXXA® is administered can vary. The MS-DRGs are a classification system intended to group together diagnoses and procedures with similar clinical characteristics and utilization of resources. We generally seek to identify sufficiently large sets of claims data with a resource/cost similarity and clinical similarity in developing diagnostic-related groups rather than smaller subsets based on the drugs administered. In reviewing this issue, our clinical advisors expressed concern regarding making potential MS-DRG changes based on a specific, single therapeutic agent, identified by unique procedure codes rather than based on a group of related procedure codes that can be reported to describe that same type or class of treatment or technology, which is more consistent with the intent of the MS-DRGs.</P>
                    <P>We recognize the average costs of the small numbers of cases involving the intravenous administration of ANDEXXA® are greater when compared to the average costs of all cases in their respective MS-DRG. The MS-DRG system is a system of averages and it is expected that within the diagnostic related groups, some cases may demonstrate higher than average costs, while other cases may demonstrate lower than average costs. We further note that section 1886(d)(5)(A) of the Act provides for Medicare payments to Medicare-participating hospitals in addition to the basic prospective payments for cases incurring extraordinarily high costs.</P>
                    <P>We acknowledge the importance of ensuring that patients diagnosed with an indication for a factor Xa inhibitor reversal agent have adequate access to care and receive the necessary treatment. While we are sensitive to the requestors' concerns about continued access to treatment for beneficiaries who require the reversal of anticoagulation due to life-threatening or uncontrolled bleeding, additional time is needed to explore options and other mechanisms through which to address low volume high-cost drugs outside of the MS-DRGs.</P>
                    <P>Furthermore, we note that we are proposing to continue new technology add-on payments for ANDEXXA® for FY 2022. We refer the reader to section II.F.4.b of the preamble of this proposed rule for further discussion regarding our proposal to allow a one-time extension of new technology add-on payments for FY 2022 for 15 technologies for which the new technology add-on payment would otherwise be discontinued, in connection with our proposal to use the FY 2019 data to develop the proposed FY 2022 relative weights.</P>
                    <P>Therefore for the reasons stated previously, for FY 2022 we are not proposing any MS-DRG changes for cases involving the intravenous administration of ANDEXXA®.</P>
                    <HD SOURCE="HD3">b. Cytokine Release Syndrome (CRS) Logic</HD>
                    <P>In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58557 through 58561), we finalized modifications to the proposed severity level designations for a subset of the diagnosis codes describing Cytokine Release Syndrome (CRS) based upon further review of the conditions and in response to public comments. We provided the following table to display the finalized severity level designations and stated that we will continue to monitor the CRS codes and their impact on resource use once the claims data becomes available to determine if further modifications to the severity level are warranted.</P>
                    <GPH SPAN="3" DEEP="115">
                        <GID>EP10MY21.066</GID>
                    </GPH>
                    <P>
                        In connection with the finalized severity level designations for the listed CRS codes, we also finalized modifications to the ICD-10 MS-DRG GROUPER logic V38 for MS-DRGs 814, 815, and 816 (Reticuloendothelial and Immunity Disorders with MCC, with CC, and without CC/MCC, respectively) to conform to the updates the CDC finalized in the ICD-10-CM Tabular List instructions for assigning and reporting the CRS codes effective with discharges on and after October 1, 2020. The following modifications to the GROUPER logic were finalized effective with discharges on and after October 1, 2020, for case assignment involving CRS following CAR T-cell therapy to MS-
                        <PRTPAGE P="25147"/>
                        DRGs 814, 815, and 816. We noted that the GROUPER logic for MS-DRGs 814, 815, and 816 will include a principal diagnosis of T89.89XA with a secondary diagnosis of any CRS code as shown in this section of this proposed rule.
                    </P>
                    <HD SOURCE="HD3">Principal Diagnosis</HD>
                    <FP SOURCE="FP-1">T80.89XA Other complications following infusion, transfusion and therapeutic injection, initial encounter</FP>
                    <FP>with</FP>
                    <HD SOURCE="HD3">Secondary Diagnosis</HD>
                    <FP SOURCE="FP-1">D89.831 Cytokine release syndrome, grade 1</FP>
                    <FP SOURCE="FP-1">D89.832 Cytokine release syndrome, grade 2</FP>
                    <FP SOURCE="FP-1">D89.833 Cytokine release syndrome, grade 3</FP>
                    <FP SOURCE="FP-1">D89.834 Cytokine release syndrome, grade 4</FP>
                    <FP SOURCE="FP-1">D89.835 Cytokine release syndrome, grade 5</FP>
                    <FP SOURCE="FP-1">D89.839 Cytokine release syndrome, grade unspecified</FP>
                    <P>As discussed in section II.D.13 of the preamble of this proposed rule, Table 6A.-New Diagnosis Codes, lists the new diagnosis codes that have been approved to date and will be effective with discharges on and after October 1, 2021. Included in Table 6A are the following codes that describe complication of immune effector cellular therapy identifying the timeframe of the encounter.</P>
                    <GPH SPAN="3" DEEP="72">
                        <GID>EP10MY21.067</GID>
                    </GPH>
                    <P>Also included in Table 6A are the following diagnosis codes that describe immune effector cell-associated neurotoxicity syndrome (ICANS), with varying degrees of severity.</P>
                    <GPH SPAN="3" DEEP="115">
                        <GID>EP10MY21.068</GID>
                    </GPH>
                    <P>Consistent with the Tabular List instruction for these two sets of diagnosis codes as presented and discussed by the CDC at the September 8-9, 2020 ICD-10 Coordination and Maintenance Committee meeting, the diagnosis codes describing a complication of the immune effector cellular therapy (T80.82XA, T80.82XD, and T80.82XS) are to be sequenced first, followed by the applicable diagnosis code to identify the specified condition resulting from the complication. For example, the types of complications that may result from immune effector cellular therapy treatment (for example, CAR T-cell therapy) include ICANS or CRS, as described by the listed diagnosis codes. Accordingly, the CDC included the following instructional note in the Tabular List modifications for code T80.82-</P>
                    <P>“Use additional code to identify the specific complication, such as:</P>
                    <P>cytokine release syndrome (D89.83-)  immune effector cell-associated neurotoxicity syndrome (G92.0-)”</P>
                    <P>
                        Materials relating to the discussions involving the diagnosis codes from the September 8-9, 2020 ICD-10 Coordination and Maintenance Committee meeting can be obtained from the CDC website at: 
                        <E T="03">https://www.cdc.gov/nchs/icd/icd10cm_maintenance.htm</E>
                        .
                    </P>
                    <P>As noted previously, the current logic for case assignment involving CRS following CAR T-cell therapy to MS-DRGs 814, 815, and 816 includes a principal diagnosis of T89.89XA with a secondary diagnosis of any CRS code. However, with the finalization of new diagnosis code T80.82-, diagnosis code T89.89XA would no longer be reported and these cases would instead report new diagnosis code T80.82XA, effective with discharges on and after October 1, 2020. As shown in Table 6A associated with this proposed rule, we are proposing to assign diagnosis code T80.82XA to MDC 16 (Diseases and Disorders of Blood, Blood Forming Organs, and Immunologic Disorders) in MS-DRGs 814, 815, and 816. If the MDC and MS-DRG assignment for new diagnosis code T80.82XA is finalized, the current logic for MS-DRGs 814, 815, and 816 that includes a principal diagnosis code of T89.89XA with a secondary diagnosis code of any CRS code would no longer be appropriate or necessary.</P>
                    <P>Therefore, we are proposing to revise the structure of MS-DRGs 814, 815, and 816 by removing the logic that includes a principal diagnosis of T89.89XA with a secondary diagnosis of any CRS code from MS-DRGs 814, 815, and 816 effective FY 2022.</P>
                    <HD SOURCE="HD3">9. MDC 17 (Myeloproliferative Diseases and Disorders, and Poorly Differentiated Neoplasms): Inferior Vena Cava Filter Procedures</HD>
                    <P>
                        In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58517 through 58520), we 
                        <PRTPAGE P="25148"/>
                        discussed the ICD-10-PCS codes that describe the insertion of an intraluminal device into the inferior vena cava that are listed in the following table.
                    </P>
                    <GPH SPAN="3" DEEP="210">
                        <GID>EP10MY21.069</GID>
                    </GPH>
                    <P>We finalized a change in the designation of ICD-10-PCS procedure code 06H03DZ from O.R. procedure to non-O.R. procedure and maintained the O.R. designation of procedure codes 06H00DZ and 06H04DZ. In that discussion, we noted our clinical advisors supported changing the O.R. designation of procedures describing insertion of an intraluminal device into the inferior vena cava performed via a percutaneous approach since the procedure does not require the resources of an operating room, while concurring that procedures describing the insertion of an intraluminal device into the inferior vena cava performed via an open or a percutaneous endoscopic approach could require greater resources than a procedure describing insertion of an intraluminal device into the inferior vena cava performed via a percutaneous approach. We also noted that the goals of changing the designation of procedures from non-O.R. to O.R., or vice versa, are to better clinically represent the resources involved in caring for these patients and to enhance the overall accuracy of the system and not whether the change in designation would impact payment in a particular direction.</P>
                    <P>In response to this final policy, for this FY 2022 IPPS/LTCH PPS proposed rule, we received a request to revise MS-DRGs 829 and 830 (Myeloproliferative Disorders or Poorly Differentiated Neoplasms with Other Procedures with and without CC/MCC, respectively) by removing the current two-way severity level split and creating a three-way severity level split. The requestor respectfully disagreed with the FY 2021 IPPS/LTCH PPS final rule decision to change the designation of the procedure code describing the insertion of an inferior vena cava intraluminal device via percutaneous approach to a non-O.R. procedure, and stated vena cava filters are most often placed in interventional radiology suites and require a high level of skill to prevent rupture of the vena cava; and although they are long-term devices, they must be placed skillfully to allow for removal later if needed.</P>
                    <P>According to the requestor, it is a conundrum that patients with principal and secondary diagnoses that qualify for medical MS-DRGs 837 (Chemotherapy with Acute Leukemia as Secondary Diagnosis or with High Dose Chemotherapy Agent with MCC), MS-DRG 838 (Chemotherapy with Acute Leukemia as Secondary Diagnosis with CC or High Dose Chemotherapy Agent), and MS-DRG 839 (Chemotherapy with Acute Leukemia as Secondary Diagnosis without CC/MCC) group to lower weighted surgical MS-DRGs 829 and 830 (Myeloproliferative Disorders or Poorly Differentiated Neoplasms with Other Procedures with and without CC/MCC, respectively) when a non-major O.R. procedure is performed. The requestor stated the difference in relative weights might be occurring because of the two-way split within MS-DRGs 829 and 830 and the three-way split within MS-DRGs 837, 838 and 839. The requestor theorized that removing the current two-way severity level split of MS-DRGs 829 and 830 and creating a three-way severity level split could help resolve the relative weight discrepancy when any non-major O.R. procedures are performed during hospitalizations for chemotherapy for acute leukemia.</P>
                    <P>This requestor also suggested that if CMS' analysis did not support creating a three-way split for MS-DRGs 829 and 830, exclusion of PCS code 06H03DZ from the list of qualifying procedures and reinstatement of O.R. procedure status to appropriately compensate providers for the cost of devices and resources to place inferior vena cava filters across the patient population should be proposed.</P>
                    <P>To evaluate the request to create a three-way severity split MS-DRG for cases reporting myeloproliferative disorders or poorly differentiated neoplasms with other procedures, we conducted an analysis of base MS-DRG 829. This analysis includes 2 years of MedPAR claims data to compare the data results from 1 year to the next to avoid making determinations about whether additional severity levels are warranted based on an isolated year's data fluctuation and also, to validate that the established severity levels within a base MS-DRG are supported.</P>
                    <P>Therefore, we reviewed the claims data for base MS-DRG 829 using the September 2018 update of the FY 2018 MedPAR file and the March 2020 update of the FY 2019 MedPAR file, which were used in our analysis of claims data for MS-DRG reclassification requests for FY 2020 and FY 2022, respectively. Our findings are shown in the table:</P>
                    <GPH SPAN="3" DEEP="48">
                        <PRTPAGE P="25149"/>
                        <GID>EP10MY21.070</GID>
                    </GPH>
                    <P>We applied the criteria to create subgroups for the three-way severity level split. We found that the criterion that there be at least 500 cases for each subgroup was not met based on the data in both the FY 2018 and FY 2019 MedPAR files, as shown in the table for both years. Specifically, for the “with MCC”, “with CC”, and “without CC/MCC” split, there were only 333 cases in the “without CC/MCC” subgroup based on the data in the FY 2019 MedPAR file and only 333 cases in the “without CC/MCC” subgroup based on the data in the FY 2018 MedPAR file. Accordingly, the claims data do not support a three-way severity level split for base MS-DRG 829.</P>
                    <P>We also reviewed the claims data for base MS-DRG 829 using the September 2019 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file, which were used in our analysis of claims data for MS-DRG reclassification requests for FY 2021 and FY 2022, respectively. Our findings are shown in the table:</P>
                    <GPH SPAN="3" DEEP="42">
                        <GID>EP10MY21.071</GID>
                    </GPH>
                    <P>We applied the criteria to create subgroups for the three-way severity level split. We found that the criterion that there be at least 500 cases for each subgroup was not met based on the data in both the FY 2019 and FY 2020 MedPAR files, as shown in the table for both years. Specifically, for the “with MCC”, “with CC”, and “without CC/MCC” split, there were only 303 cases in the “without CC/MCC” subgroup based on the data in the FY 2020 MedPAR file and, as previously noted, only 333 cases in the “without CC/MCC” subgroup based on the data in the FY 2019 MedPAR file. As shown in both sets of data and stated previously, the claims data do not support a three-way severity level split for base MS-DRG 829.</P>
                    <P>In response to the request to exclude ICD-10-PCS code 06H03DZ from a list of qualifying procedures if CMS's analysis did not support creating a three-way split for MS-DRGs 829 and 830, by definition, procedure codes designated as non-O.R. procedures, not further classified as “affecting the MS-DRG assignment”, do not influence the MS-DRG assignment. As stated previously, in the FY 2021 IPPS/LTCH PPS final rule we finalized our proposal to change the designation of ICD-10-PCS procedure code 06H03DZ from O.R. procedure to non-O.R. procedure, therefore as a non-O.R. procedure, there is no need to exclude ICD-10-PCS code 06H03DZ from a list of qualifying procedure codes for MS-DRGs 829 and 830.</P>
                    <P>In response to the request to reinstate the O.R. procedure designation of ICD-10-PCS code 06H03DZ if CMS's analysis did not support creating a three-way split for MS-DRGs 829 and 830, the change in designation from O.R. procedure to non-O.R. procedure is recent, only becoming effective October 1, 2020. Our clinical advisors continue to indicate that code 06H03DZ, describing the percutaneous insertion of an intraluminal device into the inferior vena cava, does not require the resources of an operating room, that the procedure to insert an IVC filter percutaneously is not surgical in nature and that the resources involved in furnishing this procedure are comparable to the related ICD-10-PCS procedure codes that describe the insertion of infusion devices into the inferior vena cava that are currently designated as non-O.R. procedures. Our clinical advisors state our FY 2021 final policy results in an O.R. designation of 06H03DZ that better reflects the associated technical complexity and hospital resource use of this procedure. We continue to explore alternatives on how we may restructure the current O.R. and non-O.R. designations for procedures by leveraging the detail that is now available in the ICD-10 claims data, as discussed in the FY 2021 IPPS/LTCH PPS final rule and in section II.D.11. of the preamble of this proposed rule. We continue to develop our process and methodology, and will provide more detail in future rulemaking.</P>
                    <P>In summary, based on the results of our analysis, for FY 2022, we are proposing to maintain the current structure of MS-DRGs 829 and 830.</P>
                    <HD SOURCE="HD3">10. Review of Procedure Codes in MS-DRGs 981 Through 983 and 987 Through 989</HD>
                    <P>We annually conduct a review of procedures producing assignment to MS-DRGs 981 through 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) or MS-DRGs 987 through 989 (Non-Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) on the basis of volume, by procedure, to see if it would be appropriate to move cases reporting these procedure codes out of these MS-DRGs into one of the surgical MS-DRGs for the MDC into which the principal diagnosis falls. The data are arrayed in two ways for comparison purposes. We look at a frequency count of each major operative procedure code. We also compare procedures across MDCs by volume of procedure codes within each MDC. We use this information to determine which procedure codes and diagnosis codes to examine.</P>
                    <P>We identify those procedures occurring in conjunction with certain principal diagnoses with sufficient frequency to justify adding them to one of the surgical MS-DRGs for the MDC in which the diagnosis falls. We also consider whether it would be more appropriate to move the principal diagnosis codes into the MDC to which the procedure is currently assigned.</P>
                    <P>
                        In addition to this internal review, we also consider requests that we receive to examine cases found to group to MS-DRGs 981 through 983 or MS-DRGs 987 through 989 to determine if it would be appropriate to add procedure codes to one of the surgical MS DRGs for the MDC into which the principal diagnosis falls or to move the principal diagnosis to the surgical MS DRGs to which the procedure codes are assigned.
                        <PRTPAGE P="25150"/>
                    </P>
                    <P>Based on the results of our review of the claims data from the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file, as well as our review of the requests that we received to examine cases found to group to MS-DRGs 981 through 983 or MS-DRGs 987 through 989, we are proposing to move the cases reporting the procedures and/or principal diagnosis codes described in this section of this rule from MS-DRGs 981 through 983 or MS-DRGs 987 through 989 into one of the surgical MS-DRGs for the MDC into which the principal diagnosis or procedure is assigned.</P>
                    <P>As discussed in section II.D.3.b. of the preamble of this proposed rule, we received a request to reassign cases with procedures describing control of bleeding in the cranial cavity when reported with a central nervous system diagnosis from MS-DRGs 981, 982, and 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) to MDC 01 (Diseases and Disorders of the Central Nervous System) in MS-DRGs 25, 26, and 27 (Craniotomy and Endovascular Intracranial Procedures with MCC, with CC, and without CC/MCC, respectively (for example, “craniotomy” MS-DRGs). We note that in addition to MS-DRGs 25, 26, and 27, MS-DRG 23 (Craniotomy with Major Device Implant or Acute Complex CNS Principal Diagnosis with MCC or Chemotherapy Implant or Epilepsy with Neurostimulator) and MS-DRG 24 (Craniotomy with Major Device Implant or Acute Complex CNS Principal Diagnosis without MCC) also include procedures performed on structures located within the cranial cavity and are included in the range of MS-DRGs known as the “craniotomy” MS-DRGs in MDC 01.</P>
                    <P>The management and treatment for bleeding (or hemorrhage) within the cranial cavity varies depending on the location, cause and the severity (or extent) of the bleed. Common causes include head trauma or cerebral aneurysm. Control of bleeding in the cranial cavity procedures are identified by ICD-10-PCS procedure codes 0W310ZZ (Control bleeding in cranial cavity, open approach), 0W313ZZ (Control bleeding in cranial cavity, percutaneous approach) and 0W314ZZ (Control bleeding in cranial cavity, percutaneous endoscopic approach) and are currently assigned to the following MDCs and MS-DRGs.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25151"/>
                        <GID>EP10MY21.072</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        According to the requestor, procedures performed within the cranial cavity always involve drilling or cutting through the skull regardless of the 
                        <PRTPAGE P="25152"/>
                        approach, therefore the three procedure codes identified (0W310ZZ, 0W313ZZ, and 0W314ZZ) warrant assignment to the “craniotomy” MS-DRGs.
                    </P>
                    <P>Our analysis of this grouping issue confirmed that when a procedure describing control of bleeding in the cranial cavity is reported with a principal diagnosis from MDC 01, these cases group to MS-DRGs 981, 982, and 983. Whenever there is a surgical procedure reported on the claim that is unrelated to the MDC to which the case was assigned based on the principal diagnosis, it results in a MS-DRG assignment to a surgical class referred to as “unrelated operating room procedures”.</P>
                    <P>We examined claims data from the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file for cases reporting any one of the three procedure codes (0W310ZZ, 0W313ZZ or 0W314ZZ) in MS-DRGs 981 through 983 with a principal diagnosis from MDC 01. Our findings are shown in the following tables.</P>
                    <GPH SPAN="3" DEEP="247">
                        <GID>EP10MY21.074</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="207">
                        <GID>EP10MY21.075</GID>
                    </GPH>
                    <P>As noted previously, the requestor asked that we consider reassignment of these cases to the craniotomy MS-DRGs (identified as MS-DRGs 23, 24, 25, 26, and 27). We therefore examined the data for all cases in MS-DRGs 23, 24, 25, 26, and 27. Our findings are shown in the following tables.</P>
                    <GPH SPAN="3" DEEP="157">
                        <PRTPAGE P="25153"/>
                        <GID>EP10MY21.076</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="159">
                        <GID>EP10MY21.077</GID>
                    </GPH>
                    <P>As shown, in our analyses of the claims data for MS-DRGs 981 through 983, we found a total of ten cases reporting procedures describing control of bleeding in cranial cavity with a principal diagnosis from MDC 01 in the March 2020 update of the FY 2019 MedPAR file, and a total of two cases reporting procedures describing control of bleeding in cranial cavity with a principal diagnosis from MDC 01 in the September 2020 update of the FY 2020 MedPAR file.</P>
                    <P>Our clinical advisors stated these procedures describing control of bleeding in the cranial cavity are consistent with the existing procedure codes included in the logic for case assignment to MS-DRGs 25, 26, and 27, in addition to MS-DRG 23 (Craniotomy with Major Device Implant or Acute Complex CNS Principal Diagnosis with MCC or Chemotherapy Implant or Epilepsy with Neurostimulator) and MS-DRG 24 (Craniotomy with Major Device Implant or Acute Complex CNS Principal Diagnosis without MCC) that also describe procedures performed on structures located within the cranial cavity and are included in the range of MS-DRGs known as the “craniotomy” MS-DRGs. While the claims analysis based on the March 2020 update of the FY 2019 MedPAR file identified only ten cases and the September 2020 update of the FY 2020 MedPAR file identified only two cases for which these procedures were reported as a stand-alone procedure resulting in assignment to MS-DRGs 981 through 983, and the average length of stay and average costs for these cases vary in comparison to the average length of stay and average costs of all cases in MS-DRGs 23, 24, 25, 26, and 27, given the nature of head trauma cases, the resource use would be expected to vary based on the extent of the patient's injuries. We believe it is clinically appropriate to add these procedure codes describing control of bleeding in the cranial cavity to MS-DRGs 23, 24, 25, 26, and 27 in MDC 01.</P>
                    <P>Therefore, we are proposing to add procedure codes 0W310ZZ, 0W313ZZ, and 0W314ZZ to MDC 01 in MS-DRGs 23, 24, 25, 26, and 27 (“craniotomy” MS-DRGs) for FY 2022.</P>
                    <P>We also review the list of ICD-10-PCS procedures that, when in combination with their principal diagnosis code, result in assignment to MS-DRGs 981 through 983, or 987 through 989, to ascertain whether any of those procedures should be reassigned from one of those two groups of MS-DRGs to the other group of MS-DRGs based on average costs and the length of stay. We look at the data for trends such as shifts in treatment practice or reporting practice that would make the resulting MS-DRG assignment illogical. If we find these shifts, we would propose to move cases to keep the MS-DRGs clinically similar or to provide payment for the cases in a similar manner.</P>
                    <P>In addition to this internal review, we also consider requests that we receive to examine cases found to group to MS-DRGs 981 through 983 or MS-DRGs 987 through 989 to determine if it would be appropriate for the cases to be reassigned from one of the MS-DRG groups to the other.</P>
                    <P>
                        Based on the results of our review of the claims data from the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file, as well as our review of the requests that we received to examine cases found to group to MS-DRGs 981 through 983 or MS-DRGs 987 through 989, we are proposing to move the cases reporting the procedures codes described in this section of this rule from MS-DRGs 981 through 983 to MS-DRGs 987 through 989.
                        <PRTPAGE P="25154"/>
                    </P>
                    <P>As discussed in section II.D.3.a. of the preamble of this proposed rule, we received a request that we understood to be for our consideration of the reassignment of the following three procedure codes from Extensive O.R. procedures to Non-extensive O.R. procedures.</P>
                    <GPH SPAN="3" DEEP="93">
                        <GID>EP10MY21.078</GID>
                    </GPH>
                    <P>In conducting our review of this request, our clinical advisors noted that ICD-10-PCS codes 0JB60ZZ, 0JB70ZZ, and 0JB80ZZ currently group to MS-DRGs 981 through 983 when reported with a principal diagnosis that is not assigned to one of the MDCs to which these procedure codes are assigned. While our claims analysis of both the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file did not identify any cases reporting any one of the three listed procedure codes in MS-DRGs 981, 982, or 983, our clinical advisors believe that these procedures would be more appropriately designated as Non-extensive procedures because they are more consistent with other procedures on the Non-extensive procedure code list. They stated that these procedures do not consume the resources or require a similar level of technical complexity as the procedures on the Extensive O.R. procedures list.</P>
                    <P>Therefore, we are proposing to reassign the three procedure codes listed from MS-DRGs 981, 982, and 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, without CC/MCC, respectively) to MS-DRGs 987, 988, and 989 (Non-Extensive Procedure Unrelated to Principal Diagnosis with MCC, with CC, without CC/MCC, respectively) for FY 2022.</P>
                    <P>As discussed in section II.D.4.b. of the preamble of this proposed rule, we identified 17 procedure codes describing laser interstitial thermal therapy (LITT) that are currently designated as extensive O.R. procedures. In addition to those 17 procedure codes, we identified additional procedure codes describing LITT of various body parts that are also designated as extensive O.R. procedures. The ICD-10-PCS codes describing LITT of various body parts are as follows.</P>
                    <GPH SPAN="3" DEEP="458">
                        <PRTPAGE P="25155"/>
                        <GID>EP10MY21.079</GID>
                    </GPH>
                    <P>Whenever one of these listed procedure codes is reported on a claim that is unrelated to the MDC to which the case was assigned based on the principal diagnosis, it currently results in assignment to MS-DRGs 981, 982, and 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, without CC/MCC, respectively). Our clinical advisors stated that all of the listed procedure codes warrant redesignation from the extensive procedure list and MS-DRGs 981, 982, and 983 to the non-extensive procedure list and to MS-DRGs 987, 988, and 989 (Non-Extensive Procedure Unrelated to Principal Diagnosis with MCC, with CC, without CC/MCC, respectively). Specifically, our clinical advisors stated the procedures described by these codes are minimally invasive and are consistent with other ablation (root operation Destruction) type procedures that are designated as non-extensive procedures in the ICD-10-PCS classification.</P>
                    <P>
                        In our analysis of claims from the March 2020 update of the FY 2019 MedPAR file, we identified a total of six cases reporting procedure codes describing LITT of various body sites in MS-DRGs 981, 982, and 983 with an average length of stay of 2.5 days and average costs of $7,734. Specifically, we found one case reporting procedure code DVY0KZZ (Laser interstitial thermal therapy of prostate) in MS-DRG 981 with an average length of stay of 4.0 days and average costs of $7,348. For MS-DRG 982, we found five cases in which procedure codes describing LITT of various body sites were reported. The first case reported procedure code D0Y0KZZ (Laser interstitial thermal therapy of brain) with an average length of stay of 1.0 day and average costs of $4,142, the second case reported procedure code D0Y6KZZ (Laser interstitial thermal therapy of spinal cord) with an average length of stay of 3.0 days and average costs of $20,007, the third case reported procedure code DDY1KZZ (Laser interstitial thermal therapy of stomach) with an average length of stay of 2.0 days and average costs of $3,424, the fourth case reported procedure code DDY7KZZ (Laser interstitial thermal therapy of rectum) with an average length of stay of 3.0 days and average costs of $3,735, and 
                        <PRTPAGE P="25156"/>
                        the fifth case reported procedure code DVY0KZZ (Laser interstitial thermal therapy of prostate) with an average length of stay of 2.0 days and average costs of $7,750. There were no cases found to report procedures describing LITT in MS-DRG 983. Our findings are summarized in the following table.
                    </P>
                    <GPH SPAN="3" DEEP="175">
                        <GID>EP10MY21.081</GID>
                    </GPH>
                    <P>In our analysis of claims from the September 2020 update of the FY 2020 MedPAR file, we identified one case reporting procedure code D0Y6KZZ (Laser interstitial thermal therapy of spinal cord) with an average length of stay of 6 days and average costs of $5,130, and two cases reporting procedure code DVY0KZZ (Laser interstitial thermal therapy of prostate) with an average length of stay of 8.5 days and average costs of $20,329 in MS-DRGs 981, 982, or 983. Although our claims analysis identified a limited number of cases reporting procedures describing LITT, our clinical advisors believe that these procedures would be more appropriately designated as Non-extensive procedures because they are more consistent with other procedures on the Non-extensive procedure code list.</P>
                    <P>Therefore, we are proposing to reassign the listed procedure codes describing LITT of various body parts from MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) for FY 2022.</P>
                    <P>As also discussed in section II.D.4.b. of the preamble of this proposed rule, we identified five procedure codes describing repair of the esophagus that are currently designated as extensive O.R. procedures. The procedure codes are 0DQ50ZZ (Repair esophagus, open approach), 0DQ53ZZ (Repair esophagus, percutaneous approach), 0DQ54ZZ (Repair esophagus, percutaneous endoscopic approach), 0DQ57ZZ (Repair esophagus, via natural or artificial opening), and 0DQ58ZZ (Repair esophagus, via natural or artificial opening endoscopic). Whenever one of these five procedure codes is reported on a claim that is unrelated to the MDC to which the case was assigned based on the principal diagnosis, it currently results in assignment to MS-DRGs 981, 982, and 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, without CC/MCC, respectively). Our clinical advisors stated that three of these five procedures warrant redesignation from the extensive procedure list and MS-DRGs 981, 982, and 983 to the non-extensive procedure list and to MS-DRGs 987, 988, and 989 (Non-Extensive Procedure Unrelated to Principal Diagnosis with MCC, with CC, without CC/MCC, respectively). Specifically, our clinical advisors stated the procedures identified by procedure codes 0DQ53ZZ, 0DQ57ZZ, and 0DQ58ZZ do not involve the same utilization of resources with respect to the performance of the procedure in comparison to the procedures identified by procedure codes 0DQ50ZZ and 0DQ540ZZ. In our analysis of claims from the March 2020 update of the FY 2019 MedPAR file, we identified three cases reporting procedure code 0DQ58ZZ in MS-DRGs 981, 982, and 983 with an average length of stay of 14 days and average costs of $34,894. In our analysis of claims from the September 2020 update of the FY 2020 MedPAR file, we identified two cases reporting procedure code 0DQ58ZZ in MS-DRGs 981, 982, or 983 with an average length of stay of 8 days and average costs of $12,037. Our clinical advisors believe that these procedures would be more appropriately designated as Non-extensive procedures because they are more consistent with other procedures on the Non-extensive procedure code list. Therefore, we are proposing to reassign these three procedure codes (0DQ53ZZ, 0DQ57ZZ, and 0DQ58ZZ) from MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) for FY 2022.</P>
                    <P>
                        As discussed in section II.D.11.c.24. of the preamble of this proposed rule, we identified procedure code 0T9D0ZZ (Drainage of urethra, open approach) during our review of procedure code 0U9L0ZZ (Drainage of vestibular gland, open approach), which is currently designated as a non-O.R. procedure. We noted that the procedure described by procedure code 0T9D0ZZ represents the male equivalent of the female procedure described by procedure code 0U9L0ZZ. Procedure code 0T9D0ZZ is currently designated as an extensive O.R. procedure and is reported to describe procedures performed on the Cowper's (bulbourethral) gland in males. Whenever this procedure code is reported on a claim that is unrelated to the MDC to which the case was assigned based on the principal diagnosis, it currently results in assignment to MS-DRGs 981, 982, and 983 (Extensive O.R. Procedure Unrelated to Principal 
                        <PRTPAGE P="25157"/>
                        Diagnosis with MCC, with CC, without CC/MCC, respectively).
                    </P>
                    <P>Our clinical advisors stated that this procedure warrants redesignation from the extensive procedure list and MS-DRGs 981, 982, and 983 to the non-extensive procedure list and to MS-DRGs 987, 988, and 989 (Non-Extensive Procedure Unrelated to Principal Diagnosis with MCC, with CC, without CC/MCC, respectively). Specifically, our clinical advisors stated that the procedure described by procedure code 0T9D0ZZ continues to warrant an O.R. designation because it is performed on deeper structures and requires a higher level of technical skill and it is a more complex procedure when compared to the non-O.R. procedure described by procedure code 0U9L0ZZ, however, abscess formation in the Cowper's (bulbourethral) glands is uncommon and can often be treated with ultrasound guided percutaneous aspiration. The need for open surgical management is rare and includes chronic infection unresponsive to non-operative management and complicated acute infection such as perineal fistula formation. Open surgical management would require use of the operating room for both appropriate anesthesia and for the resources required to perform the more invasive perineal surgical dissection. Therefore, our clinical advisors believe a non-extensive O.R. designation is suitable for this procedure.</P>
                    <P>We analyzed claims data from the March 2020 update of the FY 2019 MedPAR file and the September 2020 update of the FY 2020 MedPAR file for cases reporting procedure code 0T9D0ZZ in MS-DRGs 981, 982, and 983. We found one case in MS-DRG 981 with an average length of stay of 8.0 days and average costs of $23,566 in the March 2020 update of the FY 2019 MedPAR file, and no cases in the September 2020 update of the FY 2020 MedPAR file. Although our claims analysis identified only one case reporting procedure code 0T9D0ZZ, our clinical advisors believe that these procedures would be more appropriately designated as Non-extensive procedures because they are more consistent with other procedures on the Non-extensive procedure code list.</P>
                    <P>Therefore, we are proposing to reassign procedure code 0T9D0ZZ from MS-DRGs 981, 982, and 983 (Extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) to MS-DRGs 987, 988, and 989 (Non-extensive O.R. Procedures Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) for FY 2022.</P>
                    <HD SOURCE="HD3">11. Operating Room (O.R.) and Non-O.R. Issues</HD>
                    <HD SOURCE="HD3">a. Background</HD>
                    <P>Under the IPPS MS-DRGs (and former CMS MS-DRGs), we have a list of procedure codes that are considered operating room (O.R.) procedures. Historically, we developed this list using physician panels that classified each procedure code based on the procedure and its effect on consumption of hospital resources. For example, generally the presence of a surgical procedure which required the use of the operating room would be expected to have a significant effect on the type of hospital resources (for example, operating room, recovery room, and anesthesia) used by a patient, and therefore, these patients were considered surgical. Because the claims data generally available do not precisely indicate whether a patient was taken to the operating room, surgical patients were identified based on the procedures that were performed. Generally, if the procedure was not expected to require the use of the operating room, the patient would be considered medical (non-O.R.).</P>
                    <P>
                        Currently, each ICD-10-PCS procedure code has designations that determine whether and in what way the presence of that procedure on a claim impacts the MS-DRG assignment. First, each ICD-10-PCS procedure code is either designated as an O.R. procedure for purposes of MS-DRG assignment (“O.R. procedures”) or is not designated as an O.R. procedure for purposes of MS-DRG assignment (“non-O.R. procedures”). Second, for each procedure that is designated as an O.R. procedure, that O.R. procedure is further classified as either extensive or non-extensive. Third, for each procedure that is designated as a non-O.R. procedure, that non-O.R. procedure is further classified as either affecting the MS-DRG assignment or not affecting the MS-DRG assignment. We refer to these designations that do affect MS-DRG assignment as “non O.R. affecting the MS-DRG.” For new procedure codes that have been finalized through the ICD-10 Coordination and Maintenance Committee meeting process and are proposed to be classified as O.R. procedures or non-O.R. procedures affecting the MS-DRG, our clinical advisors recommend the MS-DRG assignment which is then made available in association with the proposed rule (Table 6B.—New Procedure Codes) and subject to public comment. These proposed assignments are generally based on the assignment of predecessor codes or the assignment of similar codes. For example, we generally examine the MS-DRG assignment for similar procedures, such as the other approaches for that procedure, to determine the most appropriate MS-DRG assignment for procedures proposed to be newly designated as O.R. procedures. As discussed in section II.D.13 of the preamble of this proposed rule, we are making Table 6B.—New Procedure Codes—FY 2022 available on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                        . We also refer readers to the ICD-10 MS-DRG Version 38.1 Definitions Manual at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.html</E>
                         for detailed information regarding the designation of procedures as O.R. or non-O.R. (affecting the MS-DRG) in Appendix E—Operating Room Procedures and Procedure Code/MS-DRG Index.
                    </P>
                    <P>
                        In the FY 2020 IPPS/LTCH PPS proposed rule, we stated that, given the long period of time that has elapsed since the original O.R. (extensive and non-extensive) and non-O.R. designations were established, the incremental changes that have occurred to these O.R. and non-O.R. procedure code lists, and changes in the way inpatient care is delivered, we plan to conduct a comprehensive, systematic review of the ICD-10-PCS procedure codes. This will be a multi year project during which we will also review the process for determining when a procedure is considered an operating room procedure. For example, we may restructure the current O.R. and non O.R. designations for procedures by leveraging the detail that is now available in the ICD-10 claims data. We refer readers to the discussion regarding the designation of procedure codes in the FY 2018 IPPS/LTCH PPS final rule (82 FR 38066) where we stated that the determination of when a procedure code should be designated as an O.R. procedure has become a much more complex task. This is, in part, due to the number of various approaches available in the ICD-10-PCS classification, as well as changes in medical practice. While we have typically evaluated procedures on the basis of whether or not they would be performed in an operating room, we believe that there may be other factors to consider with regard to resource utilization, 
                        <PRTPAGE P="25158"/>
                        particularly with the implementation of ICD-10.
                    </P>
                    <P>We discussed in the FY 2020 IPPS/LTCH PPS proposed rule that as a result of this planned review and potential restructuring, procedures that are currently designated as O.R. procedures may no longer warrant that designation, and conversely, procedures that are currently designated as non-O.R. procedures may warrant an O.R. type of designation. We intend to consider the resources used and how a procedure should affect the MS-DRG assignment. We may also consider the effect of specific surgical approaches to evaluate whether to subdivide specific MS DRGs based on a specific surgical approach. We plan to utilize our available MedPAR claims data as a basis for this review and the input of our clinical advisors. As part of this comprehensive review of the procedure codes, we also intend to evaluate the MS-DRG assignment of the procedures and the current surgical hierarchy because both of these factor into the process of refining the ICD-10 MS-DRGs to better recognize complexity of service and resource utilization.</P>
                    <P>In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58540 through 58541), we provided a summary of the comments we had received in response to our request for feedback on what factors or criteria to consider in determining whether a procedure is designated as an O.R. procedure in the ICD-10-PCS classification system for future consideration.</P>
                    <P>In consideration of the PHE, we believe it may be appropriate to allow additional time for the claims data to stabilize prior to selecting the timeframe to analyze for this review. Additional time is also necessary as we continue to develop our process and methodology. Therefore, we will provide more detail on this analysis and the methodology for conducting this review in future rulemaking.</P>
                    <P>In this proposed rule, we are addressing requests that we received regarding changing the designation of specific ICD-10-PCS procedure codes from non-O.R. to O.R. procedures, or changing the designation from O.R. procedure to non-O.R. procedure. In this section of the rule we discuss the process that was utilized for evaluating the requests that were received for FY 2022 consideration. For each procedure, our clinical advisors considered—</P>
                    <P>• Whether the procedure would typically require the resources of an operating room;</P>
                    <P>• Whether it is an extensive or a nonextensive procedure; and</P>
                    <P>• To which MS-DRGs the procedure should be assigned.</P>
                    <P>We note that many MS-DRGs require the presence of any O.R. procedure. As a result, cases with a principal diagnosis associated with a particular MS-DRG would, by default, be grouped to that MS-DRG. Therefore, we do not list these MS-DRGs in our discussion in this section of this rule. Instead, we only discuss MS-DRGs that require explicitly adding the relevant procedure codes to the GROUPER logic in order for those procedure codes to affect the MS-DRG assignment as intended. In cases where we are proposing to change the designation of procedure codes from non-O.R. procedures to O.R. procedures, we also are proposing one or more MS-DRGs with which these procedures are clinically aligned and to which the procedure code would be assigned.</P>
                    <P>In addition, cases that contain O.R. procedures will map to MS-DRG 981, 982, or 983 (Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) or MS-DRG 987, 988, or 989 (Non-Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC, and without CC/MCC, respectively) when they do not contain a principal diagnosis that corresponds to one of the MDCs to which that procedure is assigned. These procedures need not be assigned to MS-DRGs 981 through 989 in order for this to occur. Therefore, if requestors included some or all of MS-DRGs 981 through 989 in their request or included MS-DRGs that require the presence of any O.R. procedure, we did not specifically address that aspect in summarizing their request or our response to the request in this section of this rule.</P>
                    <P>For procedures that would not typically require the resources of an operating room, our clinical advisors determined if the procedure should affect the MS-DRG assignment.</P>
                    <P>We received several requests to change the designation of specific ICD-10-PCS procedure codes from non-O.R. procedures to O.R. procedures, or to change the designation from O.R. procedures to non-O.R. procedures. In this section of this rule, we detail and respond to some of those requests. With regard to the remaining requests, our clinical advisors believe it is appropriate to consider these requests as part of our comprehensive review of the procedure codes as previously discussed.</P>
                    <HD SOURCE="HD3">b. O.R. Procedures to Non-O.R. Procedures</HD>
                    <HD SOURCE="HD3">(1) Open Drainage of Subcutaneous Tissue and Fascia</HD>
                    <P>One requestor identified the following ICD-10-PCS procedure code that describes the open drainage of right lower leg subcutaneous tissue and fascia, shown in the following table.</P>
                    <GPH SPAN="3" DEEP="77">
                        <GID>EP10MY21.082</GID>
                    </GPH>
                    <P>In the ICD-10 MS-DRG Version 38.1 Definitions Manual, this ICD-10-PCS procedure code is currently recognized as an O.R. procedure for purposes of MS-DRG assignment. The requestor noted that this procedure consumes resources comparable to related ICD-10-PCS procedure code 0J9N00Z (Drainage of right lower leg subcutaneous tissue and fascia with drainage device, open approach) that describes the open drainage of right lower leg subcutaneous tissue and fascia with a drainage device, which is currently designated as a Non-O.R. procedure. The requestor stated that these comparable procedures should be recognized similarly for purposes of MS-DRG assignment.</P>
                    <P>
                        During our review of this issue, we identified 21 ICD-10-PCS procedure codes that describe the open drainage of subcutaneous tissue and fascia, shown in the following table that are clinically similar to ICD-10-PCS code 0J9N0ZZ, and are also designated as O.R. 
                        <PRTPAGE P="25159"/>
                        procedures in the ICD-10 MS-DRG Version 38.1 Definitions Manual.
                    </P>
                    <GPH SPAN="3" DEEP="530">
                        <GID>EP10MY21.083</GID>
                    </GPH>
                    <P>We reviewed these procedures and our clinical advisors agree that procedures that describe the open drainage of subcutaneous tissue and fascia consume resources comparable to the related ICD-10-PCS procedure codes that describe the open drainage of subcutaneous tissue and fascia with a drainage device that are currently designated as non-O.R. procedures. These procedures do not typically require the resources of an operating room, and are not surgical in nature. Therefore, we are proposing to remove the 22 codes listed in the following table from the FY 2022 ICD-10 MS-DRGs Version 39 Definitions Manual in Appendix E—Operating Room Procedures and Procedure Code/MS-DRG Index as O.R. procedures. Under this proposal, these procedures would no longer impact MS-DRG assignment.</P>
                    <GPH SPAN="3" DEEP="483">
                        <PRTPAGE P="25160"/>
                        <GID>EP10MY21.084</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="109">
                        <GID>EP10MY21.085</GID>
                    </GPH>
                    <PRTPAGE P="25161"/>
                    <HD SOURCE="HD3">c. Non-O.R. Procedures to O.R. Procedures</HD>
                    <HD SOURCE="HD3">(1) Percutaneous Introduction of Substance Into Cranial Cavity and Brain</HD>
                    <P>One requestor identified ICD-10-PCS procedure code XW0Q316 (Introduction of eladocagene exuparvovec into cranial cavity and brain, percutaneous approach, new technology group 6) that the requestor stated is currently not recognized as an O.R. procedure for purposes of MS-DRG assignment. The requestor recommended that this procedure be designated as an O.R. procedure because the procedure requires traversing the skull in order to place a substance within the cranial cavity or brain. The requestor noted that CMS disagreed with designating this procedure as an O.R. procedure last year in the absence of claims data; however, the requestor stated that because the skull must be opened by drilling or cutting a burr hole through the skull, this procedure warrants O.R. status similar to other transcranial procedures performed with an open or percutaneous approach that are classified as O.R. procedures.</P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure code XW0Q316 is currently designated as a non-O.R. procedure for purposes of MS-DRG assignment. We agree with the requestor that procedure code XW0Q316 describes a procedure that involves the creation of a burr hole in the skull. In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58579 through 58580), we stated that, consistent with our annual process of assigning new procedure codes to MDCs and MS-DRGs, and designating a procedure as an O.R. or non-O.R. procedure, we reviewed the predecessor procedure code assignment. The predecessor code for procedure code XW0Q316 is procedure code 3E0Q3GC (Introduction of other therapeutic substance into cranial cavity and brain, percutaneous approach) which is designated as a non-O.R. procedure. In the absence of claims data, our clinical advisors also considered the indication for the specific procedure being described by the new procedure code, the treatment difficulty, and the resources utilized.</P>
                    <P>Upon further review and consideration, our clinical advisors agree that procedure code XW0Q316 describing a procedure that is performed by creating a burr hole in the skull warrants designation as an O.R. procedure consistent with other percutaneous procedures performed on the cranial cavity and brain body parts. Therefore, we are proposing to add this procedure code to the FY 2022 ICD-10 MS-DRGs Version 39 Definitions Manual in Appendix E- Operating Room Procedures and Procedure Code/MS-DRG Index as an O.R. procedure, assigned to MS-DRGs 628, 629, and 630 (Other Endocrine, Nutritional and Metabolic O.R. Procedures with MCC, with CC, and without CC/MCC, respectively) in MDC 10 (Endocrine, Nutritional and Metabolic Diseases and Disorders) and to MS-DRGs 987, 988, and 989 (Non-Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC and without MCC/CC, respectively).</P>
                    <HD SOURCE="HD3">(2) Open Drainage of Maxilla and Mandible</HD>
                    <P>One requestor identified three ICD-10-PCS procedure codes that describe the open drainage of maxilla or mandible that the requestor stated are currently not recognized as O.R. procedures for purposes of MS-DRG assignment. The three procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="75">
                        <GID>EP10MY21.086</GID>
                    </GPH>
                    <P>The requestor stated that procedures that describe the open drainage of the maxilla or mandible should be designated as O.R. procedures because these procedures, indicated for diagnoses such as subperiosteal abscesses, are performed in the operating room under general anesthesia and involve making open incisions through muscle and stripping away the periosteum. The requestor identified procedure codes 0W950ZZ (Drainage of lower jaw, open approach) and 0W940ZZ (Drainage of upper jaw, open approach) that are currently designated as O.R. procedures. The requestor noted that ICD-10-PCS guidelines instruct that the procedure codes in Anatomical Regions, General, can be used when the procedure is performed on an anatomical region rather than a specific body part, or on the rare occasion when no information is available to support assignment of a code to a specific body part. The requestor stated that because bone is a specific body part in ICD-10-PCS, procedure codes should be assigned for subperiosteal drainage of mandible and maxilla bones from table 0N9, Drainage of Head and Facial Bones, instead of codes from table 0W9, Drainage of Anatomical Regions, General, when these procedures are performed. Therefore, the requestor stated that procedure codes 0N9R0ZZ, 0N9T0ZZ, and 0N9V0ZZ should also be recognized as O.R. procedures for purposes of MS-DRG assignment.</P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure codes 0N9R0ZZ, 0N9T0ZZ, and 0N9V0ZZ are currently designated as non-O.R. procedures for purposes of MS-DRG assignment. Our clinical advisors reviewed this issue and disagree that the procedures describing the open drainage of the maxilla or mandible are typically performed in the operating room under general anesthesia. Our clinical advisors state that these procedures can be done in an oral surgeon's office or an outpatient setting and are rarely performed in the inpatient setting. Our clinical advisors also state a correlation cannot be made between procedures performed in general anatomic regions and procedures performed in specific body parts because these procedures coded with the general anatomic regions body part represent a broader range of procedures that cannot be coded to a specific body part. Therefore, we are proposing to maintain the current non-O.R. designation of ICD-10-PCS procedure codes 0N9R0ZZ, 0N9T0ZZ, and 0N9V0ZZ.</P>
                    <HD SOURCE="HD3">(3) Thoracoscopic Extirpation of Pleural Cavities</HD>
                    <P>
                        One requestor identified ICD-10-PCS procedure codes 0WC94ZZ (Extirpation of matter from right pleural cavity, percutaneous endoscopic approach) and 0WCB4ZZ (Extirpation of matter from left pleural cavity, percutaneous 
                        <PRTPAGE P="25162"/>
                        endoscopic approach) that the requestor stated are currently not recognized as O.R. procedures for purposes of MS-DRG assignment. The requestor stated that these procedures should be designated as O.R. procedures because they are thoracoscopic procedures that are always performed in the operating room under general anesthesia. The requestor stated procedure codes 0W994ZZ (Drainage of right pleural cavity, percutaneous endoscopic approach) and 0W9B4ZZ (Drainage of left pleural cavity, percutaneous endoscopic approach) are currently designated as O.R. procedures, therefore procedure codes 0WC94ZZ and 0WCB4ZZ should also be recognized as O.R. procedures for purposes of MS-DRG assignment because they utilize the same resources.
                    </P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure codes 0WC94ZZ and 0WCB4ZZ are currently designated as non-O.R. procedures for purposes of MS-DRG assignment. Our clinical advisors reviewed this issue and disagree that procedure codes describing the thoracoscopic drainage of the pleural cavities should necessarily have the same designation as procedure codes describing the thoracoscopic extirpation of matter from the pleural cavities. We note that our review of the designation of ICD-10-PCS codes as an O.R. procedure or a non-O.R. procedure considers the resources used as well as whether that procedure should affect the MS-DRG assignment, and if so, in what way. Our clinical advisors state that thoracoscopic drainage of the pleural cavities is performed for distinct indications in clinically different scenarios. Our clinical advisors state that drainage is the process of taking out, or letting out, fluids and/or gases from a body part and is typically performed in the pleural cavity for indications such as congestive heart failure, infection, hemothorax and empyema. In contrast, the procedures describing the thoracoscopic extirpation of the pleural cavities are performed for a wider range of indications because the solid matter removed may be an abnormal byproduct of a biological function or a foreign body. Our clinical advisors note that the thoracoscopic extirpation of the pleural cavities is generally performed with other procedures such as heart transplant, lung transplant mechanical ventilation, and other major chest procedures and would not be the main reason for inpatient hospitalization or be considered the principal driver of resource expenditure.</P>
                    <P>Therefore, we are proposing to maintain the current non-O.R. designation of ICD-10-PCS procedure codes 0WC94ZZ and 0WCB4ZZ.</P>
                    <HD SOURCE="HD3">(4) Open Pleural Biopsy</HD>
                    <P>One requestor identified ICD-10-PCS procedure codes 0BBN0ZX (Excision of right pleura, open approach, diagnostic) and 0BBP0ZX (Excision of left pleura, open approach, diagnostic), that describe an open pleural biopsy that the requestor stated are performed in the operating room with general anesthesia. The requestor also stated that procedure codes 0BBN0ZZ (Excision of right pleura, open approach) and 0BBP0ZZ (Excision of left pleura, open approach) describing open pleural biopsy for non-diagnostic purposes are justifiably designated as O.R. procedures. According to the requestor, these procedure codes describing an open pleural biopsy should be designated as O.R. procedures regardless of whether they are performed for diagnostic or therapeutic purposes.</P>
                    <P>We note that under the ICD-10-PCS procedure classification, biopsy procedures are identified by the 7th digit qualifier value “diagnostic” in the code description. In response to the requestor's suggestion that procedures performed for a pleural biopsy by an open approach, regardless of whether it is a diagnostic or therapeutic procedure, should be designated as an O.R. procedure, we examined procedure codes 0BBN0ZX, 0BBN0ZZ, 0BBP0ZX, and 0BBP0ZZ.</P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure codes 0BBN0ZZ and 0BBP0ZZ are currently designated as O.R. procedures, however, procedure codes 0BBN0ZX and 0BBP0ZX are not recognized as O.R. procedures for purposes of MS-DRG assignment. We agree with the requestor that procedure codes 0BBN0ZX and 0BBP0ZX would typically require the resources of an operating room. Our clinical advisors also agree that procedure codes 0BBN0ZX and 0BBP0ZX would typically require the resources of an operating room. Therefore, we are proposing to add these 2 procedure codes to the FY 2022 ICD-10 MS-DRGs Version 39 Definitions Manual in Appendix E—Operating Room Procedures and Procedure Code/MS- DRG Index as O.R. procedures, assigned to MS-DRGs 166, 167, and 168 (Other Respiratory System O.R. Procedures with MCC, with CC, and without CC/MCC, respectively) in MDC 04 (Diseases and Disorders of the Respiratory System).</P>
                    <HD SOURCE="HD3">(5) Percutaneous Revision of Intraluminal Devices</HD>
                    <P>One requestor identified five ICD-10-PCS procedure codes that describe the percutaneous revision of intraluminal vascular devices that the requestor stated are currently not recognized as O.R. procedures for purposes of MS-DRG assignment. The five procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="105">
                        <GID>EP10MY21.087</GID>
                    </GPH>
                    <P>
                        The requestor stated that the procedure codes that describe the percutaneous revision of intraluminal vascular devices within arteries, veins, and great vessels should be designated as O.R. procedures to compensate for the resources needed to perform these procedures. The requestor also stated procedures to reattach, realign, or otherwise revise intraluminal devices percutaneously require anesthesia, specialized equipment for intravascular visualization, significant skill, and time, therefore, it is important for these codes 
                        <PRTPAGE P="25163"/>
                        to be designated with O.R. procedure status.
                    </P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure codes 02WY3DZ, 03WY3DZ, 04WY3DZ, 05WY3DZ, and 06WY3DZ are currently designated as non-O.R. procedures for purposes of MS-DRG assignment. We agree with the requestor that these five ICD-10-PCS procedure codes typically require the resources of an operating room. Therefore, to the FY 2022 ICD-10 MS-DRG Version 39 Definitions Manual in Appendix E—Operating Room Procedures and Procedure Code/MS-DRG Index, we are proposing to add code 02WY3DZ as an O.R. procedure assigned to MS-DRGs 270, 271, and 272 (Other Major Cardiovascular Procedures, with MCC, with CC, and without CC/MCC, respectively) in MDC 05 (Diseases and Disorders of the Circulatory System). We are also proposing to add codes 03WY3DZ, 04WY3DZ, 05WY3DZ, and 06WY3DZ as O.R. procedures assigned to MS-DRGs 252, 253, and 254 (Other Vascular Procedures with MCC, with CC, and without CC/MCC, respectively) in MDC 05 (Diseases and Disorders of the Circulatory System).</P>
                    <HD SOURCE="HD3">(6) Occlusion of Left Atrial Appendage</HD>
                    <P>One requestor identified nine ICD-10-PCS procedure codes that describe left atrial appendage closure (LAAC) procedures that the requestor stated are currently not recognized as O.R. procedures for purposes of MS-DRG assignment in all instances. The nine procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="220">
                        <GID>EP10MY21.088</GID>
                    </GPH>
                    <P>The requestor stated that these procedures are currently designated as non-O.R. procedures that route to surgical MS-DRGs only when assigned in combination with a principal diagnosis within MDC 05 (Diseases and Disorders of the Circulatory System). The requestor stated these procedures should also be designated as O.R. procedures when assigned in combination with diagnoses outside of the circulatory system, such as sepsis or trauma, to compensate for the associated resource use, skill requirements, and device costs.</P>
                    <P>In the ICD-10 MS-DRG Version 38.1 Definitions Manual, the nine ICD-10-PCS procedure codes that describe left atrial appendage closure are currently recognized as non-O.R. procedures that affect the MS-DRG to which they are assigned. We refer readers to section II.D.5.d of the preamble of this proposed rule, where we address ICD-10-PCS procedure codes 02L70CK, 02L70DK, and 02L70ZK that describe a LAAC procedure performed with an open approach. These codes were discussed in response to a request to reassign these codes to MS-DRGs 228 and 229 (Other Cardiothoracic Procedures with and without MCC, respectively) and, for the reasons discussed, we are proposing to maintain the assignment in MS-DRGs 273 and 274 (Percutaneous and Other Intracardiac Procedures with and without MCC, respectively) in MDC 05.</P>
                    <P>
                        Our clinical advisors reviewed this related issue and believe the current designation of LAAC procedures as non-O.R. procedures that affect the assignment for MS-DRGs 273 and 274 is clinically appropriate to account for the subset of patients undergoing left atrial appendage closure specifically. LAAC is indicated and approved as a treatment option for patients diagnosed with atrial fibrillation, a heart rhythm disorder that can lead to cardiovascular blood clot formation, who are also at increased risk for stroke. LAAC procedures block off the left atrial appendage to prevent emboli that may form in the left atrial appendage from exiting and traveling to other sites in the vascular system, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The ICD-10-CM diagnosis codes used to report atrial fibrillation are currently assigned to MDC 05 (Diseases and Disorders of the Circulatory System). Our clinical advisors believe that circumstances in which a patient is admitted for a principal diagnosis outside of MDC 05 and a left atrial appendage closure is performed as the only surgical procedure in the same admission are infrequent, and if they do occur, the LAAC procedure would not be a significant contributing factor in the increased intensity of resources needed for facilities to manage these complex cases. Our clinical advisors state LAAC procedures generally do not require the resources of an operating room. LAAC procedures are most often performed percutaneously in settings such as cardiac catheterization laboratories and take approximately one hour. When performed with an open approach or percutaneous endoscopic approach, these procedures share similar factors such as complexity, and resource 
                        <PRTPAGE P="25164"/>
                        utilization with all other LAAC procedures. Therefore, we are proposing to maintain the current designation of ICD-10-PCS procedure codes 02L70CK, 02L70DK, 02L70ZK, 02L73CK, 02L73DK, 02L73ZK, 02L74CK, 02L74DK, and 02L74ZK as non-O.R. procedures affecting the MS-DRGs to which they are assigned.
                    </P>
                    <HD SOURCE="HD3">(7) Arthroscopic Drainage of Joints</HD>
                    <P>One requestor identified six ICD-10-PCS procedure codes that describe the percutaneous endoscopic drainage of joints that the requestor stated are currently not recognized as O.R. procedures for purposes of MS-DRG assignment. The six procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="120">
                        <GID>EP10MY21.089</GID>
                    </GPH>
                    <P>The requestor stated that these procedures should be designated as O.R. procedures because procedures describing the arthroscopic drainage of major joints such as knee, hip, and shoulder are performed in the operating room under general anesthesia. The requestor stated these procedures are indicated for conditions such as symptomatic septic/pyogenic arthritis, which can require inpatient admission for intravenous antibiotics and arthroscopic drainage to resolve infection. Therefore, the requestor stated it is reasonable for these arthroscopic procedures to be designated as O.R. procedures to compensate for operating room resources.</P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure codes 0S9C4ZZ, 0S9D4ZZ, 0S994ZZ, 0S9B4ZZ, 0R9J4ZZ, and 0R9K4ZZ are currently designated as non-O.R. procedures for purposes of MS-DRG assignment. Our clinical advisors reviewed this issue and disagree that procedures describing the percutaneous endoscopic drainage of major joints such as knee, hip, and shoulder are typically performed in the operating room under general anesthesia. With development of better instrumentation and surgical techniques, many patients now have arthroscopic procedures performed in an outpatient setting and return home several hours after the procedure. Our clinical advisors also state the percutaneous endoscopic drainage of joints can be performed using local or regional anesthesia, and general anesthesia is not always required. In cases where the patient is admitted for diagnoses such as septic/pyogenic arthritis, as identified by the requestor, the requirement for intravenous antibiotics would be the main reason for admission because the percutaneous endoscopic drainage procedure could be done as an outpatient. Therefore, we are proposing to maintain the current non-O.R. designation of ICD-10-PCS procedure codes 0S9C4ZZ, 0S9D4ZZ, 0S994ZZ, 0S9B4ZZ, 0R9J4ZZ, and 0R9K4ZZ.</P>
                    <HD SOURCE="HD3">(8) Arthroscopic Irrigation of Joints</HD>
                    <P>One requestor identified ICD-10-PCS procedure codes 3E1U48X (Irrigation of joints using irrigating substance, percutaneous endoscopic approach, diagnostic) and 3E1U48Z (Irrigation of joints using irrigating substance, percutaneous endoscopic approach) that the requestor stated are currently not recognized as O.R. procedures for purposes of MS-DRG assignment. The requestor stated that these procedures should be designated as O.R. procedures because the arthroscopic irrigation of joints such as knee, hip, and shoulder is performed in the operating room under general anesthesia. The requestor states procedure codes 3E1U48X and 3E1U48Z are used to describe surgical joint irrigations in the absence of more definitive procedures, therefore procedure codes 3E1U48X and 3E1U48Z should be recognized as O.R. procedures for purposes of MS-DRG assignment.</P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure codes 3E1U48X and 3E1U48Z are currently designated as non-O.R. procedures for purposes of MS-DRG assignment. Our clinical advisors reviewed this issue and disagree that procedure codes describing the arthroscopic irrigation of joints should be designated as O.R. procedures. Our clinical advisors note the arthroscopic irrigation of joints is rarely performed independently as a standalone procedure in the inpatient setting to be considered the principal driver of resource expenditure in those admissions. Instead, the arthroscopic irrigation of joints is generally performed with other definitive procedures such as debridement or synovectomy. We note that in the operative note sent by the requestor to support the requested change in O.R. status, the arthroscopic irrigation of the joint was performed along with a surgical debridement procedure. Therefore, we are proposing to maintain the current non-O.R. designation of ICD-10-PCS procedure codes 3E1U48X and 3E1U48Z.</P>
                    <HD SOURCE="HD3">(9) Percutaneous Reposition With Internal Fixation</HD>
                    <P>One requestor identified four ICD-10-PCS procedure codes describing procedures performed on the sacroiliac and hip joints that involve percutaneous repositioning with internal fixation that the requestor stated are not recognized as O.R. procedures for purposes of MS-DRG assignment but warrant an O.R. designation. The procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="117">
                        <PRTPAGE P="25165"/>
                        <GID>EP10MY21.090</GID>
                    </GPH>
                    <P>Our clinical advisors reviewed the procedures described by these four procedure codes and agree that these percutaneous reposition procedures involving internal fixation in the sacroiliac and hip joint warrant an O.R. designation. They noted that these procedures are major operations that would require the resources of an operating room, involve a higher level of technical complexity and a greater utilization of hospital resources.</P>
                    <P>Therefore, we are proposing to add the two procedure codes describing percutaneous reposition of the sacroiliac joint with internal fixation procedures (0SS734Z and 0SS834Z) to the FY 2022 ICD-10 MS-DRGs Version 39 Definitions Manual in Appendix E—Operating Room Procedures and Procedure Code/MS-DRG Index as O.R. procedures, assigned to MS-DRGs 515, 516, and 517 (Other Musculoskeletal System and Connective Tissue O.R. Procedures with MCC, with CC, and without CC/MCC, respectively) in MDC 08 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue) and to MS-DRGs 987, 988, and 989 (Non-Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC and without MCC/CC, respectively). We are also proposing to add the two procedure codes describing percutaneous reposition of the hip joint with internal fixation procedures (0SS934Z and 0SSB34Z) to the FY 2022 ICD-10 MS-DRGs Version 39 Definitions Manual in Appendix E—Operating Room Procedures and Procedure Code/MS-DRG Index as O.R. procedures, assigned to MS-DRGs 480, 481, and 482 (Hip and Femur Procedures Except Major Joint with MCC, with CC, and without CC/MCC, respectively) in MDC 08 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue) and to MS-DRGs 987, 988, and 989 (Non-Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC and without MCC/CC, respectively).</P>
                    <HD SOURCE="HD3">(10) Open Insertion and Removal of Spacer Into Shoulder Joint</HD>
                    <P>One requestor identified four ICD-10-PCS procedure codes describing procedures performed on the shoulder joint that involve the insertion or removal of a spacer by an open approach that the requestor stated are not recognized as O.R. procedures for purposes of MS-DRG assignment. The procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="90">
                        <GID>EP10MY21.091</GID>
                    </GPH>
                    <P>According to the requestor, insertion and removal of joint spacers from the hips and knees are designated with an O.R. procedure status and although similar procedures performed on the shoulder joint may be performed less frequently, these procedures warrant an O.R. designation because they are performed in the operating room under general anesthesia. During our review, we noted that the following procedure codes describing procedures performed on the shoulder joint that involve the insertion or removal of a spacer by a percutaneous endoscopic approach are also not recognized as O.R. procedures for purposes of MS-DRG assignment.</P>
                    <GPH SPAN="3" DEEP="90">
                        <GID>EP10MY21.092</GID>
                    </GPH>
                    <PRTPAGE P="25166"/>
                    <P>Our clinical advisors reviewed the procedures described by these eight procedure codes and agree that these procedures involving the insertion or removal of a spacer in the shoulder joint with an open or percutaneous endoscopic approach warrant an O.R. designation. They noted that the insertion of a spacer is typically performed to treat an infection at the site of a previously placed prosthesis and the removal of a spacer is typically performed once the infection is healed and the site is ready for a new prosthetic replacement or to exchange for a new spacer if the infection is not yet healed.</P>
                    <P>Therefore, we are proposing to add the listed procedure codes describing the insertion or removal of spacer in the shoulder joint to the FY 2022 ICD-10 MS-DRGs Version 39 Definitions Manual in Appendix E—Operating Room Procedures and Procedure Code/MS-DRG Index as O.R. procedures, assigned to MS-DRGs 510, 511, and 512 (Shoulder, Elbow or Forearm Procedures, Except Major Joint Procedures with MCC, with CC, and without CC/MCC, respectively) in MDC 08 (Diseases and Disorders of the Musculoskeletal System and Connective Tissue) and to MS-DRGs 987, 988, and 989 (Non-Extensive O.R. Procedure Unrelated to Principal Diagnosis with MCC, with CC and without MCC/CC, respectively).</P>
                    <HD SOURCE="HD3">(11) Open/Percutaneous Extirpation of Jaw</HD>
                    <P>One requestor identified four ICD-10-PCS procedure codes that describe the extirpation of matter from the upper or lower jaw that the requestor stated are currently not recognized as O.R. procedures for purposes of MS-DRG assignment. The four procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="90">
                        <GID>EP10MY21.093</GID>
                    </GPH>
                    <P>The requestor stated that the procedure codes that describe the extirpation of matter from the upper or lower jaw by an open or percutaneous endoscopic approach should be designated as O.R. procedures. The requestor stated these procedures would commonly be performed under general anesthesia and require the resources of an operating room. The requestor also stated that these ICD-10-PCS codes were specifically created to describe the surgical evacuation of solid matter from deep jaw structures therefore, it is important for these codes to be designated with O.R. procedure status.</P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure codes 0WC40ZZ, 0WC44ZZ, 0WC50ZZ, 0WC54ZZ are currently designated as non-O.R. procedures for purposes of MS-DRG assignment. We agree with the requestor that these four ICD-10-PCS procedure codes typically require the resources of an operating room. Therefore, to the FY 2022 ICD-10 MS-DRG Version 39 Definitions Manual in Appendix E—Operating Room Procedures and Procedure Code/MS-DRG Index, we are proposing to add codes 0WC40ZZ, 0WC44ZZ, 0WC50ZZ, 0WC54ZZ as O.R. procedures assigned to MS-DRGs 143, 144 and 145 (Other Ear, Nose, Mouth and Throat O.R. procedures, with MCC, with CC, and without CC/MCC, respectively) in MDC 03 (Diseases and Disorders of the Ear, Nose, Mouth and Throat).</P>
                    <HD SOURCE="HD3">(12) Open Extirpation of Subcutaneous Tissue and Fascia</HD>
                    <P>One requestor identified 22 ICD-10-PCS procedure codes that describe the open extirpation of matter from the subcutaneous tissue and fascia that the requestor stated are currently not recognized as O.R. procedures for purposes of MS-DRG assignment. The 22 procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="360">
                        <PRTPAGE P="25167"/>
                        <GID>EP10MY21.094</GID>
                    </GPH>
                    <P>The requestor stated that procedure codes that describe the open extirpation of matter from the subcutaneous tissue and fascia should be designated as O.R. procedures because these procedures are performed through open incisions with direct visualization of subcutaneous tissue and fascia in the operating room under general anesthesia. The requestor noted procedure codes that describe the open drainage of subcutaneous tissue and fascia and use comparable resources are currently designated as O.R. procedures. The requestor noted that root operation “Drainage” is assigned when fluid is drained; and root operation of “Extirpation” is assigned when any of the substance evacuated is solid. The requestor stated whether the evacuated substance is fluid, gelatinous, or solid, a procedure involving an open incision with direct visualization of subcutaneous tissue and fascia for evacuation of substances should be classified as an O.R. procedure. Therefore, the requestor stated that these procedures should also be recognized as O.R. procedures for purposes of MS-DRG assignment.</P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, the 22 ICD-10-PCS procedure codes listed in the table are currently designated as non-O.R. procedures for purposes of MS-DRG assignment. While we disagree that drainage procedures are comparable to extirpation procedures, we agree with the requestor that these 22 ICD-10-PCS procedure codes typically require the resources of an operating room. Our clinical advisors state that drainage is the process of taking out, or letting out, fluids and/or gases from a body part and is typically performed for indications such as abscess, infection, and other systemic conditions. In contrast, extirpation procedures are performed for a wider range of indications because the solid matter removed may be an abnormal byproduct of a biological function or a retained foreign body. Therefore, to the FY 2022 ICD-10 MS-DRG Version 39 Definitions Manual in Appendix E—Operating Room Procedures and Procedure Code/MS-DRG Index, we are proposing to add the 22 ICD-10-PCS listed previously as O.R. procedures assigned to MS-DRGs 579, 580 and 581 (Other Skin, Subcutaneous Tissue and Breast Procedures, with MCC, with CC, and without CC/MCC, respectively) in MDC 09 (Diseases and Disorders of the Skin, Subcutaneous Tissue and Breast) and MS-DRGs 907, 908, and 909 (Other O.R. Procedures for Injuries with MCC, with CC, and without CC/MCC, respectively) in MDC 21 (Injuries, Poisonings and Toxic Effects of Drugs).</P>
                    <HD SOURCE="HD3">(13) Open Revision and Removal of Devices From Subcutaneous Tissue and Fascia</HD>
                    <P>One requestor identified six ICD-10-PCS procedure codes describing open revision and removal of neurostimulator generators, monitoring devices, and totally implantable vascular access devices (TIVADs) procedures that are not currently designated as O.R. procedures for purposes of MS-DRG assignment. The six procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="189">
                        <PRTPAGE P="25168"/>
                        <GID>EP10MY21.096</GID>
                    </GPH>
                    <P>The requestor stated that although removal of these devices is often performed in outpatient surgery, device complications can require removal or revision during inpatient hospitalizations. The requestor indicated it is reasonable for these open procedures to be designated as O.R. procedures to compensate for operating room resources during such inpatient stays.</P>
                    <P>Our clinical advisors reviewed this request and do not agree that these procedures warrant an O.R. designation. They noted that these procedures are generally performed in the outpatient setting and when performed during a hospitalization, it is typically in conjunction with another O.R. procedure. Therefore, we are proposing to maintain the current non-O.R. designation for procedure codes 0JPT0MZ, 0JPT02Z, 0JPT0WZ, 0JWT0MZ, 0JWT0WZ, and 0JWT03Z for FY 2022.</P>
                    <HD SOURCE="HD3">(14) Open Insertion of Feeding Device</HD>
                    <P>One requestor identified ICD-10-PCS procedure code 0DHA0UZ (Insertion of feeding device into jejunum, open approach) that the requestor stated is currently not recognized as an O.R. procedure for purposes of MS-DRG assignment. The requestor stated the open insertion of a feeding device into the jejunum should be designated as an O.R. procedure because this procedure is performed in the operating room under general anesthesia. The requestor noted comparable procedure code 0DH60UZ (Insertion of feeding device into stomach, open approach) is currently designated as an O.R. procedure. Therefore, the requestor stated that procedure code 0DHA0UZ should also be recognized as an O.R. procedure for purposes of MS-DRG assignment.</P>
                    <P>Our analysis of this issue confirmed that in the ICD-10 MS-DRG Version 38.1 Definitions Manual, for purposes of MS-DRG assignment, 0DHA0UZ is recognized as a non-O.R. procedure and 0DH60UZ is currently recognized as an O.R. procedure. In reviewing this request, we also identified the following four related codes:</P>
                    <GPH SPAN="3" DEEP="141">
                        <GID>EP10MY21.097</GID>
                    </GPH>
                    <P>In the ICD-10 MS-DRGs Version 38.1, these four ICD-10-PCS codes are currently recognized as non-O.R. procedure for purposes of MS-DRG assignment. While we agree with the requestor that procedures describing the open insertion of a feeding device into the jejunum are comparable to procedures describing the open insertion of a feeding device into the stomach, we do not agree that these procedures should be designated as O.R. procedures. Our clinical advisors state the procedures that describe the open insertion of a feeding device into the jejunum or the stomach should instead have the same designation as the related ICD-10-PCS procedure codes that describe the open insertion of a feeding device into the esophagus, small intestine, duodenum and ileum that are currently designated as non-O.R. procedures.</P>
                    <P>
                        With advancements in procedural techniques, feeding devices are most commonly placed using a percutaneous endoscopic approach. Our clinical advisors state feeding devices are usually not placed using an open surgical approach; this approach is 
                        <PRTPAGE P="25169"/>
                        generally only used if the patient requires another surgical procedure at the same time. When placed at the same time as another surgical procedure, our clinical advisors state the surgical procedure, as the main determinant of resource use for those cases, should drive the MS-DRG assignment, not the procedure that describes the open insertion of a feeding device. For these reasons, our clinical advisors state procedures that describe the open insertion of a feeding device in the gastrointestinal system should all have the same non-O.R. designation in the ICD-10 MS-DRGs Version 39 for coherence.
                    </P>
                    <P>Therefore, we are proposing to maintain the current non-O.R. designation of ICD-10-PCS procedure code 0DHA0UZ. We are also proposing to remove ICD-10-PCS procedure code 0DH60UZ from the FY 2022 ICD-10 MS-DRG Version 39 Definitions Manual in Appendix E—Operating Room Procedures and Procedure Code/MS-DRG Index as an O.R. procedure. Under this proposal, this procedure would no longer impact MS-DRG assignment.</P>
                    <HD SOURCE="HD3">(15) Laparoscopic Insertion of Feeding Tube</HD>
                    <P>One requestor identified ICD-10-PCS procedure codes 0DH64UZ (Insertion of feeding device into stomach, percutaneous endoscopic approach) and 0DHA4UZ (Insertion of feeding device into jejunum, percutaneous endoscopic approach) that the requestor stated are currently not recognized as O.R. procedures for purposes of MS-DRG assignment. The requestor stated the procedures describing the percutaneous endoscopic insertion of a feeding device into the stomach or the jejunum should be designated as O.R. procedures because these procedures are performed in the operating room under general anesthesia. The requestor stated all laparoscopic procedures, regardless if they are diagnostic or therapeutic, should be classified as O.R. procedures to compensate for operating room resources.</P>
                    <P>Our analysis of this issue confirmed that in the ICD-10 MS-DRG Version 38.1 Definitions Manual, 0DH64UZ and 0DHA4UZ are currently designated as non-O.R. procedures for purposes of MS-DRG assignment. In reviewing this request, we also identified the following four related codes:</P>
                    <GPH SPAN="3" DEEP="185">
                        <GID>EP10MY21.098</GID>
                    </GPH>
                    <P>In the ICD-10 MS-DRGs Version 38.1, these four ICD-10-PCS codes are currently recognized as non-O.R. procedures for purposes of MS-DRG assignment. Our clinical advisors reviewed this request and do not agree that unilaterally all laparoscopic procedures should be designated as O.R. procedures. While the procedural approach is an important consideration in the designation of a procedure, there are other clinical factors such as the site of procedure, the procedure complexity, and resource utilization that should also be considered. In this regard, our clinical advisors indicated that codes 0DH64UZ and 0DHA4UZ describing the percutaneous endoscopic insertion of a feeding device into the stomach or the jejunum, do not require the resources of an operating room, are not surgical in nature, and are generally performed in the outpatient setting. The percutaneous endoscopic insertion of a feeding device also does not require general anesthesia. As opposed to being rendered unconscious, patients can receive a local anesthetic (usually a lidocaine spray), an intravenous (IV) pain reliever, and a mild sedative if needed. Patients receiving these devices usually return home the same day after placement, unless they are in the hospital for treatment of another condition.</P>
                    <P>Our clinical advisors state the percutaneous endoscopic insertion of a feeding device into the stomach or the jejunum is comparable to the related ICD-10-PCS procedure codes that describe the insertion of feeding devices of other gastrointestinal system body parts that are currently designated as non-O.R. procedures. Our clinical advisors believe all procedures that describe the percutaneous endoscopic insertion of a feeding device in the gastrointestinal system should continue to have the same non-O.R. designation in the ICD-10 MS-DRGs Version 39 for coherence. Therefore, for the reasons discussed, we are proposing to maintain the current non-O.R. designation of ICD-10-PCS procedure codes 0DH64UZ and 0DHA4UZ.</P>
                    <HD SOURCE="HD3">(16) Endoscopic Fragmentation and Extirpation of Matter of Urinary Tract</HD>
                    <P>One requestor sent two separate but related requests related to endoscopic procedures performed in the urinary system. With regard to the first request, the requestor identified six ICD-10-PCS procedure codes that describe endoscopic fragmentation in the kidney pelvis, ureter, bladder, and bladder neck that the requestor stated are currently not recognized as O.R. procedures for purposes of MS-DRG assignment. The six procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="120">
                        <PRTPAGE P="25170"/>
                        <GID>EP10MY21.099</GID>
                    </GPH>
                    <P>The requestor stated that these procedures should be designated as O.R. procedures because procedures such as the endoscopic fragmentation of calculi within the kidney pelvis, ureter, bladder, and bladder neck are performed in the operating room under anesthesia. The requestor stated that procedures that describe the endoscopic extirpation of calculi from the kidney pelvis or ureter use comparable resources, and are designated as O.R. procedures. Therefore, the requestor asserted it is reasonable that procedure codes that describe endoscopic fragmentation in kidney pelvis, ureter, bladder, and bladder neck also be designated as O.R. procedures.</P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure codes 0TF38ZZ, 0TF48ZZ, 0TF68ZZ, 0TF78ZZ, 0TFB8ZZ, and 0TFC8ZZ are designated as non-O.R. procedures for purposes of MS-DRG assignment. Our clinical advisors reviewed this issue and disagree that procedures describing the endoscopic fragmentation of calculi within the kidney pelvis, ureter, bladder, and bladder neck are typically performed in the operating room. In endoscopic fragmentation procedures in the kidney pelvis, ureter, bladder, and bladder neck, the scope is passed through a natural or artificial orifice. The procedure is not surgical in nature and involves no skin incisions. With advancements in scope size, deflection capabilities, video imaging, and instrumentation, many patients now have these endoscopic urinary procedures performed in an outpatient setting, instead of the inpatient setting. Therefore, we are proposing to maintain the current non-O.R. designation of ICD-10-PCS procedure codes 0TF38ZZ, 0TF48ZZ, 0TF68ZZ, 0TF78ZZ, 0TFB8ZZ, and 0TFC8ZZ.</P>
                    <P>In the second request, the requestor also identified two ICD-10-PCS procedure codes that describe endoscopic extirpation of matter from the bladder and bladder neck that the requestor stated are also currently not recognized as O.R. procedures for purposes of MS-DRG assignment. The two procedure codes are listed in the following table.</P>
                    <GPH SPAN="3" DEEP="60">
                        <GID>EP10MY21.100</GID>
                    </GPH>
                    <P>The requestor stated that these procedures also should be designated as O.R. procedures because they performed in the operating room under anesthesia.</P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure codes 0TCB8ZZ and 0TCC8ZZ are currently designated as a non-O.R. procedure for purposes of MS-DRG assignment. To review the request to designate 0TCB8ZZ and 0TCC8ZZ as O.R. procedures and in response to the requestor's suggestion that resource consumption is comparable in procedures describing endoscopic fragmentation in the urinary system and procedures describing the endoscopic extirpation in the urinary system, we examined the following procedure codes:</P>
                    <GPH SPAN="3" DEEP="195">
                        <PRTPAGE P="25171"/>
                        <GID>EP10MY21.101</GID>
                    </GPH>
                    <P>In the ICD-10 MS-DRG Version 38.1 Definitions Manual, these six ICD-10-PCS procedure codes are currently recognized as O.R. procedures for purposes of MS-DRG assignment. Our clinical advisors indicated that these procedures are not surgical in nature. In endoscopic extirpation procedures, the scope enters the urinary tract through the urethra, which is the tube that carries urine out of the body, or through an artificial orifice. Our clinical advisors state the urinary system is one conduit so the scope continues to pass through the urethra, bladder, and into the ureter or kidney (if necessary) to access the stone. For that reason, the procedures describing endoscopic extirpation from a urinary body part should all have the same non-O.R. designation in the ICD-10 MS-DRGs Version 39 for coherence.</P>
                    <P>Therefore, we are proposing to maintain the current non-O.R. designation of ICD-10-PCS procedure codes 0TCB8ZZ and 0TCC8ZZ. We are also proposing to remove ICD-10-PCS procedure codes 0TC08ZZ, 0TC18ZZ, 0TC38ZZ, 0TC48ZZ, 0TC68ZZ, and 0TC78ZZ from the FY 2022 ICD-10 MS-DRG Version 39 Definitions Manual in Appendix E—Operating Room Procedures and Procedure Code/MS-DRG Index as O.R. procedures. Under this proposal, these procedures would no longer impact MS-DRG assignment.</P>
                    <HD SOURCE="HD3">(17) Endoscopic Removal of Ureteral Stent</HD>
                    <P>One requestor identified ICD-10-PCS procedure code 0TP98DZ (Removal of intraluminal device from ureter, via natural or artificial opening endoscopic) that the requestor stated is not recognized as an O.R. procedure for purposes of MS-DRG assignment. The requestor suggested that this procedure warrants an O.R. designation because the procedure code describes a procedure that is performed in the operating room with anesthesia. The requestor stated that while most ureteral stents can be removed by string, some complicated cases require endoscopic removal using forceps in the operating room under general anesthesia and may be performed during inpatient stays precipitated by severe urinary tract infection, sepsis, or urinary obstructions. The requestor asserted that procedure codes for insertion of ureteral stent(s) via a ureteroscopic, endoscopic approach have been justifiably designated as O.R. procedures because they are performed in the O.R. under anesthesia. Therefore, the requestor suggested it is reasonable for endoscopic removal of the stent to be designated with OR procedure status to compensate for operating room resources and anesthesia.</P>
                    <P>Our clinical advisors reviewed this procedure and do not agree that it warrants an O.R. designation. They noted that this procedure is generally not the focus of the admission when it is performed and does not reflect the technical complexity or resource intensity in comparison to other procedures that are designated as O.R. procedures. Therefore, we are proposing to maintain the current non-O.R. designation for procedure code 0TP98DZ for FY 2022.</P>
                    <HD SOURCE="HD3">(18) Endoscopic/Transorifice Inspection of Ureter</HD>
                    <P>One requestor identified ICD-10-PCS procedure code 0TJ98ZZ (Inspection of ureter, via natural or artificial opening endoscopic), that describes procedures involving endoscopic viewing of the ureter that the requestor stated is currently not recognized as an O.R. procedure for purposes of MS-DRG assignment.</P>
                    <P>The requestor stated this ureteroscopy procedure is performed in the operating room with anesthesia. According to the requestor, the inspection of ureter procedure code is assigned when obstruction is found during the ureteroscopy and procedures to break up (fragmentation), remove calculi (extirpation), or place a ureteral stent cannot be performed.</P>
                    <P>Our clinical advisors reviewed this procedure and disagree that it warrants an O.R. designation. They noted that this procedure typically does not require hospitalization and is generally not the reason for the patient's admission since it is often performed in connection with another O.R. procedure when it is performed. Therefore, we are proposing to maintain the current non-O.R. designation for procedure code 0TJ789ZZ for FY 2022.</P>
                    <HD SOURCE="HD3">(19) Endoscopic Biopsy of Ureter and Kidney</HD>
                    <P>
                        One requestor identified six ICD-10-PCS procedure codes that describe endoscopic biopsy procedures performed on the ureter and kidney structures that the requestor stated are currently not recognized as O.R. procedures for purposes of MS-DRG assignment. According to the requestor, regardless of whether it is a diagnostic or therapeutic procedure, these procedures should be designated as O.R. procedures because the procedures utilize operating room, anesthesia and recovery room resources. The requestor stated that after the surgeon places the scope into the bladder that ureteral orifices must be identified and instruments carefully navigated to obtain excisional biopsies from within the ureter or further within the kidney. 
                        <PRTPAGE P="25172"/>
                        The six procedure codes are listed in the following table.
                    </P>
                    <GPH SPAN="3" DEEP="147">
                        <GID>EP10MY21.102</GID>
                    </GPH>
                    <P>We note that under the ICD-10-PCS procedure classification, biopsy procedures are identified by the 7th digit qualifier value “diagnostic” in the code description.</P>
                    <P>Our clinical advisors do not agree that endoscopic biopsy procedures performed on the ureter and kidney structures warrant an O.R. designation. They stated these procedures are typically not the focus for the patient's admission and are frequently performed in conjunction with another O.R. procedure. Therefore, we are proposing to maintain the current non-O.R. designation for procedure codes 0TB08ZX, 0TB18ZX, 0TB38ZX, 0TB48ZX, 0TB68ZX, and 0TB78ZX for FY 2022.</P>
                    <HD SOURCE="HD3">(20) Transorifice Insertion of Ureteral Stent</HD>
                    <P>One requestor identified three ICD-10-PCS procedure codes that the requestor stated are not recognized as O.R. procedures for purposes of MS-DRG assignment. The requestor suggested that the procedure described by these procedure codes warrants an O.R. designation because it involves the insertion of an indwelling ureteral stent through a nephrostomy with image-guidance in the interventional radiology suite. According to the requestor, image-guided technology now allows placement of ureteral stents through nephrostomy tracts. The requestor stated this procedure may or may not be performed in the operating room, however, it involves placement of device(s), interventional radiology resources, sedation, and continuous monitoring of vital signs. The three procedure codes are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="75">
                        <GID>EP10MY21.103</GID>
                    </GPH>
                    <P>Our clinical advisors reviewed this request and do not agree that this procedure warrants an O.R. designation. They noted that this procedure is not surgical in nature, does not require the resources of an operating room and is not a technically complex procedure requiring increased hospital resources. Therefore, we are proposing to maintain the current non-O.R. designation for procedure codes 0T767DZ, 0T777DZ, and 0T787DZ for FY 2022.</P>
                    <HD SOURCE="HD3">(21) Percutaneous Insertion of Ureteral Stent</HD>
                    <P>One requestor identified three ICD-10-PCS procedure codes that the requestor stated are not recognized as O.R. procedures for purposes of MS-DRG assignment. The requestor suggested that the procedure described by these procedure codes warrants an O.R. designation because the procedure is typically performed following a failed ureteral stent insertion procedure in the operating room, which can only be reported as a cystoscopy or ureteroscopy, neither of which are designated as O.R. procedures. According to the requestor, percutaneous ureteral stenting through the abdominal wall is subsequently performed in an interventional radiology suite with image-guidance, sedation, and continuous vital sign monitoring. The three procedure codes are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="75">
                        <GID>EP10MY21.104</GID>
                    </GPH>
                    <PRTPAGE P="25173"/>
                    <P>Our clinical advisors reviewed this request and do not agree that the procedure warrants an O.R. designation. They noted that this procedure is not surgical in nature, does not involve technical complexity or require the resources of an operating rom. Therefore, we are proposing to maintain the current non-O.R. designation for procedure codes 0T763DZ, 0T773DZ, and 0T783DZ for FY 2022.</P>
                    <HD SOURCE="HD3">(22) Endoscopic Dilation of Urethra</HD>
                    <P>One requestor identified ICD-10-PCS procedure code 0T7D8DZ (Dilation of urethra with intraluminal device, via natural or artificial opening endoscopic) that the requestor stated is not recognized as an O.R. procedure for purposes of MS-DRG assignment. The requestor suggested that this procedure warrants an O.R. designation because the procedure code describes a procedure that utilizes the UroLift® System, a minimally invasive technology to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). According to the requestor, the technology is placed endoscopically within the prostatic urethra in the operating room under anesthesia.</P>
                    <P>Our clinical advisors reviewed this request and do not agree that the procedure warrants an O.R. designation. They noted that this procedure is performed without incision, resection or thermal injury to the prostate and is primarily performed in the outpatient setting. It is generally not the cause for the patient's admission and utilization of resources when it is performed. Therefore, we are proposing to maintain the current non-O.R. designation for procedure code 00T7D8DZ for FY 2022.</P>
                    <HD SOURCE="HD3">(23) Open Repair of Scrotum</HD>
                    <P>One requestor identified ICD-10-PCS procedure code 0VQ50ZZ (Repair scrotum, open approach) that the requestor stated is not recognized as an O.R. procedure for purposes of MS-DRG assignment. The requestor suggested that this procedure warrants an O.R. designation because it involves repair of scrotal tissue deeper than the skin with direct visualization and utilizes general anesthesia in the operating room.</P>
                    <P>Our clinical advisors do not agree that open repair of the scrotum merits an O.R. designation. They stated this procedure would not typically require the resources of an operating room and would generally not be a contributing factor impacting hospital resource use during the patient's admission when it is performed. Therefore, we are proposing to maintain the current non-O.R. designation for procedure code 0VQ50ZZ for FY 2022.</P>
                    <HD SOURCE="HD3">(24) Open Drainage of Vestibular Gland</HD>
                    <P>One requestor identified ICD-10-PCS procedure code 0U9L0ZZ (Drainage of vestibular gland, open approach) that describes a procedure commonly performed for the treatment of an abscess that the requestor stated is performed in the operating room under general anesthesia and therefore warrants an O.R designation. The requestor stated this procedure is comparable to the procedure described by procedure code 0UBL0ZZ (Excision of vestibular gland, open approach) which is currently designated as an O.R. procedure.</P>
                    <P>During our review of procedure code 0U9L0ZZ, we also examined procedure codes 0U9L0ZX (Drainage of vestibular gland, open approach, diagnostic), 0U9LXZX (Drainage of vestibular gland, external approach, diagnostic), and 0UBL0ZZ. Separately, we reviewed procedure code 0T9D0ZZ (Drainage of urethra, open approach) because it represents the male equivalent of the female procedure described by procedure code 0U9L0ZZ.</P>
                    <P>In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure codes 0T9D0ZZ, 0U9L0ZX, 0U9LXZX, and 0UBL0ZZ are currently designated as O.R. procedures, however, procedure code 0U9L0ZZ is not recognized as an O.R. procedure for purposes of MS-DRG assignment. We examined procedure code 0U9L0ZZ and do not believe this drainage procedure warrants an O.R. designation, nor do we agree that this drainage of the vestibular gland procedure (0U9L0ZZ) is comparable to an excision of the vestibular gland procedure (0UBL0ZZ), which is currently designated as an O.R. procedure.</P>
                    <P>In the ICD-10-PCS classification, drainage is defined as taking or letting out fluids and/or gases from a body part and excision is defined as cutting out or off, without replacement, a portion of a body part. Therefore, the classification specifically defines and distinguishes the underlying objectives of each distinct procedure. Our clinical advisors stated a drainage procedure is frequently performed in the outpatient setting and is generally not the cause for the patient's admission and utilization of resources when it is performed. Drainage of the vestibular gland, also known as Bartholin's glands, is typically indicated when a cyst or abscess is present and may or may not involve the placement of a Word catheter. Conversely, excision of the vestibular gland is not considered an office-based procedure and is generally reserved for a vulvar mass or for patients who have not responded to more conservative attempts to create a drainage tract. In addition, after review, our clinical advisors recommended changing the O.R. status for procedure codes 0U9L0ZX and 0U9LXZX from O.R. to non-O.R. for similar reasons. These procedures do not typically require the resources of an operating room.</P>
                    <P>Therefore, we are proposing to remove procedure codes 0U9L0ZX and 0U9LXZX from the FY 2022 ICD-10 MS-DRGs Version 39 Definitions Manual in Appendix E- Operating Room Procedures and Procedure Code/MS-DRG Index as O.R. procedures. Under this proposal, these procedure codes would no longer impact MS-DRG assignment. We refer the reader to section II.D.10 of the preamble of this proposed rule for further discussion related to procedure code 0T9D0ZZ.</P>
                    <HD SOURCE="HD3">(25) Transvaginal Repair of Vagina</HD>
                    <P>One requestor identified ICD-10-PCS procedure code 0UQG7ZZ (Repair vagina, via natural or artificial opening) that the requestor stated is currently not recognized as an O.R. procedure for purposes of MS-DRG assignment. The requestor stated that procedures described by this code such as the non-obstetric transvaginal repair of the vaginal cuff and the non-obstetric transvaginal repair of vaginal lacerations should be designated as O.R. procedures because these procedures are performed in the operating room under general anesthesia. The requestor noted procedure codes 0USG7ZZ (Reposition vagina, via natural or artificial opening), 0UBG7ZZ (Excision of vagina, via natural or artificial opening), and 0UQG8ZZ (Repair vagina, via natural or artificial opening endoscopic) are currently designated as O.R. procedures, therefore procedure code 0UQG7ZZ should also be recognized as an O.R. procedure for purposes of MS-DRG assignment.</P>
                    <P>
                        In the ICD-10 MS-DRGs Definitions Manual Version 38.1, procedure code 0UQG7ZZ is currently designated as a non-O.R. procedure for purposes of MS-DRG assignment. Our clinical advisors reviewed this issue and disagree that a correlation can be made between procedures described as the transvaginal repair of the vagina and the procedures described by ICD-10-PCS codes 0USG7ZZ, 0UBG7ZZ, and 0UQG8ZZ. The root operation “repair” represents a broad range of procedures for restoring the anatomic structure of a body part such as suture of lacerations, while the root operations “reposition,” and “excision” define procedures with more 
                        <PRTPAGE P="25174"/>
                        distinct objectives. Also the approach “via natural or artificial opening”, for example, transvaginal, is defined as the entry of instrumentation through a natural or artificial external opening to reach the site of the procedure while the “via natural or artificial opening endoscopic approach” is defined as the entry of instrumentation (for example a scope) through a natural or artificial external opening to both reach and visualize the site of the procedure. Our clinical advisors also disagree that procedures described as the transvaginal repair of the vagina are typically performed in the operating room under general anesthesia. Our clinical advisors state transvaginal repair can be performed using regional anesthesia, used to numb only the area of the body that requires surgery instead of rendering the patient unconscious. Therefore, for the reasons described, we are proposing to maintain the current non-O.R. designation of ICD-10-PCS procedure code 0UQG7ZZ.
                    </P>
                    <HD SOURCE="HD3">(26) Percutaneous Tunneled Vascular Access Devices</HD>
                    <P>One requestor identified ten ICD-10-PCS procedure codes describing percutaneous insertion of tunneled vascular access devices into various body parts that the requestor stated are not recognized as an O.R. procedure for purposes of MS-DRG assignment. The requestor suggested that these procedures warrant an O.R. designation because they are placed in an interventional radiology suite or in the operating room under anesthesia. The ten procedure codes are shown in the following table.</P>
                    <GPH SPAN="3" DEEP="317">
                        <GID>EP10MY21.105</GID>
                    </GPH>
                    <P>According to the requestor, it does not make sense for tunneled vascular access devices to group to procedural MS-DRGs in limited circumstances as is the case currently with the logic in MDC 9 (Diseases and Disorders of the Skin, Subcutaneous Tissue and Breast) and MDC 11 (Diseases and Disorders of the Kidney and Urinary Tract). The requestor stated that these procedures should be grouping to procedural MS-DRGs across all MDCs.</P>
                    <P>We note that we have addressed requests related to these procedures in previous rulemaking (85 FR 58511 through 58517). Our clinical advisors reviewed this request and disagree that procedures performed to insert a tunneled vascular access device should group to procedural MS-DRGs across all MDCs. They stated that these percutaneous procedures are generally performed in the outpatient setting and when performed during a hospitalization, they are frequently performed in combination with another O.R. procedure. Therefore, we are proposing to maintain the current non-O.R. status for the ten procedure codes listed previously for FY 2022.</P>
                    <HD SOURCE="HD3">12. Proposed Changes to the MS-DRG Diagnosis Codes for FY 2022</HD>
                    <HD SOURCE="HD3">a. Background of the CC List and the CC Exclusions List</HD>
                    <P>
                        Under the IPPS MS-DRG classification system, we have developed a standard list of diagnoses that are considered CCs. Historically, we developed this list using physician panels that classified each diagnosis code based on whether the diagnosis, when present as a secondary condition, would be considered a substantial complication or comorbidity. A substantial complication or comorbidity was defined as a condition that, because 
                        <PRTPAGE P="25175"/>
                        of its presence with a specific principal diagnosis, would cause an increase in the length-of-stay by at least 1 day in at least 75 percent of the patients. However, depending on the principal diagnosis of the patient, some diagnoses on the basic list of complications and comorbidities may be excluded if they are closely related to the principal diagnosis. In FY 2008, we evaluated each diagnosis code to determine its impact on resource use and to determine the most appropriate CC subclassification (NonCC, CC, or MCC) assignment. We refer readers to sections II.D.2. and 3. of the preamble of the FY 2008 IPPS final rule with comment period for a discussion of the refinement of CCs in relation to the MS-DRGs we adopted for FY 2008 (72 FR 47152 through 47171).
                    </P>
                    <HD SOURCE="HD3">b. Overview of Comprehensive CC/MCC Analysis</HD>
                    <P>In the FY 2008 IPPS/LTCH PPS final rule (72 FR 47159), we described our process for establishing three different levels of CC severity into which we would subdivide the diagnosis codes. The categorization of diagnoses as a MCC, a CC, or a NonCC was accomplished using an iterative approach in which each diagnosis was evaluated to determine the extent to which its presence as a secondary diagnosis resulted in increased hospital resource use. We refer readers to the FY 2008 IPPS/LTCH PPS final rule (72 FR 47159) for a complete discussion of our approach. Since the comprehensive analysis was completed for FY 2008, we have evaluated diagnosis codes individually when assigning severity levels to new codes and when receiving requests to change the severity level of specific diagnosis codes.</P>
                    <P>We noted in the FY 2020 IPPS/LTCH PPS proposed rule (84 FR 19235 through 19246) that with the transition to ICD-10-CM and the significant changes that have occurred to diagnosis codes since the FY 2008 review, we believed it was necessary to conduct a comprehensive analysis once again. Based on this analysis, we proposed changes to the severity level designations for 1,492 ICD-10-CM diagnosis codes and invited public comments on those proposals. As summarized in the FY 2020 IPPS/LTCH PPS final rule, many commenters expressed concern with the proposed severity level designation changes overall and recommended that CMS conduct further analysis prior to finalizing any proposals. After careful consideration of the public comments we received, as discussed further in the FY 2020 final rule, we generally did not finalize our proposed changes to the severity designations for the ICD-10-CM diagnosis codes, other than the changes to the severity level designations for the diagnosis codes in category Z16- (Resistance to antimicrobial drugs) from a NonCC to a CC. We stated that postponing adoption of the proposed comprehensive changes in the severity level designations would allow further opportunity to provide additional background to the public on the methodology utilized and clinical rationale applied across diagnostic categories to assist the public in its review. We refer readers to the FY 2020 IPPS/LTCH PPS final rule (84 FR 42150 through 42152) for a complete discussion of our response to public comments regarding the proposed severity level designation changes for FY 2020.</P>
                    <P>We discussed in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58550 through 58554) that we plan to continue a comprehensive CC/MCC analysis, using a combination of mathematical analysis of claims data as discussed in the FY 2020 IPPS/LTCH PPS proposed rule (84 FR 19235) and the application of nine guiding principles and plan to present the findings and proposals in future rulemaking. The nine guiding principles are as follows:</P>
                    <P>• Represents end of life/near death or has reached an advanced stage associated with systemic physiologic decompensation and debility.</P>
                    <P>• Denotes organ system instability or failure.</P>
                    <P>• Involves a chronic illness with susceptibility to exacerbations or abrupt decline.</P>
                    <P>• Serves as a marker for advanced disease states across multiple different comorbid conditions.</P>
                    <P>• Reflects systemic impact.</P>
                    <P>• Post-operative/post-procedure condition/complication impacting recovery.</P>
                    <P>• Typically requires higher level of care (that is, intensive monitoring, greater number of caregivers, additional testing, intensive care unit care, extended length of stay).</P>
                    <P>• Impedes patient cooperation and/or management of care.</P>
                    <P>• Recent (last 10 years) change in best practice, or in practice guidelines and review of the extent to which these changes have led to concomitant changes in expected resource use.</P>
                    <P>We refer readers to the FY 2021 IPPS/LTCH PPS final rule for a complete discussion of our response to public comments regarding the nine guiding principles. We continue to solicit feedback regarding these guiding principles, as well as other possible ways we can incorporate meaningful indicators of clinical severity. When providing additional feedback or comments, we encourage the public to provide a detailed explanation of how applying a suggested concept or principle would ensure that the severity designation appropriately reflects resource use for any diagnosis code.</P>
                    <P>For new diagnosis codes approved for FY 2022, consistent with our annual process for designating a severity level (MCC, CC or NonCC) for new diagnosis codes, we first review the predecessor code designation, followed by review and consideration of other factors that may be relevant to the severity level designation, including the severity of illness, treatment difficulty, complexity of service and the resources utilized in the diagnosis and/or treatment of the condition. We note that this process does not automatically result in the new diagnosis code having the same designation as the predecessor code. We refer the reader to II.D.13 of this proposed rule for the discussion of the proposed changes to the ICD-10-CM and ICD-10-PCS coding systems for FY 2022.</P>
                    <P>For this FY 2022 IPPS/LTCH PPS proposed rule, we received several requests to change the severity level designations of specific ICD-10-CM diagnosis codes. Our clinical advisors believe it is appropriate to consider these requests in connection with our continued comprehensive CC/MCC analysis in future rulemaking, rather than proposing to change the designation of individual ICD-10-CM diagnosis codes at this time. As stated earlier in this section, we plan to continue a comprehensive CC/MCC analysis, using a combination of mathematical analysis of claims data and the application of nine guiding principles. We will consider these individual requests received for changes to severity level designations as we continue our comprehensive CC/MCC analysis and will provide more detail in future rulemaking.</P>
                    <HD SOURCE="HD3">c. Potential Change to Severity Level Designation for Unspecified Diagnosis Codes for FY 2022</HD>
                    <P>
                        For this FY 2022 IPPS/LTCH PPS proposed rule, as another interval step as we continue to address the comprehensive review of the severity designations of ICD-10-CM diagnosis codes in which we have been engaged over the past two years, we are requesting public comments on a potential change to the severity level designations for “unspecified” ICD-10-CM diagnosis codes that we are considering adopting for FY 2022. 
                        <PRTPAGE P="25176"/>
                        Specifically, we are considering changing the severity level designation of all “unspecified” diagnosis codes to a NonCC where there are other codes available in that code subcategory that further specify the anatomic site, effective for FY 2022, after consideration of the public comments we receive in response to this proposed rule.
                    </P>
                    <P>According to the ICD-10-CM Official Guidelines for Coding and Reporting, codes titled “unspecified” are for use when the information in the medical record is insufficient to assign a more specific code. In our review of severity level designation of the codes in the ICD-10-CM classification, we noted 3,490 “unspecified” diagnosis codes designated as either CC or MCC, where there are other codes available in that code subcategory that further specify the anatomic site with an equivalent severity level designation. For example, ICD-10-CM code L89.003 (Pressure ulcer of unspecified elbow, stage 3) is currently designated as a MCC. In the same code subcategory of L89.0- (Pressure ulcer of elbow), ICD-10-CM codes L89.013 (Pressure ulcer of right elbow, stage 3) and code L89.023 (Pressure ulcer of left elbow, stage 3) are also designed as MCCs.</P>
                    <P>In the FY 2008 IPPS/LTCH PPS final rule (72 FR 47159), we described the categorization of diagnoses as an MCC, a CC, or a NonCC, accomplished using an iterative approach in which each diagnosis was evaluated to determine the extent to which its presence as a secondary diagnosis resulted in increased hospital resource use. As such, the designation of CC or MCC is intended to account for the increased resources required to address a condition as a secondary diagnosis. The usage of “unspecified” diagnosis codes where there are other codes available in that code subcategory that further specify the anatomic site may contribute to and eventually result in less reliable data for researching clinical outcomes. If documentation is not available to code to the highest level of specificity as to the laterality of the condition treated, and an unspecified code is reported by the hospital, it may be harder to quantify in the claims data what additional resources were expended to address that condition in terms of requiring clinical evaluation, therapeutic treatment, diagnostic procedures, extended length of hospital stay, increased nursing care and/or monitoring.</P>
                    <P>As stated previously, we discussed in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58550 through 58554) that we plan to continue a comprehensive CC/MCC analysis, using a combination of mathematical analysis of claims data, and the application of nine guiding principles, and plan to present the findings and proposals in future rulemaking. As patients present with a variety of diagnoses, in examining the secondary diagnoses, we stated we would consider what additional resources are required, that surpasses those that are already being utilized to address the principal diagnosis and/or other secondary diagnoses that might also be present on the claim. The goal of our comprehensive analysis is to create stratification for reimbursing inpatient hospitalization in the fewest amount of categories with the most explanatory power in a clinically cohesive way. We believe more robust claims data would facilitate this effort to determine the impact on resource use and inform our decision-making in determining the most appropriate CC subclass (NonCC, CC, or MCC) assignment for each diagnosis as a secondary diagnosis. As part of this effort, we are soliciting comments on adopting a change to the severity level designation of the 3,490 “unspecified” diagnosis codes currently designated as either CC or MCC, where there are other codes available in that code subcategory that further specify the anatomic site, to a NonCC for FY 2022.</P>
                    <P>As discussed in the HIPAA Administrative Simplification: Modification to Medical Data Code Set Standards To Adopt ICD-10-CM and ICD-10-PCS proposed rule (73 FR 49796 through 49803), in proposing the adoption of ICD-10-CM and ICD-10-PCS, we listed that the addition of laterality in ICD-10-CM— specifying which organ or part of the body is involved when the location could be on the right, the left, or could be bilateral, was one of several improvements over ICD-9-CM. We also noted that in comparison to ICD-9-CM, ICD-10-CM diagnosis codes are very specific and that this specificity improves the richness of data for analysis and improves the accuracy of data used for medical research. In the Modifications to Medical Data Code Set Standards To Adopt ICD-10-CM and ICD-10-PCS final rule (74 FR 3328 through 3362), we adopted the ICD-10-CM and ICD-10-PCS as medical data code sets under HIPAA, replacing ICD-9-CM Volumes 1 and 2, and Volume 3 and noted that ICD-10-CM and ICD-10-PCS provide specific diagnosis and treatment information that can improve quality measurements and patient safety, and the evaluation of medical processes and outcomes. We continue to believe that reporting the most specific diagnosis codes supported by the available medical record documentation and clinical knowledge of the patient's health condition would more accurately reflect the health care encounter and improve the reliability and validity of the coded data.</P>
                    <P>We believe that changing the severity level for these “unspecified codes” as compared to the more specific codes in the same subcategory recognizing laterality would leverage the additional specificity available under the ICD-10 system, by fostering the reporting of the most specific diagnosis codes supported by the available medical record documentation and clinical knowledge of the patient's health condition to more accurately reflect each health care encounter and improve the reliability and validity of the coded data. However in consideration of the PHE, and to the extent that some providers may not currently have programs in place that focus on improving documentation, we are requesting public comments on making this change to the severity level designation for these unspecified ICD-10-CM diagnosis codes for FY 2022.</P>
                    <P>
                        The diagnosis codes for which we are soliciting comments on a change in severity level designation as described in this proposed rule are shown in Table 6P.2a (which is available via the internet on the CMS website at: 
                        <E T="03">http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                        ). We note we are also making available the data describing the impact on resource use when reported as a secondary diagnosis for all 3,490 ICD-10-CM unspecified diagnosis codes. While these claims data were not used in our identification of the “unspecified” diagnosis codes for which there are other codes available in the code subcategory that further specify the anatomic site, as mentioned earlier in this section, these data are consistent with data historically used to mathematically measure impact on resource use for secondary diagnoses, and the data which we plan to use in combination with application of the nine guiding principles as we continue a comprehensive CC/MCC analysis. Therefore, we are displaying the data on these unspecified codes in order to facilitate public comment on these potential changes in the severity level designation for these codes.
                    </P>
                    <P>
                        In Table 6P.2a associated with this proposed rule, column C displays the FY 2020 severity level designation for these diagnosis codes in MS-DRG Grouper Version 37.2. Column D displays CMS' current FY 2021 severity level designation in MS-DRG Grouper 
                        <PRTPAGE P="25177"/>
                        Version 38.1 and column E displays the potential changes to the severity level designation that we are considering adopting. Columns F-O show data on the impact on resource use generated using discharge claims from the September 2019 update of the FY 2019 MedPAR file and MS-DRG Grouper Version 37.2. Columns Q-Z show data on the impact on resource use generated using discharge claims from the September 2020 update of the FY 2020 MedPAR file and MS-DRG Grouper Version 38.1.
                    </P>
                    <P>
                        For further information on the data on the impact on resource use as displayed in Columns F-O and Columns Q-Z, we refer readers to the FY 2008 IPPS/LTCH PPS final rule (72 FR 47159) for a complete discussion of the methodology utilized to mathematically measure the impact on resource use. Also, as discussed in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32550), to provide the public with more information on the CC/MCC comprehensive analysis discussed in the FY 2020 IPPS/LTCH PPS proposed and final rules, CMS hosted a listening session on October 8, 2019. The listening session included a review of this methodology utilized to mathematically measure the impact on resource use. We refer readers to 
                        <E T="03">https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.html</E>
                         for the transcript and audio file of the listening session. We also refer readers to 
                        <E T="03">https://www.cms.gov/Medicare/MedicareFee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software.html</E>
                         for the supplementary file containing the data describing the impact on resource use of specific ICD-10-CM diagnosis codes when reported as a secondary diagnosis that was made available for the listening session.
                    </P>
                    <P>This table shows the Version 38.1 ICD-10 MS-DRG categorization of diagnosis codes by severity level.</P>
                    <GPH SPAN="3" DEEP="100">
                        <GID>EP10MY21.106</GID>
                    </GPH>
                    <P>We are requesting public comments on a modification to the Version 38.1 severity level subclass assignments for 4.8 percent of the ICD-10-CM diagnosis codes, potentially effective with the Version 39 ICD-10 MS-DRG MCC/CC list. The following table compares the Version 38.1 ICD-10 MS-DRG MCC/CC list and the potential Version 39 ICD-10 MS-DRG MCC/CC list. There are 17,957 diagnosis codes on the Version 38.1 MCC/CC lists. These potential MCC/CC severity level changes would reduce the number of diagnosis codes on the MCC/CC lists to 14,467 (2,771+ 11,696).</P>
                    <GPH SPAN="3" DEEP="169">
                        <GID>EP10MY21.107</GID>
                    </GPH>
                    <P>The net result of these potential changes to the Version 39 ICD-10 MS-DRG MCC/CC list, for the 72,621 diagnosis codes in the ICD-10-CM classification, would be a decrease of 507 (3,278−2,771) codes designated as an MCC, a decrease of 2,983 (14,679−11,696) codes designated as a CC, and an increase of 3,490 (58,154−54,664) codes designated as a NonCC.</P>
                    <P>The following table compares the Version 38.1 ICD-10 MS-DRG severity level list and the potential Version 39 ICD-10 MS-DRG severity level list by each of the 22 chapters of the ICD-10-CM classification to display how each chapter of ICD-10-CM might be affected by these modifications.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="534">
                        <PRTPAGE P="25178"/>
                        <GID>EP10MY21.108</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="558">
                        <PRTPAGE P="25179"/>
                        <GID>EP10MY21.109</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>As shown in the table, the Diseases of the Musculoskeletal System and Connective Tissue (M00-M99) chapter of ICD-10-CM would have the largest percentage reduction in codes designated as CC/MCC. Twelve chapters would have a zero percentage change to the percentage of codes designated as CC/MCC.</P>
                    <P>
                        As stated previously, we are requesting public comments on our possible adoption of a change to the severity level designation of these 3,490 “unspecified” diagnosis codes currently designated as either CC or MCC, where there are other codes available in that code subcategory that further specify the anatomic site, to a NonCC, potentially effective with the Version 39 ICD-10 MS-DRG MCC/CC list. As part of this request, we would be interested in comments regarding whether this modification might present operational challenges and how we might otherwise foster the reporting of the most specific diagnosis codes supported by the available medical record documentation and clinical knowledge of the patient's health condition to more accurately 
                        <PRTPAGE P="25180"/>
                        reflect each health care encounter and improve the reliability and validity of the coded data.
                    </P>
                    <HD SOURCE="HD3">d. Proposed Additions and Deletions to the Diagnosis Code Severity Levels for FY 2022</HD>
                    <P>
                        The following tables identify the proposed additions and deletions to the diagnosis code MCC severity levels list and the proposed additions to the diagnosis code CC severity levels list for FY 2022 and are available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html.</E>
                    </P>
                    <P>Table 6I.1—Proposed Additions to the MCC List—FY2022;</P>
                    <P>Table 6I.2— Proposed Deletions to the MCC List—FY2022; and</P>
                    <P>Table 6J.1— Proposed Additions to the CC List—FY2022.</P>
                    <HD SOURCE="HD3">e. Proposed CC Exclusions List for FY 2022</HD>
                    <P>In the September 1, 1987 final notice (52 FR 33143) concerning changes to the DRG classification system, we modified the GROUPER logic so that certain diagnoses included on the standard list of CCs would not be considered valid CCs in combination with a particular principal diagnosis. We created the CC Exclusions List for the following reasons: (1) To preclude coding of CCs for closely related conditions; (2) to preclude duplicative or inconsistent coding from being treated as CCs; and (3) to ensure that cases are appropriately classified between the complicated and uncomplicated DRGs in a pair.</P>
                    <P>In the May 19, 1987 proposed notice (52 FR 18877) and the September 1, 1987 final notice (52 FR 33154), we explained that the excluded secondary diagnoses were established using the following five principles:</P>
                    <P>• Chronic and acute manifestations of the same condition should not be considered CCs for one another;</P>
                    <P>• Specific and nonspecific (that is, not otherwise specified (NOS)) diagnosis codes for the same condition should not be considered CCs for one another;</P>
                    <P>• Codes for the same condition that cannot coexist, such as partial/total, unilateral/bilateral, obstructed/unobstructed, and benign/malignant, should not be considered CCs for one another;</P>
                    <P>• Codes for the same condition in anatomically proximal sites should not be considered CCs for one another; and</P>
                    <P>• Closely related conditions should not be considered CCs for one another.</P>
                    <P>The creation of the CC Exclusions List was a major project involving hundreds of codes. We have continued to review the remaining CCs to identify additional exclusions and to remove diagnoses from the master list that have been shown not to meet the definition of a CC. We refer readers to the FY 2014 IPPS/LTCH PPS final rule (78 FR 50541 through 50544) for detailed information regarding revisions that were made to the CC and CC Exclusion Lists under the ICD-9-CM MS-DRGs.</P>
                    <P>
                        The ICD-10 MS-DRGs Version 38.1 CC Exclusion List is included as Appendix C in the ICD-10 MS-DRG Definitions Manual, which is available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                        , and includes two lists identified as Part 1 and Part 2. Part 1 is the list of all diagnosis codes that are defined as a CC or MCC when reported as a secondary diagnosis. For all diagnosis codes on the list, a link is provided to a collection of diagnosis codes which, when reported as the principal diagnosis, would cause the CC or MCC diagnosis to be considered as a NonCC. Part 2 is the list of diagnosis codes designated as a MCC only for patients discharged alive; otherwise, they are assigned as a NonCC.
                    </P>
                    <P>
                        As discussed in section II.D.12.c. of the preamble of this proposed rule, we are requesting public comments on potential changes to the severity level for 3,490 diagnosis codes describing an “unspecified” anatomic site, from a CC severity level to a NonCC severity level, for FY 2022. We refer the reader to Table 6P.3a associated with this proposed rule (which is available via the internet on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                        <E T="03">)</E>
                         for the list of the 3,490 diagnosis codes that are currently listed in Part 1 of the CC Exclusions List and are defined as a CC when reported as a secondary diagnosis. Table 6P.3a is divided into several tabs, with the first tab titled “SDX Codes and Exclu Categories” containing columns A, B, and C. Column A (titled “ICD-10-CM Code”) lists the “unspecified” diagnosis codes that are currently listed in Part 1 of Appendix C of the CC Exclusions List, column B (titled “Description”) lists the narrative description of each diagnosis code, and column C (titled Exclusion Category) contains a hyperlink to the collection of diagnosis codes which, when reported as the principal diagnosis, would cause the CC diagnosis to be considered as a NonCC. For example, for line 2, Column A displays diagnosis code C34.00, column B displays “Malignant neoplasm of unspecified main bronchus” and column C displays a hyperlink to Exclusion Category number 280. When the user clicks on the hyperlink for number 280, they are directed to another tab labeled “PDX Category 280” that contains the list of diagnosis codes which, when reported as the principal diagnosis, would cause the corresponding CC diagnosis to be considered as a NonCC. In connection with the request for public comments on the potential changes to the severity level for 3,490 diagnosis codes describing an “unspecified” anatomic site, from a CC severity level to a NonCC severity level for FY 2022, Table 6P.3a is being made available for readers to review and consider the list of the 3,490 “unspecified” diagnosis codes that are currently included in Part 1 of the CC Exclusions List and the principal diagnosis exclusion category with which they are currently associated. If we were to finalize the potential changes to the severity level for the 3,490 diagnosis codes describing an “unspecified” anatomic site from a CC severity level to a NonCC severity level for FY 2022, we would also finalize the removal of these codes from the CC Exclusions List for FY 2022.
                    </P>
                    <P>We received three requests related to the CC Exclusions List logic, as we discuss in this section of this proposed rule.</P>
                    <P>We received a request to review the secondary diagnoses that are excluded as a CC or MCC in the CC Exclusions List logic when any one of the following three diagnosis codes is reported as the principal diagnosis.</P>
                    <GPH SPAN="3" DEEP="72">
                        <PRTPAGE P="25181"/>
                        <GID>EP10MY21.110</GID>
                    </GPH>
                    <P>According to the requestor, in the ICD-10 MS-DRGs version 37.2 CC Exclusions List logic, the predecessor code for the listed diagnosis codes, diagnosis code O99.89 (Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium) is listed in the collection of principal diagnosis list number 1000, therefore, when a CC or MCC secondary diagnosis associated with that principal diagnosis list describes a condition as occurring in pregnancy, childbirth or the puerperium, the CC Exclusions List logic will render that diagnosis code as a NonCC. The requestor stated that because diagnosis code O99.89 under version 37.2 of the ICD-10 MS-DRGs is now a subcategory under version 38.1 of the ICD-10 MS-DRGs, with three unique diagnosis codes to specify which obstetric stage the patient is in, that further analysis of the new diagnosis codes (O99.891, O99.892, and O99.893) should occur to determine if changes to the collection of principal diagnosis list is warranted. The requestor provided three examples for CMS to review and consider for possible changes to the CC Exclusions List logic.</P>
                    <P>In the first example, the requestor noted that diagnosis code O72.1 (Other immediate postpartum hemorrhage) is listed as a CC secondary diagnosis associated with the collection of principal diagnosis list number 1000, and that under the ICD-10 MS-DRGs version 38.1 CC Exclusions List logic, the diagnosis listed in principal diagnosis collection 1000 is now diagnosis code O99.893 (Other specified diseases and conditions complicating puerperium). Thus, both diagnosis codes (O72.1 and O99.893) are describing conditions occurring specifically in the postpartum or puerperium period. The postpartum period is defined as the period beginning immediately after delivery and continues for six weeks following delivery. A postpartum complication is any complication occurring within the six-week period. The requestor stated that because diagnosis code O72.1 is assigned for documented postpartum uterine atony with hemorrhage when it occurs immediately following the delivery of the baby and placenta, that CMS should review diagnosis code O99.892 (Other specified diseases and conditions complicating childbirth) and determine if it should be added to the collection of principal diagnosis list number 1000 to cause diagnosis code O72.1 to be considered as a NonCC when diagnosis code O99.892 is reported as the principal diagnosis.</P>
                    <P>In the second example, the requestor noted that diagnosis code O98.32 (Other infections with a predominantly sexual mode of transmission complicating childbirth) is associated with principal diagnosis collection number 1012. The requestor also noted that principal diagnosis collection number 1012 does not list diagnosis codes O99.891, O99.892, or O99.893 as a principal diagnosis to exclude the CC secondary diagnosis code O98.32, however, it does list diagnosis codes O98.311 (Other infections with a predominantly sexual mode of transmission complicating pregnancy, first trimester), O98.312 (Other infections with a predominantly sexual mode of transmission complicating pregnancy, second trimester), and O98.313 (Other infections with a predominantly sexual mode of transmission complicating pregnancy, third trimester) as a principal diagnosis to exclude the CC secondary diagnosis code O98.32. The requestor recommended CMS review diagnosis codes O98.32 (Other infections with a predominantly sexual mode of transmission complicating childbirth) and O98.33 (Other infections with a predominantly sexual mode of transmission complicating the puerperium), to determine if diagnosis codes O99.891, O99.892 or O99.893, when reported as a principal diagnosis, should exclude CC secondary diagnosis codes O98.32 and O98.33. Thus, the requestor suggested CMS consider if it is appropriate to add diagnosis codes O99.891, O99.892 and O99.893 to principal diagnosis collection number 1012 to cause diagnosis code O98.32 to be considered as a NonCC when diagnosis codes O99.891, O99.892 or O99.893 are reported as the principal diagnosis.</P>
                    <P>In the third example, the requestor noted that diagnosis code O87.2 (Hemorrhoids in the puerperium) is associated with principal diagnosis collection number 4041. The requestor also noted that principal diagnosis collection number 4041 lists diagnosis code O99.893 as a principal diagnosis to exclude the CC diagnosis code O87.2, however, it does not list diagnosis code O99.892. The requestor further noted that the “Includes” note at Category O87 (Venous complications and hemorrhoids in the puerperium) in the FY 2021 ICD-10-CM Tabular List includes “venous complications in labor, delivery and the puerperium”, therefore, diagnosis code O87.2 would also be reported for documented hemorrhoids during labor and delivery. The requestor recommended CMS review diagnosis code O99.892 to determine if, when reported as a principal diagnosis, it should exclude CC diagnosis code O87.2. Thus, the requestor suggested CMS consider if it is appropriate to add diagnosis code O99.892 to principal diagnosis collection number 4041 to cause diagnosis code O87.2 to be considered as a NonCC when diagnosis code O99.892 is reported as the principal diagnosis.</P>
                    <P>
                        We reviewed diagnosis codes O99.891, O99.892 and O99.893 with respect to the principal diagnosis collection list and because these diagnosis codes are specifically describing “other specified diseases and conditions complicating pregnancy, childbirth, and the puerperium,” respectively, we do not believe that any of these three diagnosis codes, when reported as a principal diagnosis, should exclude any CC secondary diagnosis. In cases where any one of these three diagnosis codes is reported as a principal diagnosis, which are generally anticipated to be rare, it is understood that there is not a more specific diagnosis code available in the classification to report as the principal diagnosis that identifies the underlying or associated cause of the disease or the condition complicating the specific obstetric stage (pregnancy, childbirth, or puerperium), hence the “other specified” in the code title. Specifically, the title of category O99 is “Other maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium” and there are nine subcategories, each of which is generally associated with a single organ 
                        <PRTPAGE P="25182"/>
                        system or etiology, with the exception of the “other specified” subcategory (O99.8) as displayed in the following table.
                    </P>
                    <GPH SPAN="3" DEEP="296">
                        <GID>EP10MY21.111</GID>
                    </GPH>
                    <P>The instructional note at category O99 states “use additional code to identify specific condition” and included at each subcategory (O99.0-O99.7) are a range of codes that refer to diagnoses that are associated with the condition in the title of the subcategory that are to be reported in addition to the applicable code within the respective subcategory. For example, at subcategory O99.0 (Anemia complicating pregnancy, childbirth, and the puerperium), the range of associated codes to identify the specific condition (for example, type of anemia) includes conditions in diagnosis code range D50-D64, meaning that when any one of the diagnosis codes under subcategory O99.0 describing anemia complicating a specific obstetric stage (pregnancy, childbirth, or puerperium) is reported, a code within the D50-D64 code range to identify the specific type of anemia would also be expected to be reported when supported by the medical record documentation. It is therefore reasonable to associate the two conditions (one from subcategory O99.0 and one from code range D50-D64) when reported on a claim. However, the same cannot be stated for subcategory O99.8. There is no range of associated codes from which users are instructed to report located at this particular subcategory in addition to the specific code under sub-subcategory O99.89 (Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium). We note that subcategory O99.8 and sub-subcategory O99.89 have the same title. Therefore, when a diagnosis code from other than that sub-subcategory is reported that describes a condition occurring in any one of the obstetric stages (pregnancy, childbirth, or puerperium) it is not clear if the condition can reasonably be associated to correspond to the “other specified diseases and conditions” diagnosis. In addition, the code ranges included at subcategory O99.8 are D00-D48, H00-H95, M00-N99, and Q00-Q99. Consequently, diagnosis codes within those code ranges would be expected to be reported with one of the diagnosis codes under subcategory O99.8 when reported as a principal diagnosis.</P>
                    <P>In all three of the requestor's examples, the diagnosis codes provided for CMS to review and consider are located in the “O” code range (O72.1, O98.32, and O87.2 in addition to O99.891, O99.892, and O99.893). As noted previously, the code ranges included at subcategory O99.8 as listed, do not include any codes in “O” code range. Upon review of the diagnosis codes provided by the requestor, it is also reasonable to expect that any one of those diagnosis codes (O72.1, O98.32, and O87.2) could be reported as a principal diagnosis alone. For instance, there are no instructional notes at diagnosis code O72.1 that preclude that diagnosis code from being reported as the principal diagnosis.</P>
                    <P>During our review of the CC Exclusions List logic in response to the requestor's recommendations, we also identified some diagnosis codes describing the specific trimester of pregnancy that we believe warrant further examination. We are unable to fully evaluate these conditions for FY 2022, therefore, we will continue to analyze for future rulemaking.</P>
                    <P>
                        For the reasons discussed, we do not believe that any of the three diagnosis codes (O99.891, O99.892, and O99.893), when reported as a principal diagnosis, should exclude any CC secondary diagnosis. Therefore, we are proposing to remove diagnosis codes O99.891, O99.892, and O99.893 from the CC Exclusions List logic principal diagnosis collection lists. Specifically, we are proposing to remove those diagnosis codes from the following principal 
                        <PRTPAGE P="25183"/>
                        diagnosis collection list numbers 0085, 0954, 0956 through 0963, 0972, 0988, 0991 through 0998, 1000 through 1002, 1004, 1006, 1009, 1011, 1014, 1015, 1019, 3999, 4000, 4002 through 4006, 4008, 4010, through 4013, 4017, 4020, 4021, 4023 through 4026, 4030, 4031, 4033 through 4043, 4050 through 4054, 4059 through 4063, 4065 and 4067, effective FY 2022.
                    </P>
                    <P>We also received a request to review diagnosis codes describing oxygen dependence, chronic obstructive pulmonary disease with exacerbation, and chronic respiratory failure with regard to assignment in MS-DRG 191 (Chronic Obstructive Pulmonary Disease with CC) and to consider whether any changes to principal diagnosis collection number 0744 in the CC Exclusions List logic are warranted.</P>
                    <P>The requestor provided diagnosis codes J44.1 (Chronic obstructive pulmonary disease with (acute) exacerbation), J96.11 (Chronic respiratory failure with hypoxia (CC)) and Z99.81 (Dependence on supplemental oxygen) for CMS to review. Specifically, the requestor suggested that if oxygen dependence, by definition, is clinically inherent to chronic respiratory failure, then CMS should consider adding diagnosis code J44.1 to the CC Exclusions List logic principal diagnosis collection list number 0744 and cause diagnosis code J96.11 to be considered as a NonCC when J44.1 is reported as the principal diagnosis.</P>
                    <P>We reviewed the diagnosis codes and MS-DRG assignment as the requestor suggested. We confirmed that when diagnosis code J44.1 is reported as the principal diagnosis with the CC secondary diagnosis code J96.11, and secondary diagnosis code Z99.81, the resulting MS-DRG assignment is MS-DRG 191. We believe that diagnosis code J96.11 should continue to group as a CC, to the “with CC” MS-DRG 191, when reported as a secondary diagnosis code with diagnosis code J44.1 reported as the principal diagnosis. We disagree with the requestor's suggestion that every oxygen-dependent COPD patient has chronic respiratory failure, and that separately reporting the chronic respiratory failure is clinically redundant. Patients can be oxygen-dependent with COPD and not have a diagnosis of chronic respiratory failure. Therefore, we are proposing to maintain the structure of principal diagnosis collection list number 0744 in the CC Exclusions List logic for FY 2022.</P>
                    <P>Finally, we received a request to reconsider the MCC exclusions for diagnosis code I11.0 (Hypertensive heart disease with heart failure) when reported as the principal diagnosis. According to the requestor, there appears to be an inconsistency for the CC Exclusions List logic. Specifically, the requestor noted that when diagnosis code I11.0 is reported as the principal diagnosis, it causes the following MCC secondary diagnosis codes to be considered as a NonCC.</P>
                    <GPH SPAN="3" DEEP="156">
                        <GID>EP10MY21.112</GID>
                    </GPH>
                    <P>However, the requestor stated that diagnosis codes I50.21 (Acute systolic (congestive) heart failure) and I50.31 (Acute diastolic (congestive) heart failure) are not excluded from acting as MCCs when diagnosis code I11.0 is reported as the principal diagnosis. The requestor also stated that all diagnosis codes in category I50 (Heart Failure) share common etiologies and demonstrate comparable severity of illness. Therefore, the requestor suggested that none of the conditions in this category (I50) should be excluded from acting as a MCC when diagnosis code I11.0 is reported as a principal diagnosis.</P>
                    <P>We examined all the diagnosis codes in category I50 with regard to the CC Exclusions List logic. In addition to diagnosis code I11.0, we also reviewed diagnosis code I13.2 (Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease) when reported as a principal diagnosis because that diagnosis code also has the Tabular instruction “use additional code to identify the type of heart failure”.</P>
                    <P>We found additional inconsistencies in the CC secondary diagnosis heart failure codes where some diagnoses were excluded depending on the principal diagnosis reported and others were not excluded. As a result, we are proposing to revise the CC Exclusions Logic list for diagnosis codes I11.0 and I13.2 when reported as a principal diagnosis to ensure they are consistent in the CC and MCC diagnoses they exclude. In the following table we show the findings for each diagnosis code in category I50 with respect to the current severity level (MCC, CC or NonCC), if it is currently excluded as a CC or MCC when reported with either diagnosis code I11.0 or I13.2 as the principal diagnosis, and what our proposal is under the CC Exclusions List logic for FY 2022.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25184"/>
                        <GID>EP10MY21.113</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="492">
                        <PRTPAGE P="25185"/>
                        <GID>EP10MY21.114</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        We are proposing additional changes to the ICD-10 MS-DRGs Version 39 CC Exclusion List based on the diagnosis and procedure code updates as discussed in section II.D.13. of this FY 2022 IPPS/LTCH PPS proposed rule. Therefore, we have developed Table 6G.1.—Proposed Secondary Diagnosis Order Additions to the CC Exclusions List—FY 2022; Table 6G.2.—Proposed Principal Diagnosis Order Additions to the CC Exclusions List—FY 2022; Table 6H.1.—Proposed Secondary Diagnosis Order Deletions to the CC Exclusions List—FY 2022; and Table 6H.2.—Proposed Principal Diagnosis Order Deletions to the CC Exclusions List—FY 2022. For Table 6G.1, each secondary diagnosis code proposed for addition to the CC Exclusion List is shown with an asterisk and the principal diagnoses proposed to exclude the secondary diagnosis code are provided in the indented column immediately following it. For Table 6G.2, each of the principal diagnosis codes for which there is a CC exclusion is shown with an asterisk and the conditions proposed for addition to the CC Exclusion List that will not count as a CC are provided in an indented column immediately following the affected principal diagnosis. For Table 6H.1, each secondary diagnosis code proposed for deletion from the CC Exclusion List is shown with an asterisk followed by the principal diagnosis codes that currently exclude it. For Table 6H.2, each of the principal diagnosis codes is shown with an asterisk and the proposed deletions to the CC Exclusions List are provided in an indented column immediately following the affected principal diagnosis. Tables 6G.1., 6G.2., 6H.1., and 6H.2. associated with this proposed rule are available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                        .
                        <PRTPAGE P="25186"/>
                    </P>
                    <HD SOURCE="HD3">13. Proposed Changes to the ICD-10-CM and ICD-10-PCS Coding Systems</HD>
                    <P>To identify new, revised and deleted diagnosis and procedure codes, for FY 2022, we have developed Table 6A.—New Diagnosis Codes, Table 6B.—New Procedure Codes, Table 6C.—Invalid Diagnosis Codes, Table 6D.—Invalid Procedure Codes and Table 6E.—Revised Diagnosis Code Titles for this proposed rule.</P>
                    <P>
                        These tables are not published in the Addendum to this proposed rule, but are available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                         as described in section VI. of the Addendum to this proposed rule. As discussed in section II.D.16. of the preamble of this proposed rule, the code titles are adopted as part of the ICD-10 (previously ICD-9-CM) Coordination and Maintenance Committee meeting process. Therefore, although we publish the code titles in the IPPS proposed and final rules, they are not subject to comment in the proposed or final rules.
                    </P>
                    <P>We are proposing the MDC and MS-DRG assignments for the new diagnosis codes and procedure codes as set forth in Table 6A.—New Diagnosis Codes and Table 6B.—New Procedure Codes. In addition, the proposed severity level designations for the new diagnosis codes are set forth in Table 6A. and the proposed O.R. status for the new procedure codes are set forth in Table 6B. Consistent with our established process, we examined the MS-DRG assignment and the attributes (severity level and O.R. status) of the predecessor diagnosis or procedure code, as applicable, to inform our proposed assignments and designations. Specifically, we review the predecessor code and MS-DRG assignment most closely associated with the new diagnosis or procedure code, and in the absence of claims data, we consider other factors that may be relevant to the MS-DRG assignment, including the severity of illness, treatment difficulty, complexity of service and the resources utilized in the diagnosis and/or treatment of the condition. We note that this process does not automatically result in the new diagnosis or procedure code being proposed for assignment to the same MS-DRG or to have the same designation as the predecessor code.</P>
                    <P>
                        We are making available on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                         the following tables associated with this proposed rule:
                    </P>
                    <P>• Table 6A.—New Diagnosis Codes—FY 2022;</P>
                    <P>• Table 6B.—New Procedure Codes—FY 2022;</P>
                    <P>• Table 6C.—Invalid Diagnosis Codes—FY 2022;</P>
                    <P>• Table 6D.—Invalid Procedure Codes—FY 2022;</P>
                    <P>• Table 6E.—Revised Diagnosis Code Titles—FY 2022;</P>
                    <P>• Table 6G.1.—Proposed Secondary Diagnosis Order Additions to the CC Exclusions List—FY 2022;</P>
                    <P>• Table 6G.2.—Proposed Principal Diagnosis Order Additions to the CC Exclusions List—FY 2022;</P>
                    <P>• Table 6H.1.—Proposed Secondary Diagnosis Order Deletions to the CC Exclusions List—FY 2022;</P>
                    <P>• Table 6H.2.—Proposed Principal Diagnosis Order Deletions to the CC Exclusions List—FY 2022;</P>
                    <P>• Table 6I.1.—Proposed Additions to the MCC List—FY 2022;</P>
                    <P>• Table 6I.2.—Proposed Deletions to the MCC List—FY 2022; and</P>
                    <P>• Table 6J.1.—Proposed Additions to the CC List—FY 2022.</P>
                    <HD SOURCE="HD3">14. Proposed Changes to the Medicare Code Editor (MCE)</HD>
                    <P>The Medicare Code Editor (MCE) is a software program that detects and reports errors in the coding of Medicare claims data. Patient diagnoses, procedure(s), and demographic information are entered into the Medicare claims processing systems and are subjected to a series of automated screens. The MCE screens are designed to identify cases that require further review before classification into an MS-DRG.</P>
                    <P>
                        As discussed in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58448), we made available the FY 2021 ICD-10 MCE Version 38 manual file. The manual contains the definitions of the Medicare code edits, including a description of each coding edit with the corresponding diagnosis and procedure code edit lists. The link to this MCE manual file, along with the link to the mainframe and computer software for the MCE Version 38 (and ICD-10 MS-DRGs) are posted on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software</E>
                        .
                    </P>
                    <P>For this FY 2022 IPPS/LTCH PPS proposed rule, we address the MCE requests we received by the November 1, 2020 deadline. We also discuss the proposals we are making based on our internal review and analysis.</P>
                    <HD SOURCE="HD3">a. External Causes of Morbidity Codes as Principal Diagnosis</HD>
                    <P>In the MCE, the external cause codes (V, W, X, or Y codes) describe the circumstance causing an injury, not the nature of the injury, and therefore should not be used as a principal diagnosis.</P>
                    <P>As discussed in section II.D.13. of the preamble of this proposed rule, Table 6A.—New Diagnosis Codes, lists the diagnosis codes that have been approved to date which will be effective with discharges on and after October 1, 2021. We are proposing to add the following new ICD-10-CM diagnosis codes to the External Causes of Morbidity edit code list.</P>
                    <GPH SPAN="3" DEEP="113">
                        <GID>EP10MY21.115</GID>
                    </GPH>
                    <PRTPAGE P="25187"/>
                    <HD SOURCE="HD3">b. Age Conflict Edit</HD>
                    <P>In the MCE, the Age conflict edit exists to detect inconsistencies between a patient's age and any diagnosis on the patient's record; for example, a 5-year-old patient with benign prostatic hypertrophy or a 78-year-old patient coded with a delivery. In these cases, the diagnosis is clinically and virtually impossible for a patient of the stated age. Therefore, either the diagnosis or the age is presumed to be incorrect. Currently, in the MCE, the following four age diagnosis categories appear under the Age conflict edit and are listed in the manual and written in the software program:</P>
                    <P>• Perinatal/Newborn—Age 0 years only; a subset of diagnoses which will only occur during the perinatal or newborn period of age 0 (for example, tetanus neonatorum, health examination for newborn under 8 days old).</P>
                    <P>• Pediatric—Age is 0-17 years inclusive (for example, Reye's syndrome, routine child health exam).</P>
                    <P>• Maternity—Age range is 9-64 years inclusive (for example, diabetes in pregnancy, antepartum pulmonary complication).</P>
                    <P>• Adult—Age range is 15-124 years inclusive (for example, senile delirium, mature cataract).</P>
                    <HD SOURCE="HD3">(1) Pediatric Diagnoses</HD>
                    <P>Under the ICD-10 MCE, the Pediatric diagnoses category for the Age conflict edit considers the age range of 0 to 17 years inclusive. For that reason, the diagnosis codes on this Age conflict edit list would be expected to apply to conditions or disorders specific to that age group only.</P>
                    <P>As discussed in section II.D.13. of the preamble of this proposed rule, Table 6A.—New Diagnosis Codes, lists the diagnosis codes that have been approved to date which will be effective with discharges on and after October 1, 2021. We are proposing to add the following new ICD-10-CM diagnosis codes to the Pediatric diagnoses category code list under the Age conflict edit.</P>
                    <GPH SPAN="3" DEEP="60">
                        <GID>EP10MY21.116</GID>
                    </GPH>
                    <HD SOURCE="HD3">c. Sex Conflict Edit</HD>
                    <P>In the MCE, the Sex conflict edit detects inconsistencies between a patient's sex and any diagnosis or procedure on the patient's record; for example, a male patient with cervical cancer (diagnosis) or a female patient with a prostatectomy (procedure). In both instances, the indicated diagnosis or the procedure conflicts with the stated sex of the patient. Therefore, the patient's diagnosis, procedure, or sex is presumed to be incorrect.</P>
                    <HD SOURCE="HD3">(1) Diagnoses for Females Only Edit</HD>
                    <P>As discussed in section II.D.13. of the preamble of this proposed rule, Table 6A.—New Diagnosis Codes, lists the new diagnosis codes that have been approved to date which will be effective with discharges on and after October 1, 2021. We are proposing to add the following new ICD-10-CM diagnosis codes to the edit code list for the Diagnoses for Females Only edit.</P>
                    <GPH SPAN="3" DEEP="60">
                        <GID>EP10MY21.117</GID>
                    </GPH>
                    <HD SOURCE="HD3">d. Unacceptable Principal Diagnosis Edit</HD>
                    <P>In the MCE, there are select codes that describe a circumstance which influences an individual's health status but does not actually describe a current illness or injury. There also are codes that are not specific manifestations but may be due to an underlying cause. These codes are considered unacceptable as a principal diagnosis. In limited situations, there are a few codes on the MCE Unacceptable Principal Diagnosis edit code list that are considered “acceptable” when a specified secondary diagnosis is also coded and reported on the claim.</P>
                    <P>As discussed in Section II.D.13. of the preamble of this proposed rule, Table 6A.—New Diagnosis Codes, lists the new diagnosis codes that have been approved to date which will be effective with discharges on and after October 1, 2021. In addition, as a result of proposed new instructional notes to “Code first underlying disease” (which indicate the proper sequencing order of the codes) for existing diagnosis codes found at subcategory M40.1 (Other secondary kyphosis) and subcategory M41.5 (Other secondary scoliosis) discussed at the September 8-9, 2020 ICD-10 Coordination and Maintenance Committee meeting, we are proposing to add the following new and, if these instructional notes are finalized, existing ICD-10-CM diagnosis codes at subcategories M40.1 and M41.5, to the Unacceptable Principal Diagnosis edit code list.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25188"/>
                        <GID>EP10MY21.118</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        In addition, as discussed in section II.D.13. of the preamble of this proposed rule, Table 6C.—Invalid Diagnosis Codes, lists the diagnosis codes that are 
                        <PRTPAGE P="25189"/>
                        no longer effective October 1, 2021. Included in this table are the following ICD-10-CM diagnosis codes that are currently listed on the Unacceptable Principal Diagnosis edit code list. We are proposing to delete these codes from the Unacceptable Principal Diagnosis edit code list.
                    </P>
                    <GPH SPAN="3" DEEP="138">
                        <GID>EP10MY21.119</GID>
                    </GPH>
                    <HD SOURCE="HD3">e. Unspecified Codes</HD>
                    <P>
                        As discussed in section II.D.12.c. of the preamble of this proposed rule, we are requesting public comments on a potential change to the severity level designations for “unspecified” ICD-10-CM diagnosis codes that we are considering adopting for FY 2022. In connection with that request, we are also requesting public comments on the potential creation of a new MCE code edit involving these “unspecified” codes for FY 2022. Specifically, this MCE code edit could trigger when an “unspecified” diagnosis code currently designated as either a CC or MCC, that includes other codes available in that code subcategory that further specify the anatomic site, is entered. We refer the reader to table 6P.3a (which is available via the internet on the CMS website at: 
                        <E T="03">http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                        ) for the list of unspecified diagnosis codes that would be subject to this edit. This edit could signal to the provider that a more specific code is available to report. We believe this edit aligns with documentation improvement efforts and leverages the specificity within ICD-10. As part of our request for comment on the potential creation of this new MCE code edit for these “unspecified” codes, we are interested in comments on how this MCE code edit may be developed for FY 2022 to more accurately reflect each health care encounter and improve the reliability and validity of the coded data.
                    </P>
                    <HD SOURCE="HD3">f. Future Enhancement</HD>
                    <P>In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38053 through 38054) we noted the importance of ensuring accuracy of the coded data from the reporting, collection, processing, coverage, payment and analysis aspects. Subsequently, in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20235) we stated that we engaged a contractor to assist in the review of the limited coverage and non-covered procedure edits in the MCE that may also be present in other claims processing systems that are utilized by our MACs. The MACs must adhere to criteria specified within the National Coverage Determinations (NCDs) and may implement their own edits in addition to what is already incorporated into the MCE, resulting in duplicate edits. The objective of this review is to identify where duplicate edits may exist and to determine what the impact might be if these edits were to be removed from the MCE.</P>
                    <P>We have also noted that the purpose of the MCE is to ensure that errors and inconsistencies in the coded data are recognized during Medicare claims processing. As we indicated in the FY 2019 IPPS/LTCH PPS final rule (83 FR 41228), we are considering whether the inclusion of coverage edits in the MCE necessarily aligns with that specific goal because the focus of coverage edits is on whether or not a particular service is covered for payment purposes and not whether it was coded correctly.</P>
                    <P>
                        As we continue to evaluate the purpose and function of the MCE with respect to ICD-10, we encourage public input for future discussion. As we have discussed in prior rulemaking, we recognize a need to further examine the current list of edits and the definitions of those edits. We continue to encourage public comments on whether there are additional concerns with the current edits, including specific edits or language that should be removed or revised, edits that should be combined, or new edits that should be added to assist in detecting errors or inaccuracies in the coded data. Comments should be directed to the MS-DRG Classification Change Mailbox located at 
                        <E T="03">MSDRGClassificationChange@cms.hhs.gov</E>
                         by November 1, 2021.
                    </P>
                    <HD SOURCE="HD3">15. Proposed Changes to Surgical Hierarchies</HD>
                    <P>Some inpatient stays entail multiple surgical procedures, each one of which, occurring by itself, could result in assignment of the case to a different MS-DRG within the MDC to which the principal diagnosis is assigned. Therefore, it is necessary to have a decision rule within the GROUPER by which these cases are assigned to a single MS-DRG. The surgical hierarchy, an ordering of surgical classes from most resource-intensive to least resource-intensive, performs that function. Application of this hierarchy ensures that cases involving multiple surgical procedures are assigned to the MS-DRG associated with the most resource-intensive surgical class.</P>
                    <P>
                        A surgical class can be composed of one or more MS-DRGs. For example, in MDC 11, the surgical class “kidney transplant” consists of a single MS-DRG (MS-DRG 652) and the class “major bladder procedures” consists of three MS-DRGs (MS-DRGs 653, 654, and 655). Consequently, in many cases, the surgical hierarchy has an impact on more than one MS-DRG. The methodology for determining the most resource-intensive surgical class involves weighting the average resources for each MS-DRG by frequency to determine the weighted average resources for each surgical class. For example, assume surgical class A includes MS-DRGs 001 and 002 and surgical class B includes MS-DRGs 003, 004, and 005. Assume also that the average costs of MS-DRG 001 are higher than that of MS-DRG 003, but the average costs of MS-DRGs 004 and 005 
                        <PRTPAGE P="25190"/>
                        are higher than the average costs of MS-DRG 002. To determine whether surgical class A should be higher or lower than surgical class B in the surgical hierarchy, we would weigh the average costs of each MS-DRG in the class by frequency (that is, by the number of cases in the MS-DRG) to determine average resource consumption for the surgical class. The surgical classes would then be ordered from the class with the highest average resource utilization to that with the lowest, with the exception of “other O.R. procedures” as discussed in this proposed rule.
                    </P>
                    <P>This methodology may occasionally result in assignment of a case involving multiple procedures to the lower-weighted MS-DRG (in the highest, most resource-intensive surgical class) of the available alternatives. However, given that the logic underlying the surgical hierarchy provides that the GROUPER search for the procedure in the most resource-intensive surgical class, in cases involving multiple procedures, this result is sometimes unavoidable.</P>
                    <P>We note that, notwithstanding the foregoing discussion, there are a few instances when a surgical class with a lower average cost is ordered above a surgical class with a higher average cost. For example, the “other O.R. procedures” surgical class is uniformly ordered last in the surgical hierarchy of each MDC in which it occurs, regardless of the fact that the average costs for the MS-DRG or MS-DRGs in that surgical class may be higher than those for other surgical classes in the MDC. The “other O.R. procedures” class is a group of procedures that are only infrequently related to the diagnoses in the MDC, but are still occasionally performed on patients with cases assigned to the MDC with these diagnoses. Therefore, assignment to these surgical classes should only occur if no other surgical class more closely related to the diagnoses in the MDC is appropriate.</P>
                    <P>A second example occurs when the difference between the average costs for two surgical classes is very small. We have found that small differences generally do not warrant reordering of the hierarchy because, as a result of reassigning cases on the basis of the hierarchy change, the average costs are likely to shift such that the higher-ordered surgical class has lower average costs than the class ordered below it.</P>
                    <P>For this FY 2022 IPPS/LTCH PPS proposed rule, we received a request to examine the MS-DRG hierarchy within MDC 05 (Diseases and Disorders of the Circulatory System). The requestor stated its request to review the hierarchy within MDC 05 was based on the relative weights within each MS-DRG subdivision which they stated are supportive of higher position within the hierarchy. The requestor stated that when multiple procedures are performed, it is reasonable for providers to be compensated for the highest weighted procedure. The requestor did not specify which data year it analyzed to identify the relative weights. As discussed in this section, in reviewing the surgical hierarchy, we weigh the average costs of each MS-DRG in the class by frequency (that is, by the number of cases in the MS-DRG), not the relative weights of each MS-DRG as suggested by the requestor, to determine average resource consumption for the surgical class; therefore, consistent with our annual process, we used the methodology as described previously to review the surgical hierarchy within MDC 05.</P>
                    <P>Based on our review of the surgical hierarchy within MDC 05 in response to this request, and in response to the request we received to review the MS-DRG assignments for cases involving the surgical ablation procedure for atrial fibrillation as discussed in section II.D.5.e. of the preamble of this proposed rule, we are proposing to revise the surgical hierarchy for the MS-DRGs in MDC 05 for FY 2022. Specifically, we are proposing to sequence MS-DRGs 231-236 above MS-DRGs 222-227 and below MS-DRGs 216-221, sequence MS-DRGs 222-227 above MS-DRGs 266-227 and below MS-DRGs 231-236, sequence MS-DRGs 266-267 above MS-DRGs 268-269 and below MS-DRGs 222-227, sequence MS-DRGs 228-229 above MS-DRGs 319-320 and below MS-DRGs 268-269.</P>
                    <P>Our proposal for Appendix D MS-DRG Surgical Hierarchy by MDC and MS-DRG of the ICD-10 MS-DRG Definitions Manual Version 39 is illustrated in the following table.</P>
                    <GPH SPAN="3" DEEP="117">
                        <GID>EP10MY21.120</GID>
                    </GPH>
                    <HD SOURCE="HD3">16. Maintenance of the ICD-10-CM and ICD-10-PCS Coding Systems</HD>
                    <P>In September 1985, the ICD-9-CM Coordination and Maintenance Committee was formed. This is a Federal interdepartmental committee, co-chaired by the Centers for Disease Control and Prevention's (CDC) National Center for Health Statistics (NCHS) and CMS, charged with maintaining and updating the ICD-9-CM system. The final update to ICD-9-CM codes was made on October 1, 2013. Thereafter, the name of the Committee was changed to the ICD-10 Coordination and Maintenance Committee, effective with the March 19-20, 2014 meeting. The ICD-10 Coordination and Maintenance Committee addresses updates to the ICD-10-CM and ICD-10-PCS coding systems. The Committee is jointly responsible for approving coding changes, and developing errata, addenda, and other modifications to the coding systems to reflect newly developed procedures and technologies and newly identified diseases. The Committee is also responsible for promoting the use of Federal and non-Federal educational programs and other communication techniques with a view toward standardizing coding applications and upgrading the quality of the classification system.</P>
                    <P>
                        The official list of ICD-9-CM diagnosis and procedure codes by fiscal year can be found on the CMS website at: 
                        <E T="03">
                            http://cms.hhs.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/
                            <PRTPAGE P="25191"/>
                            codes.html
                        </E>
                        . The official list of ICD-10-CM and ICD-10-PCS codes can be found on the CMS website at: 
                        <E T="03">http://www.cms.gov/Medicare/Coding/ICD10/index.html</E>
                        .
                    </P>
                    <P>The NCHS has lead responsibility for the ICD-10-CM and ICD-9-CM diagnosis codes included in the Tabular List and Alphabetic Index for Diseases, while CMS has lead responsibility for the ICD-10-PCS and ICD-9-CM procedure codes included in the Tabular List and Alphabetic Index for Procedures.</P>
                    <P>The Committee encourages participation in the previously mentioned process by health-related organizations. In this regard, the Committee holds public meetings for discussion of educational issues and proposed coding changes. These meetings provide an opportunity for representatives of recognized organizations in the coding field, such as the American Health Information Management Association (AHIMA), the American Hospital Association (AHA), and various physician specialty groups, as well as individual physicians, health information management professionals, and other members of the public, to contribute ideas on coding matters. After considering the opinions expressed during the public meetings and in writing, the Committee formulates recommendations, which then must be approved by the agencies.</P>
                    <P>The Committee presented proposals for coding changes for implementation in FY 2022 at a public meeting held on September 8-9, 2020 and finalized the coding changes after consideration of comments received at the meetings and in writing by November 09, 2020.</P>
                    <P>
                        The Committee held its 2021 meeting on March 9-10, 2021. The deadline for submitting comments on these code proposals was April 9, 2021. It was announced at this meeting that any new diagnosis and procedure codes for which there was consensus of public support and for which complete tabular and indexing changes would be made by June 2021 would be included in the October 1, 2021 update to the ICD-10-CM diagnosis and ICD-10-PCS procedure code sets. As discussed in earlier sections of the preamble of this proposed rule, there are new, revised, and deleted ICD-10-CM diagnosis codes and ICD-10-PCS procedure codes that are captured in Table 6A.—New Diagnosis Codes, Table 6B.—New Procedure Codes, Table 6C.—Invalid Diagnosis Codes, Table 6D.—Invalid Procedure Codes, and Table 6E.—Revised Diagnosis Code Titles for this proposed rule, which are available via the internet on the CMS website at: 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                        . The code titles are adopted as part of the ICD-10 (previously ICD-9-CM) Coordination and Maintenance Committee process. Therefore, although we make the code titles available for the IPPS proposed rule, they are not subject to comment in the proposed rule. Because of the length of these tables, they are not published in the Addendum to the proposed rule. Rather, they are available via the internet as discussed in section VI. of the Addendum to the proposed rule.
                    </P>
                    <P>
                        Recordings for the virtual meeting discussions of the procedure codes at the Committee's September 8-9, 2020 meeting and the March 9-10, 2021 meeting can be obtained from the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Coding/ICD10/C-and-M-Meeting-Materials</E>
                        . The materials for the discussions relating to diagnosis codes at the September 8-9, 2020 meeting and March 9-10, 2021 meeting can be found at: 
                        <E T="03">http://www.cdc.gov/nchs/icd/icd10cm_maintenance.html</E>
                        . These websites also provide detailed information about the Committee, including information on requesting a new code, participating in a Committee meeting, timeline requirements and meeting dates.
                    </P>
                    <P>
                        We encourage commenters to submit questions and comments on coding issues involving diagnosis codes via Email to: 
                        <E T="03">nchsicd10cm@cdc.gov</E>
                        .
                    </P>
                    <P>
                        Questions and comments concerning the procedure codes should be submitted via Email to: 
                        <E T="03">ICDProcedureCodeRequest@cms.hhs.gov</E>
                        <E T="03">.</E>
                    </P>
                    <P>As a result of the ongoing COVID-19 public health emergency, the CDC implemented six new diagnosis codes describing conditions related to COVID-19 into the ICD-10-CM effective with discharges on and after January 1, 2021. The diagnosis codes are</P>
                    <GPH SPAN="3" DEEP="169">
                        <GID>EP10MY21.121</GID>
                    </GPH>
                    <P>
                        We refer the reader to the CDC web page at 
                        <E T="03">https://www.cdc.gov/nchs/icd/icd10cm.htm</E>
                         for additional details regarding the implementation of these new diagnosis codes.
                    </P>
                    <P>
                        We provided the MS-DRG assignments for the six diagnosis codes effective with discharges on and after January 1, 2021, consistent with our established process for assigning new diagnosis codes. Specifically, we review the predecessor diagnosis code and MS-DRG assignment most closely associated with the new diagnosis code, and consider other factors that may be relevant to the MS-DRG assignment, including the severity of illness, treatment difficulty, and the resources utilized for the specific condition/diagnosis. We note that this process does not automatically result in the new 
                        <PRTPAGE P="25192"/>
                        diagnosis code being assigned to the same MS-DRG as the predecessor code. The assignments for the previously listed diagnosis codes are reflected in Table 6A- New Diagnosis Codes (which is available via the internet on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS</E>
                        ). As with the other new diagnosis codes and MS-DRG assignments included in Table 6A of this proposed rule, we are soliciting public comments on the most appropriate MDC, MS-DRG, and severity level assignments for these codes for FY 2022, as well as any other options for the GROUPER logic.
                    </P>
                    <P>In addition, CMS implemented 21 new procedure codes describing the introduction or infusion of therapeutics, including monoclonal antibodies and vaccines for COVID-19 treatment, into the ICD-10-PCS effective with discharges on and after January 01, 2021. The 21 procedure codes listed in this section of this rule are designated as non-O.R. and do not affect any MDC or MS-DRG assignment as shown in the following table</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="144">
                        <GID>EP10MY21.122</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="592">
                        <PRTPAGE P="25193"/>
                        <GID>EP10MY21.123</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        The ICD-10 MS-DRG assignment for cases reporting any one of the 21 procedure codes is dependent on the reported principal diagnosis, any secondary diagnoses defined as a CC or MCC, procedures or services performed, age, sex, and discharge status. The 21 procedure codes are reflected in Table 6B—New Procedure Codes (which is available via the internet on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS</E>
                        <E T="03">.)</E>
                         As with the other new procedure codes and MS-DRG assignments included in Table 6B of this proposed rule, we are soliciting public comments on the most appropriate MDC, MS-DRG, and operating room status assignments for 
                        <PRTPAGE P="25194"/>
                        these codes for FY 2022, as well as any other options for the GROUPER logic.
                    </P>
                    <P>
                        We note that Change Request (CR) 11895, Transmittal 10654, titled “Fiscal Year (FY) 2021 Annual Update to the Medicare Code Editor (MCE) and International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) and Procedure Coding System (ICD-10-PCS)”, was issued on March 12, 2021 (available via the internet on the CMS website at: 
                        <E T="03">https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Transmittals/r10654cp</E>
                        ) regarding the release of an updated version of the ICD-10 MS-DRG GROUPER and Medicare Code Editor software, Version 38.1, effective with discharges on and after January 1, 2021, reflecting the new diagnosis and procedure codes. The updated software, along with the updated ICD-10 MS-DRG V38.1 Definitions Manual and the Definitions of Medicare Code Edits V38.1 manual is available at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/MS-DRG-Classifications-and-Software</E>
                        .
                    </P>
                    <P>In the September 7, 2001 final rule implementing the IPPS new technology add-on payments (66 FR 46906), we indicated we would attempt to include proposals for procedure codes that would describe new technology discussed and approved at the Spring meeting as part of the code revisions effective the following October.</P>
                    <P>Section 503(a) of Public Law 108-173 included a requirement for updating diagnosis and procedure codes twice a year instead of a single update on October 1 of each year. This requirement was included as part of the amendments to the Act relating to recognition of new technology under the IPPS. Section 503(a) of Public Law 108-173 amended section 1886(d)(5)(K) of the Act by adding a clause (vii) which states that the Secretary shall provide for the addition of new diagnosis and procedure codes on April 1 of each year, but the addition of such codes shall not require the Secretary to adjust the payment (or diagnosis-related group classification) until the fiscal year that begins after such date. This requirement improves the recognition of new technologies under the IPPS by providing information on these new technologies at an earlier date. Data will be available 6 months earlier than would be possible with updates occurring only once a year on October 1.</P>
                    <P>While section 1886(d)(5)(K)(vii) of the Act states that the addition of new diagnosis and procedure codes on April 1 of each year shall not require the Secretary to adjust the payment, or DRG classification, under section 1886(d) of the Act until the fiscal year that begins after such date, we have to update the DRG software and other systems in order to recognize and accept the new codes. We also publicize the code changes and the need for a mid-year systems update by providers to identify the new codes. Hospitals also have to obtain the new code books and encoder updates, and make other system changes in order to identify and report the new codes.</P>
                    <P>
                        The ICD-10 (previously the ICD-9-CM) Coordination and Maintenance Committee holds its meetings in the spring and fall in order to update the codes and the applicable payment and reporting systems by October 1 of each year. Items are placed on the agenda for the Committee meeting if the request is received at least 3 months prior to the meeting. This requirement allows time for staff to review and research the coding issues and prepare material for discussion at the meeting. It also allows time for the topic to be publicized in meeting announcements in the 
                        <E T="04">Federal Register</E>
                         as well as on the CMS website. A complete addendum describing details of all diagnosis and procedure coding changes, both tabular and index, is published on the CMS and NCHS websites in June of each year. Publishers of coding books and software use this information to modify their products that are used by health care providers. Historically, this 5-month time period has proved to be necessary for hospitals and other providers to update their systems.
                    </P>
                    <P>A discussion of this timeline and the need for changes are included in the December 4-5, 2005 ICD-9-CM Coordination and Maintenance Committee Meeting minutes. The public agreed that there was a need to hold the fall meetings earlier, in September or October, in order to meet the new implementation dates. The public provided comment that additional time would be needed to update hospital systems and obtain new code books and coding software. There was considerable concern expressed about the impact this April update would have on providers.</P>
                    <P>In the FY 2005 IPPS final rule, we implemented section 1886(d)(5)(K)(vii) of the Act, as added by section 503(a) of Public Law 108-173, by developing a mechanism for approving, in time for the April update, diagnosis and procedure code revisions needed to describe new technologies and medical services for purposes of the new technology add-on payment process. We also established the following process for making these determinations. Topics considered during the Fall ICD-10 (previously ICD-9-CM) Coordination and Maintenance Committee meeting are considered for an April 1 update if a strong and convincing case is made by the requestor during the Committee's public meeting. The request must identify the reason why a new code is needed in April for purposes of the new technology process. Meeting participants and those reviewing the Committee meeting materials are provided the opportunity to comment on this expedited request. All other topics are considered for the October 1 update. Participants of the Committee meeting and those reviewing the Committee meeting materials are encouraged to comment on all such requests. There were no code requests approved for an expedited April 1, 2021 implementation at the September 8-9, 2020 Committee meetings. Therefore, there were no new codes implemented April 1, 2021.</P>
                    <P>
                        At the March 9-10, 2021 ICD-10 Coordination and Maintenance Committee meeting we announced our consideration of an April 1 implementation date for ICD-10-CM diagnosis and ICD-10-PCS procedure code updates, in addition to the current October 1 annual update for ICD-10-CM diagnosis codes and ICD-10-PCS procedure codes. We stated that this April 1 code update would be in addition to the existing April 1 update under section 1886(d)(5)(k)(vii) of the Act for diagnosis or procedure code revisions needed to describe new technologies and medical services for purposes of the new technology add-on payment process. As explained during the March 9-10, 2021 meeting, we believe this additional April 1 implementation date for new codes would allow for earlier recognition of diagnoses, conditions, and illnesses as well as procedures, services, and treatments in the claims data. We also believe this earlier recognition would be beneficial for purposes of reporting, data collection, tracking clinical outcomes, claims processing, surveillance, research, policy decisions and data interoperability. We note, as previously summarized, that in 2005, in connection with the implementation of the current April 1 update for diagnosis or procedure code revisions for purposes of the new technology add-on payment process, stakeholders expressed concerns with an April 1 update, specifically with regard to the time needed to update hospital systems and obtain new code books and coding software. We believe that the advances in technology that have occurred since 
                        <PRTPAGE P="25195"/>
                        that time, including the use of electronic health records (EHRs), electronic coding books, and updated encoder software that are now utilized by the majority of providers, would alleviate those concerns and make a broader April 1 update more feasible today. Consistent with our established process for the existing April 1 update under section 1886(d)(5)(k)(vii) of the Act, if adopted, any new ICD-10 code updates finalized for implementation on the following April 1 would be announced in November of the prior year, which would provide a 4-month timeframe for the public to receive notice about the diagnosis and/or procedure code updates with respect to the codes, code descriptions, code designations (severity level for diagnosis codes or O.R. status for procedure code) and code assignment under the ICD-10 MS-DRGs. As discussed during the March 9-10, 2021 meeting, all April 1 code update files would be made publicly available by February 1, providing a 2-month timeframe for providers to incorporate systems updates. We also do not anticipate any need for code book publishers to issue new code books as a result of an April 1 code update, if adopted. Rather, as was done in the past at the publisher's discretion, supplemental pages containing the code update information were made available and sent to purchasers of the code book products. We further note that historically, coders would hand-write any updates or notes directly into their code books. In addition, with the availability of electronic code book files, we would anticipate any April 1 code updates, if adopted, could be reasonably completed in the allotted timeframe. For these same reasons, we also do not believe a 5-month time period would continue to be needed to update providers' systems to reflect newly approved coding changes. We further note that if an April 1 update were to be adopted, it could be through a phased approach, such that initially, the number and nature of the code updates would be fewer and less comprehensive as compared to the existing October 1 update. For example, it was discussed during the meeting that consideration could first be given to proposals identified as “Addenda”. For diagnosis codes, the proposed addenda updates typically consist primarily of minor revisions to the Index and Tabular List, such as corrections to typos and changes to instructional notes. For procedure codes, the proposed addenda updates typically consist primarily of minor revisions to the Index and Tables, such as adding or deleting entries to describe a body part or approach value or making changes to the Substance and Device Keys. We would use our established process to implement an April 1 code update, which would include presenting proposals for April 1 consideration at the September ICD-10 Coordination and Maintenance Committee meeting, requesting public comments, reviewing the public comments, finalizing codes, and announcing the new codes with their assignments consistent with the new GROUPER release information. Under our contemplated process, requestors would indicate whether they are submitting their code request for consideration for an April 1 implementation date, if adopted, or an October 1 implementation date. The ICD-10 Coordination and Maintenance Committee would make efforts to accommodate the requested implementation date for each request submitted. However, the Committee would determine which requests would be presented for consideration for an April 1 implementation date or an October 1 implementation date. We refer the reader to the Agenda packet from the meeting at: 
                        <E T="03">https://www.cms.gov/Medicare/Coding/ICD10/C-and-M-Meeting-Materials</E>
                         for additional information regarding this announcement and our request for comments.
                    </P>
                    <P>If this new April 1 implementation date is adopted, we would assign the codes approved for the April 1 update to an MS-DRG(s) using our established process for GROUPER assignments for new diagnosis and procedure codes. Specifically, consistent with our established process for assigning new diagnosis and procedure codes, we would review the predecessor code and MS-DRG assignment most closely associated with the new diagnosis or procedure code, and in the absence of claims data, we would consider other factors that may be relevant to the MS-DRG assignment, including the severity of illness, treatment difficulty, complexity of service and the resources utilized in the diagnosis and/or treatment of the condition. We note that this process would not automatically result in the new diagnosis or procedure code being assigned to the same MS-DRG or having the same designation as the predecessor code.</P>
                    <P>
                        ICD-9-CM addendum and code title information is published on the CMS website at: 
                        <E T="03">http://www.cms.hhs.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html?redirect=/icd9ProviderDiagnosticCodes/01overview.asp#TopofPage</E>
                        . ICD-10-CM and ICD-10-PCS addendum and code title information is published on the CMS website at: 
                        <E T="03">http://www.cms.gov/Medicare/Coding/ICD10/index.html</E>
                        . CMS also sends electronic files containing all ICD-10-CM and ICD-10-PCS coding changes to its Medicare contractors for use in updating their systems and providing education to providers.
                    </P>
                    <P>
                        Information on ICD-10-CM diagnosis codes, along with the Official ICD-10-CM Coding Guidelines, can be found on the CDC website at: 
                        <E T="03">https://www.cdc.gov/nchs/icd/icd10cm.htm.</E>
                    </P>
                    <P>
                        Additionally, information on new, revised, and deleted ICD-10-CM diagnosis and ICD-10-PCS procedure codes is provided to the AHA for publication in the 
                        <E T="03">Coding Clinic for ICD-10.</E>
                         The AHA also distributes coding update information to publishers and software vendors.
                    </P>
                    <P>
                        For FY 2021, there are currently 72,621 diagnosis codes and 78,136 ICD-10-PCS procedure codes. As displayed in Table 6A.—New Diagnosis Codes and in Table 6B.—New Procedure Codes associated with this proposed rule (and available via the internet on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index/,</E>
                         there are 147 new diagnosis codes and 106 new procedure codes that have been finalized for FY 2022 at the time of the development of this proposed rule. The code titles are adopted as part of the ICD-10 Coordination and Maintenance Committee process. Thus, although we publish the code titles in the IPPS proposed and final rules, they are not subject to comment in the proposed or final rules. We will continue to provide the October updates in this manner in the IPPS proposed and final rules.
                    </P>
                    <HD SOURCE="HD3">17. Replaced Devices Offered Without Cost or With a Credit</HD>
                    <HD SOURCE="HD3">a. Background</HD>
                    <P>
                        In the FY 2008 IPPS final rule with comment period (72 FR 47246 through 47251), we discussed the topic of Medicare payment for devices that are replaced without cost or where credit for a replaced device is furnished to the hospital. We implemented a policy to reduce a hospital's IPPS payment for certain MS-DRGs where the implantation of a device that subsequently failed or was recalled determined the base MS-DRG assignment. At that time, we specified that we will reduce a hospital's IPPS payment for those MS-DRGs where the hospital received a credit for a replaced device equal to 50 percent or more of the cost of the device.
                        <PRTPAGE P="25196"/>
                    </P>
                    <P>In the FY 2012 IPPS/LTCH PPS final rule (76 FR 51556 through 51557), we clarified this policy to state that the policy applies if the hospital received a credit equal to 50 percent or more of the cost of the replacement device and issued instructions to hospitals accordingly.</P>
                    <HD SOURCE="HD3">b. Proposed Changes for FY 2022</HD>
                    <P>For FY 2022 we are proposing not to add any MS-DRGs to the policy for replaced devices offered without cost or with a credit. We are proposing to continue to include the existing MS-DRGs currently subject to the policy as displayed in the following table.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25197"/>
                        <GID>EP10MY21.124</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="538">
                        <PRTPAGE P="25198"/>
                        <GID>EP10MY21.125</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>The final list of MS-DRGs subject to the IPPS policy for replaced devices offered without cost or with a credit will be included in the FY 2022 IPPS/LTCH PPS final rule and also will be issued to providers in the form of a Change Request (CR).</P>
                    <HD SOURCE="HD1">II. Proposed Changes to Medicare Severity Diagnosis-Related Group (MS-DRG) Classifications and Relative Weights</HD>
                    <HD SOURCE="HD2">E. Recalibration of the FY 2022 MS-DRG Relative Weights</HD>
                    <HD SOURCE="HD3">1. Data Sources for Developing the Relative Weights</HD>
                    <P>
                        In accordance with our proposal as discussed in section I.F. of this proposed rule, for the purposes of establishing the FY 2022 MS-DRG relative weights, we are proposing to use the FY 2019 MedPAR claims data, based on claims received by CMS through March 31, 2020, and the March 2020 update of the FY 2018 HCRIS file where we ordinarily would have used the FY 2020 MedPAR claims data, based on claims received by CMS through December 31, 2020, and the December 2020 update of the FY 2019 HCRIS file. We refer the reader to section I.F. of this 
                        <PRTPAGE P="25199"/>
                        proposed rule for further discussion of our analysis of the best available data for purposes of the FY 2022 ratesetting and our related proposals.
                    </P>
                    <P>Consistent with our established policy, in developing the MS-DRG relative weights for FY 2022, we are proposing to use two data sources: Claims data and cost report data. The claims data source is the MedPAR file, which includes fully coded diagnostic and procedure data for all Medicare inpatient hospital bills. The FY 2019 MedPAR data used in this proposed rule include discharges occurring on October 1, 2018, through September 30, 2019, based on bills received by CMS through March 31, 2020, from all hospitals subject to the IPPS and short-term, acute care hospitals in Maryland (which at that time were under a waiver from the IPPS).</P>
                    <P>The FY 2019 MedPAR file used in calculating the proposed relative weights includes data for approximately 9,217,828 Medicare discharges from IPPS providers. Discharges for Medicare beneficiaries enrolled in a Medicare Advantage managed care plan are excluded from this analysis. These discharges are excluded when the MedPAR “GHO Paid” indicator field on the claim record is equal to “1” or when the MedPAR DRG payment field, which represents the total payment for the claim, is equal to the MedPAR “Indirect Medical Education (IME)” payment field, indicating that the claim was an “IME only” claim submitted by a teaching hospital on behalf of a beneficiary enrolled in a Medicare Advantage managed care plan. In addition, the March 31, 2020 update of the FY 2019 MedPAR file complies with version 5010 of the X12 HIPAA Transaction and Code Set Standards, and includes a variable called “claim type.” Claim type “60” indicates that the claim was an inpatient claim paid as fee-for-service. Claim types “61,” “62,” “63,” and “64” relate to encounter claims, Medicare Advantage IME claims, and HMO no-pay claims. Therefore, the calculation of the proposed relative weights for FY 2022 also excludes claims with claim type values not equal to “60.” The data exclude CAHs, including hospitals that subsequently became CAHs after the period from which the data were taken. We note that the proposed FY 2022 relative weights are based on the ICD-10-CM diagnosis codes and ICD-10-PCS procedure codes from the FY 2019 MedPAR claims data, grouped through the ICD-10 version of the proposed FY 2022 GROUPER (Version 39).</P>
                    <P>
                        The second data source used in the cost-based relative weighting methodology is the Medicare cost report data files from the HCRIS. Normally, we use the HCRIS dataset that is 3 years prior to the IPPS fiscal year. However, as discussed earlier in this section, we are proposing to use the March 31, 2020 update of the FY 2018 HCRIS for calculating the proposed FY 2022 cost-based relative weights. Consistent with our historical practice, for this FY 2022 proposed rule, we are providing the version of the HCRIS from which we calculated these proposed 19 CCRs on the CMS website at: 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                        . Click on the link on the left side of the screen titled “FY 2022 IPPS Proposed Rule Home Page” or “Acute Inpatient Files for Download.” We note that this file is identical to the file used for the FY 2021 IPPS/LTCH PPS final rule. As discussed previously, we are also making available the FY 2019 HCRIS and the FY 2020 MedPAR file as well as other related information and data files for purposes of public comment on our alternative approach of using the same FY 2020 data that we would ordinarily use for purposes of FY 2022 ratesetting.
                    </P>
                    <HD SOURCE="HD3">2. Methodology for Calculation of the Relative Weights</HD>
                    <HD SOURCE="HD3">a. General</HD>
                    <P>We calculated the proposed FY 2022 relative weights based on 19 CCRs, as we did for FY 2021. The methodology we are proposing to use to calculate the FY 2022 MS-DRG cost-based relative weights based on claims data in the FY 2019 MedPAR file and data from the FY 2018 Medicare cost reports is as follows:</P>
                    <P>• To the extent possible, all the claims were regrouped using the proposed FY 2022 MS-DRG classifications discussed in sections II.B. and II.F. of the preamble of this proposed rule.</P>
                    <P>• The transplant cases that were used to establish the relative weights for heart and heart-lung, liver and/or intestinal, and lung transplants (MS-DRGs 001, 002, 005, 006, and 007, respectively) were limited to those Medicare-approved transplant centers that have cases in the FY 2019 MedPAR file. (Medicare coverage for heart, heart-lung, liver and/or intestinal, and lung transplants is limited to those facilities that have received approval from CMS as transplant centers.)</P>
                    <P>• Organ acquisition costs for kidney, heart, heart-lung, liver, lung, pancreas, and intestinal (or multivisceral organs) transplants continue to be paid on a reasonable cost basis.</P>
                    <P>Because these acquisition costs are paid separately from the prospective payment rate, it is necessary to subtract the acquisition charges from the total charges on each transplant bill that showed acquisition charges before computing the average cost for each MS-DRG and before eliminating statistical outliers.</P>
                    <P>Section 108 of the Further Consolidated Appropriations Act, 2020 provides that, for cost reporting periods beginning on or after October 1, 2020, costs related to hematopoietic stem cell acquisition for the purpose of an allogeneic hematopoietic stem cell transplant shall be paid on a reasonable cost basis. We refer the reader to the FY 2021 IPPS/LTCH PPS final rule for further discussion of the reasonable cost basis payment for cost reporting periods beginning on or after October 1, 2020 (85 FR 58835 to 58842). For FY 2022 and subsequent years, we are proposing to subtract the hematopoietic stem cell acquisition charges from the total charges on each transplant bill that showed hematopoietic stem cell acquisition charges before computing the average cost for each MS-DRG and before eliminating statistical outliers.</P>
                    <P>• Claims with total charges or total lengths of stay less than or equal to zero were deleted. Claims that had an amount in the total charge field that differed by more than $30.00 from the sum of the routine day charges, intensive care charges, pharmacy charges, implantable devices charges, supplies and equipment charges, therapy services charges, operating room charges, cardiology charges, laboratory charges, radiology charges, other service charges, labor and delivery charges, inhalation therapy charges, emergency room charges, blood and blood products charges, anesthesia charges, cardiac catheterization charges, CT scan charges, and MRI charges were also deleted.</P>
                    <P>• At least 92.8 percent of the providers in the MedPAR file had charges for 14 of the 19 cost centers. All claims of providers that did not have charges greater than zero for at least 14 of the 19 cost centers were deleted. In other words, a provider must have no more than five blank cost centers. If a provider did not have charges greater than zero in more than five cost centers, the claims for the provider were deleted.</P>
                    <P>
                        • Statistical outliers were eliminated by removing all cases that were beyond 3.0 standard deviations from the geometric mean of the log distribution of both the total charges per case and the total charges per day for each MS-DRG.
                        <PRTPAGE P="25200"/>
                    </P>
                    <P>• Effective October 1, 2008, because hospital inpatient claims include a POA indicator field for each diagnosis present on the claim, only for purposes of relative weight-setting, the POA indicator field was reset to “Y” for “Yes” for all claims that otherwise have an “N” (No) or a “U” (documentation insufficient to determine if the condition was present at the time of inpatient admission) in the POA field.</P>
                    <P>Under current payment policy, the presence of specific HAC codes, as indicated by the POA field values, can generate a lower payment for the claim. Specifically, if the particular condition is present on admission (that is, a “Y” indicator is associated with the diagnosis on the claim), it is not a HAC, and the hospital is paid for the higher severity (and, therefore, the higher weighted MS-DRG). If the particular condition is not present on admission (that is, an “N” indicator is associated with the diagnosis on the claim) and there are no other complicating conditions, the DRG GROUPER assigns the claim to a lower severity (and, therefore, the lower weighted MS-DRG) as a penalty for allowing a Medicare inpatient to contract a HAC. While the POA reporting meets policy goals of encouraging quality care and generates program savings, it presents an issue for the relative weight-setting process. Because cases identified as HACs are likely to be more complex than similar cases that are not identified as HACs, the charges associated with HAC cases are likely to be higher as well. Therefore, if the higher charges of these HAC claims are grouped into lower severity MS-DRGs prior to the relative weight-setting process, the relative weights of these particular MS-DRGs would become artificially inflated, potentially skewing the relative weights. In addition, we want to protect the integrity of the budget neutrality process by ensuring that, in estimating payments, no increase to the standardized amount occurs as a result of lower overall payments in a previous year that stem from using weights and case-mix that are based on lower severity MS-DRG assignments. If this would occur, the anticipated cost savings from the HAC policy would be lost.</P>
                    <P>To avoid these problems, we reset the POA indicator field to “Y” only for relative weight-setting purposes for all claims that otherwise have an “N” or a “U” in the POA field. This resetting “forced” the more costly HAC claims into the higher severity MS-DRGs as appropriate, and the relative weights calculated for each MS-DRG more closely reflect the true costs of those cases.</P>
                    <P>
                        In addition, in the FY 2013 IPPS/LTCH PPS final rule, for FY 2013 and subsequent fiscal years, we finalized a policy to treat hospitals that participate in the Bundled Payments for Care Improvement (BPCI) initiative the same as prior fiscal years for the IPPS payment modeling and ratesetting process without regard to hospitals' participation within these bundled payment models (77 FR 53341 through 53343). Specifically, because acute care hospitals participating in the BPCI Initiative still receive IPPS payments under section 1886(d) of the Act, we include all applicable data from these subsection (d) hospitals in our IPPS payment modeling and ratesetting calculations as if the hospitals were not participating in those models under the BPCI initiative. We refer readers to the FY 2013 IPPS/LTCH PPS final rule for a complete discussion on our final policy for the treatment of hospitals participating in the BPCI initiative in our ratesetting process. For additional information on the BPCI initiative, we refer readers to the CMS' Center for Medicare and Medicaid Innovation's website at: 
                        <E T="03">http://innovation.cms.gov/initiatives/Bundled-Payments/index.html</E>
                         and to section IV.H.4. of the preamble of the FY 2013 IPPS/LTCH PPS final rule (77 FR 53341 through 53343).
                    </P>
                    <P>
                        The participation of hospitals in the BPCI initiative concluded on September 30, 2018. The participation of hospitals in the BPCI Advanced model started on October 1, 2018. The BPCI Advanced model, tested under the authority of section 1115A of the Act, is comprised of a single payment and risk track, which bundles payments for multiple services beneficiaries receive during a Clinical Episode. Acute care hospitals may participate in BPCI Advanced in one of two capacities: As a model Participant or as a downstream Episode Initiator. Regardless of the capacity in which they participate in the BPCI Advanced model, participating acute care hospitals will continue to receive IPPS payments under section 1886(d) of the Act. Acute care hospitals that are Participants also assume financial and quality performance accountability for Clinical Episodes in the form of a reconciliation payment. For additional information on the BPCI Advanced model, we refer readers to the BPCI Advanced web page on the CMS Center for Medicare and Medicaid Innovation's website at: 
                        <E T="03">https://innovation.cms.gov/initiatives/bpci-advanced/</E>
                        . Consistent with our policy for FY 2021, and consistent with how we have treated hospitals that participated in the BPCI Initiative, for FY 2022, we continue to believe it is appropriate to include all applicable data from the subsection (d) hospitals participating in the BPCI Advanced model in our IPPS payment modeling and ratesetting calculations because, as noted previously, these hospitals are still receiving IPPS payments under section 1886(d) of the Act. Consistent with the FY 2021 IPPS/LTCH PPS final rule, we are also proposing to include all applicable data from subsection (d) hospitals participating in the Comprehensive Care for Joint Replacement (CJR) Model in our IPPS payment modeling and ratesetting calculations. The charges for each of the 19 cost groups for each claim were standardized to remove the effects of differences in area wage levels, IME and DSH payments, and for hospitals located in Alaska and Hawaii, the applicable cost-of-living adjustment. Because hospital charges include charges for both operating and capital costs, we standardized total charges to remove the effects of differences in geographic adjustment factors, cost-of-living adjustments, and DSH payments under the capital IPPS as well. Charges were then summed by MS-DRG for each of the 19 cost groups so that each MS-DRG had 19 standardized charge totals. Statistical outliers were then removed. These charges were then adjusted to cost by applying the proposed national average CCRs developed from the FY 2018 cost report data, consistent with our proposed FY 2022 ratesetting discussed in section II.A.4 of the Addendum of this proposed rule.
                    </P>
                    <P>
                        The 19 cost centers that we used in the proposed relative weight calculation are shown in a supplemental data file, Cost Center HCRIS Lines Supplemental Data File, posted via the internet on the CMS website for this proposed rule and available at 
                        <E T="03">http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html</E>
                        . The supplemental data file shows the lines on the cost report and the corresponding revenue codes that we used to create the proposed 19 national cost center CCRs. If we receive comments about the groupings in this supplemental data file, we may consider these comments as we finalize our policy.
                    </P>
                    <P>
                        Consistent with historical practice, we account for rare situations of non-monotonicity in a base MS-DRG and its severity levels, where the mean cost in the higher severity level is less than the mean cost in the lower severity level, in determining the relative weights for the different severity levels. If there are initially non-monotonic relative weights 
                        <PRTPAGE P="25201"/>
                        in the same base DRG and its severity levels, then we combine the cases that group to the specific non-monotonic MS-DRGs for purposes of relative weight calculations. For example, if there are two non-monotonic MS-DRGs, combining the cases across those two MS-DRGs results in the same relative weight for both MS-DRGs. The relative weight calculated using the combined cases for those severity levels is monotonic, effectively removing any non-monotonicity with the base DRG and its severity levels. For this FY 2022 proposed rule, this calculation was applied to address non-monotonicity for cases that grouped to MS-DRG 504 and MS-DRG 505. We note that cases were also combined in calculating the relative weights for these two MS-DRGs for FY 2021. In the supplemental file titled AOR/BOR File, we include statistics for the affected MS-DRGs both separately and with cases combined.
                    </P>
                    <P>We are inviting public comments on our proposals related to recalibration of the proposed FY 2022 relative weights and the changes in relative weights from FY 2021.</P>
                    <HD SOURCE="HD3">b. Relative Weight Calculation for MS-DRG 018</HD>
                    <P>As discussed in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58599 through 58600), we created MS-DRG 018 for cases that include procedures describing CAR T-cell therapies, which were reported using ICD-10-PCS procedure codes XW033C3 or XW043C3. We refer the reader to section II.D.2. of this proposed rule for discussion of the procedure codes for CAR T-cell and non-CAR T-cell therapies and other immunotherapies that we are proposing for assignment to MS-DRG 018 for FY 2022.</P>
                    <P>In the FY 2021 IPPS/LTCH PPS final rule, we finalized our proposals to modify our existing relative weight methodology to ensure that the relative weight for new MS-DRG 018 appropriately reflects the relative resources required for providing CAR T-cell therapy outside of a clinical trial, while still accounting for the clinical trial cases in the overall average cost for all MS-DRGs, with additional refinements in response to comments. For cases that group to MS-DRG 018, we finalized to not include claims determined to be clinical trial claims that group to new MS-DRG 018 when calculating the average cost for new MS-DRG 018 that is used to calculate the relative weight for this MS-DRG, with the additional refinements that (a) when the CAR T-cell therapy product is purchased in the usual manner, but the case involves a clinical trial of a different product, the claim will be included when calculating the average cost for new MS-DRG 018 to the extent such claims can be identified in the historical data, and (b) when there is expanded access use of immunotherapy, these cases will not be included when calculating the average cost for new MS-DRG 018 to the extent such claims can be identified in the historical data (85 FR 58600). We also finalized our proposal to calculate an adjustment to account for the CAR T-cell therapy cases determined to be clinical trial cases, as described in the FY 2021 IPPS/LTCH PPS final rule, with the additional refinement of including revenue center 891 in our calculation of standardized drug charges for MS-DRG 018. Applying this finalized methodology, based on the March 2020 update of the FY 2019 MedPAR file for the FY 2021 IPPS/LTCH PPS final rule, we estimated that the average costs of CAR T-cell therapy cases determined to be clinical trial cases ($46,062) were 17 percent of the average costs of CAR T cell therapy cases determined to be non-clinical trial cases ($276,042), and therefore, in calculating the national average cost per case for purposes of the FY 2021 IPPS/LTCH PPS final rule, each case identified as a clinical trial case was adjusted by 0.17. We also noted that we were applying this adjustor for cases determined to be CAR T-cell therapy clinical trial cases for purposes of budget neutrality and outlier simulations. We refer the reader to the FY 2021 IPPS/LTCH PPS final rule for complete discussion of our finalized modifications to the relative weight calculation for MS-DRG 018.</P>
                    <P>Since we are proposing to use the same FY 2019 MedPAR claims data for FY 2022 ratesetting that we did for the FY 2021 final rule, we are also proposing to continue to use the same process to identify clinical trial claims in the FY 2019 MedPAR for purposes of calculating the FY 2022 relative weights. We continue to use the proxy of standardized drug charges of less than $373,000, which was the average sales price of KYMRIAH and YESCARTA, which are the two CAR T-cell biological products in the MedPAR data used for the FY 2021 final rule and this proposed rule. Using the same methodology from the FY 2021 IPPS/LTCH PPS final rule, we are proposing to apply an adjustment to account for the CAR T cell therapy cases identified as clinical trial cases in calculating the national average standardized cost per case that is used to calculate the relative weights for all MS-DRGs:</P>
                    <P>• Calculate the average cost for cases to be assigned to new MS-DRG 018 that contain ICD-10-CM diagnosis code Z00.6 or contain standardized drug charges of less than $373,000.</P>
                    <P>• Calculate the average cost for cases to be assigned to new MS-DRG 018 that do not contain ICD-10-CM diagnosis code Z00.6 or standardized drug charges of at least $373,000.</P>
                    <P>• Calculate an adjustor by dividing the average cost calculated in step 1 by the average cost calculated in step 2.</P>
                    <P>• Apply the adjustor calculated in step 3 to the cases identified in step 1 as clinical trial cases, then add this adjusted case count to the non-clinical trial case count prior to calculating the average cost across all MS-DRGs.</P>
                    <P>Additionally, we are continuing our finalized methodology for calculating this payment adjustment, such that: (a) When the CAR T-cell therapy product is purchased in the usual manner, but the case involves a clinical trial of a different product, the claim will be included when calculating the average cost for cases not determined to be clinical trial cases and (b) when there is expanded access use of immunotherapy, these cases will be included when calculating the average cost for cases determined to be clinical trial cases. However, we continue to believe to the best of our knowledge there are no claims in the historical data (FY 2019 MedPAR) used in the calculation of the adjustment for cases involving a clinical trial of a different product, and to the extent the historical data contain claims for cases involving expanded access use of immunotherapy we believe those claims would have drug charges less than $373,000. Consistent with our proposal to use the FY 2019 data for the FY 2022 ratesetting, we are also proposing to calculate this adjustor based on the March 2020 update of the FY 2019 MedPAR file for purposes of establishing the FY 2022 relative weights. Accordingly, as we did for FY 2021, we are proposing to adjust the transfer-adjusted case count for MS-DRG 018 by applying the proposed adjustor of 17 percent to the applicable clinical trial cases, and to use this adjusted case count for MS-DRG 018 in calculating the national average cost per case, which is used in the calculation of the relative weights. Therefore, in calculating the national average cost per case for purposes of this proposed rule, each case identified as a clinical trial case was adjusted by 17 percent. As we did for FY 2021, we are proposing to apply this same adjustor for the applicable cases that group to MS-DRG 018 for purposes of budget neutrality and outlier simulations.</P>
                    <P>
                        As discussed in section I.F. of this proposed rule, we are also soliciting 
                        <PRTPAGE P="25202"/>
                        comments on an alternative approach of using the same FY 2020 data that we would ordinarily use for purposes of the FY 2022 rulemaking, which we may consider finalizing for FY 2022 based on consideration of comments received. We note that using the methodology as finalized in the FY 2021 IPPS/LTCH PPS final rule, we calculated an adjustor of 0.25 based on this alternative approach of using the FY 2020 MedPAR file.
                    </P>
                    <HD SOURCE="HD3">3. Development of Proposed National Average CCRs</HD>
                    <P>Consistent with our proposal to use the FY 2019 data for the FY 2022 ratesetting, as discussed earlier in this section, we are proposing to continue to use the national average CCRs that were calculated for the FY 2021 final rule using that same data. Specifically, we calculated these national average CCRs as follows:</P>
                    <P>Using the FY 2018 cost report data, we removed CAHs, Indian Health Service hospitals, all-inclusive rate hospitals, and cost reports that represented time periods of less than 1 year (365 days). We included hospitals located in Maryland because we include their charges in our claims database. Then we created CCRs for each provider for each cost center (see the supplemental data file for line items used in the calculations) and removed any CCRs that were greater than 10 or less than 0.01. We normalized the departmental CCRs by dividing the CCR for each department by the total CCR for the hospital for the purpose of trimming the data. Then we took the logs of the normalized cost center CCRs and removed any cost center CCRs where the log of the cost center CCR was greater or less than the mean log plus/minus 3 times the standard deviation for the log of that cost center CCR. Once the cost report data were trimmed, we calculated a Medicare-specific CCR. The Medicare-specific CCR was determined by taking the Medicare charges for each line item from Worksheet D-3 and deriving the Medicare-specific costs by applying the hospital-specific departmental CCRs to the Medicare-specific charges for each line item from Worksheet D-3. Once each hospital's Medicare-specific costs were established, we summed the total Medicare-specific costs and divided by the sum of the total Medicare-specific charges to produce national average, charge-weighted CCRs.</P>
                    <P>After we multiplied the total charges for each MS-DRG in each of the 19 cost centers by the corresponding national average CCR, we summed the 19 “costs” across each MS-DRG to produce a total standardized cost for the MS-DRG. The average standardized cost for each MS-DRG was then computed as the total standardized cost for the MS-DRG divided by the transfer-adjusted case count for the MS-DRG. The average cost for each MS-DRG was then divided by the national average standardized cost per case to determine the proposed relative weight.</P>
                    <P>The proposed FY 2022 cost-based relative weights were then normalized by an adjustment factor of 1.820783 so that the average case weight after recalibration was equal to the average case weight before recalibration. The normalization adjustment is intended to ensure that recalibration by itself neither increases nor decreases total payments under the IPPS, as required by section 1886(d)(4)(C)(iii) of the Act.</P>
                    <P>The proposed 19 national average CCRs for FY 2022 are as follows:</P>
                    <GPH SPAN="3" DEEP="144">
                        <GID>EP10MY21.126</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="158">
                        <GID>EP10MY21.127</GID>
                    </GPH>
                    <PRTPAGE P="25203"/>
                    <P>Since FY 2009, the relative weights have been based on 100 percent cost weights based on our MS-DRG grouping system.</P>
                    <P>When we recalibrated the DRG weights for previous years, we set a threshold of 10 cases as the minimum number of cases required to compute a reasonable weight. We are proposing to use that same case threshold in recalibrating the proposed MS-DRG relative weights for FY 2022. Using data from the FY 2019 MedPAR file, there were 7 MS-DRGs that contain fewer than 10 cases. For FY 2022, because we do not have sufficient MedPAR data to set accurate and stable cost relative weights for these low-volume MS-DRGs, we are proposing to compute relative weights for the low-volume MS-DRGs by adjusting their final FY 2021 relative weights by the percentage change in the average weight of the cases in other MS-DRGs from FY 2021 to FY 2022. The crosswalk table is as follows.</P>
                    <GPH SPAN="3" DEEP="191">
                        <GID>EP10MY21.128</GID>
                    </GPH>
                    <HD SOURCE="HD2">F. Add-On Payments for New Services and Technologies for FY 2022</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>Sections 1886(d)(5)(K) and (L) of the Act establish a process of identifying and ensuring adequate payment for new medical services and technologies (sometimes collectively referred to in this section as “new technologies”) under the IPPS. Section 1886(d)(5)(K)(vi) of the Act specifies that a medical service or technology will be considered new if it meets criteria established by the Secretary after notice and opportunity for public comment. Section 1886(d)(5)(K)(ii)(I) of the Act specifies that a new medical service or technology may be considered for new technology add-on payment if, based on the estimated costs incurred with respect to discharges involving such service or technology, the DRG prospective payment rate otherwise applicable to such discharges under this subsection is inadequate. We note that, beginning with discharges occurring in FY 2008, CMS transitioned from CMS-DRGs to MS-DRGs. The regulations at 42 CFR 412.87 implement these provisions and 42 CFR 412.87(b) specifies three criteria for a new medical service or technology to receive the additional payment: (1) The medical service or technology must be new; (2) the medical service or technology must be costly such that the DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate; and (3) the service or technology must demonstrate a substantial clinical improvement over existing services or technologies. In addition, certain transformative new devices and antimicrobial products may qualify under an alternative inpatient new technology add-on payment pathway, as set forth in the regulations at § 412.87(c) and (d). We note that section 1886(d)(5)(K)(i) of the Act requires that the Secretary establish a mechanism to recognize the costs of new medical services and technologies under the payment system established under that subsection, which establishes the system for paying for the operating costs of inpatient hospital services. The system of payment for capital costs is established under section 1886(g) of the Act. Therefore, as discussed in prior rulemaking (72 FR 47307 through 47308), we do not include capital costs in the add-on payments for a new medical service or technology or make new technology add-on payments under the IPPS for capital-related costs. In this rule, we highlight some of the major statutory and regulatory provisions relevant to the new technology add-on payment criteria, as well as other information. For a complete discussion of the new technology add-on payment criteria, we refer readers to the FY 2012 IPPS/LTCH PPS final rule (76 FR 51572 through 51574), FY 2020 IPPS/LTCH PPS final rule (84 FR 42288 through 42300) and the FY 2021 IPPS/LTCH PPS final rule (85 FR 58736 through 58742).</P>
                    <HD SOURCE="HD3">a. New Technology Add On Payment Criteria</HD>
                    <HD SOURCE="HD3">(1) Newness Criterion</HD>
                    <P>
                        Under the first criterion, as reflected in § 412.87(b)(2), a specific medical service or technology will no longer be considered “new” for purposes of new medical service or technology add-on payments after CMS has recalibrated the MS-DRGs, based on available data, to reflect the cost of the technology. We note that we do not consider a service or technology to be new if it is substantially similar to one or more existing technologies. That is, even if a medical product receives a new FDA approval or clearance, it may not necessarily be considered “new” for purposes of new technology add-on payments if it is “substantially similar” to another medical product that was approved or cleared by FDA and has been on the market for more than 2 to 3 years. In the FY 2010 IPPS/RY 2010 LTCH PPS final rule (74 FR 43813 through 43814), we established criteria for evaluating whether a new technology is substantially similar to an existing technology, specifically: (1) 
                        <PRTPAGE P="25204"/>
                        Whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome; (2) whether a product is assigned to the same or a different MS-DRG; and (3) whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population. If a technology meets all three of these criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments. For a detailed discussion of the criteria for substantial similarity, we refer readers to the FY 2006 IPPS final rule (70 FR 47351 through 47352) and the FY 2010 IPPS/LTCH PPS final rule (74 FR 43813 through 43814).
                    </P>
                    <HD SOURCE="HD3">(2) Cost Criterion</HD>
                    <P>
                        Under the second criterion, § 412.87(b)(3) further provides that, to be eligible for the add-on payment for new medical services or technologies, the MS-DRG prospective payment rate otherwise applicable to discharges involving the new medical service or technology must be assessed for adequacy. Under the cost criterion, consistent with the formula specified in section 1886(d)(5)(K)(ii)(I) of the Act, to assess the adequacy of payment for a new technology paid under the applicable MS-DRG prospective payment rate, we evaluate whether the charges of the cases involving a new medical service or technology will exceed a threshold amount that is the lesser of 75 percent of the standardized amount (increased to reflect the difference between cost and charges) or 75 percent of one standard deviation beyond the geometric mean standardized charge for all cases in the MS-DRG to which the new medical service or technology is assigned (or the case-weighted average of all relevant MS-DRGs if the new medical service or technology occurs in many different MS-DRGs). The MS-DRG threshold amounts generally used in evaluating new technology add-on payment applications for FY 2022 are presented in a data file that is available, along with the other data files associated with the FY 2021 IPPS/LTCH PPS final rule and correction notice, on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index</E>
                        .
                    </P>
                    <P>We note that, under the policy finalized in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58603 through 58605), beginning with FY 2022, we use the proposed threshold values associated with the proposed rule for that fiscal year to evaluate the cost criterion for all applications for new technology add-on payments and previously approved technologies that may continue to receive new technology add-on payments, if those technologies would be assigned to a proposed new MS-DRG for that same fiscal year.</P>
                    <P>
                        As finalized in the FY 2019 IPPS/LTCH PPS final rule (83 FR 41275), beginning with FY 2020, we include the thresholds applicable to the next fiscal year (previously included in Table 10 of the annual IPPS/LTCH PPS proposed and final rules) in the data files associated with the prior fiscal year. Accordingly, the proposed thresholds for applications for new technology add-on payments for FY 2023 are presented in a data file that is available on the CMS website, along with the other data files associated with this FY 2022 proposed rule, by clicking on the FY 2022 IPPS Proposed Rule Home Page at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index</E>
                        . We note, for the reasons discussed in section I.F of the preamble of this proposed rule, we are proposing to use the FY 2019 MedPAR claims data where we ordinarily would have used the FY 2020 MedPAR claims data for purposes of proposed FY 2022 ratesetting. We refer the reader to section I.F. of the preamble of this proposed rule for further discussion of our analysis of the best available data for FY 2022 ratesetting and our related proposals. For the FY 2023 proposed threshold values, consistent with our proposal, we are proposing to use FY 2019 claims data to evaluate whether the charges of the cases involving a new medical service or technology will exceed a threshold amount that is the lesser of 75 percent of the proposed FY 2022 standardized amount (increased to reflect the difference between cost and charges) or 75 percent of one standard deviation beyond the geometric mean standardized charge (using FY 2019 claims data) for all cases in the MS-DRG (using FY 2019 claims data) to which the new medical service or technology is assigned (or the case-weighted average of all relevant MS-DRGs if the new medical service or technology occurs in many different MS-DRGs), rather than the FY 2020 data we would otherwise use. As discussed in section I.F of the preamble of this proposed rule, we are also considering, as an alternative to our proposal, the use of the same FY 2020 data that we would ordinarily use for purposes of FY 2022 ratesetting. If we were to finalize this alternative approach for FY 2022, we would use the FY 2020 claims data for purposes of the final thresholds for applications for new technology add-on payments for FY 2023 in the FY 2022 IPPS/LTCH PPS final rule. We are making available the threshold values calculated using the FY 2020 claims data at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS</E>
                        . In the September 7, 2001 final rule that established the new technology add-on payment regulations (66 FR 46917), we discussed that applicants should submit a significant sample of data to demonstrate that the medical service or technology meets the high-cost threshold. Specifically, applicants should submit a sample of sufficient size to enable us to undertake an initial validation and analysis of the data. We also discussed in the September 7, 2001 final rule (66 FR 46917) the issue of whether the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule at 45 CFR parts 160 and 164 applies to claims information that providers submit with applications for new medical service or technology add-on payments. We refer readers to the FY 2012 IPPS/LTCH PPS final rule (76 FR 51573) for complete information on this issue.
                    </P>
                    <HD SOURCE="HD3">(3) Substantial Clinical Improvement Criterion</HD>
                    <P>Under the third criterion at § 412.87(b)(1), a medical service or technology must represent an advance that substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries. In the FY 2020 IPPS/LTCH PPS final rule (84 FR 42288 through 42292), we prospectively codified in our regulations at § 412.87(b) the following aspects of how we evaluate substantial clinical improvement for purposes of new technology add-on payments under the IPPS:</P>
                    <P>• The totality of the circumstances is considered when making a determination that a new medical service or technology represents an advance that substantially improves, relative to services or technologies previously available, the diagnosis or treatment of Medicare beneficiaries.</P>
                    <P>• A determination that a new medical service or technology represents an advance that substantially improves, relative to services or technologies previously available, the diagnosis or treatment of Medicare beneficiaries means—</P>
                    <P>
                        ++ The new medical service or technology offers a treatment option for a patient population unresponsive to, or 
                        <PRTPAGE P="25205"/>
                        ineligible for, currently available treatments;
                    </P>
                    <P>++ The new medical service or technology offers the ability to diagnose a medical condition in a patient population where that medical condition is currently undetectable, or offers the ability to diagnose a medical condition earlier in a patient population than allowed by currently available methods, and there must also be evidence that use of the new medical service or technology to make a diagnosis affects the management of the patient;</P>
                    <P>++ The use of the new medical service or technology significantly improves clinical outcomes relative to services or technologies previously available as demonstrated by one or more of the following: A reduction in at least one clinically significant adverse event, including a reduction in mortality or a clinically significant complication; a decreased rate of at least one subsequent diagnostic or therapeutic intervention; a decreased number of future hospitalizations or physician visits; a more rapid beneficial resolution of the disease process treatment including, but not limited to, a reduced length of stay or recovery time; an improvement in one or more activities of daily living; an improved quality of life; or, a demonstrated greater medication adherence or compliance; or</P>
                    <P>++ The totality of the circumstances otherwise demonstrates that the new medical service or technology substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries.</P>
                    <P>• Evidence from the following published or unpublished information sources from within the United States or elsewhere may be sufficient to establish that a new medical service or technology represents an advance that substantially improves, relative to services or technologies previously available, the diagnosis or treatment of Medicare beneficiaries: Cinical trials, peer reviewed journal articles; study results; meta-analyses; consensus statements; white papers; patient surveys; case studies; reports; systematic literature reviews; letters from major healthcare associations; editorials and letters to the editor; and public comments. Other appropriate information sources may be considered.</P>
                    <P>• The medical condition diagnosed or treated by the new medical service or technology may have a low prevalence among Medicare beneficiaries.</P>
                    <P>• The new medical service or technology may represent an advance that substantially improves, relative to services or technologies previously available, the diagnosis or treatment of a subpopulation of patients with the medical condition diagnosed or treated by the new medical service or technology.</P>
                    <P>We refer the reader to the FY 2020 IPPS/LTCH PPS final rule for additional discussion of the evaluation of substantial clinical improvement for purposes of new technology add-on payments under the IPPS.</P>
                    <P>We note, consistent with the discussion in the FY 2003 IPPS final rule (67 FR 50015), that although we are affiliated with the FDA and we do not question the FDA's regulatory responsibility for decisions related to marketing authorization (for example, approval, clearance, etc.), we do not rely upon FDA criteria in our determination of what drugs, devices, or technologies qualify for new technology add-on payments under Medicare. Our criteria do not depend on the standard of safety and efficacy on which the FDA relies but on a demonstration of substantial clinical improvement in the Medicare population (particularly patients over age 65).</P>
                    <HD SOURCE="HD3">c. Alternative Inpatient New Technology Add-On Payment Pathway</HD>
                    <P>Beginning with applications for FY 2021 new technology add-on payments, under the regulations at § 412.87(c), a medical device that is part of FDA's Breakthrough Devices Program may qualify for the new technology add-on payment under an alternative pathway. Additionally, under the regulations at § 412.87(d) for certain antimicrobial products, beginning with FY 2021, a drug that is designated by the FDA as a Qualified Infectious Disease Product (QIDP), and, beginning with FY 2022, a drug that is approved by the FDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), may also qualify for the new technology add-on payment under an alternative pathway. We refer the reader to the FY 2020 IPPS/LTCH PPS final rule (84 FR 42292 through 42297) and the FY 2021 IPPS/LTCH PPS final rule (85 FR 58737 through 58739) for a complete discussion on this policy. We note that a technology is not required to have the specified FDA designation at the time the new technology add-on payment application is submitted. CMS will review the application based on the information provided by the applicant under the alternative pathway specified by the applicant. However, to receive approval for the new technology add-on payment under that alternative pathway, the technology must have the applicable FDA designation and meet all other requirements in the regulations in § 412.87(c) and (d), as applicable.</P>
                    <HD SOURCE="HD3">(1) Alternative Pathway for Certain Transformative New Devices</HD>
                    <P>For applications received for new technology add-on payments for FY 2021 and subsequent fiscal years, if a medical device is part of FDA's Breakthrough Devices Program and received FDA marketing authorization, it will be considered new and not substantially similar to an existing technology for purposes of the new technology add-on payment under the IPPS, and will not need to meet the requirement under § 412.87(b)(1) that it represent an advance that substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries. This policy is codified at § 412.87(c). Under this alternative pathway, a medical device that has received FDA marketing authorization (that is, has been approved or cleared by, or had a De Novo classification request granted by, FDA) and that is part of FDA's Breakthrough Devices Program will need to meet the cost criterion under § 412.87(b)(3), and will be considered new as reflected in § 412.87(c)(2). We note, in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58734 through 58736), we clarified our policy that a new medical device under this alternative pathway must receive marketing authorization for the indication covered by the Breakthrough Devices Program designation. We refer the reader to the FY 2021 IPPS/LTCH PPS final rule (85 FR 58734 through 58736) for a complete discussion regarding this clarification.</P>
                    <HD SOURCE="HD3">(2) Alternative Pathway for Certain Antimicrobial Products</HD>
                    <P>
                        For applications received for new technology add-on payments for certain antimicrobial products, beginning with FY 2021, if a technology is designated by FDA as a QIDP and received FDA marketing authorization, and, beginning with FY 2022, if a drug is approved under FDA's LPAD pathway and used for the indication approved under the LPAD pathway, it will be considered new and not substantially similar to an existing technology for purposes of new technology add-on payments and will not need to meet the requirement that it represent an advance that substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries. We codified this policy at § 412.87(d). Under this alternative pathway for QIDPs and LPADs, a medical product that has received FDA marketing authorization and is designated by FDA 
                        <PRTPAGE P="25206"/>
                        as a QIDP or approved under the LPAD pathway will need to meet the cost criterion under § 412.87(b)(3), and will be considered new as reflected in § 412.87(d)(2).
                    </P>
                    <P>We refer the reader to the FY 2020 IPPS/LTCH PPS final rule (84 FR 42292 through 42297) and FY 2021 IPPS/LTCH PPS final rule (85 FR 58737 through 58739) for a complete discussion on this policy. We note, in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58737 through 58739), we clarified that a new medical product seeking approval for the new technology add-on payment under the alternative pathway for QIDPs must receive marketing authorization for the indication covered by the QIDP designation. We also finalized our policy to expand our alternative new technology add-on payment pathway for certain antimicrobial products to include products approved under the LPAD pathway and used for the indication approved under the LPAD pathway.</P>
                    <HD SOURCE="HD3">d. Additional Payment for New Medical Service or Technology</HD>
                    <P>The new medical service or technology add-on payment policy under the IPPS provides additional payments for cases with relatively high costs involving eligible new medical services or technologies, while preserving some of the incentives inherent under an average-based prospective payment system. The payment mechanism is based on the cost to hospitals for the new medical service or technology. As noted previously, we do not include capital costs in the add-on payments for a new medical service or technology or make new technology add-on payments under the IPPS for capital-related costs (72 FR 47307 through 47308).</P>
                    <P>For discharges occurring before October 1, 2019, under § 412.88, if the costs of the discharge (determined by applying operating cost-to-charge ratios (CCRs) as described in § 412.84(h)) exceed the full DRG payment (including payments for IME and DSH, but excluding outlier payments), CMS made an add-on payment equal to the lesser of: (1) 50 percent of the costs of the new medical service or technology; or (2) 50 percent of the amount by which the costs of the case exceed the standard DRG payment.</P>
                    <P>Beginning with discharges on or after October 1, 2019, for the reasons discussed in the FY 2020 IPPS/LTCH PPS final rule (84 FR 42297 through 42300), we finalized an increase in the new technology add-on payment percentage, as reflected at § 412.88(a)(2)(ii). Specifically, for a new technology other than a medical product designated by FDA as a QIDP, beginning with discharges on or after October 1, 2019, if the costs of a discharge involving a new technology (determined by applying CCRs as described in § 412.84(h)) exceed the full DRG payment (including payments for IME and DSH, but excluding outlier payments), Medicare will make an add-on payment equal to the lesser of: (1) 65 percent of the costs of the new medical service or technology; or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment. For a new technology that is a medical product designated by FDA as a QIDP, beginning with discharges on or after October 1, 2019, if the costs of a discharge involving a new technology (determined by applying CCRs as described in § 412.84(h)) exceed the full DRG payment (including payments for IME and DSH, but excluding outlier payments), Medicare will make an add-on payment equal to the lesser of: (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment. For a new technology that is a medical product approved under FDA's LPAD pathway, beginning with discharges on or after October 1, 2020, if the costs of a discharge involving a new technology (determined by applying CCRs as described in § 412.84(h)) exceed the full DRG payment (including payments for IME and DSH, but excluding outlier payments), Medicare will make an add-on payment equal to the lesser of: (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment. As set forth in § 412.88(b)(2), unless the discharge qualifies for an outlier payment, the additional Medicare payment will be limited to the full MS-DRG payment plus 65 percent (or 75 percent for certain antimicrobial products (QIDPs and LPADs)) of the estimated costs of the new technology or medical service.</P>
                    <P>We refer the reader to the FY 2020 IPPS/LTCH PPS final rule (84 FR 42297 through 42300) for complete discussion on the increase in the new technology add on payment beginning with discharges on or after October 1, 2019.</P>
                    <P>Section 503(d)(2) of Public Law 108-173 provides that there shall be no reduction or adjustment in aggregate payments under the IPPS due to add-on payments for new medical services and technologies. Therefore, in accordance with section 503(d)(2) of Public Law 108-173, add-on payments for new medical services or technologies for FY 2005 and subsequent years have not been subjected to budget neutrality.</P>
                    <HD SOURCE="HD3">e. Evaluation of Eligibility Criteria for New Medical Service or Technology Applications</HD>
                    <P>In the FY 2009 IPPS final rule (73 FR 48561 through 48563), we modified our regulations at § 412.87 to codify our longstanding practice of how CMS evaluates the eligibility criteria for new medical service or technology add-on payment applications. That is, we first determine whether a medical service or technology meets the newness criterion, and only if so, do we then make a determination as to whether the technology meets the cost threshold and represents a substantial clinical improvement over existing medical services or technologies. We specified that all applicants for new technology add-on payments must have FDA approval or clearance by July 1 of the year prior to the beginning of the fiscal year for which the application is being considered. In the FY 2021 IPPS final rule, to more precisely describe the various types of FDA approvals, clearances and classifications that we consider under our new technology add-on payment policy, we finalized a technical clarification to the regulation to indicate that new technologies must receive FDA marketing authorization (such as pre-market approval (PMA); 510(k) clearance; the granting of a De Novo classification request, or approval of a New Drug Application (NDA)) by July 1 of the year prior to the beginning of the fiscal year for which the application is being considered. Consistent with our longstanding policy, we consider FDA marketing authorization as representing that a product has received FDA approval or clearance when considering eligibility for the new technology add-on payment under § 412.87(e)(2) (85 FR 58742).</P>
                    <P>
                        Additionally, in the FY 2021 IPPS final rule (85 FR 58739 through 58742), we finalized our proposal to provide conditional approval for new technology add-on payment for a technology for which an application is submitted under the alternative pathway for certain antimicrobial products at § 412.87(d) that does not receive FDA marketing authorization by the July 1 deadline specified in § 412.87(e)(2), provided that the technology otherwise meets the applicable add-on payment criteria. Under this policy, cases involving eligible antimicrobial products would begin receiving the new technology add-on payment sooner, effective for discharges the quarter after the date of FDA marketing authorization provided 
                        <PRTPAGE P="25207"/>
                        that the technology receives FDA marketing authorization by July 1 of the particular fiscal year for which the applicant applied for new technology add-on payments.
                    </P>
                    <HD SOURCE="HD3">f. Council on Technology and Innovation (CTI)</HD>
                    <P>The Council on Technology and Innovation at CMS oversees the agency's cross-cutting priority on coordinating coverage, coding and payment processes for Medicare with respect to new technologies and procedures, including new drug therapies, as well as promoting the exchange of information on new technologies and medical services between CMS and other entities. The CTI, composed of senior CMS staff and clinicians, was established under section 942(a) of Public Law 108-173. The Council is co-chaired by the Director of the Center for Clinical Standards and Quality (CCSQ) and the Director of the Center for Medicare (CM), who is also designated as the CTI's Executive Coordinator.</P>
                    <P>The specific processes for coverage, coding, and payment are implemented by CM, CCSQ, and the local Medicare Administrative Contractors (MACs) (in the case of local coverage and payment decisions). The CTI supplements, rather than replaces, these processes by working to assure that all of these activities reflect the agency-wide priority to promote high-quality, innovative care. At the same time, the CTI also works to streamline, accelerate, and improve coordination of these processes to ensure that they remain up to date as new issues arise. To achieve its goals, the CTI works to streamline and create a more transparent coding and payment process, improve the quality of medical decisions, and speed patient access to effective new treatments. It is also dedicated to supporting better decisions by patients and doctors in using Medicare-covered services through the promotion of better evidence development, which is critical for improving the quality of care for Medicare beneficiaries.</P>
                    <P>
                        To improve the understanding of CMS' processes for coverage, coding, and payment and how to access them, the CTI has developed an “Innovator's Guide” to these processes. The intent is to consolidate this information, much of which is already available in a variety of CMS documents and in various places on the CMS website, in a user friendly format. This guide was published in 2010 and is available on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Coverage/CouncilonTechInnov/Downloads/Innovators-Guide-Master-7-23-15.pdf</E>
                        .
                    </P>
                    <P>As we indicated in the FY 2009 IPPS final rule (73 FR 48554), we invite any product developers or manufacturers of new medical services or technologies to contact the agency early in the process of product development if they have questions or concerns about the evidence that would be needed later in the development process for the agency's coverage decisions for Medicare.</P>
                    <P>
                        The CTI aims to provide useful information on its activities and initiatives to stakeholders, including Medicare beneficiaries, advocates, medical product manufacturers, providers, and health policy experts. Stakeholders with further questions about Medicare's coverage, coding, and payment processes, or who want further guidance about how they can navigate these processes, can contact the CTI at 
                        <E T="03">CTI@cms.hhs.gov</E>
                        .
                    </P>
                    <HD SOURCE="HD3">g. Application Information for New Medical Services or Technologies</HD>
                    <P>
                        Applicants for add-on payments for new medical services or technologies for FY 2023 must submit a formal request, including a full description of the clinical applications of the medical service or technology and the results of any clinical evaluations demonstrating that the new medical service or technology represents a substantial clinical improvement (unless the application is under one of the alternative pathways as previously described), along with a significant sample of data to demonstrate that the medical service or technology meets the high-cost threshold. Complete application information, along with final deadlines for submitting a full application, will be posted as it becomes available on the CMS website at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech.html</E>
                        . To allow interested parties to identify the new medical services or technologies under review before the publication of the proposed rule for FY 2023, the CMS website also will post the tracking forms completed by each applicant. We note that the burden associated with this information collection requirement is the time and effort required to collect and submit the data in the formal request for add-on payments for new medical services and technologies to CMS. The aforementioned burden is subject to the PRA and approved under OMB control number 0938-1347.
                    </P>
                    <P>As discussed previously, in the FY 2020 IPPS/LTCH PPS final rule, we adopted an alternative inpatient new technology add-on payment pathway for certain transformative new devices and for Qualified Infectious Disease Products, as set forth in the regulations at § 412.87(c) and (d). The change in burden associated with these changes to the new technology add-on payment application process were discussed in a revision of the information collection requirement (ICR) request currently approved under OMB control number 0938-1347. In accordance with the implementing regulations of the PRA, we detailed the revisions of the ICR and published the required 60-day notice on August 15, 2019 (84 FR 41723) and 30-day notice on December 17, 2019 (84 FR 68936) to solicit public comments.</P>
                    <HD SOURCE="HD3">2. Public Input Before Publication of a Notice of Proposed Rulemaking on Add-On Payments</HD>
                    <P>Section 1886(d)(5)(K)(viii) of the Act, as amended by section 503(b)(2) of Public Law 108-173, provides for a mechanism for public input before publication of a notice of proposed rulemaking regarding whether a medical service or technology represents a substantial clinical improvement or advancement. The process for evaluating new medical service and technology applications requires the Secretary to—</P>
                    <P>• Provide, before publication of a proposed rule, for public input regarding whether a new service or technology represents an advance in medical technology that substantially improves the diagnosis or treatment of Medicare beneficiaries;</P>
                    <P>• Make public and periodically update a list of the services and technologies for which applications for add-on payments are pending;</P>
                    <P>• Accept comments, recommendations, and data from the public regarding whether a service or technology represents a substantial clinical improvement; and</P>
                    <P>• Provide, before publication of a proposed rule, for a meeting at which organizations representing hospitals, physicians, manufacturers, and any other interested party may present comments, recommendations, and data regarding whether a new medical service or technology represents a substantial clinical improvement to the clinical staff of CMS.</P>
                    <P>
                        In order to provide an opportunity for public input regarding add-on payments for new medical services and technologies for FY 2022 prior to publication of this FY 2022 IPPS/LTCH PPS proposed rule, we published a notice in the 
                        <E T="04">Federal Register</E>
                         on October 16, 2020 (85 FR 65815), and held a virtual town hall meeting on December 15 and 16, 2020. In the announcement notice for the meeting, 
                        <PRTPAGE P="25208"/>
                        we stated that the opinions and presentations provided during the meeting would assist us in our evaluations of applications by allowing public discussion of the substantial clinical improvement criterion for the FY 2022 new medical service and technology add on payment applications before the publication of the FY 2022 IPPS/LTCH PPS proposed rule.
                    </P>
                    <P>
                        Approximately 330 individuals registered to attend the 2-day virtual town hall meeting. We posted the recordings of the 2-day virtual town hall on the CMS web page at: 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech</E>
                        . We considered each applicant's presentation made at the town hall meeting, as well as written comments received by the December 28, 2020 deadline, in our evaluation of the new technology add on payment applications for FY 2022 in the development of this FY 2022 IPPS/LTCH PPS proposed rule.
                    </P>
                    <P>
                        In response to the published notice and the December 15-16, 2020 New Technology Town Hall meeting, we received written comments regarding the applications for FY 2022 new technology add on payments. As explained earlier and in the 
                        <E T="04">Federal Register</E>
                         notice announcing the New Technology Town Hall meeting (85 FR 65815 through 65817), the purpose of the meeting was specifically to discuss the substantial clinical improvement criterion with regard to pending new technology add-on payment applications for FY 2022. Therefore, we are not summarizing those written comments in this proposed rule that are unrelated to the substantial clinical improvement criterion. In section II.H.5. of the preamble of this proposed rule, we are summarizing comments regarding individual applications, or, if applicable, indicating that there were no comments received in response to the New Technology Town Hall meeting notice or New Technology Town Hall meeting, at the end of each discussion of the individual applications.
                    </P>
                    <HD SOURCE="HD3">3. ICD-10-PCS Section “X” Codes for Certain New Medical Services and Technologies</HD>
                    <P>
                        As discussed in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49434), the ICD-10-PCS includes a new section containing the new Section “X” codes, which began being used with discharges occurring on or after October 1, 2015. Decisions regarding changes to ICD-10-PCS Section “X” codes will be handled in the same manner as the decisions for all of the other ICD-10-PCS code changes. That is, proposals to create, delete, or revise Section “X” codes under the ICD-10-PCS structure will be referred to the ICD-10 Coordination and Maintenance Committee. In addition, several of the new medical services and technologies that have been, or may be, approved for new technology add-on payments may now, and in the future, be assigned a Section “X” code within the structure of the ICD-10-PCS. We posted ICD-10-PCS Guidelines on the CMS website at: 
                        <E T="03">https://www.cms.gov/medicare/icd-10/2021-icd-10-pcs</E>
                        , including guidelines for ICD-10-PCS Section “X” codes. We encourage providers to view the material provided on ICD-10-PCS Section “X” codes.
                    </P>
                    <HD SOURCE="HD3">4. Proposed FY 2022 Status of Technologies Approved for FY 2021 New Technology Add-On Payments</HD>
                    <P>In this section of the proposed rule, we discuss the proposed FY 2022 status of 23 technologies approved for FY 2021 new technology add-on payments, as set forth in the tables that follow. In general, we extend new technology add-on payments for an additional year only if the 3-year anniversary date of the product's entry onto the U.S. market occurs in the latter half of the upcoming fiscal year. We refer the reader to section II.F.6.b.(1). of the preamble of this proposed rule for discussion of CONTEPO, which we conditionally approved for FY 2021 new technology add-on payments under the alternative pathway for certain antimicrobial products, subject to the technology receiving FDA marketing authorization by July 1, 2021. As of the time of the development of this proposed rule, CONTEPO has not yet received FDA marketing authorization.</P>
                    <HD SOURCE="HD3">a. Proposed Continuation of New Technology Add-On Payments for FY 2022 for Technologies Still Considered To Be New</HD>
                    <P>In the table in this section of the proposed rule, we present our proposals to continue the new technology add-on payment for FY 2022 for those technologies that were approved for the new technology add-on payment for FY 2021 and which would still considered “new” for purposes of new technology add-on payments for FY 2022.</P>
                    <P>Our policy is that a medical service or technology may continue to be considered “new” for purposes of new technology add-on payments within 2 or 3 years after the point at which data begin to become available reflecting the inpatient hospital code assigned to the new service or technology. Our practice has been to begin and end new technology add-on payments on the basis of a fiscal year, and we have generally followed a guideline that uses a 6-month window before and after the start of the fiscal year to determine whether to extend the new technology add-on payment for an additional fiscal year. In general, we extend new technology add-on payments for an additional year only if the 3-year anniversary date of the product's entry onto the U.S. market occurs in the latter half of the fiscal year (70 FR 47362).</P>
                    <P>The table in this section lists the technologies for which we are proposing to continue making new technology add-on payments for FY 2022 because they would still be considered new for purposes of new technology add-on payments. This table also presents the newness start date, new technology add-on payment start date, relevant final rule citations from prior fiscal years, proposed maximum add-on payment amount, and coding assignments. We refer readers to the cited final rules in the following table for a complete discussion of the new technology add-on payment application, coding and payment amount for these technologies, including the applicable indications and discussion of the newness start date.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25209"/>
                        <GID>EP10MY21.129</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25210"/>
                        <GID>EP10MY21.130</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="210">
                        <PRTPAGE P="25211"/>
                        <GID>EP10MY21.131</GID>
                    </GPH>
                    <HD SOURCE="HD3">b. Proposal To Extend New Technology Add-On Payments</HD>
                    <P>Section 1886(d)(5)(K)(ii)(II) of the Act provides for the collection of data with respect to the costs of a new medical service or technology described in subclause (I) for a period of not less than 2 years and not more than 3 years beginning on the date on which an inpatient hospital code is issued with respect to the service or technology. As explained in the FY 2005 IPPS final rule (69 FR 49002), the intent of section 1886(d)(5)(K) of the Act and regulations under § 412.87(b)(2) is to pay for new medical services and technologies for the first 2 to 3 years that a product comes on the market, during the period when the costs of the new technology are not yet fully reflected in the DRG weights. Generally, we use FDA approval (that is, marketing authorization) as the indicator of the time when a technology begins to become available on the market and data reflecting the costs of the technology begin to become available for recalibration of the DRGs. The costs of the new medical service or technology, once paid for by Medicare for this 2-year to 3-year period, are accounted for in the MedPAR data that are used to recalibrate the DRG weights on an annual basis. Therefore, we limit the add-on payment window for those technologies that have passed this 2- to 3-year timeframe.</P>
                    <P>As discussed in the FY 2006 IPPS final rule (70 FR 47349) and subsequent years, we do not believe that case volume is a relevant consideration for making the determination as to whether a product is “new.” Consistent with the statute, a technology no longer qualifies as “new” once it is more than 2 to 3 years old, irrespective of how frequently it has been used in the Medicare population. Therefore, if a product is more than 2 to 3 years old, we have historically considered its costs to be included in the MS-DRG relative weights whether its use in the Medicare population has been frequent or infrequent.</P>
                    <P>However, in light of the unique circumstances for FY 2022 ratesetting, for which we are proposing to use the FY 2019 MedPAR claims data where we ordinarily would have used the FY 2020 MedPAR claims data for purposes of developing the FY 2022 relative weights, for the reasons discussed in section I.F. of the preamble of this proposed rule, we believe it may be appropriate to make a one-time exception to this long-standing policy for all technologies approved for new technology add-on payments for FY 2021, but for which the add-on payments would otherwise be discontinued beginning in FY 2022 because the technologies would no longer be considered new.</P>
                    <P>As discussed in section I.F. of the preamble of this proposed rule, ordinarily, the best available MedPAR data for ratesetting would be the most recent MedPAR file that contains claims from discharges for the fiscal year that is 2 years prior to the fiscal year that is the subject of the rulemaking. For FY 2022 ratesetting, under ordinary circumstances, the best available data would be the FY 2020 MedPAR file. As discussed in section I.F. of the preamble of this proposed rule, the FY 2020 MedPAR claims file contains data significantly impacted by the COVID-19 PHE, primarily in that the utilization of inpatient services was generally markedly different for certain types of services in FY 2020 than would have been expected in the absence of the PHE. Accordingly, we question whether the FY 2020 MedPAR claims file is the best available data to use for the FY 2022 ratesetting.</P>
                    <P>In our discussion in section I.F. of the preamble of this proposed rule, we highlighted two factors we considered in assessing which data sources would represent the best available data to use in the FY 2022 ratesetting. The first factor is whether the FY 2019 data, which is from before the COVID-19 PHE, or the FY 2020 data, which includes the COVID-19 PHE time period, is a better overall approximation of the FY 2022 inpatient experience. After analyzing this issue, for the reasons discussed in section I.F. of the preamble of this proposed rule, we believe for purposes of this proposed rule that FY 2019 data are generally a better overall approximation of FY 2022. The second factor is to what extent the decision to use the FY 2019 or FY 2020 data differentially impacts the FY 2022 IPPS ratesetting. As discussed more fully in section I.F of the preamble of this proposed rule, after analyzing this issue, we determined that the decision does differentially impact the overall FY 2022 IPPS ratesetting. For example, we determined that the effect on the FY 2022 MS-DRG relative weights is more limited if the FY 2019-based weights are used rather than the FY 2020-based weights, should the FY 2022 inpatient experience not match the assumption used to calculate the MS-DRG relative weights.</P>
                    <P>
                        Based on our analyses, we are proposing to use FY 2019 data for the FY 2022 ratesetting for circumstances 
                        <PRTPAGE P="25212"/>
                        where the FY 2020 data is significantly impacted by the COVID-19 PHE. Because we believe the FY 2020 MedPAR claims data is significantly impacted by the COVID-19 PHE, we are proposing to use the FY 2019 MedPAR claims data for purposes where we ordinarily would have used the FY 2020 MedPAR claims data, including for purposes of developing the FY 2022 relative weights. We refer the reader to section I.F. of the preamble of this proposed rule for a further discussion on our analysis of the best available data for FY 2022 ratesetting.
                    </P>
                    <P>As discussed previously, in general, we extend new technology add-on payments for an additional year only if the 3-year anniversary date of the product's entry onto the U.S. market occurs in the latter half of the upcoming fiscal year. Because we are proposing to use FY 2019 MedPAR data instead of FY 2020 MedPAR data for the FY 2022 IPPS ratesetting, the costs for a new technology for which the 3-year anniversary date of the product's entry onto the U.S. market occurs prior to the latter half of the upcoming fiscal year (FY 2022) may not be fully reflected in the MedPAR data used to recalibrate the MS-DRG relative weights for FY 2022. Therefore, in light of our proposal to use FY 2019 data instead of FY 2020 data to develop the FY 2022 relative weights, we believe it would be appropriate to allow for a one-year extension of new technology add-on payments for those technologies for which the new technology add-on payment would otherwise be discontinued beginning with FY 2022. Accordingly, we are proposing to use our authority under section 1886(d)(5)(I) of the Act to provide for a one-year extension of new technology add-on payments for FY 2022 for those technologies listed in the table that follows. We note that if we were to finalize our alternative approach of using the same FY 2020 data that we would ordinarily use for purposes of FY 2022 ratesetting, including development of the FY 2022 relative weights, as discussed in section I.F. of the preamble of this proposed rule, we would also finalize to discontinue the new technology add-on payments for these expiring technologies beginning in FY 2022, consistent with our historic policies.</P>
                    <P>We note that this table also presents the newness start date, new technology add-on payment start date, relevant final rule citations from prior fiscal years, proposed maximum add-on payment amount, and coding assignments for these technologies. We refer readers to the final rules cited in the table for a complete discussion of the new technology add-on payment application, coding and payment amount for these technologies, including the applicable indications and discussion of the newness start date.</P>
                    <P>We are inviting public comment on our proposal to use our authority under section 1886(d)(5)(I) of the Act to provide for a 1-year extension of new technology add-on payments for FY 2022 for those technologies for which the new technology add-on payment would otherwise be discontinued beginning with FY 2022.</P>
                    <P>We finally note, with regard to ContaCT which is a technology sold on a subscription basis, we continue to welcome comments from the public as to the appropriate method to determine a cost per case for technologies sold on a subscription basis, including comments on whether the cost per case should be estimated based on subscriber hospital data as described previously, and if so, whether the cost analysis should be updated based on the most recent subscriber data for each year for which the technology may be eligible for the new technology add-on payment.</P>
                    <GPH SPAN="3" DEEP="577">
                        <PRTPAGE P="25213"/>
                        <GID>EP10MY21.132</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25214"/>
                        <GID>EP10MY21.133</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25215"/>
                        <GID>EP10MY21.134</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25216"/>
                        <GID>EP10MY21.135</GID>
                    </GPH>
                    <PRTPAGE P="25217"/>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">5. FY 2022 Applications for New Technology Add-On Payments (Traditional Pathway)</HD>
                    <HD SOURCE="HD3">a. Aidoc Briefcase for PE</HD>
                    <P>Aidoc Medical Ltd. (Aidoc) submitted an application for new technology add-on payments for Aidoc Briefcase for PE (“Briefcase for PE”) for FY 2022. According to the applicant, Briefcase for PE is an FDA cleared, artificial intelligence (AI)-based solution for triage and notification of suspected pulmonary embolism (PE) cases.</P>
                    <P>The applicant stated that the device assists hospitals and radiologists by flagging and communicating suspected positive findings of PE in computed tomography (CT) pulmonary angiography (CTPA) examinations, which prompts the radiologist to assess relevant Digital Imaging and Communications in Medicine (DICOM) imaging files, allowing suspect cases to receive attention sooner than otherwise would have occurred, which in turn improves clinical outcomes. According to the applicant, patients with PE or suspected PE typically present at hospital emergency departments (EDs). The applicant stated that for these patients, ED physicians complete a brief evaluation and order imaging, which typically includes CTPA. With Briefcase for PE, CTPA images are automatically forwarded to the applicant's cloud-based engine where they are analyzed by an AI algorithm. The applicant claims that when Briefcase for PE detects a suspected PE, the radiologist is alerted via the user interface of the Aidoc Worklist Application that is installed on the radiologist's desktop. The applicant asserted that the notification prompts the radiologist to review the CTPA images and communicate with the emergency room team currently caring for the patient so that the appropriate clinical action may be taken sooner than it would otherwise have occurred in the absence of the tool.</P>
                    <P>
                        The applicant stated that acute PE is a severe manifestation of venous thromboembolism (VTE) and occurs when a blood clot (thrombus) forms in a vein and then dislodges and travels to the pulmonary arteries in the lungs. The applicant stated acute symptomatic PE can cause death within 1 hour of onset in up to 10 percent of cases 
                        <SU>7</SU>
                        <FTREF/>
                         and it is estimated to be the third largest cause of cardiovascular death after coronary artery disease and stroke.
                        <E T="51">8 9 10 11</E>
                        <FTREF/>
                         The applicant further noted that acute PE is a life-threatening medical emergency that demands urgent intervention and clinical studies have demonstrated a strong correlation between time to communication of PE findings, treatment, and clinical outcomes.
                        <E T="51">12 13 14</E>
                        <FTREF/>
                         According to the applicant, in a typical workflow, a patient presenting to a hospital with signs or symptoms of PE would move through the system as follows: (1) Patient presents with suspected PE to the ED; (2) Patient receives contrast-enhanced CTPA imaging; (3) Technologist processes and reconstructs the CT images and manually routes them to the hospital picture archiving and communication system (PACS); (4) The exam enters a first-in-first-out (FIFO) reading queue, where it awaits radiological interpretation; (5) Radiologist reads the CT images and makes the diagnosis of PE; (6) The radiologist informs the referring physician of positive PE either verbally or through the radiologist report; (7) ED physician and/or on-call pulmonologist decide on the management strategy; (8) If appropriate, the patient proceeds to treatment.
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             Naess IA, Christiansen SC, Romundstad P, Cannegieter SC, Rosendaal FR, Hammerstrøm J. Incidence and mortality of venous thrombosis: A population-based study. 
                            <E T="03">J Thromb Haemost.</E>
                             2007 Apr;5(4):692-9. doi: 10.1111/j.1538-7836.2007.02450.x. PMID: 17367492.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             Giuntini C, Di Ricco G, Marini C, Melillo E, Palla A. Pulmonary embolism: Epidemiology. 
                            <E T="03">Chest.</E>
                             1995 Jan;107(1 Suppl):3S-9S. doi: 10.1378/chest.107.1_supplement.3s. PMID: 7813326.
                        </P>
                        <P>
                            <SU>9</SU>
                             Becattini C, Agnelli G. Risk factors for adverse short-term outcome in patients with pulmonary embolism. 
                            <E T="03">Thromb Res.</E>
                             2001 Sep 15;103(6):V239-44. doi: 10.1016/s0049-3848(01)00291-2. PMID: 11567661.
                        </P>
                        <P>
                            <SU>10</SU>
                             Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: Clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). 
                            <E T="03">Lancet.</E>
                             1999 Apr 24;353(9162):1386-9. doi: 10.1016/s0140-6736(98)07534-5. PMID: 10227218.
                        </P>
                        <P>
                            <SU>11</SU>
                             Klok FA, Mos IC, Huisman MV. Brain-type natriuretic peptide levels in the prediction of adverse outcome in patients with pulmonary embolism: A systematic review and meta-analysis. 
                            <E T="03">Am J Respir Crit Care Med.</E>
                             2008 Aug 15;178(4):425-30. doi: 10.1164/rccm.200803-459OC. Epub 2008 Jun 12. PMID: 18556626.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             Smith SB, Geske JB, Maguire JM, Zane NA, Carter RE, Morgenthaler TI. Early anticoagulation is associated with reduced mortality for acute pulmonary embolism. 
                            <E T="03">Chest.</E>
                             2010 Jun;137(6):1382-90. doi: 10.1378/chest.09-0959. Epub 2010 Jan 15. PMID: 20081101; PMCID: PMC3021363.
                        </P>
                        <P>
                            <SU>13</SU>
                             Soh S, Kim JM, Park JH, Koh SO, Na S. Delayed anticoagulation is associated with poor outcomes in high-risk acute pulmonary embolism. J Crit Care. 2016 Apr;32:21-5. doi: 10.1016/j.jcrc.2015.11.024. Epub 2015 Dec 8. PMID: 26764578.
                        </P>
                        <P>
                            <SU>14</SU>
                             Wood KE. Major pulmonary embolism: Review of a pathophysiologic approach to the golden hour of hemodynamically significant pulmonary embolism. 
                            <E T="03">Chest.</E>
                             2002 Mar;121(3):877-905. PMID: 11888976.
                        </P>
                    </FTNT>
                    <P>The applicant asserted that the FIFO workflow is the standard of care. The applicant stated that Briefcase for PE allows facilities to substantially shorten the period of time between when the patient receives CTPA imaging (Step 2) and when the radiologist informs the referring physician of positive PE (Step 5). The applicant stated that Briefcase for PE streamlines this workflow using AI to analyze CTPA images of the chest automatically and notifies the radiologist that a suspected PE has been identified, enabling the radiologist to review imaging and make diagnostic decisions faster by prioritizing these images for review in the queue.</P>
                    <P>With respect to the newness criterion, Briefcase for PE received FDA 510(k) clearance on April 15, 2019 to market the device under FDA 510(k) number K190072. The FDA clearance for Briefcase for PE was based on substantial equivalence to the legally marketed predicate device, Briefcase for Intracranial Hemorrhage (ICH) (FDA 510(k) number K180647), as both of these devices use AI algorithms to analyze images and highlight cases for further action based on CT images. Briefcase for ICH received FDA 510(k) clearance on August 1, 2018. The predicate device for Briefcase for ICH is Viz.AI's ContaCT, which received De Novo premarket approval in February of 2018. The applicant asserted Briefcase for ICH is indicated for use in the analysis of non-enhanced head CT images, whereas Briefcase for PE is indicated for use in the analysis of non-enhanced CTPA images. According to the applicant, there are currently no ICD-10-PCS procedure codes to adequately describe Briefcase for PE. The applicant submitted a request for approval of a unique ICD-10-PCS procedure code to identify use of the technology beginning FY 2022.</P>
                    <P>Under the newness criterion, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>With respect to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, according to the applicant, Briefcase for PE is the only FDA-cleared technology that uses computer-aided triage and notification to rapidly detect PE and shorten time to notification of the radiologist. The applicant claimed that no other FDA approved or cleared technology uses the same mechanism of action for computer-aided triage and prioritization of PE.</P>
                    <P>
                        With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant stated it expects that patients evaluated for PE or suspected PE using Briefcase for PE will be assigned to the 
                        <PRTPAGE P="25218"/>
                        same DRGs as patients evaluated for PE or suspected PE under the current workflow or standard of care. The applicant estimates that under the MS-DRG grouper for FY 2021, Briefcase for PE could map to 279 different MS-DRGs, with MS-DRGs 175 (Pulmonary embolism with major complication or comorbidity (MCC) or acute cor pulmonale) and 176 (Pulmonary embolism without MCC) accounting for approximately 45 percent of the estimated cases.
                    </P>
                    <P>With respect to the third criterion, whether the new use of technology involves the treatment of the same or similar type of disease and the same or similar patient population when compared to an existing technology, the applicant did not directly respond to the criterion but reiterated that no other existing technology is comparable to Briefcase for PE and that Briefcase for PE is the only FDA-cleared technology that uses computer aided triage and notification to rapidly detect PE and shorten time to notification of the radiologist.</P>
                    <P>We have the following concerns regarding whether the technology meets the substantial similarity criteria and whether it should be considered new. We note that the applicant asserted that Briefcase for ICH, the predicate device for Briefcase for PE, is identical in all aspects and differs only with respect to the training of the algorithm on PE (that is, non-enhanced head CT) and ICH (that is, non-enhanced CTPA) images. We are unclear whether the training of the algorithim on PE and ICH images would distinguish the mechanism of action for Briefcase for PE from Briefcase for ICH, or its predicate device, ContaCT, and we invite comment on whether Briefcase for PE represents a new mechanism of action. We note that although the applicant did not directly state whether Briefcase for PE involves the treatment of the same or similar type of disease and the same or similar patient population, we believe that Briefcase for PE would be used for a different disease and patient population than Briefcase for ICH and ContaCT.</P>
                    <P>We continue to be interested in public comments regarding issues related to determining newness for technologies that use AI, an algorithm, or software, as discussed in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58628). Specifically, we are interested in public comment on how these technologies, including devices classified as radiological computer aided triage and notification software and radiological computer-assisted diagnostic software, may be considered for the purpose of identifying a unique mechanism of action; how updates to AI, an algorithm or software would affect an already approved technology or a competing technology; whether software changes for an already approved technology could be considered a new mechanism of action, and whether an improved algorithm by competing technologies would represent a unique mechanism of action if the outcome is the same as an already approved AI new technology.</P>
                    <P>We invite public comments on whether Briefcase for PE meets the newness criterion.</P>
                    <P>With regard to the cost criterion, the applicant presented the following analysis. The applicant first identified the principal diagnoses associated with the PE-related MS-DRGs 175 (“Pulmonary embolism with MCC or acute cor pulmonale”) and 176 (“Pulmonary embolism without MCC”). The applicant then searched the FY 2019 proposed rule MedPAR Limited Data Set (LDS) for claims where the principal diagnoses were listed in any position on an inpatient claim. The applicant mapped the 2,517 identified claims to the list of unique MS-DRGs corresponding to these claims and aggregated the claims by MS-DRG. Per the applicant, under the MS-DRG grouper for FY 2021, potential cases representing patients who may be eligible for treatment using Briefcase for PE map to 279 MS-DRGs, with MS-DRGs 175 and 176 accounting for approximately 45 percent of estimated cases. The applicant also provided a table of the top 10 MS-DRGs, which represent approximately 69 percent of estimated cases.</P>
                    <GPH SPAN="3" DEEP="130">
                        <GID>EP10MY21.136</GID>
                    </GPH>
                    <P>
                        The applicant standardized the charges and applied the 2-year charge inflation factor used to adjust the outlier threshold determination, which the applicant stated was 10.22 percent. We note that the actual 2-year inflation factor in the FY 2021 IPPS/LTCH PPS final rule was 13.2 percent (85 FR 59039), which would have increased the inflated charges figure. The applicant did not remove charges for prior technology as the applicant maintained that no existing technology is comparable to Briefcase for PE. However, the applicant removed 31.9 percent of total accommodation charges, which the applicant maintained is consistent with their internal study which indicated that Briefcase for PE reduced the length of stay for PE-diagnosed patients.
                        <SU>15</SU>
                        <FTREF/>
                         Per the applicant, the study demonstrated a mean length of stay of 8.77 and 5.97 days for pre-AI and post-AI time periods, respectively.
                        <SU>16</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             Maya M. et al. Artificial Intelligence Software for Flagging Pulmonary Embolism on CTPA Associated with Reduced Length of Stay. Abstract draft of an internal study performed by the applicant (unpublished).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        Next, the applicant added charges for the new technology. To calculate the charges for the new technology, the applicant multiplied the cases involving Briefcase for PE from each of its subscribing providers by a Medicare share of 52 percent to obtain the total estimated Medicare and non-Medicare cases. The applicant obtained the 52 percent Medicare share figure from a 
                        <PRTPAGE P="25219"/>
                        nationwide sample of inpatient claims provided by the Agency for Healthcare Research and Quality (AHRQ). Specifically, the applicant searched data from the Healthcare Cost and Utilization Project for discharges with the following codes: I2699, I2609, I2692, I2602, I2782, T790XXA, T800XXA, T791XXA, I2693, I2694, and I2601.
                        <SU>17</SU>
                        <FTREF/>
                         The applicant found 189,575 discharges, of which 52 percent identified Medicare as the payer. The applicant divided the total cost of the technology by the estimated total number of cases for each customer to obtain a provider-specific cost per case, which it then averaged across all customers to obtain an overall average cost per case. Finally, the applicant divided the average cost per case by the national average CCR for the CT cost center of 0.034 from the FY 2021 IPPS/LTCH PPS final rule (85 FR 58601).
                    </P>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             Healthcare Cost and Utilization Project. Free Health Care Statistics. 
                            <E T="03">https://hcupnet.ahrq.gov/#setup</E>
                            .
                        </P>
                    </FTNT>
                    <P>The applicant calculated a final inflated average case-weighted standardized charge per case of $87,483, which exceeded the average case-weighted threshold amount of $71,312. Because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount, the applicant maintained that Briefcase for PE meets the cost criterion.</P>
                    <P>We would like more information regarding the methodology by which the applicant selected the diagnosis codes associated with MS-DRGs 175 and 176, as well as subanalyses that limit the cases to MS-DRGs 175 and 176 and the top 10 MS-DRGs, which per the applicant represent 45 percent of estimated cases and 69 percent of estimated cases, respectively. Additionally, the applicant appears to have used a single list price of Briefcase for PE per hospital with a cost per patient that can vary based on the volume of cases. We question whether the cost per patient varies based on the utilization of the technology by the hospitals. We are interested in more information about the applicant's cost per case calculation, including how the applicant selected the codes it used to search for discharges from the Healthcare Cost and Utilization Project, as well as the per unit cost of Briefcase for PE and how the total cost of the technology was calculated for each subscribing provider.</P>
                    <P>In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58630), we stated our understanding that there are unique circumstances to determining a cost per case for a technology that utilizes a subscription for its cost. We stated our intent to continue to consider the issues relating to the calculation of the cost per unit of technologies sold on a subscription basis as we gain more experience in this area. We continue to welcome comments from the public as to the appropriate method to determine a cost per case for such technologies, including comments on whether the cost per case should be estimated based on subscriber hospital data as described previously, and if so, whether the cost analysis should be updated based on the most recent subscriber data for each year for which the technology may be eligible for the new technology add-on payment. We also invite public comment on whether Briefcase for PE meets the cost criterion, particularly in light of the subscription model, for which the number of subscribers and the estimated cost per case based on that subscriber data may change over time.</P>
                    <P>With regard to the substantial clinical improvement criterion, the applicant claimed that Briefcase for PE represents an advance that substantially improves the ability to diagnose pulmonary embolism by pre-reading images of CTPAs, automatically identifying suspected PE in CTPA images, and notifying the radiologist before the radiologist would have opened the study in the standard of care, which the applicant claims is the FIFO workflow. The applicant also asserted that because of a reduction in time-to-exam-open, where Briefcase for PE notifies the radiologist to open and read CTPA studies that have a high probability of being positive for PE sooner than the radiologist would have under the FIFO workflow, the treating physician can initiate treatment sooner, which can reduce mortality and reduce length of stay related to PE.</P>
                    <P>
                        The applicant provided data from an FDA pivotal study in support of its assertion that Briefcase for PE reduces time-to-exam-open compared to the standard of care and helps in prioritization of diagnosis.
                        <SU>18</SU>
                        <FTREF/>
                         For the FDA pivotal study, the applicant conducted a retrospective, blinded, multicenter, multinational study of the assessment of 184 CTPAs from 3 clinical sites (2 US and 1 outside US) using Briefcase for PE. The primary endpoint was to evaluate the software's performance in identifying pulmonary embolism on an approximately equal number of positive and negative cases (images with PE versus without PE), with a performance goal of at least 80 percent sensitivity (true positive rate) and specificity (true negative rate). Per the applicant, both measures exceeded the performance goal, with 90.6 percent sensitivity (95 percent CI: 82.2 percent-95.9 percent) and 89.9 percent specificity (95 percent CI: 82.2 percent-95.1 percent).
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             Aidoc Briefcase for PE—Pivotal Study 1—FDA 510(k)—K190072. 
                            <E T="03">http://www.accessdata.fda.gov/cdrh_docs/pdf19/K190072.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>According to the applicant, the secondary endpoint of the FDA pivotal study was to evaluate time-to-notification for true positive PE cases compared to the FIFO workflow. The study showed that time-to-notification with Briefcase for PE is 3.9 minutes (95 percent CI: 3.7-4.1). The applicant noted that, in contrast, the time-to-exam-open in the FIFO workflow was significantly longer at 64.1 minutes (95 percent CI 36.6-91.5). The applicant stated the mean difference of 60.2 minutes (95 percent CI 32.7-87.6) for these two metrics is statistically significant, and assuming the radiologist receives a notification on a true positive PE case and acts on it immediately, it can save an average of 60.2 minutes (95 percent CI 32.7-87.6) compared to the time-to exam-open in a FIFO reading queue. Based on this data, the applicant concluded Briefcase for PE substantially shortened the time to diagnosis for PE cases as compared with the FIFO workflow.</P>
                    <P>
                        The applicant further claimed that clinical studies and other real-world data have demonstrated comparable performance characteristics and shown that the integration of the Briefcase for PE software into the radiology workflow markedly improves time to notification for PE patients across a variety of clinical settings, geographies, and facilities. The applicant submitted a retrospective, single-site study by Weikert T., et al., which evaluated Briefcase for PE performance on 1,465 retrospective CTPA examinations from 2017 in an academic center outside the US.
                        <SU>19</SU>
                        <FTREF/>
                         The sensitivity and specificity were measured to be 92.7 percent (95 percent CI: 88.3-95.5 percent) and 95.5 percent (95 percent CI: 94.2-96.6 percent), respectively. The researchers concluded that the system has high diagnostic performance for the automatic detection of PE on CTPA exams and as such, speeds up the diagnostic workup of critical cases.
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             Weikert T, Winkel DJ, Bremerich J, Stieltjes B, Parmar V, Sauter AW, Sommer G. Automated detection of pulmonary embolism in CT pulmonary angiograms using an AI-powered algorithm. 
                            <E T="03">Eur Radiol.</E>
                             2020 Jul 3. doi: 10.1007/s00330-020-06998-0. Epub ahead of print. PMID: 32621243
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that unpublished data maintained by Aidoc suggest that real-world performance of Briefcase for PE is consistent with what was found in 
                        <PRTPAGE P="25220"/>
                        the FDA pivotal study.
                        <E T="51">20 21</E>
                        <FTREF/>
                         The applicant stated that across 26 sites encompassing a variety of geographic locations across the United States, a total of 36,084 CTPA examinations were analyzed over a 90-day period (July 13, 2020-October 11, 2020). Time-to-notification metrics were calculated for all 4,748 CTPAs analyzed by the software and identified as positive for PE. Time-to-notification was calculated as the time to get the DICOM exam, de-identify it, upload it to the cloud, analyze and send a notification back to the worklist application. The applicant claimed that the mean time-to-notification for PE was 7.0 minutes (median: 6.1/IQR: 4.8). According to the applicant, over 85 percent of CTPA examinations identified as positive for PE were notified in under 10 minutes. The applicant concluded that the study demonstrates the ability of Briefcase for PE to provide fast time-to-notification on positive PE cases and its generalizability across different centers and patient populations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             Avondo, J. Yalon R., Ashkenasi C. Time-to-notification Analysis Across US Facilities with Aidoc Briefcase for PE. Internal study performed by the applicant (unpublished).
                        </P>
                        <P>
                            <SU>21</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted additional unpublished data from the 26 sites spread across a variety of geographic locations of the United States aggregated over a different 90-day period (September 17, 2020 to December 17, 2020).
                        <SU>22</SU>
                        <FTREF/>
                         Seven sites were excluded from the analysis due to having third-party integrations that prevented the ability to capture engagement metrics. Two engagement metrics were calculated: The open percentage and the time-to-open. The open percentage metric was calculated as the percentage of notifications that were presented to the radiologist and opened by at least one radiologist. The time-to-open metric was measured by calculating the time between the arrival of the Briefcase for PE notification and the time first opened by a radiologist. A total of 2,138 notifications for CTPA examinations found to be positive for PE by Briefcase for PE were analyzed. The open percentage was found to be 97 percent across all sites (min: 80 percent, max: 100 percent), and the mean time-to-open was found to be 2.13 minutes (median: 1.0/interquartile range: 2.0). The data provided by the applicant indicated over 90 percent of notifications were found to be opened in under 5 minutes. Based on this data, the study concluded that radiologists in the US readily engage with notifications for positive PE cases provided by Briefcase for PE and do so in a timely manner. The study asserted that engagement is an important metric to assess radiologist adoption of this technology, which is critical to its practical utility in shortening time to diagnosis and communication of PE to reduce the time to treatment and improve clinical outcomes.
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             Avondo, J. Yalon R., Ashkenasi C. Radiologist Engagement Analysis Across US Facilities with Aidoc Briefcase for PE. Internal study performed by the applicant (unpublished).
                        </P>
                    </FTNT>
                    <P>
                        The applicant also claimed that Briefcase for PE significantly improves clinical outcomes relative to the current standard of care using the FIFO workflow because the use of Briefcase for PE reduces time to diagnosis and treatment by notifying the radiologist to review the image for suspected PE faster in the workflow. The applicant claimed early diagnosis and treatment is important in acute PE where there exists a “golden hour,” during which a timely approach to diagnosis and therapy can affect outcomes by reducing mortality and reducing length of stay.
                        <SU>23</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             The term “golden hour” references a critical period of time which may be longer or shorter than a literal hour.
                        </P>
                    </FTNT>
                    <P>
                        The applicant provided two unpublished internal studies in support of the impact of Briefcase for PE on clinical outcomes. The applicant stated that in a single-site retrospective study, Maya M., et al. have shown a reduction in hospital length of stay for PE patients following the use of the Briefcase for PE system, compared to an equivalent time period prior to the use of the system.
                        <SU>24</SU>
                        <FTREF/>
                         The applicant stated that Maya M., et al. compared mean length of stay for 366 patients with a positive PE diagnosis during 10-month periods before and after Briefcase for PE was implemented at Cedars-Sinai Medical Center in December 2018 (206 patients before the use of Briefcase for PE and 160 patients after the AI intervention). 3,997 patient encounters that underwent CTPA imaging but that were not diagnosed with PE were split as 1,926 and 2,071 patient encounters for the pre/post-AI periods based on the admission dates. Hip fracture was chosen as a comparison group due to acuity, treatment-related factors, and similar length of stay to PE. 2,422 patient encounters for patients diagnosed with hip fractures, identified by ICD9 code 820 and 821, were split as 1,279 and 1,143 patient encounters for the pre/post-AI periods based on the admission dates. According to the applicant, the pre- and post-implementation had similar seasonality and numbers of “hospital-wide patient encounters” (103,626 vs 104,733 encounters). The applicant noted that for the PE diagnosed patients, a mean length of stay of 8.77 and 5.97 days was observed for the pre-AI and post-AI time periods, respectively. The applicant stated that the mean difference was 2.80 days (p-value &lt;0.05). For the group that underwent related PE imaging but was not diagnosed with PE, a mean length of stay of 9.28 and 9.70 days was observed for the pre-AI and post-AI time periods, respectively (mean difference was −0.42 days (p-value &lt;0.05)). For the hip fracture diagnosed patients, a mean length of stay of 6.90 and 6.69 days was observed for the pre-AI and post-AI time periods, respectively. The mean difference was 0.21 days (p-value &gt;0.05). Additionally, for the hospital wide patients, a mean length of stay of 5.78 and 5.96 days was observed for the pre-AI and post-AI time periods, respectively. The mean difference was −0.18 days (p-value &lt;0.05). According to the applicant, Maya et al. concluded that implementation of Briefcase for PE for flagging and prioritization of patients with PE resulted in significant reduction of length of stay that was not observed in other control groups.
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             Maya M. et al. Artificial Intelligence Software for Flagging Pulmonary Embolism on CTPA Associated with Reduced Length of Stay. Abstract draft of an internal study performed by the applicant (unpublished).
                        </P>
                    </FTNT>
                    <P>
                        The applicant also submitted a study by Raskin D., et al. which completed an additional retrospective, single-armed, single-site, study that indicated improved outcomes in PE patients, compared to a time period prior to the use of Briefcase for PE.
                        <SU>25</SU>
                        <FTREF/>
                         In Raskin D., et al., data for all patients older than 18 years with a diagnosis of PE on CTPA and admitted to the institution's ED was collected for the period before the use of the AI software (January 1, 2016-January 1, 2018; pre-AI) and afterwards (January 1, 2019-December 6, 2019; post-AI). According to the applicant, study variables included demographics, clinical data, and imaging data. The applicant stated the primary variables for outcomes were 30- and 120-day all-cause mortality. 175 patients were eligible for the entire analyzed period (123 pre-AI, 52 Post-AI). The study found that 30- and 120-day all-cause mortality were significantly reduced post-AI (8.1 percent vs 7.7 percent, 15.5 percent vs 9.6 percent, respectively, p&lt;0.05). According to the applicant, Raskin D., et al. concluded that 
                        <PRTPAGE P="25221"/>
                        implementation of Briefcase for PE for flagging patients with PE resulted in significant reduction of 30- and 120-day all-cause mortality.
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             Daniel Raskin D.,MD, Chen Hoffmann C.,MD, Gilad Twig G.,MD Ph.D., Eli Konen E.,MD, Gal Yaniv GMD Ph.D. Artificial Intelligence Software for Flagging Pulmonary Embolism on CTPA Associated with Reduction of Mortality. Abstract draft of an internal study performed by the applicant (unpublished).
                        </P>
                    </FTNT>
                    <P>The applicant submitted five additional clinical studies that do not directly involve the use of Briefcase for PE to demonstrate a strong correlation between time to communication of PE findings, initiation of treatment, and clinical outcomes. The applicants submitted a review by Kenneth E. Wood, further establishing a “golden hour” of PE during which a timely approach to diagnosis and therapy can potentially impact outcomes. According to the applicant, Wood states that major PE results whenever the combination of embolism size and underlying cardiopulmonary status interact to produce hemodynamic instability and that most deaths in patients occur within the first few hours after presentation, and rapid diagnosis and treatment is therefore essential to save patients' lives. One prospective, single-site study, Kumamaru K., et al. indicates the prevalence of a “golden hour” for PE diagnosis and treatment and concluded that delay (&gt;1.5 hours of CTPA acquisition) in direct communication of acute PE diagnosis from radiologists to referring physicians was significantly correlated with a higher risk of delayed treatment initiation and death within 30 days. Another prospective, single-site study, Kline J., et al., concluded that patients with a delayed diagnosis had a higher rate of in-hospital adverse events (9 percent vs. 30 percent; p = 0.01). An additional retrospective, single-site study by Smith S., et al. observed an association between early administration of anticoagulation therapy and reduced mortality for patients with acute PE. Lastly, a retrospective, single-site study asserting a “golden hour” by Soh S., et al. was submitted by the applicant to demonstrate an association between early initiation of anticoagulation therapy and in-hospital mortality in high-risk PE patients who needed ICU care. According to the applicant, Soh S., et al. concluded that their analysis showed that the cutoff point of anticoagulation initiation to achieve improved survival rates was 5.2 hours (that is, golden hour). The applicant stated that the study observed an association between early anticoagulation and reduced mortality for patients with acute PE.</P>
                    <P>In reviewing the information submitted by the applicant as part of its FY 2022 new technology add-on payment application for Briefcase for PE, we note that the clinical literature provided by the applicant only compares the technology to unassisted FIFO workflows and not against existing electronic (for example, EHR “stat” orders) or manual (for example, verbal communication to radiologist) forms of prioritization, or other types of existing risk stratification tools or features currently available in EHRs. Additionally, we note that some of the studies provided by the applicant that took place over many years may not have accounted for confounding variables (for example, improvements in care for patients with suspected PE) that may have occurred during the study period. Comparing to the FIFO workflow alone assumes that no other changes occurred before and after the adoption of the system and that the hospitals in question did not implement any other changes to their standard operating procedures to stratify suspected PE cases over the period of time many of the provided studies took place. We also note that the applicant has not provided data on potential outcome concerns associated with this type of clinical decision support tool (for example, treatment delays due to false negatives, false positives, or multiple workflow prioritization alerts presented to the physician at the same time). We invite public comment on whether these issues may affect the tool's ability to help diagnose a medical condition earlier in a patient population.</P>
                    <P>Lastly, we note that the applicant does not measure the effect of its technology on actual treatment outcomes, instead relying on the assumption that faster treatment results in better outcomes. Without measuring this impact on treatment outcomes, we are uncertain if the technology will lead to substantive clinical outcomes. Given that the applicant references a critical “golden hour” which may be as long as 5.2 hours, the potential time savings resulting from the use of Briefcase for PE may be insubstantial in relation to the time within which outcomes are affected in the setting of PE.</P>
                    <P>We are inviting public comments on whether Briefcase for PE meets the substantial clinical improvement criterion.</P>
                    <P>We received a written public comment from the applicant in response to the New Technology Town Hall meeting regarding the application of Briefcase for PE for new technology add-on payments.</P>
                    <P>
                        <E T="03">Comment:</E>
                         The applicant responded to questions received at the New Technology Town Hall Meeting. First the applicant was asked what the sensitivity and specificity of the standalone device is for identifying pulmonary embolism and how the sensitivity and specificity of the radiologist alone compare to the sensitivity and specificity of the radiologist when using the device. The applicant responded by reiterating the sensitivity and specificity data provided in the FDA pivotal study and restating that Briefcase for PE is a computer-aided triage and notification system that is not intended to aid in the diagnosis of PE but rather, Briefcase for PE identifies cases of suspected PE on CTPAs and, via triage and notification, prioritizes these cases for radiologist review.
                        <E T="51">26 27</E>
                        <FTREF/>
                         The applicant further restated that this triage and notification modifies the traditional radiology workflow in which images are reviewed on a FIFO basis to reduce the time-to-open-exam from over one hour to several minutes (standard of care vs. Briefcase for PE). The applicant restated that this reduction in time-to-open-exam has been demonstrated to improve patient outcomes, including hospital length of stay and post-discharge mortality. The applicant further noted that, because Briefcase for PE is a triage and notification system, no patient harm results from false positives or false negatives that may occur. The applicant explained that with respect to false positives, these suspected cases of PE will be triaged and the radiologist will be notified, prompting earlier review and diagnosis of the CTPA image by the radiologist. The applicant explained that for cases of PE that are missed by Briefcase for PE (that is, false negatives), the radiologist will review these CTPA images on a FIFO basis the same as today's standard of care and that triage and notification do not occur in the standard of care.
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             Aidoc Briefcase for PE—Pivotal Study 1—FDA 510(k)—K190072. 
                            <E T="03">http://www.accessdata.fda.gov/cdrh_docs/pdf19/K190072.pdf.</E>
                        </P>
                        <P>
                            <SU>27</SU>
                             Weikert T, Winkel DJ, Bremerich J, et al. Automated detection of pulmonary embolism in CT pulmonary angiograms using an AI-powered algorithm. 
                            <E T="03">Eur Radiol.</E>
                             2020;30(12):6545-6553. doi:10.1007/s00330-020-06998-0.
                        </P>
                    </FTNT>
                    <P>
                        Second, the applicant was asked if Briefcase for PE decreased time outside of clinical trial protocols and how the applicant can be certain reducing time-to-notification affects the time period between when the CTPA is completed and the study is interpreted. In response, the applicant again reiterated data from the FDA pivotal study in restating that implementation of Briefcase for PE saves on average 60.2 minutes relative to the standard of care FIFO clinical workflow and that data maintained by Aidoc demonstrate that real-world performance of Briefcase for PE is consistent with the results achieved in the FDA study. The 
                        <PRTPAGE P="25222"/>
                        applicant also submitted data summarized previously indicating mean time-to-open, as measured by calculating the time between when a notification first became available in the application and the time of open, was 2.13 minutes (median: 1.0/IQR: 2.0). The applicant restated that in addition to measuring the mean time-to-open, the open rate, or the percentage of notifications opened, was measured for this same population and the open rate was found to be 97 percent (min: 80 percent, max: 100 percent), with over 90 percent of notifications found to be opened in under 5 minutes.
                        <SU>28</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             Avondo, J. Yalon R., Ashkenasi C. Radiologist Engagement Analysis Across US Facilities with Aidoc Briefcase for PE. Internal study performed by the applicant (unpublished).
                        </P>
                    </FTNT>
                    <P>
                        Also in response to this second question, the applicant reiterated data describing an independent analysis performed by Raskin, et al., examining the impact of Briefcase for PE implementation on 30- and 120-day all-cause mortality for all patients age 18 years or older with a diagnosis of PE on CTPA and admitted to Sheba Medical Center in Tel Aviv, Israel. The applicant restated data described previously indicating that investigators found that the post- Briefcase cohort had significantly reduced 30- and 120-day all-cause mortality compared to the pre-Briefcase cohort—14.9 percent vs 11.0 percent and 26.1 percent vs 20.4 percent, respectively. The applicant stated these observed effects equate to a reduction ratio of 26.6 percent (p &lt;0.05) and an odds-ratio of 1.425 (95 CI: 1.01-2.02) for 30-day all-cause mortality and a reduction ratio of 21.8 percent (p &lt;0.05) and an odds-ratio of 1.34 (95 percent CI: 1.05-1.81) for 120-day all-cause mortality.
                        <SU>29</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             Daniel Raskin D.,MD, Chen Hoffmann C.,MD, Gilad Twig G.,MD Ph.D., Eli Konen E.,MD, Gal Yaniv GMD Ph.D. Artificial Intelligence Software for Flagging Pulmonary Embolism on CTPA Associated with Reduction of Mortality. Abstract draft of an internal study performed by the applicant (unpublished).
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the applicant's comments. We will take these comments into consideration when deciding whether to approve new technology add-on payments for Briefcase for PE.
                    </P>
                    <HD SOURCE="HD3">b. Amivantamab</HD>
                    <P>Johnson &amp; Johnson Health Care Systems, Inc. submitted an application for new technology add-on payments for amivantamab for FY 2022. Amivantamab is intended for the treatment of metastatic non-small cell lung cancer (NSCLC). The applicant stated amivantamab is a bispecific monoclonal antibody able to inhibit the epidermal growth factor receptor (EGFR) and c-MET tyrosine kinase signaling pathways known to be involved in the pathogenesis of NSCLC. Per the applicant, amivantamab works by binding EGFR and c-MET targets present on the outside of the cell. The applicant noted lung cancer is the second most common cancer in the U.S., and approximately 85 percent of all lung cancers are NSCLC. The applicant stated EGFR mutations are present in 10 to 15 percent of patients with NSCLC and are categorized as either common EGFR mutations or atypical EGFR mutations. Per the applicant, common EGFR mutations in patients with NSCLC can be treated with small molecule, oral tyrosine kinase inhibitors that work inside the cell while patients with atypical EGFR mutations, such as exon 20 insertion mutations, do not respond well to small-molecule, oral EGFR inhibitors or to chemotherapy. The applicant stated exon 20 insertion mutations are the most frequently observed atypical EGFR mutations affecting 4 to 10 percent of NSCLC patients with an EGFR mutation, but there are no FDA approved targeted therapies for NSCLC patients with exon 20 insertion mutations.</P>
                    <P>With respect to the newness criterion, the applicant stated that, in March 2020, amivantamab (also known as JNJ-61186372) received Breakthrough Therapy designation from the FDA for the treatment of patients with metastatic NSCLC with EGFR exon 20 insertion mutation whose disease has progressed on or after platinum-based chemotherapy. The applicant stated they are seeking a Biologics License Application (BLA) for amivantamab for the treatment of patients with metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy and have not yet received FDA marketing authorization. Per the applicant, amivantamab is administered as an infusion on a 28 day cycle; weekly for the first cycle and then every 2 weeks, and continued until disease progression or unacceptable toxicity. The applicant stated there are currently no ICD-10-PCS procedure codes that uniquely identify the use of amivantamab. We note the applicant submitted a request for approval of a unique ICD-10-PCS procedure code to identify use of the technology beginning in FY 2022.</P>
                    <P>As previously discussed, if a technology meets all three of the substantial similarity criteria under the newness criterion, it would be considered substantially similar to an existing technology and would not be considered “new” for the purpose of new technology add-on payments.</P>
                    <P>With regard to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, the applicant asserted that the mechanism of action of amivantamab for treating NSCLC is unique as amivantamab is anticipated to be the first FDA-approved bispecific antibody therapy targeting EGFR and MET mutations simultaneously. The applicant asserted that both EGFR and MET are involved in NSCLC pathogenesis, progression, and development of resistance to other therapies. According to the applicant, the most common first-line treatment for atypical EGFR-positive patients due to exon 20 insertion mutations is platinum-based chemotherapy. Per the applicant, there is no standard of care after progression for second-line treatment, and patients receive a variety of therapies such as chemotherapy, immunotherapy, and tyrosine kinase inhibitors, as well as combinations of these therapies. The applicant reiterated that none of these treatments are FDA approved for this patient population and that they are associated with limited efficacy for these patients.</P>
                    <P>With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant stated that the use of amivantamab is not expected to affect the DRG assignment. In their cost analysis, as shown below, the applicant identified several MS-DRGs relevant to this technology.</P>
                    <GPH SPAN="3" DEEP="135">
                        <PRTPAGE P="25223"/>
                        <GID>EP10MY21.137</GID>
                    </GPH>
                    <P>With respect to the third criterion, whether the new use of the technology involves the treatment of the same or a similar type of disease and the same or similar patient population, the applicant stated that amivantamab treats a distinct patient population with metastatic NSCLC: Metastatic NSCLC with exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Per the applicant, there is currently no FDA-approved therapy for this patient population, and the most commonly used therapies are associated with limited efficacy.</P>
                    <P>In summary, the applicant asserted that amivantamab should be considered new and not substantially similar to an existing technology because the mechanism of action of amivantamab for treating NSCLC is unique and it treats a distinct patient population.</P>
                    <P>We are inviting public comments on whether amivantamab is substantially similar to other currently available therapies and/or technologies and whether this technology meets the newness criterion.</P>
                    <P>With regard to the cost criterion, the applicant provided the following analysis to demonstrate that the technology meets the cost criterion. The applicant searched the FY 2019 Medicare Provider Analysis and Review (MedPAR) final rule file for cases based on the presence of one of the following ICD-10-CM diagnosis codes for lung cancer:</P>
                    <GPH SPAN="3" DEEP="271">
                        <GID>EP10MY21.138</GID>
                    </GPH>
                    <P>We note that the applicant also provided the following ICD-10-PCS procedure codes, which the applicant stated could be used to identify cases involving amivantamab in the absence of a unique ICD-10-PCS code.</P>
                    <GPH SPAN="3" DEEP="61">
                        <PRTPAGE P="25224"/>
                        <GID>EP10MY21.139</GID>
                    </GPH>
                    <P>
                        To further refine the cases used in the analysis, the applicant used the following methodology. Per the applicant, clinical data suggests 80 to 85 percent of lung cancer patients are NSCLC patients.
                        <SU>30</SU>
                        <FTREF/>
                         The applicant stated that, of those patients, 10-15 percent are EGFR-mutations patients,
                        <E T="51">31 32</E>
                        <FTREF/>
                         and of those, at least 9 percent have atypical EGFR mutations like exon 20 ins.
                        <SU>33</SU>
                        <FTREF/>
                         The applicant selected 0.93% (82.5% * 12.5% * 9%) of the cases identified based on the lung cancer diagnosis codes listed previously. The applicant stated this is the target population for amivantamab, which the applicant used for the cost analysis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             “What is Lung Cancer?” American Cancer Society. 1 October 2019: 
                            <E T="03">https://www.cancer.org/content/cancer/en/cancer/lung-</E>
                              
                            <E T="03">cancer/about/what-is.htm</E>
                            l.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             Wee, P., &amp; Wang, Z. (2017). Epidermal growth factor receptor cell proliferation signaling pathways. 
                            <E T="03">Cancers,</E>
                             9(5), 52.
                        </P>
                        <P>
                            <SU>32</SU>
                             Pao, W., &amp; Girard, N. (2011). New driver mutations in non-small-cell lung cancer. 
                            <E T="03">The Lancet Oncology,</E>
                             12(2), 175-180.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             Arcila, M. E., Nafa, K., Chaft, J. E., Rekhtman, N., Lau, C., Reva, B. A., and Ladanyi, M. (2013). EGFR exon 20 insertion mutations in lung adenocarcinomas: Prevalence, molecular heterogeneity, and clinicopathologic characteristics. 
                            <E T="03">Molecular Cancer Therapeutics,</E>
                             12(2), 220-229.
                        </P>
                    </FTNT>
                    <P>The applicant then accounted for the circumstances where amivantamab would be administered during an inpatient stay. The applicant stated that amivantamab will typically be administered in the outpatient setting, and that it assumed that amivantamab would be administered during an inpatient stay, possibly for care unrelated to a patient's cancer treatment, when that stay coincided with the 2-week cycle during which a patient receiving amivantamab would undergo an infusion in the outpatient setting were it not for their inpatient admission. The applicant stated that, because it is very important that patients receive continuity of cancer care, it assumed that some patients would receive their amivantamab infusion during their hospital stay. To account for this scenario, the applicant calculated the average length of stay for all of the cases in its patient population, which it asserted was about 5.862 days. The applicant then divided the average length of stay for all of the cases by 14, as per the applicant amivantamab is administered on 28-day cycle, with a weekly administration for the first cycle, and an administration every 2 weeks thereafter.</P>
                    <P>The applicant stated that current clinical guidelines are expected to give medical professionals discretion to administer amivantamab during the hospitalization or pause the treatment cycle. To account for physician discretion, the applicant included only 50 percent of these cases in the final cost analysis.</P>
                    <P>The applicant identified 349 cases mapping to the following MS-DRGs. The applicant has not made a request for amivantamab to map to a new or different MS-DRG for FY 2022.</P>
                    <GPH SPAN="3" DEEP="108">
                        <GID>EP10MY21.140</GID>
                    </GPH>
                    <P>The applicant assumed patients receiving amivantamab would receive one dose of the drug during their inpatient stay. Because amivantamab would be administered in addition to any other drugs the patient was receiving during their inpatient admission, the applicant did not remove costs associated with any previous technology. The applicant then standardized the charges using the FY 2019 IPPS/LTCH PPS final rule Impact file. Then the applicant applied the 2-year inflation factor of 13.2 percent (1.13218) from the FY 2021 IPPS/LTCH PPS final rule (85 FR 59039). The applicant then added charges for amivantamab, which the applicant determined using the inverse of the FY 2021 IPPS/LTCH PPS final rule pharmacy national average cost to charge ratio (CCR) of 0.187 (85 FR 58601).</P>
                    <P>Because the applicant calculated a final inflated average case-weighted standardized charge per case of $108,159, which exceeds the case weighted threshold of $64,736, the applicant maintains the technology meets the cost criterion.</P>
                    <P>
                        Based on the information provided by the applicant, we have several concerns with regard to whether the technology meets the cost criterion. In its cost analysis, the applicant combined 234 cases from multiple MS-DRGs into one group with a case-weight of 67 percent of cases. We do not believe this is appropriate for the cost analysis. As reflected in § 412.87(b)(3), where cases eligible for a particular technology may be assigned to multiple MS-DRGs, in performing the cost analysis, the applicant should compare the charges of the cases to a threshold amount that is the lesser of 75 percent of the standardized amount or 75 percent of one standard deviation beyond the case-weighted average of all MS-DRGs to which the cases map. In the event that a single MS-DRG has fewer than 11 cases, the applicant should impute a minimum case number of 11 rather than the actual value. In this way, the appropriate threshold and case weighted threshold value can be calculated.
                        <PRTPAGE P="25225"/>
                    </P>
                    <P>In its analysis, the applicant appears to take a sample of a larger case population based on clinical data. It is unclear whether the applicant is taking a simple random sample or a targeted sample of cases. We note that, if the applicant obtained a random sample, this sample may not be any more representative of the larger population of cases identified by the lung cancer diagnosis codes listed previously. If the applicant instead non-randomly sampled cases from the larger population, we would like to understand the process used by the applicant to identify this targeted sample. Under either approach, we would request information on how a sampling of cases from the greater population is more representative of potential amivantamab patients.</P>
                    <P>We are inviting public comments on whether amivantamab meets the cost criterion.</P>
                    <P>With respect to the substantial clinical improvement criterion, the applicant asserted that amivantamab represents a substantial clinical improvement over existing technologies. The applicant asserted several claims of substantial clinical improvement for amivantamab: (1) Amivantamab is anticipated to be the first therapy to treat the metastatic NSCLC with exon 20 insertion mutations for patients whose disease has progressed on or after platinum-based chemotherapy; (2) the objective response rate (ORR) was higher than what would be expected with chemotherapy or immunotherapy; (3) a clinical benefit rate higher than what would be expected with chemotherapy or immunotherapy; (4) a duration of response higher than what would be expected with chemotherapy or immunotherapy; (5) the median progression free survival was higher than what would be expected with chemotherapy or immunotherapy; and (6) the incidence and severity of diarrhea was lower than what would be expected with any oral EGFR inhibitor.</P>
                    <P>
                        The applicant stated that patients with NSCLC and EGFR exon 20 insertion mutations have a form of disease that is generally insensitive to available EGFR TKI treatments and, as a result, carries a worse prognosis compared to patients with more common EGFR mutations.
                        <SU>34</SU>
                        <FTREF/>
                         Per the applicant, the current standard of care for the initial treatment of exon 20 insertion metastatic NSCLC is platinum-based chemotherapy; 
                        <SU>35</SU>
                        <FTREF/>
                         and, after a patient with EGFR exon 20 insertion metastatic NSCLC disease progresses on or during platinum-based chemotherapy, there is no standard of care. The applicant stated there are currently no FDA-approved targeted therapies for patients with lung cancer who have EGFR exon 20 insertion mutations.
                        <SU>36</SU>
                        <FTREF/>
                         The applicant cited an analysis of the Flatiron Health database, which includes electronic health data records from over 265 cancer clinics representing over 2 million active US cancer patients, that found prescribers use a wide variety of treatment strategies, all of which have an unclear role in the second-line treatment of exon 20 insertion mutated metastatic NSCLC or are known to be ineffective and/or have potential tolerability issues.
                        <SU>37</SU>
                        <FTREF/>
                         Specifically, the analysis showed that in the second-line treatment of exon 20 insertion metastatic NSCLC, approximately 33 percent of patients received single-agent immunotherapy, 14.1 percent received an EGFR-targeting oral agent, 5.9 percent received chemoimmunotherapy combination, 5.9 percent received chemotherapy with a VEGF inhibitor, 5.9 percent received a clinical study drug, and the remainder received a variety of single-agent chemotherapies or other regimens. The applicant stated this re-iterates the lack of an accepted standard of care for the second-line treatment of exon 20 insertion metastatic NSCLC and thus underscores the unmet need of these patients. According to the applicant, based on the Breakthrough Therapy designation for amivantamab, it is anticipated that amivantamab's first expected approval will be for the second-line treatment of exon 20 insertion metastatic NSCLC.
                    </P>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             Vyse, S., and Huang, P. H. (2019). Targeting EGFR exon 20 insertion mutations in non-small cell lung cancer. 
                            <E T="03">Signal Transduction and Targeted Therapy,</E>
                             4(1), 1-10.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             Chantharasamee, J., Poungvarin, N., Danchaivijitr, P., and Techawatanawanna, S. (2019). Clinical outcome of treatment of metastatic non-small cell lung cancer in patients harboring uncommon EGFR mutation. 
                            <E T="03">BMC Cancer,</E>
                             19(1), 701.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             Yasuda, H., Kobayashi, S., and Costa, D. B. (2012). EGFR exon 20 insertion mutations in non-small-cell lung cancer: Preclinical data and clinical implications. 
                            <E T="03">The Lancet Oncology,</E>
                             13(1), e23-e31.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             Flatiron Health database, Second Line Treatment Regimens in Advanced NSCLC (January 2015-October 2019).
                        </P>
                    </FTNT>
                    <P>The applicant provided three references to support a finding of substantial clinical improvement for amivantamab as well as some supplementary information in the application itself. The first reference was a conference presentation given at the 2019 Annual Meeting of the Society for Clinical Oncology titled “JNJ-61186372 (JNJ-372), an EGFR-cMet bispecific antibody, in EGFR-driven advanced non-small cell lung cancer (NSCLC)” by Haura et al. The second was a poster presented at the 2020 Annual Meeting of the American Society for Clinical Oncology titled “Amivantamab (JNJ-61186372), an anti-EGFR-MET bispecific antibody, in patients with EGFR Exon 20 insertion (Exon20ins)-mutated non-small cell lung cancer (NSCLC)” by Park et al. The third was a conference presentation given in January 2021 at the World Conference on Lung Cancer titled “Amivantamab in Post-platinum EGFR Exon 20 Insertion Mutant Non-small Cell Lung Cancer” by Sabari et al.</P>
                    <P>
                        These three references all describe the ongoing Phase 1 trial titled “A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer” (
                        <E T="03">https://clinicaltrials.gov/ct2/show/NCT02609776</E>
                        ). This open label, multicenter, first-in-human study, also known as “CHRYSALIS,” consists of two parts.
                        <SU>38</SU>
                        <FTREF/>
                         Part 1 was a dose escalation study used to establish the recommended Phase 2 dosing regimen.
                        <SU>39</SU>
                        <FTREF/>
                         Part 2 was a dose expansion study to assess safety and efficacy at the recommended Phase 2 dosing regimen.
                        <SU>40</SU>
                        <FTREF/>
                         The primary efficacy endpoint was the overall response rate per Response Evaluation Criteria in Solid Tumors v1.1.
                        <SU>41</SU>
                        <FTREF/>
                         Key secondary endpoints included clinical benefit rate (CBR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
                        <SU>42</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             
                            <E T="03">https://clinicaltrials.gov/ct2/show/study/NCT02609776</E>
                              
                            <E T="03">https://clinicaltrials.gov/ct2/show/study/NCT02609776</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             Sabari JK, Shu CA, Park K, et al. Amivantamab in post-platinum EGFR exon 20 insertion mutant non-small cell lung cancer. Oral presentation presented at: International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer Singapore (WCLC 2020); January 28-31, 2021; Worldwide Virtual Event.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        Key eligibility criteria for the post-platinum population of patients enrolled in the study included: Metastatic/unresectable NSCLC, EGFR exon 20 insertion mutation, and progression on platinum-based chemotherapy.
                        <SU>43</SU>
                        <FTREF/>
                         Patients received the recommended Phase 2 dose of 1050 mg (1400 mg for patients ≥80 kg) amivantamab intravenously once weekly for the first cycle and biweekly thereafter.
                        <SU>44</SU>
                        <FTREF/>
                         The safety population 
                        <PRTPAGE P="25226"/>
                        (N=114) included all post-platinum exon 20 ins patients who received amivantamab at the recommended Phase 2 dose, and the response-evaluable population (n=81) included post-platinum exon 20 ins patients who had at least three disease assessments or had discontinued, progressed, or died prior to the third post-baseline assessment at the time of clinical cut-off.
                        <SU>45</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        In the efficacy population, the median age was 62.
                        <SU>46</SU>
                        <FTREF/>
                         In addition, 59 percent of the patients were female, 49 percent of the patients were Asian, and 47 percent had a history of smoking.
                        <SU>47</SU>
                        <FTREF/>
                         Median time from initial diagnosis was 17 months with a range of 1-130 months.
                        <SU>48</SU>
                        <FTREF/>
                         All patients, by definition, had a prior history of platinum-based chemotherapy while 46 percent had prior immuno-oncology therapy and 25 percent had a history of EGFR TKI treatment.
                        <SU>49</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        In the safety population, 98 percent of patients experienced a treatment-related adverse event.
                        <SU>50</SU>
                        <FTREF/>
                         Of these, 16 percent were Grade 3 or higher, 9 percent were serious, 4 percent led to discontinuation, 13 percent led to dose reduction, and 21 percent led to dose interruption.
                        <SU>51</SU>
                        <FTREF/>
                         Of note, 2 percent discontinued due to rash and 10 percent had treatment-related diarrhea with 8.5 percent at grade 1-2 and 3.5 percent at grade 3.
                        <SU>52</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that preliminary safety results from the CHRYSALIS trial presented at the 2020 ASCO meeting appear to demonstrate that amivantamab has a manageable safety profile, with 60% of adverse events at grade 1 to 2.
                        <SU>53</SU>
                        <FTREF/>
                         Per the applicant, this appears to be an improvement relative to the types and frequency of adverse events reported for platinum based chemotherapies overall in advanced NSCLC, with over half of patients reporting adverse events of grade 3 to 5, such as neutropenia, nausea, and vomiting.
                        <SU>54</SU>
                        <FTREF/>
                         The applicant noted the best tolerated EGFR-targeting oral agent osimertinib was associated with a rate of discontinuation due to adverse events of 13 percent in the phase 3 FLAURA study.
                        <SU>55</SU>
                        <FTREF/>
                         In addition, the applicant noted osimertinib was associated with a rate of any grade diarrhea of 58 percent with 2 percent of patients having grade 3 or higher in this study.
                        <SU>56</SU>
                        <FTREF/>
                         In the same phase 3 FLAURA study, the applicant noted the comparator arm (gefitinib or erlotinib) was associated with a 57 percent incidence of any grade diarrhea with 2 percent of patients experiencing grade 3 or higher.
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             2020 ASCO Annual Meeting: Park, K, et al. J Clin Oncol 38:2020 (suppl; abstr 9512).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             Schiller, JH et al. (2002). Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. 
                            <E T="03">New England Journal of Medicine,</E>
                             346(2), 92-98.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        Regarding efficacy, in the Sabari et al reference, a blinded independent central review found an ORR in the efficacy population of 40 percent (95 percent CI 29-51) and a median DOR of 11.1 months (95 percent CI 6.9-not reached).
                        <SU>57</SU>
                        <FTREF/>
                         Patients experienced a complete response in 4 percent of cases, partial response in 36 percent of cases, stable disease in 48 percent of cases, progressive disease in 10 percent of cases, and one percent of patients was not evaluable.
                        <SU>58</SU>
                        <FTREF/>
                         Finally, the CBR (defined as complete response, partial response, or stable disease for at least two disease assessments) was 74 percent (95 percent CI 63-83).
                        <SU>59</SU>
                        <FTREF/>
                         The median patient follow-up in this most recent analysis was 9.7 months (range 1.1-29.3). Of note, 47 percent of patients remained on treatment at time of data cutoff and 63 percent had responses of at least six months.
                        <SU>60</SU>
                        <FTREF/>
                         The median PFS was 8.3 months (95 percent CI 6.5-10.9), and the median overall survival was 22.8 months (95 percent CI 14.6-not reached).
                        <SU>61</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             Sabari JK, Shu CA, Park K, et al. Amivantamab in post-platinum EGFR exon 20 insertion mutant non-small cell lung cancer. Oral presentation presented at: International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer Singapore (WCLC 2020); January 28-31, 2021; Worldwide Virtual Event.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that, while direct comparison between therapies cannot be definitively made in the absence of comparative trials, amivantamab results appear promising and numerically better than those expected with current therapies (chemotherapy, immunotherapy, chemoimmunotherapy combination, or oral EGFR tyrosine kinase inhibitors) based on available data. The applicant stated platinum-based chemotherapy has been associated with a median progression free survival of 5.1 to 6.0 months in patients with exon 20 T790m mutations-the most common mutation observed following resistance to small molecule TKI inhibitors commonly used in advanced EGFR mutation positive NSCLC.
                        <SU>62</SU>
                        <FTREF/>
                         The applicant stated that oral EGFR tyrosine kinase inhibitors (for example, erlotinib, gefitinib, afatinib, dacomitinib, osimertinib) and immunotherapies are also used to treat patients with exon 20 insertion metastatic NSCLC but generally have limited efficacy as exon 20 insertion mutations have been associated with resistance to EGFR tyrosine kinase inhibitors.
                        <SU>63</SU>
                        <FTREF/>
                         The applicant stated most immunotherapy and chemoimmunotherapy studies have excluded patients with EGFR mutation because single-agent immunotherapies have very limited efficacy in patients with EGFR-mutated NSCLC.
                    </P>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             Yoshida, T., Kuroda, H., Oya, Y., Shimizu, J., Horio, Y., Sakao, Y., et al. . . . and Yatabe, Y. (2017). Clinical outcomes of platinum-based chemotherapy according to T790M mutation status in EGFR-positive non-small cell lung cancer patients after initial EGFR-TKI failure. Lung Cancer, 109, 89-91.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             Vyse, S., &amp; Huang, P. H. (2019). Targeting EGFR exon 20 insertion mutations in non-small cell lung cancer. 
                            <E T="03">Signal Transduction and Targeted Therapy,</E>
                             4(1), 1-10.
                        </P>
                    </FTNT>
                    <P>The applicant provided the following table 1, which outlines median progression free survival (mPFS) and response rate (ORR) data among patients with exon 20 insertion mutation for amivantamab and some of the currently existing therapies. The applicant noted this table is intended to provide general information about individual therapies and is not intended for making direct comparisons between therapies as differences between study populations, follow-up time, prior treatments, and other factors may exist.</P>
                    <GPH SPAN="3" DEEP="62">
                        <GID>EP10MY21.141</GID>
                    </GPH>
                    <PRTPAGE P="25227"/>
                    <P>
                        Finally, the applicant cited an analysis presented at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, which found patients experienced a median ORR of 13% and PFS of 3.5 months when receiving a wide variety of different therapies, including immunotherapies, chemoimmunotherapies, EGFR-targeting TKIs, and other chemotherapy regimens as second-line treatment.
                        <SU>64</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             Park, K. (2020, May). Amivantamab (JNJ-61186372), an anti-EGFR-MET bispecific antibody, in patients with EGFR Exon 20 insertion (Exon20ins)-mutated non-small cell lung cancer (NSCLC). Poster presented at the 2020 Annual Meeting of the American Society of Clinical Oncology.
                        </P>
                    </FTNT>
                    <P>After review of the information provided by the applicant, we have the following concerns regarding whether the technology meets the substantial clinical improvement criterion. Currently, results provided by the applicant are based on an ongoing Phase 1 trial. We are concerned that these are potentially partial results, from which end conclusions may not be drawn, and also about the potential for overestimating treatment effects when trials stop early or report interim results. We further note that the only study cited by the application to establish substantial clinical improvement is a single-armed study assessing the safety and efficacy of amivantamab in the target population. As noted by the applicant, no formal comparisons to other therapies have been made. Without the ability to control for factors such as study design, patient characteristics, etc., we may be unable to determine whether any differences seen are the result of amivantamab's potentially superior efficacy or confounding variables. We also note that the single-arm study design results in an inability to distinguish between the effect of amivantamab treatment, a placebo effect, and the effect of natural course of the disease.</P>
                    <P>We are inviting public comments on whether amivantamab meets the substantial clinical improvement criterion.</P>
                    <P>
                        We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for amivantamab.
                    </P>
                    <HD SOURCE="HD3">c. Breyanzi® (lisocabtagene maraleucel)</HD>
                    <P>Juno Therapeutics, a Bristol-Myers Squibb Company, submitted an application for new technology add-on payment for FY 2022 for Breyanzi®. Breyanzi® is a CD19-directed, autologous chimeric antigen receptor (CAR) T-cell immunotherapy that is comprised of individually formulated CD8 (killer) and CD4 (helper) CAR T-cells indicated for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after at least two prior therapies. We note that Juno Therapeutics previously submitted an application for new technology add-on payments for Breyanzi® for FY 2021, as summarized in the FY 2021 IPPS/LTCH PPS proposed rule, under the name lisocabtagene maraleucel (85 FR 32647-32652).</P>
                    <P>
                        According to the National Comprehensive Cancer Network, Diffuse Large B-cell lymphoma (DLBCL) is the most common type of Non-Hodgkin's Lymphoma (NHL) in the U.S. and worldwide, accounting for nearly 30% of newly diagnosed cases of B-cell NHL in U.S.
                        <SU>65</SU>
                        <FTREF/>
                         DLBCL is characterized by spreading of B-cells through the body that have either arrived de novo or by the transformation from indolent lymphoma.
                    </P>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             Ferlay J, Colombet M, Soerjomataram, et al., Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods, Int J Cancer. 144: 1941-1953 (Ferlay, 2019); NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V. 5.2019. © National Comprehensive Cancer Network, Inc. 2019 (NCCN, 2019).
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, the standard-of-care, first-line immune-chemotherapy for DLBCL includes regimens such as cyclophosphamide, doxorubicin, vincristine, and prednisone plus rituximab (R-CHOP).
                        <SU>66</SU>
                        <FTREF/>
                         These regimens result in long-lasting remission in more than 50% of patients.
                        <SU>67</SU>
                        <FTREF/>
                         However, approximately 10% to 15% of patients will have primary refractory disease (that is, nonresponse or relapse within 3 months of first-line therapy), and an additional 20% to 25% will relapse following an initial response to therapy.
                        <SU>68</SU>
                        <FTREF/>
                         Patients with relapses of aggressive B-cell lymphomas are believed to have a poor prognosis because of potential treatment resistance and rapid tumor growth, with only about 30% to 40% responding to salvage chemotherapy (for example, R-ICE, DHAP, or Gem-ox) followed by high-dose therapy and autologous stem cell transplantation for patients demonstrating chemotherapy-sensitive disease.
                        <E T="51">69 70</E>
                        <FTREF/>
                         Among patients eligible to undergo autologous stem cell transplantation (ASCT), only 50% will achieve a remission adequate to proceed to ASCT, and approximately 50% will relapse after transplantation.
                        <SU>71</SU>
                        <FTREF/>
                         The applicant also noted that transplant eligibility is also restricted based on age and tolerance to high dose chemotherapy and thus excludes a moderate subset of patients with r/r DLBCL.
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             Coiffier, BBertrand et. al, Long-term outcome of patients in the LNH-98.5 trial, the first randomized study comparing rituximab-CHOP to standard CHOP chemotherapy in DLBCL patients: a study by Group d'Etudes des Lymphomes de l'Adulte, blood 2010 116: 2040-2045. (Coiffier, 2010).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             
                            <E T="03">Ibid</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             Ibid
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             Crump M, Neelapu SS, Farooq U, et al., Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study, Blood. 2017; 130(16): 1800-1808 (Crump, 2017).);
                        </P>
                        <P>
                            <SU>70</SU>
                             Cunningham D, Hawkes EA, Jack A, et al. Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles Lancet. 2013; 381: 1817-1826 (Cunningham, 2013).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             
                            <E T="03">Ibid</E>
                        </P>
                    </FTNT>
                    <P>Additionally, the applicant explained that the available therapies for 3L+ large B-cell lymphoma include the following:</P>
                    <P>
                        • CD19-directed genetically modified autologous CAR T-cell immunotherapy axicabtagene ciloleucel (YESCARTA®), approved in October 2017 for the treatment of adult patients with r/r large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (FL).
                        <SU>72</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             YESCARTA®'s approval was based on a single arm study (ZUMA-1) demonstrating an IRC-assessed ORR of 72%, CR of 51%, and an estimated median DOR of 9.2 months in 101 subjects included in the modified intent-to-treat (mITT population).
                        </P>
                    </FTNT>
                    <P>
                        • CAR T-cell therapy tisagenlecluecel (KYMRIAH®), approved in May 2018, for the treatment of adult patients with r/r large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, high grade B-cell lymphoma, and DLBCL arising from FL.
                        <SU>73</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             KYMRIAH®'s approval was based on a single-arm study (JULIET) demonstrating an ORR of 50% and a CR rate of 32% in 68 efficacy-evaluable subjects. A median DOR was not reached with a median follow-up of 9.4 months.
                        </P>
                    </FTNT>
                    <P>
                        • Programmed death receptor-1 (PD-1)-blocking antibody (KEYTRUDA®), approved in 2018, for the treatment of adult and pediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.
                        <SU>74</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Keytruda USPI (2019).
                        </P>
                    </FTNT>
                    <P>
                        • CD79b-directed antibody-drug conjugate polatuzumab vedotin (POLIVY®), in combination with bendamustine and rituximab, approved in 2019, for the treatment of adult patients with r/r DLBCL, not otherwise specified, after at least two prior therapies.
                        <PRTPAGE P="25228"/>
                    </P>
                    <P>
                        According to the applicant, despite the availability of these therapies, r/r large B-cell lymphoma remains a major cause of morbidity and mortality due to the aggressive disease course. The applicant noted that the safety profiles of these therapies exclude many r/r large B-cell lymphoma patients from being able to undergo treatment with these therapies.
                        <SU>75</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             Smith SD, Reddy P, Sokolova A, et al., Eligibility for CAR T-cell therapy: An analysis of selection criteria and survival outcomes in chemorefractory DLBCL, Am. J. Hematol. 2019; E119: 1-4 (Smith, 2019).
                        </P>
                    </FTNT>
                    <P>With respect to the newness criterion, the applicant submitted a BLA for Breyanzi® in October 2019, and was approved by FDA on February 5, 2021. Breyanzi® was granted Breakthrough Therapy Designation (BTD) on December 15, 2016 and Regenerative Medicine Advanced Therapy (RMAT) designation on October 20, 2017, for the treatment of patients with r/r aggressive large B-cell NHL, including DLBCL, not otherwise specified (DLBCL NOS; de novo or transformed from indolent lymphoma), primary mediastinal B-cell lymphoma (PMBCL), or follicular lymphoma Grade 3B (FL3B)). Breyanzi® is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Breyanzi® is not indicated for the treatment of patients with primary central nervous system lymphoma. We note that effective October 1, 2021 the following ICD-10-PCS codes may be used to uniquely describe procedures involving the infusion of Breyanzi®: XW033N7 (Introduction of lisocabtagene maraleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7) and XW043N7 (Introduction of lisocabtagene maraleucel immunotherapy into central vein, percutaneous approach, new technology group 7). The applicant also submitted a request for a new HCPCS code, which will uniquely describe procedures involving the use of Breyanzi®. The applicant noted in their application that Breyanzi® would likely map to the same MS-DRG as other CAR T-cell therapies, MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell Immunotherapy).</P>
                    <P>As previously discussed, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>With regard to the first criterion, whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome, the applicant described two ways in which it believes the mechanism of action for Breyanzi® differs from previously approved therapies for DLBCL. First, the applicant described the therapy as being comprised of individually formulated cryopreserved patient-specific helper (CD4) and killer (CD8) CAR T-cells in suspension that are administered as a defined composition of CAR-positive viable T-cells (from individually formulated CD8 and CD4 components). The applicant stated that the therapy involves a different mechanism of action from other CAR-T cell therapies because the CD4 and CD8 T-cells are purified and cultured separately to maintain compositional control of each cell type. Furthermore, during culture, each cell type is separately modified to have the CAR on the cell surface, expanded and quantified, and frozen in two separate cell suspensions. The applicant then described how Breyanzi® is infused with the same target dose of CD4 and CD8 CAR T-cells for every patient. The applicant asserted that because Breyanzi® controls the same dosage for both CD4 and CD8, it differs from other CAR T-cell therapies for DLBCL and could potentially provide for higher safety and efficacy; the applicant stated that CAR T-cell therapies that do not control for CD8 CAR T-cell dosage have demonstrated higher rates of severe and life-threatening toxicities, such as cytokine release syndrome (CRS) and neurotoxicity (NT).</P>
                    <P>
                        The second feature the applicant described as distinguishing Breyanzi®'s mechanism of action from existing CD19-directed CAR T-cell therapies was the presence of an EGFRt cell surface tag. The applicant explained that the EGFRt cell surface tag could hypothetically be targeted for CAR T-cell clearance by separately administering cetuximab, a monoclonal antibody. According to the applicant, if the patient was separately administered cetuximab, the presence of the EGFRt cell surface tag within Breyanzi® would allow cetuximba to bind to the CAR T-cells and clear the cells from the patient. The applicant highlighted studies that showed that persistent functional CD19-directed CAR T-cells in patients caused sustained depletion of a patient's normal B-cells that expressed CD19, resulting in hypogammaglobulinemia and an increased risk of life-threatening or chronic infections.
                        <SU>76</SU>
                        <FTREF/>
                         The applicant further explained that such prolonged low levels of normal B-cells could place a patient at risk of life-threatening or chronic infections. According to the applicant, the ability to deplete CAR T-cells, via the administration of cetuximab, when a patient achieves a long-term remission could hypothetically allow recovery of normal B-cells and potentially reduce the risk of life-threatening or chronic infections. The applicant noted that experiments in a laboratory setting showed that targeting EGFRt with the monoclonal antibody cetuximab eliminated CAR T-cells expressing the EGFRt marker, which resulted in long-term reversal of B-cell aplasia in mice.
                        <SU>77</SU>
                        <FTREF/>
                         However, the applicant noted that this mechanism of CAR T-cell clearance, via administration of cetuximab and EGFRt cell surface tags/markers, has not been tested in humans, including patients treated with Breyanzi®.
                    </P>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             Kalos M, Levine BL, Porter DL, et al., T Cells with Chimeric Antigen Receptors Have Potent Antitumor Effects and Can Establish Memory in Patients with Advanced Leukemia, Sci Transl Med. 2011; 3(95): 1-21 (Kalos, 2011).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             Paszkiewicz PJ, Frable SP, Srivastava S, et al., Targeted antibody-mediated depletion of murine CD19 CAR T cells permanently reverses B cell aplasia, J Clin Invest. 2016; 126(11): 4262-4272 (Paszkiewicz, 2016).
                        </P>
                    </FTNT>
                    <P>With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant acknowledged that the ICD-10-PCS procedure codes used to uniquely identify procedures involving the administration of Breyanzi® XW033N7 (Introduction of lisocabtagene maraleucel Immunotherapy into peripheral vein, percutaneous approach, new technology group 7) and XW043N7 (Introduction of lisocabtagene maraleucel Immunotherapy into central vein, percutaneous approach, new technology group 7) are assigned to MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell Immunotherapy). The applicant has not made a request for the technology to map to a new or different MS-DRG for FY 2022.</P>
                    <P>
                        With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, according to the applicant, Breyanzi® fills an unmet need in the treatment of large B-cell lymphoma because Breyanzi® would be indicated as a third-line treatment option for patients with r/r DLBCL, who cannot be treated with existing CAR T-
                        <PRTPAGE P="25229"/>
                        cell therapies. The applicant asserted that Breyanzi® would be able to treat these patients that present with uncommon subtypes of DLBCL including, PMBCL, FL3B, and DLBCL transformed from indolent lymphoma from other follicular lymphoma, elderly patients (≥ 65 years old), patients with secondary CNS involvement by lymphoma, and those with moderate renal or cardiac comorbidities. The applicant asserted that these patient populations were excluded from registrational trials for YESCARTA® and KYMRIAH®, and therefore represent an unmet patient need.
                    </P>
                    <P>
                        Regarding newness, we are concerned whether a differing production and/or dosage represents a different mechanism of action as compared to previously FDA-approved CAR T-cell therapies. We are also concerned about whether the existence of an EGFRt cell surface tag equates to a new mechanism of action given that in order to activate this cell surface tag, an additional medication, cetuximab, which targets the CAR T-cells for clearance, would be needed. We also express concern that, based on our understanding, the presence of the EGFRt cell surface tag is a potential way to treat an adverse event of the Breyanzi® therapy and is not critical to the way the drug treats the underlying disease. We note that the applicant referenced that while this EGFRt cell surface tag is included within the Breyanzi® compound, it remains dormant without activation by cetuximab. Finally, the applicant noted that Breyanzi® has been shown safe and effective for patient populations excluded from registrational trials for YESCARTA® and KYMRIAH®, including patients with uncommon subtypes of large B-cell lymphoma, including PMBCL, FL3B, and DLBCL transformed from indolent lymphoma other than FL, elderly patients (≥ 65 years old), patients with secondary CNS involvement by lymphoma and those with moderate renal or cardiac comorbidities.
                        <SU>78</SU>
                        <FTREF/>
                         We note that the FDA label for YESCARTA® and KYMRIAH® does not appear to specifically exclude these patient populations or NHL subtypes. As such, it is unclear whether Breyanzi® would in fact treat a patient population different from other CAR T-cell therapies that treat patients with DLBCL.
                    </P>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             Lisocabtagene maraleucel Biologics License Application (BLA).
                        </P>
                    </FTNT>
                    <P>We are inviting public comments on whether Breyanzi® is substantially similar to other technologies and whether Breyanzi® meets the newness criterion.</P>
                    <P>With regard to the cost criterion, the applicant searched the FY 2019 MedPAR correction notice (December 1, 2020) data file to identify potential cases representing patients who may be eligible for treatment using Breyanzi®. The applicant identified claims that reported an ICD-10-CM diagnosis code of: C83.30 (DLBCL, unspecified site); C83.31 (DLBCL, lymph nodes of head, face and neck); C83.32 (DLBCL, intrathoracic lymph nodes); C83.33 (DLBCL, intra-abdominal lymph nodes); C83.34 (DLBCL, lymph nodes of axilla and upper limb); C83.35 (DLBCL, lymph nodes of inquinal region and lower limb); C83.36 (DLBCL, intrapelvic lymph nodes); C83.37 (DLBCL, spleen); or C83.38 (DLBCL, lymph nodes of multiple sites) in one of the first five diagnosis code positions on the claim. The applicant excluded claims if they had one or more diagnoses from the list below because these conditions would preclude use of Breyanzi®.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="168">
                        <GID>EP10MY21.142</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25230"/>
                        <GID>EP10MY21.143</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="356">
                        <PRTPAGE P="25231"/>
                        <GID>EP10MY21.144</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>However, the applicant noted that the aforementioned C83.XX ICD-10-CM codes do not differentiate r/r patients from the broader DLBCL population. A clinical literature search completed by the applicant found that the r/r population makes up one-fourth of the DLBCL population, but since r/r patients typically have higher inpatient costs the applicant selected 19.36 percent of the cases with the highest total charges for their cost analysis. Applying the previously mentioned parameters, the applicant found a total of 991 cases mapped to 12 MS-DRGs.</P>
                    <P>The applicant stated that the use of Breyanzi®'s therapy would replace chemotherapy or other drug therapies, including other CAR T-cell therapies. Because of this, the applicant stated they removed all charges in the drug cost center since it was not possible to differentiate between different drugs on inpatient claims. The standardized charges per case were then calculated using the 2019 IPPS/LTCH PPS final rule Impact file and the 2-year inflation factor of 13.2 percent (1.3218) was applied. Finally, to determine the charges for Breyanzi®, the applicant used the inverse of a simulated alternative cost-to-charge ratio (CCR) specifically for CAR T-CELL therapies to account for CAR T-cell therapies' higher costs compared to other drugs. To determine this alternative CCR for CAR T-cell therapies, the applicant referred to the FY 2021 IPPS final rule AOR/BOR file and calculated an alternative markup percentage by dividing the AOR drug charges within MS-DRG 018 by the number of cases to determine a per case drug charge. The applicant then divided the drug charges per case by $373,000, the acquisition cost of YESCARTA and KYMRIAH, the CAR T-cell products used in those claims, to arrive at a CCR of 0.295. The applicant noted that the cost of Breyanzi® had not yet been determined at the time of application. However, for the purposes of its cost analysis, the applicant assumed the per-patient cost to the hospital will be $373,000. Based on the FY 2021 IPPS/LTCH PPS final rule correction notice data file thresholds for FY 2022, the applicant calculated a final inflated average case-weighted standardized charge per case of $1,377,616 which exceeded the MS-DRG 018 average case-weighted threshold of $1,251,127 by $126,489. Therefore, the applicant stated that Breyanzi® met the cost criterion.</P>
                    <P>As noted in previous discussions, the submitted costs for CAR T-cell therapies vary widely due to differences in provider billing and charging practices for this therapy. Therefore, with regard to the use of this data for purposes of calculating a CAR T-cell CCR, we are uncertain how representative this data is for use in the applicant's cost analyses given this potential for variability.</P>
                    <P>
                        We continue to be interested in public comments regarding the eligibility of CAR T-cell technologies for new technology add-on payments when assigned to MS-DRG 018. As we have noted in prior rulemaking with regard to the CAR T-cell therapies (83 FR 41172 and 85 FR 58603 through 58608), if a new MS-DRG were to be created, then consistent with section 1886(d)(5)(K)(ix) of the Act, there may no longer be a need for a new technology add-on payment under section 1886(d)(5)(K)(ii)(III) of the Act. We welcome comment on this issue.
                        <PRTPAGE P="25232"/>
                    </P>
                    <P>We invite public comment on whether Breyanzi® meets the cost criterion.</P>
                    <P>With respect to the substantial clinical improvement criterion, the applicant asserted that Breyanzi® represents a substantial clinical improvement over existing technologies because: (1) The totality of the circumstances regarding Breyanzi®'s clinical efficacy, safety, and data make clear that Breyanzi® substantially improves, relative to services or technologies previously available, the treatment of Medicare beneficiaries with R/R NHL; (2) Breyanzi® offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatments; (3) Breyanzi® has, overall, an improved safety profile compared to YESCARTA and KYMRIAH; (4) Breyanzi® has a comparable or superior effectiveness compared to existing therapies; and (5) Breyanzi®'s patient population in its registrational study more accurately reflects real-world NHL patients compared to the studies of currently available CAR T-cell therapies.</P>
                    <P>The applicant asserts that the totality of the clinical efficacy and safety data from the TRANSCEND NHL 001 trial, which is a prospective, single arm, multicenter study of Breyanzi® in patients with r/r aggressive B-cell NHL, and the supportive safety data from the Breyanzi® clinical studies included in their Biologics License Application (BLA) submission demonstrate that Breyanzi® has equal or better efficacy and a better safety profile in a broad R/R patient population that better approximates the real world large B-cell lymphoma patient population—a population that the applicant asserted includes NHL subtypes not studied or approved for treatment with current approved or conditionally approved agents.</P>
                    <P>
                        The applicant shared the results of the Phase I TRANSCEND NHL 001 trial, which was a prospective, single arm, multicenter study of lisocabtagene maraleucel in patients with relapsed/refractory aggressive B-cell NHL. The applicant noted that TRANSCEND NHL 001 included subjects with the average age of 63 years with 111 subjects (41%) over 65 years of age and 27 (10%) subjects older than 75 years of age. These patients also failed previous therapies. Of the total number of subjects studied (efficacy: n=256; safety: n=269), 137 subjects (51%) had DLBCL, 60 (22%) had DLBCL transformed from FL, 18 (7%) had DLBCL transformed other indolent lymphomas, 36 patients (13%) had high grade lymphoma, 15 (6%) had PMBCL and 3 (1%) had FL3B.
                        <SU>79</SU>
                        <FTREF/>
                         Additionally, the applicant explained that TRANSCEND NHL 001 was more inclusive, compared to the registrational trials for KYMRIAH® and YESCARTA®, of Medicare aged patients with comorbidities and NHL disease subtypes seen in the real world presentation of the disease. To support this, the applicant referenced that within this study, between 40% to 50% of subjects studied had cardiac ejection fraction, 3% had secondary CNS lymphoma, 51 patients (19%) had a creatinine clearance between 30-60 mL/min and 39 patients (14.6%) had grade ≥ 3 cytopenias. Furthermore, the applicant noted that 51 patients (19%) had decreased renal function and 13 patients (4.9%) had decreased cardiac function. The applicant stated that the TRANSCEND NHL 001 study showcased that the patient population treated during the study better reflected the real world large B-cell lymphoma patient population, a population that the applicant asserted included NHL subtypes not studied or approved for treatment with currently approved or conditionally approved agents, while providing similar safety and efficacy. The applicant contended that these high-unmet need large B-cell lymphoma subsets included patients with DLBCL transformed from rare indolent lymphomas other than FL, patients with FL3B, patients 65 years of age and older, as well as patients with moderate comorbidities of renal and cardiac insufficiency.
                    </P>
                    <FTNT>
                        <P>
                            <SU>79</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        The applicant further explained that Breyanzi® provided improved effectiveness as compared to existing therapies. Patients with aggressive large B-cell NHL who have failed at least 2 prior therapies or SCT are treated with combinations of agents or monotherapy based on institutional preferences, but there is no standard of care for salvage therapies beyond first treatment therapy.
                        <SU>80</SU>
                        <FTREF/>
                         The applicant noted that commonly used salvage therapies (non-CAR T-cell therapies) for relapsed, large B-cell lymphoma demonstrated objective response rates (ORRs) in the range of 12% to 46% and complete response (CR) rates of 6% to 38%. Among the patients who did achieve a response, the median duration of response (DOR) ranges from approximately 6 to 17 months and median overall survival was generally less than 12 months.
                        <E T="51">81 82 83 84 85 86 87</E>
                        <FTREF/>
                         Comparatively, TRANSCEND NHL 001, which provided subjects with Breyanzi®, met its primary endpoint of Independent Review Committee (IRC)-assessed ORR in adult patients with r/r large lymphoma after at least 2 prior therapies, as reported by the applicant. In the 256 efficacy evaluable patients, the ORR was 73% (95% confidence interval (CI): 67.0% to 78.3%), and the CR rate was 53% (95% CI: 46.6% to 59.2%). With a median follow-up of 10.8 months, the median DOR per IRC assessment was 13.3 months and the median DOR for CR was not reached. By comparison, the applicant summarized that YESCARTA®, as demonstrated in the Phase I-II ZUMA-1 study (see the FY 2019 IPPS/LTCH PPS final rule 83 FR 41295 for a description of this study), had an ORR of 72.0% (95% confidence interval (CI: 62.0% to 81.0%)). Also, according to the applicant, KYMRIAH®, as demonstrated by the Phase II JULIET study (see the FY 2019 IPPS/LTCH PPS final rule 83 FR 41293 for a description of this study), had an ORR of 50.0% (95% confidence interval (CI: 38.0% to 62.0%)). The applicant contended that the results for Breyanzi® (ORR of 73% (95% confidence interval (CI): 67.0% to 78.3%), and the CR rate of 53% (95% CI: 46.6% to 59.2%)  were observed across all subgroups tested, including 
                        <PRTPAGE P="25233"/>
                        elderly subjects, those with high burden disease or high baseline inflammatory biomarkers, those requiring anti-lymphoma therapy for disease control, as well as rare patient populations with a high unmet medical need (for example, PMBCL, DLBCL transformed from indolent lymphoma other than FL, and FL3B). The applicant contended that this data supports that Breyanzi® demonstrates comparable or superior effectiveness compared to existing therapies for patients with r/r large B-cell NHL.
                        <E T="51">88 89</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             National Comprehensive CancerNetwork Treatment of Cancer: Guidelines, 2019. NCCN, 2019.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             Czuczman MS, Davies A, Linton KM, et al., A Phase 2/3 Multicenter, Randomized Study Comparing the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Relapsed/Refractory DLBCL, Blood. 2014; 124: 628 (Czuczman, 2014).
                        </P>
                        <P>
                            <SU>82</SU>
                             Jacobsen ED, Sharman JP, Oki Y, et al., Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression, Blood. 2015; 125(9): 1394-1402 (Jacobsen, 2015).
                        </P>
                        <P>
                            <SU>83</SU>
                             Nagle SJ, Woo K, Schuster SJ, et al., Outcomes of patients with relapsed/refractory diffuse large B-cell lymphoma with progression of lymphoma after autologous stem cell transplantation in the rituximab era, Am. J. Hematol. 2013; 88: 890-894 (Nagle, 2013).
                        </P>
                        <P>
                            <SU>84</SU>
                             Pettengell R, Coiffier B, Narayanan G, et al., Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicenter, open-label, randomised trial, Lancet Oncol. 2012; 13: 696-706 (Pettengell, 2012).
                        </P>
                        <P>
                            <SU>85</SU>
                             Rigacci L, Puccini B, Cortelazzo S, et al., Bendamustine with or without rituximab for the treatment of heavily pretreated non-Hodgkin's lymphoma patients, Ann Hematol. 2012; 91: 1013-1022 (Rigacci, 2012).
                        </P>
                        <P>
                            <SU>86</SU>
                             Van Den Neste E, Schmitz N, Mounier N, et al., Outcome of patients with relapsed diffuse large B-cell lymphoma who fail second-line salvage regimens in the International CORAL study, Bone Marrow Transplantation. 2016; 51: 51-57 (Van Den Neste, 2016).
                        </P>
                        <P>
                            <SU>87</SU>
                             Wang M, Fowler N, Wagner-Bartak N, et al., Oral lenalidomide with rituximab in relapsed or refractory diffuse large cell, follicular and transformed lymphoma: a phase II clinical trial, Leukemia. 2013; 27: 1902-1909 (Wang, 2013).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>88</SU>
                             YESCARTA® United States Prescribing Information USPI (2019).
                        </P>
                        <P>
                            <SU>89</SU>
                             KYMRIAH® United States Prescribing Information USPI (2018).
                        </P>
                    </FTNT>
                    <P>
                        Furthermore, the applicant stated that Breyanzi® had an improved safety profile in comparison to YESCARTA® and KYMRIAH®. The applicant stated that both of these FDA-approved CAR T-cell therapies had higher rates of toxicity as compared to Breyanzi®. In the TRANSCEND NHL 001 registrational study (n=268), 42% and 2% of subjects developed all-grade and Grade &gt; 3 CRS, respectively, and 30% and 10% developed all-grade and Grade &gt; 3 NT. The applicant compared these results to the results of the JULIET study as found in KYMRIAH's® prescribing information and summarized that KYMRIAH® had higher rates of all-grade and Grade &gt; 3 CRS (74% and 23%, respectively) and all-grade and Grade &gt; 3 NT (58% and 18%, respectively). The applicant provided the same comparison of the toxicity results of Breyanzi® to the results showcased in the ZUMA-1 study featuring YESCARTA® as found in YESCARTA®'s prescribing information and summarized that YESCARTA® had higher rates of all-grade and Grade &gt; 3 CRS (94% and 13%, respectively) and all-grade and Grade &gt; 3 NT (87% and 31%, respectively).
                        <E T="51">90 91</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>90</SU>
                             YESCARTA® USPI (2019).
                        </P>
                        <P>
                            <SU>91</SU>
                             KYMRIAH® USPI (2018).
                        </P>
                    </FTNT>
                    <P>After reviewing the information submitted by the applicant as part of its FY 2022 new technology add-on payment application, we are concerned that there are no published studies directly comparing Breyanzi® and the two currently available CAR T-cell therapies for r/r DLBCL, YESCARTA® and KYMRIAH®. Additionally, we are concerned with the lack of long-term data supporting the effectiveness and efficacy of Breyanzi® and whether the lack of long-term data may limit the generalizability of the findings from the TRANSCEND NHL 001 study to the general Medicare population. While there have been no direct comparison studies of Breyanzi®, YESCARTA® and KYMRIAH®, the applicant does provide a comparison of the ORR, CR, PR and DOR across all three CAR T-cell therapies. While we note that Breyanzi® does appear to provide an improved ORR, CR, PR, and DOR compared to the other FDA-approved CAR T-cell therapies based on the data presented by the applicant, we further note that these differences appear to be small in magnitude, between 1-2% for the ORR, CR, and PR. Without a direct comparison of outcomes between these therapies, we are concerned as to whether these differences translate to clinically meaningful differences or improvements. Breyanzi® appears to demonstrate similar patient outcomes to that of YESCARTA® and we question whether the TRANSCEND NHL 001 study is evidence that Breyanzi® is a more effective therapy to treat DLBCL over existing CAR T-cell therapies. Additionally, as previously discussed, the applicant noted that Breyanzi® has been shown safe and effective for patient populations excluded from registrational trials for YESCARTA® and KYMRIAH®. However, it is unclear whether this suggests that Breyanzi® is a treatment option for patients who cannot be treated with these existing CAR T-cell therapies, given that the FDA label for YESCARTA® and KYMRIAH® appears to not specifically exclude these patient populations. Finally, we are concerned that the use of the EGFRt cell surface tag was not activated in patients receiving Breyanzi® to study the impact of clearing these CAR T-cells after remission and that this feature has not yet been tested on humans or in conjunction with patients treated with Breyanzi®. We express concern regarding the safety and efficacy of this feature given its lack of testing.</P>
                    <P>We are inviting public comments on whether Breyanzi® meets the substantial clinical improvement criterion.</P>
                    <P>
                        We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for Breyanzi® or at the New Technology Town Hall meeting.
                    </P>
                    <HD SOURCE="HD3">d. Ciltacabtagene Autoleucel</HD>
                    <P>Janssen Biotech, Inc., submitted an application for new technology add-on payments for ciltacabtagene autoleucel for FY 2022. Ciltacabtagene autoleucel is an autologous chimeric-antigen receptor (CAR) T-cell therapy directed against B cell maturation antigen (BCMA) for the treatment of patients with multiple myeloma.</P>
                    <P>Ciltacabtagene autoleucel refers to both JNJ-4528, an investigational BCMA-directed CAR T-cell therapy for previously treated patients with multiple myeloma, and LCAR-B38M, the investigational product (ciltacabtagene autoleucel) being studied in China. Both JNJ-4528 and LACAR-B38M are representative of the same CAR T-cell therapy, ciltacabtagene autoleucel. Ciltacabtagene autoleucel has not yet received FDA approval.</P>
                    <P>Multiple myeloma (MM) is typically characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. The plasma cells proliferate in the bone marrow and can result in extensive skeletal destruction with osteolytic lesions, osteopenia, and/or pathologic fractures. The diagnosis of MM is often suspected because of one (or more) of the following clinical presentations:</P>
                    <P>• Bone pain with lytic lesions discovered on routine skeletal films or other imaging modalities.</P>
                    <P>• An increased total serum protein concentration and/or the presence of a monoclonal protein in the urine or serum.</P>
                    <P>• Systemic signs or symptoms suggestive of malignancy, such as unexplained anemia.</P>
                    <P>• Hypercalcemia, which is either symptomatic or discovered incidentally.</P>
                    <P>• Acute renal failure with a bland urinalysis or rarely nephrotic syndrome due to concurrent immunoglobulin light chain (AL) amyloidosis.</P>
                    <P>
                        It is important to distinguish MM both from other causes of the clinical presentations mentioned previously and from other plasma cell dyscrasias for the purposes of prognosis and treatment.
                        <SU>92</SU>
                        <FTREF/>
                         Data from the US Surveillance, Epidemiology, and End Results (SEER) registry estimate 32,000 new cases of MM and 13,000 deaths from MM annually in the U.S. This correlates with an annual incidence of approximately 7 per 100,000 men and women per year. MM is largely a disease of older adults. The median age at diagnosis is 65 to 74 years. MM is also slightly more frequent in men than in women (approximately 1.4:1). MM is associated with substantial morbidity and mortality 
                        <FTREF/>
                        <SU>93</SU>
                          
                        <PRTPAGE P="25234"/>
                        and approximately 25% of patients have a median survival of 2 years or less.
                        <SU>94</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>92</SU>
                             Laubauch, J.P. (2021). Multiple myeloma: Clinical features, laboratory manifestations, and diagnosis. UptoDate. Available from 
                            <E T="03">https://www.uptodate.com/contents/multiple-myeloma-clinical-features-laboratory-manifestations-anddiagnosis?search=multiple%20myeloma&amp;source=search_result&amp;selectedTitle=1~150&amp; usage_type=default&amp;display_rank=1</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>93</SU>
                             Cowan AJ, Allen C, Barac A, Basaleem H, Bensenor I, Curado MP, Foreman K, Gupta R, 
                            <PRTPAGE/>
                            Harvey J, Hosgood HD, Jakovljevic M, Khader Y, Linn S, Lad D, Mantovani L, Nong VM, Mokdad A, Naghavi M, Postma M, Roshandel G, Shackelford K, Sisay M, Nguyen CT, Tran TT, Xuan BT, Ukwaja KN, Vollset SE, Weiderpass E, Libby EN, Fitzmaurice C. Global Burden of Multiple Myeloma: A Systematic Analysis for the Global Burden of Disease Study 2016. JAMA Oncol. 2018 Sep 1;4(9):1221-1227.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>94</SU>
                             Biran N, Jagannath S, Chari A. Risk stratification in multiple myeloma, part 1: characterization of high-risk disease. Clin Adv Hematol Oncol. 2013 Aug;11(8):489-503.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, introduction of new treatment options in the last 2 decades has extended the median survival of multiple myeloma patients. The applicant asserted that the introduction of proteasome inhibitors (PI) (
                        <E T="03">e.g.,</E>
                         bortezomib, carfilzomib, and ixazomib), histone deacetylase inhibitors (
                        <E T="03">e.g.,</E>
                         panobinostat, vorinostat), immunomodulatory agents (IMiD) (
                        <E T="03">e.g.,</E>
                         thalidomide, lenalidomide, and pomalidomide), monoclonal antibodies (daratumumab and elotuzumab), and stem cell transplantation, have allowed numerous therapeutic options for patients with multiple myeloma (Rajkumar 2020). According to the applicant, the National Comprehensive Cancer Network (NCCN) recommended treatment regimen for first-line therapy of multiple myeloma is Bortezomib (a proteosome inhibitor (PI)), lenalidomide (an immunomodulatory agent (IMiD)) and dexamethasone.
                        <SU>95</SU>
                        <FTREF/>
                         The strategy of triplet therapies for patients with newly diagnosed multiple myeloma, followed by high-dose chemotherapy and autologous stem-cell transplantation for eligible patients, and subsequently consolidation and maintenance therapy, is the current treatment roadmap for patients.
                        <SU>96</SU>
                        <FTREF/>
                         However, despite these treatments, according to the applicant, most patients will relapse after first-line treatment and require further treatment 
                        <SU>97</SU>
                        <FTREF/>
                         with only 50% survival of relapsed patients after 5 years.
                        <E T="51">98 99</E>
                        <FTREF/>
                         As multiple myeloma progresses, each subsequent line of treatment is associated with shorter progression free survival (PFS) and decreased rate, depth, and durability of response and worsening of quality of life.
                        <SU>100</SU>
                        <FTREF/>
                         In addition, cumulative and long-term toxicities are often associated with long-term therapy (Ludwig, 2018). Thus, according to the applicant, there remains an ongoing need for additional therapeutic approaches when the disease is resistant to available therapy.
                    </P>
                    <FTNT>
                        <P>
                            <SU>95</SU>
                             National Comprehensive Cancer Network (NCCN) NCCN clinical practice guidelines in oncology. Multiple Myeloma. Version 2. 2021-September 9, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>96</SU>
                             Branagan A, Lei M, Lou U, Raje N. Current Treatment Strategies for Multiple Myeloma. JCO Oncol Pract. 2020 Jan;16(1):5-14.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>97</SU>
                             Sonneveld P, Broij lA. Treatment of relapsed and refractory multiple myeloma. Haematologica. 2016;101(4):396-406.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>98</SU>
                             SEER database 2020; 
                            <E T="03">https://seer.cancer.gov/statfacts/html/mulmy.html</E>
                            .
                        </P>
                        <P>
                            <SU>99</SU>
                             GLOBOCAN database 2018; 
                            <E T="03">https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>100</SU>
                             Yong K, Delforge M, Driessen C, Fink L, Flinois A, Gonzalez-McQuire S, Safaei R, Karlin L, Mateos MV, Raab MS, Schoen P, Cavo M. Multiple myeloma: patient outcomes in real-world practice. Br J Haematol. 2016 Oct;175(2):252-264.
                        </P>
                    </FTNT>
                    <P>
                        The applicant asserts that relapsed and refractory multiple myeloma (RRMM) constitutes a specific unmet medical need. According to the applicant, patients with r/r disease are defined as those who, having achieved a minor response or better, relapse and then progress while on therapy, or experience progression within 60 days of their last therapy.
                        <SU>101</SU>
                        <FTREF/>
                         The introduction of a new class of agents, CD38-targeting monoclonal antibodies (CD38 MoABs), daratumumab and isatuximab, have improved options in r/r patients.
                        <SU>102</SU>
                        <FTREF/>
                         The applicant asserts that given these advances, guideline recommendations following first-line therapy are varied, with treatment options including combinations of novel agents with existing standard of care regimens, and triplet and quadruplet regimens, creating a complex treatment landscape.
                        <SU>103</SU>
                        <FTREF/>
                         According to the applicant, while triplet regimens should be used as the standard therapy for patients with multiple myeloma, elderly or frail patients may be treated with double regimens.
                        <E T="51">104 95</E>
                        <FTREF/>
                         The applicant further states that for patients with RRMM who have received at least 3 prior lines of therapy including a PI, an IMiD and an anti-CD38, there does not exist a standard or consensus for treatment at this time, and often, supportive care/palliative care is the only option.
                        <SU>105</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>101</SU>
                             Castelli R, Orofino N, Losurdo A, Gualtierotti R, Cugno M. Choosing treatment options for patients with relapsed/refractory multiple myeloma. Expert Rev Anticancer Ther. 2014 Feb;14(2):199-215.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>102</SU>
                             Van de Donk NWCJ, Richardson PG, Malavasi F. CD38 antibodies in multiple myeloma: back to the future. Blood. 2018 Jan 4;131(1):13-29.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>103</SU>
                             National Comprehensive Cancer Network (NCCN) NCCN clinical practice guidelines in oncology. Multiple Myeloma. Version 2. 2021—September 9, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>104</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>105</SU>
                             Maples KT, Joseph NS, Harvey RD. Current developments in the combination therapy of relapsed/refractory multiple myeloma. Expert Rev Anticancer Ther. 2020 Sep 24.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, multiple myeloma remains incurable and most patients eventually relapse, even with the advent of new treatments.
                        <SU>106</SU>
                        <FTREF/>
                         The applicant further states that novel, innovative therapies are needed to improve long-term survival and outcomes. The applicant asserts that CAR T-cell-based therapies offer potential advantages over current therapeutic strategies. According to the applicant, while other therapies require long-term repetitive administration generally until progression of disease, CAR T-cell therapy is a single infusion treatment due to live T-cell expansion in the patient and long-term disease response. The applicant asserts that ciltacabtagene autoleucel is an autologous CAR T-cell therapy directed against B cell maturation antigen (BCMA) for the treatment of patients with multiple myeloma. The applicant states that BCMA, a protein that is highly expressed on myeloma cells 
                        <SU>107</SU>
                        <FTREF/>
                         and is a member of the tumor necrosis factor (TNF) receptor family, plays a central role in regulating B-cell maturation and differentiation into plasma cells.
                        <SU>108</SU>
                        <FTREF/>
                         BCMA is selectively expressed on a subset of B cells (plasma cell neoplasms including myeloma cells) and is more stably expressed specifically on the B cell lineage, compared with key plasma cell marker CD138 which is also expressed on normal fibroblasts and epithelial cells.
                        <E T="51">109 110 111</E>
                        <FTREF/>
                         These expression characteristics, per the applicant, make BCMA an ideal therapeutic target for the treatment of multiple myeloma.
                        <E T="51">112 113</E>
                        <FTREF/>
                         Ciltacabtagene autoleucel, according to the applicant, is a unique, structurally differentiated BCMA-targeting chimeric antigen receptor with two distinct BCMA-binding domains that can identify and eliminate myeloma cells.
                    </P>
                    <FTNT>
                        <P>
                            <SU>106</SU>
                             Rajkumar SV, Kumar S. Multiple myeloma current treatment algorithms. Blood Cancer J. 2020 Sep 28;10(9):94.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>107</SU>
                             Cho SF, Anderson KC, Tai YT. Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. Front Immunol. 2018 Aug 10;9:1821.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>108</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>109</SU>
                             Ibid.
                        </P>
                        <P>
                            <SU>110</SU>
                             Tai YT, Anderson KC. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015;7(11):1187-99.
                        </P>
                        <P>
                            <SU>111</SU>
                             Palaiologou M, Delladetsima I, Tiniakos D. CD138 (syndecan-1) expression in health and disease. Histol Histopathol. 2014 Feb;29(2):177-89.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>112</SU>
                             Ibid.
                        </P>
                        <P>
                            <SU>113</SU>
                             Frigyesi I, Adolfsson J, Ali M, Christophersen MK, Johnsson E, Turesson I, Gullberg U, Hansson M, Nilsson B. Robust isolation of malignant plasma cells in multiple myeloma. Blood. 2014 Feb 27;123(9):1336-40.
                        </P>
                    </FTNT>
                    <P>
                        The applicant asserts that CAR T-cell technology is a form of immunotherapy and is a “living drug” that utilizes specially altered T cells, part of the immune system, to fight cancer. A 
                        <PRTPAGE P="25235"/>
                        sample of the patient's T cells are collected from the blood, then modified in a laboratory setting to express a chimeric antigen receptor (CAR).
                        <SU>114</SU>
                        <FTREF/>
                         Chimeric antigen receptors are specifically designed receptor proteins that are made up of three distinct features: (1) A target recognition domain (typically derived from a single domain of an antibody) that sits on the cell's exterior, (2) a co-stimulatory domain on the cell's interior that boosts activation, enhances survival and expansion of the modified cells, and (3) an interior stimulatory domain that supports activation and target killing.
                        <SU>115</SU>
                        <FTREF/>
                         The binding domain expressed on the surface of T cells gives them the new ability to target a specific protein. When the target is recognized, the intracellular portions of the receptor send signals within the T cells to destroy the target cells. These engineered CAR T-cells are reinfused back into the same patient which enables these specialized T cells to latch onto the target antigen and abolish the tumor cells.
                    </P>
                    <FTNT>
                        <P>
                            <SU>114</SU>
                             June CH, Sadelain M. Chimeric Antigen Receptor Therapy. N Engl J Med. 2018 Jul 5;379(1):64-73.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>115</SU>
                             Sadelain M. Chimeric antigen receptors: driving immunology towards synthetic biology. Curr Opin Immunol. 2016 Aug;41:68-76.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, ciltacabtagene autoleucel is a CAR T-cell immunotherapy designed to recognize myeloma cells and target their destruction. Ciltacabtagene autoleucel's CAR T-cell technology consists of harvesting the patient's own T cells, programming them to express a chimeric antigen receptor that identifies BCMA, a protein highly expressed on the surface of malignant multiple myeloma B-lineage cells, and reinfusing these modified cells back into the patient where they bind to and eliminate myeloma tumor cells. The applicant asserts that, unlike the chimeric antigen receptor design of currently approved CAR T-cell immunotherapies, which are composed of a single-domain antibody (sdAbs), ciltacabtagene autoleucel is composed of two antibody binding domains that allow for high recognition of human BCMA (CD269) and elimination of BCMA expressing myeloma cells. The two distinct BCMA-binding domains, according to the applicant, confer avidity and distinguish ciltacabtagene autoleucel from other BCMA-targeting products. The BCMA binding domains are linked to the receptor's interior costimulatory (4-1BB) and signaling (CD3ζ) domains through a transmembrane linker (CD8a). These intracellular domains are critical components for T cell growth and anti-tumor activity 
                        <SU>116</SU>
                        <FTREF/>
                         in the body once CAR T-cells are bound to a BCMA target on multiple myeloma cells.
                    </P>
                    <FTNT>
                        <P>
                            <SU>116</SU>
                             Maher J, Brentjens RJ, Gunset G, Rivière I, Sadelain M. Human T-lymphocyte cytotoxicity and proliferation directed by a single chimeric TCRzeta/CD28 receptor.
                        </P>
                    </FTNT>
                    <P>With respect to the newness criterion, according to the applicant, ciltacabtagene autoleucel was granted Breakthrough Therapy designation in December 2019 for the treatment of patients with RRMM who have previously received a PI, an IMiD, and an anti-CD38 antibody. In December 2020, the applicant submitted a Biologic License Application (BLA) with the FDA but at the time of the development of this proposed rule, it has not yet received FDA approval. The applicant stated that procedures involving the administration of ciltacabtagene autoleucel can be reported using the following ICD-10-PCS procedure codes: XW033C3 (Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 3); and XW043C3 (Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into central vein, percutaneous approach, new technology group 3). The applicant noted that there are currently no ICD-10-PCS codes that uniquely identify procedures involving the use of ciltacabtagene autoleucel. The applicant submitted a request for unique ICD-10-PCS codes to describe the administration of ciltacabtagene autoleucel beginning in FY 2022. The applicant also noted that they will submit a request for a Healthcare Common Procedure Coding System (HCPCS) code specific to the administration of ciltacabtagene autoleucel once the product is eligible for such a code.</P>
                    <P>As previously stated, if a technology meets all three of the substantial similarity criteria as previously described, it would be considered substantially similar to an existing technology and therefore would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>With respect to whether a product uses the same or a similar mechanism of action when compared to an existing technology to achieve a therapeutic outcome, the applicant asserts that ciltacabtagene autoleucel has a unique mechanism of action because it has two distinct binding domains that confer avidity to the BCMA antigen, a 4-1BB costimulatory domain and a CD3z signaling domain, whereas other CAR T-cell products have only one target binding domain. However, we note that idecabtagnene vicleucel, another CAR T-cell therapy for which an application for new technology add-on payments was submitted for FY 2022, as discussed later in this section, appears to have a mechanism of action that is similar to that of ciltabatagene: A chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The idecabtagene vicleucel CAR construct includes an anti-BCMA scFv-targeting domain for antigen specificity, a transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain. Antigen-specific activation of idecabtagene vicleucel results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.</P>
                    <P>The applicant also asserts that its mechanism of action differs from Blenrep's mechanism of action. Blenrep is a BCMA-targeting agent indicated in the treatment of RRMM. According to the applicant, Blenrep belongs to the class of antibody-drug conjugates, which are therapies that are essentially composed of a monoclonal antibody linked to a toxic drug. Once the antibody portion of Blenrep recognizes BCMA on multiple myeloma cells, the toxin is released into cells, resulting in cell death. Therefore, according to the applicant, ciltacbtagene autoleucel's mechanism of action differs from Blenrep's. Additionally, the applicant states that there is currently no commercially available CAR T-cell product that binds to the BCMA antigen. Lastly, the applicant provided a list of other currently available treatments for multiple myeloma and a description of their mechanisms of action (Table 1).</P>
                    <GPH SPAN="3" DEEP="266">
                        <PRTPAGE P="25236"/>
                        <GID>EP10MY21.145</GID>
                    </GPH>
                    <P>
                        With regard to whether
                        <FTREF/>
                         a product is assigned to the same DRG when compared to an existing technology, the applicant expects that cases involving the administration of ciltacabtagene autoleucel will be assigned to the same MS-DRG, MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell Immunotherapy), as other CAR T-cell therapies.
                    </P>
                    <FTNT>
                        <P>
                            <SU>117</SU>
                             Cook G, et al. Crit Rev Oncol Hematol. 2018;121:74-89.
                        </P>
                        <P>
                            <SU>118</SU>
                             Nejadmoghaddam MR, et al. Avicennna J Med Biotechnol. 2019;11(1):3-23.
                        </P>
                        <P>
                            <SU>119</SU>
                             Pufall MA. Adv Exp Med Biol. 2015;872:315-33.
                        </P>
                        <P>
                            <SU>120</SU>
                             Siddik ZH. The Cancer Handbook. New York: John Wiley &amp; Sons, Ltd; 2002.
                        </P>
                        <P>
                            <SU>121</SU>
                             Podar K, et al. Expert Opin Pharmacother. 2020 Mar;21(4):399-408.
                        </P>
                    </FTNT>
                    <P>With regard to whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population when compared to an existing technology, the applicant asserts that ciltacabtagene autoleucel is indicated for a broader population than other available therapies, specifically multiple myeloma patients having received three prior therapies.</P>
                    <P>In summary, the applicant asserts that ciltacabtagene autoleucel meets the newness criterion and is not substantially similar to other available therapies because it has a unique mechanism of action with two distinct binding domains that confer avidity to the BCMA antigen, and because it treats a different patient population, RRMM patients who received three prior therapies. However, we note that ciltacabtagene autoleucel may have a similar mechanism of action to that of idecabtagene vicleucel, for which we received an application for new technology add-on payments for FY 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Per the new technology add-on payment application for idecabtagene vicleucel, the technology's mechanism of action is described as targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The chimeric antigen receptor (CAR) construct includes an anti-BCMA scFv-targeting domain for antigen specificity, a transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain. Antigen-specific activation of idecabtagene vicleucel results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. Because of the potential similarity with the BCMA antigen and other actions, we believe that the mechanism of action for ciltacabtagene autoleucel may be the same or similar to that of idecabtagene vicleucel.</P>
                    <P>We believe that ciltacabtagene autoleucel may not treat the same or similar patient population as currently existing treatments. However, we believe that ciltacabtagene autoleucel and idecabtagene vicleucel may treat the same or similar disease (RRMM) in the same or similar patient population (patients who have previously received a proteasome inhibitor (PI), and immunomodulatory agent (IMiD) and an anti-CD38 antibody). Accordingly, as it appears that ciltacabtagene autoleucel and idecabtagene vicleucel are purposed to achieve the same therapeutic outcome using the same or similar mechanism of action and would be assigned to the same MS-DRG, we believe that these technologies may be substantially similar to each other such that they should be considered as a single application for purposes of new technology add-on payments. We are interested in information on how these two technologies may differ from each other with respect to the substantial similarity criteria and newness criterion, to inform our analysis of whether idecabtagene vicleucel and ciltacabtagne autoleucel are substantially similar to each other and therefore should be considered as a single application for purposes of new technology add-on payments.</P>
                    <P>
                        We are inviting public comment on whether ciltacabtagene autoleucel meets the newness criterion, including whether ciltacabtagene autoleucel is substantially similar to idecabtagene vicleucel and whether these technologies should be evaluated as a single technology for purposes of new technology add-on payments.
                        <PRTPAGE P="25237"/>
                    </P>
                    <P>With regard to the cost criterion, the applicant searched the FY 2019 MedPAR correction notice (December 1, 2020) file to identify potential cases representing patients who may be eligible for treatment using Ciltacabtagene autoleucel. In its analysis, the applicant identified a primary cohort to assess whether this therapy met the cost criterion. The following ICD-10-CM diagnosis codes were used to identify claims involving multiple myeloma procedures.</P>
                    <GPH SPAN="3" DEEP="65">
                        <GID>EP10MY21.146</GID>
                    </GPH>
                    <P>The applicant chose to limit its analysis to MS-DRG 016 (Autologous Bone Marrow Transplant W CC/MCC or T-Cell Immunotherapy) because patients receiving autologous bone marrow transplant (BMT) are generally patients with relapsed or refractory multiple myeloma and are most similar to patients who would be eligible to receive CAR T-cell therapy. The claim search conducted by the applicant resulted in 1,215 claims mapped to MS-DRG 016 using the FY 2019 MedPAR. The applicant determined an average unstandardized case weighted charge per case of $1,237,393. The applicant used the New Technology Threshold for FY 2022 from the FY 2021 IPPS/LTCH PPS final rule for MS-DRG 018. The applicant removed all charges in the drug cost center for the prior technology because, according to the applicant, it is not possible to differentiate between different drugs on inpatient claims. The applicant added that this is likely an overestimate of the charges that would be replaced by the use of ciltacabtagene autoleucel. The applicant then standardized the charges using the FY 2019 final rule impact file. Next, the applicant applied the 2-year inflation factor used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier threshold charges (1.13218). To calculate the charges for the new technology, the applicant used the inverse of a simulated alternative cost-to-charge ratio (CCR) specifically for CAR T cell therapies to account for CAR T-cell therapies' higher costs compared to other drugs and the potential for hospitals' charging practices to differ for these drugs. To determine this alternative CCR for CAR T-cell therapies, the applicant referred to the FY 2021 IPPS final rule AOR/BOR file and calculated an alternative markup percentage by dividing the AOR drug charges within MS-DRG 018 by the number of cases to determine a per case drug charge. The applicant then divided the drug charges per case by $373,000, the acquisition cost of YESCARTA and KYMRIAH, the CAR T-cell products used in those claims, to arrive at a CCR of 0.295. The applicant calculated a final inflated average case-weighted standardized charge per case of $1,646,522, which it stated exceeded the average case-weighted threshold amount of $1,251,126. The applicant stated that because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount, the therapy meets the cost criterion.</P>
                    <P>As noted in previous discussions, the submitted costs for CAR T-cell therapies vary widely due to differences in provider billing and charging practices for this therapy. Therefore, with regard to the use of this data for purposes of calculating a CAR T-cell CCR, we are uncertain how representative this data is for use in the applicant's cost analyses given this potential for variability.</P>
                    <P>We continue to be interested in public comments regarding the eligibility of CAR T-cell technologies for new technology add-on payments when assigned to MS-DRG 018. As we have noted in prior rulemaking with regard to the CAR T-cell therapies (83 FR 41172 and 85 FR 58603 through 58608), if a new MS-DRG were to be created, then consistent with section 1886(d)(5)(K)(ix) of the Act, there may no longer be a need for a new technology add-on payment under section 1886(d)(5)(K)(ii)(III) of the Act.</P>
                    <P>We invite public comment on whether ciltacabtagene autoleucel meets the cost criterion.</P>
                    <P>With regard to the substantial clinical improvement criterion, the applicant asserted that it believes that ciltacabtagene autoleucel represents a substantial clinical improvement over existing technologies because it: (1) Offers a treatment for a patient population with limited options and continued disease progression, despite having been treated with multiple prior therapies; and (2) provides a significantly improved clinical outcome relative to other therapies, either approved or still under FDA review, used in the relapsed and refractory multiple myeloma setting. With regard to the applicant's assertion that ciltacabtagene autoleucel offers a treatment for a patient population with limited options and continued disease progression, despite having been treated with multiple prior therapies, the applicant cited results from the CARTITUDE-1 STUDY, a Phase 1b/2, open-label, multicenter, multi-national (including US) study to evaluate the safety and efficacy of ciltacabtagene autoleucel in adult patients who have RRMM who have previously received a PI, an IMiD, and an anti-CD38 antibody. The applicant asserts that ciltacabtagene autoleucel was granted Breakthrough Therapy designation for patients who have RRMM who have previously received a PI, an IMiD, and an anti-CD38 antibody, based on data from the Phase1b/2 CARTITUDE-1 study. One hundred thirteen patients were enrolled in the study. Sixteen patients discontinued the study, including 9 patients who died due to progressive disease. Ninety-seven patients received ciltacabtagene autoleucel. The Phase 1b portion of the study included 29 of the 97 patients.</P>
                    <P>Two patients died during the study: one due to CRS and one due to acute myeloid leukemia (not treatment-related). Twenty-four of the remaining patients were ongoing in the Phase 1b dose confirmation period, with an additional 59 patients ongoing in the Phase 2 portion. The primary objective of the Phase 1b portion of the trial was to confirm the safety of the selected dose based on the data from the ongoing Phase 1 trial in China (Legend-2), as discussed later in this section. The primary objective of the Phase 2 portion of the trial is to evaluate the efficacy of ciltacabtagene autoleucel.</P>
                    <P>
                        The applicant asserts that at median follow-up of 12.4 months, ciltacabtagene autoleucel led to a 97% overall response rate (ORR) in all 97 study patients who 
                        <PRTPAGE P="25238"/>
                        received ciltacabtagene autoleucel.
                        <SU>122</SU>
                        <FTREF/>
                         The applicant asserts that this unprecedented overall response rate of (97%), represents early, deep, and durable responses in all patients, minimal residual disease negativity (meaning minimal residual cancer cells after treatment to the -nth degree) in the majority of patients who achieved a complete response (CR) and a very manageable toxicity profile. The applicant provided a comparison of the ORR in phase 1 studies for other therapies used to treat RRMM and noted the following: idecabtagene vicleucel ORR 73%,
                        <SU>123</SU>
                        <FTREF/>
                         daratumumab ORR 31%,
                        <SU>124</SU>
                        <FTREF/>
                         Selinexor ORR 26% 
                        <SU>125</SU>
                        <FTREF/>
                         and Blenrep ORR 31%.
                        <SU>126</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>122</SU>
                             Madduri D et. al. CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen-Directed Chimeric Antigen Receptor T-Cell Therapy, in Relapsed/Refractory Multiple Myeloma
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>123</SU>
                             Munshi et al. ASCO 2020
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>124</SU>
                             Usmari et al. Blood 2016, 128(1), 37-44.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>125</SU>
                             Chari A et al N Engl J Med 22019, 38 2(8);727-738
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>126</SU>
                             DREAMM2 Lonai S et al Lancet 2019.
                        </P>
                    </FTNT>
                    <P>
                        The applicant further asserts that ciltacabtagene autoleucel led to early and deep clinical responses in the phase1b/2 portion of the CARTITUDE-1 study at median follow up of 12.4 months. Results of CARTITUDE-1 showed a 97% overall response rate (ORR) with 67% of patients attaining a stringent complete response (sCR) and 93% of patients attaining a very good partial response (VGPR) or better after receiving a low dose (median of 0.72 million CAR T-cells per kilogram) of ciltacabtagene autoleucel within approximately a year. ORR and depth of response were independent of BCMA expression on myeloma cells at baseline. The median time to first response was one month (range, 0.9-8.5).
                        <SU>127</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>127</SU>
                             Berdeja JG, Madduri D, Usmani SZ, Singh I, Zudaire E, Yeh TM, Allred AJ, Olyslager Y, Banerjee A, Goldberg JD, Schecter S, Geng D, Wu X, Carrasco-Alfonso M, Rizvi S, Fan F, Jakubowiak AJ, Jagannath S. Update of CARTITUDE-1: A phase Ib/II study of JNJ-4528, a B-cell maturation antigen (BCMA)-directed CAR-T cell therapy, in relapsed/refractory multiple myeloma. Journal of Clinical Oncology. 2020 38:15_suppl, 8505-8505.
                        </P>
                    </FTNT>
                    <P>
                        The applicant also asserted that most patients attained a status of minimal residual disease (MRD)-negativity by the time they were evaluable for a complete response (CR). Of evaluable patients, 93.0% achieved MRD 10
                        <E T="51">−5</E>
                         negativity. Fifty-eight percent of patients were both MRD negative and in sCR at MRD detection level of 10
                        <E T="51">−5</E>
                        . Median time to MRD 10
                        <E T="51">−5</E>
                         negativity: 1 month (0.8-7.7). Among patients with 6 months individual follow-up, most had ciltacabtagene autoleucel CAR+ T-cells below the level of quantification (2 cells/μL) in peripheral blood.
                    </P>
                    <P>
                        In addition, progression-free survival (PFS) at 12 months was 77% (95% CI; 66.0-84.37).
                        <SU>128</SU>
                        <FTREF/>
                         The applicant believes this represents a substantial clinical improvement when compared to existing technologies that treat RRMM. The applicant further asserts that nearly all of the individuals participating in the study (22 of the 29 patients) were alive and continued showing no signs of disease progression after a period of 9 months. Median PFS was not reached. At median follow-up of 12.4 months, there were 14 deaths during the Phase 1b/2 study: One due to cytokine release syndrome (CRS) and hemophagocytic lymphohistiocytosis (HLH), one due to neurotoxicity, and 12 due to other causes.
                        <SU>98</SU>
                         The applicant asserts that the CRS was manageable in most patients. CRS was the most common adverse event (AE) (94.8%) observed in the CARTITUDE-1 study. The median time to onset of CRS was 7 days (range 1-12 days) post ciltacabtagene autoleucel infusion. The median duration of CRS was 4 days. Eighty-seven patients (94.6%) experienced Grade 1-2 CRS and 5 patients (5% experienced grade 3 or greater CRS)122.
                    </P>
                    <FTNT>
                        <P>
                            <SU>128</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>The applicant noted that neurotoxicity with immune effector cell-associated neurotoxicity syndrome (ICANS) was infrequently observed in the context of CRS and was generally low grade. Neurotoxicity with ICANS was observed in 20 patients (20.6%) including 10 patients (10.3%) with Grade 3 or above toxicity.122</P>
                    <P>
                        The LEGEND-2 study 
                        <SU>129</SU>
                        <FTREF/>
                         is an ongoing Phase 1, single-arm, open-label, multicenter, first-in-human trial to determine the safety and efficacy of ciltacabtagene autoleucel (LCAR-B38M in China) in the treatment of patients with relapsed or refractory multiple myeloma. Enrollment in this investigator-initiated study (study proposed, initiated, and conducted by an investigator that is funded by industry) completed in November 2017; a total of 74 patients with RRMM have been treated with ciltacabtagene autoleucel CAR T-cell therapy. The clinical cutoff for the analysis of these 74 patients was February 6, 2018 with updated survival and efficacy data as of November 26, 2019 (which represents 2 years of follow-up from the date of the last subject's infusion). Seventeen patients (17/57-29%) died during the study and follow up period (19 months) mostly due to progressive disease. None were related to cytokine release syndrome or neurotoxicity, the two most common adverse events associated with CAR T-cell therapy. At data cutoff, 57 patients had received LCAR-B38M CAR T-cells.
                    </P>
                    <FTNT>
                        <P>
                            <SU>129</SU>
                             Zhao et al. Journal of Hematology and Oncology. (2018) 11:141.
                        </P>
                    </FTNT>
                    <P>
                        The applicant further asserts that outcomes from the LEGEND-2 study show that cilltacabtagene autoleucel provides a significantly improved clinical outcome relative to other therapies, either approved or still under FDA review, used in the RRMM setting. At cutoff, the median follow-up was 19 months [17-22]. The overall survival (OS) rate at 18 months was 68% with a median duration of response (mDOR) of 22 months. Of MRD-negative patients with CR, 91% were still alive at data cut, with a 27 month mDOR. The median time to first response was 1.1 months. There was no relationship between best response and baseline BCMA expression level or weight-adjusted CAR T-cells infused.
                        <SU>105</SU>
                    </P>
                    <P>The applicant asserts that of patients in the LEGEND-2 study with CR, 39 of 42 were minimal residual disease negative (MRD-neg) and remained RRMM progression-free. The median PFS rate for all treated patients was 20 months; median PFS for MRD-neg patients with CR was 28 months. At 18 months, the PFS rate was 50% for all patients and 71% for MRD-neg patients with CR. Seventeen patients died during the study and the follow-up period. The causes of death included progressive disease (PD; n=11), disease relapse, PD with lung infection, suicide after PD, esophageal carcinoma, infection, pulmonary embolism and acute coronary syndrome (n=1 each). Of these, 4 did not achieve partial response (PR) or better; and 1 was not evaluable.</P>
                    <P>From the LEGEND-2 study, the median time to onset of CRS was 9 days (range, 1-19) with a median duration of 9 days (range, 3-57); all but 1 CRS events resolved. Tocilizumab (46%), oxygen (35%), vasopressor (11%), and intubation (1 patient) were used to treat CRS. Neurotoxicity with grade 1 aphasia, agitation and seizure-like activity was observed in 1 patient in the LEGEND-2 study. The applicant believes that since ciltacabtagene autoleucel displayed a manageable CRS safety profile that it represents a substantial clinical improvement over existing therapies.</P>
                    <P>
                        After reviewing the information submitted by the applicant as part of its FY 2022 new technology add-on payment application for ciltacabtagene autoleucel, we note that there are no head-to-head comparisons of ciltacabtagene autoleucel and other CAR T-cell therapies and BCMA-targeted 
                        <PRTPAGE P="25239"/>
                        therapies. We also note that the applicant chose to use ORR data as a measure of substantial clinical improvement rather than the available, and more clinically relevant, OS data.
                    </P>
                    <P>We are inviting public comment on whether ciltacabtagene autolecuel meets the substantial clinical improvement criterion.</P>
                    <P>
                        We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for ciltacabtagene autoleucel.
                    </P>
                    <HD SOURCE="HD3">e. COSELA (trilaciclib)</HD>
                    <P>
                        G1 Therapeutics submitted an application for new technology add-on payments for Trilaciclib for FY 2022. COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).
                        <SU>130</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>130</SU>
                             G1 Therapeutics Inc., Rev. 2/2021, COSELA prescribing information: 
                            <E T="03">https://www.g1therapeutics.com/cosela/pi/#:~:text=COSELA%20is%20indicated%20to%20decrease,cancer%20(ES%2DSCLC).&amp;text=The%20recommended%20dose%20of%20COSELA%20is%20240%20mg%2Fm2%20per%20dose</E>
                            .
                        </P>
                    </FTNT>
                    <P>According to the applicant, Trilaciclib is a first-in-class myelopreservation therapy that has the potential to mitigate chemotherapy-induced myelosuppression (CIM). Trilaciclib is a selective, transient inhibitor of cyclin dependent kinases 4 and 6 (CDK4/6) with potential antineoplastic and chemoprotective activities. CDK4 and CDK6 are key regulators of the G1 cell-cycle checkpoint and play important roles in cell proliferation and associated biological processes. One of the most common pathways dysregulated in cancer is the cyclin D-cyclin-dependent kinase four or six (CDK4/6)-retinoblastoma (RB) pathway. Trilaciclib arrests hematopoietic stem and progenitor (HSPCs) bone marrow cells in the G1 phase of the cell cycle during chemotherapy exposure, protecting them from chemotherapy-induced damage.</P>
                    <P>
                        According to the applicant, the defining characteristic of cancer is uncontrolled cellular proliferation, a phenomenon that requires tumor cells to avoid or disable normal, physiologic cell-cycle regulation. While there are both CDK 4/6 independent and dependent cells, HSPCs and immune cells are CDK 4/6 dependent whereas SCLC cells are CDK 4/6 independent. According to the applicant, the transient arrest of HSPCs and lymphocytes by trilaciclib during the administration of chemotherapy is thought to have a number of beneficial effects, including a reduction in chemotherapy-induced myelosuppression and preservation of immune function, as well as an enhanced immune response.
                        <E T="51">131 132 133</E>
                        <FTREF/>
                         Specifically, SCLC cells replicate independently of CDK 4/6 and therefore these cells are damaged by chemotherapy. Because HSPCs and lymphocytes are CDK 4/6 dependent, trilaciclib's mechanism of action is believed to preserve these cells by temporarily arresting their proliferation during chemotherapy. In this way, trilaciclib reduces chemotherapy-induced myelosuppression in patients with extensive-stage small-cell lung cancer (ES-SCLC).
                        <SU>134</SU>
                        <FTREF/>
                         The applicant also asserted that in preclinical models, CDK4/6 inhibition by trilaciclib also alters the tumor immune microenvironment through transient inhibition of the immune cells known as lymphocytes that are also dependent on CDK4/6 activity for proliferation.
                        <SU>135</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>131</SU>
                             Daniel D, Kuchava V, Bondarenko I, et al. Trilaciclib (T) decreases myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) patients receiving first-line chemotherapy plus atezolizumab. Ann Oncol. 2019;30:v713, Abstract 1742PD: 
                            <E T="03">https://www.g1741therapeutics.com/file.cfm/1734/docs/tr-G1741_ESMO2019_Daniel.pdf</E>
                            .
                        </P>
                        <P>
                            <SU>132</SU>
                             Weiss JM, Csoszi T, Maglakelidze M, et al. Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial. Ann Oncol. 2019;30(10):1613-1621.
                        </P>
                        <P>
                            <SU>133</SU>
                             Hart LL, Andric ZG, Hussein MA, et al. Effect of trilaciclib, a CDK 4/6 inhibitor, on myelosuppression in patients with previously treated extensive-stage small cell lung cancer receiving topotecan. J Clin Oncol. 2019;37(15_suppl): Abstract 8505: 
                            <E T="03">https://www.g8501therapeutics.com/file.cfm/8534/docs/tr-G8501T8528-8503%8520ASCO%202019%202020Oral%202020Presentation%20060119-20060111.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>134</SU>
                             Donjerkovic D, Scott DW. Regulation of the G1 phase of the mammalian cell cycle. 
                            <E T="03">Cell Res.</E>
                             2000;10(1):1-16.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>135</SU>
                             Lai AY, Sorrentino JA, Dragnev KH, et al. CDK4/6 inhibition enhances antitumor efficacy of chemotherapy and immune checkpoint inhibitor combinations in preclinical models and enhances T-cell activation in patients with SCLC receiving chemotherapy. J Immunother Cancer. 2020;0:e000847. doi:10.1136/jitc-2020-000847.
                        </P>
                    </FTNT>
                    <P>According to the applicant, chemotherapy remains the cornerstone of treatment for extensive stage small cell lung cancer (ES-SCLC). The applicant asserted that almost all of the ~18,600 ES-SCLC patients diagnosed each year are treated with platinum/etoposide-containing or topotecan-containing chemotherapy regimens. Chemotherapy drugs target cells at different phases of the cell cycle. According to the applicant, systemic chemotherapy, alone or in combination with immune checkpoint inhibitors, is the standard of care for patients with advanced SCLC. Additionally, per the applicant, rescue interventions, including growth factors and blood transfusions, are commonly routine therapies for SCLC. The applicant also indicated that granulocyte colony-stimulating factors (G-CSFs) only address neutropenia, while erythropoiesis stimulating agent (ESAs) and red blood cell (RBC) transfusions only address anemia, and there is no available treatment that broadly mitigates myelosuppressive effects and their corresponding impact on patient well-being before chemotherapy damage occurs.</P>
                    <P>
                        COSELA (trilaciclib) received FDA's New Drug Application approval on February 12, 2021. COSELA is for intravenous use only. The recommended dose of COSELA is 240 mg/m2 as a 30-minute intravenous infusion completed within four hours prior to the start of chemotherapy on each day chemotherapy is administered.
                        <SU>136</SU>
                        <FTREF/>
                         The applicant also stated that in 2019, trilaciclib was granted Breakthrough Therapy Designation for the mitigation of clinically significant chemotherapy-induced myelosuppression in adult patients with SCLC. The applicant submitted a request for a new ICD-10-PCS code as the applicant states that there are no existing ICD-10-PCS codes that uniquely identify the administration of trilaciclib.
                    </P>
                    <FTNT>
                        <P>
                            <SU>136</SU>
                             G1 Therapeutics Inc., Rev. 2/2021, COSELA prescribing information: 
                            <E T="03">https://www.g1therapeutics.com/cosela/pi/#:~:text=COSELA%20is%20indicated%20to%20decrease,cancer%20(ES%2DSCLC).&amp;text=The%20recommended%20dose%20of%20COSELA%20is%20240%20mg%2Fm2%20per%20dose</E>
                            .
                        </P>
                    </FTNT>
                    <P>As previously discussed, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and, therefore, would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>
                        With respect to the first criterion, whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome, the applicant asserted that trilaciclib, also referred to as G1T28, has a unique mechanism of action as a small molecule, competitive inhibitor of CDK4/6, with potential antineoplastic and chemoprotective activities. The applicant stated that upon administration, trilaciclib binds to and inhibits the activity of CDK4/6, thereby blocking the phosphorylation of 
                        <PRTPAGE P="25240"/>
                        the retinoblastoma protein (Rb) in early G1. This prevents G1/S phase transition, causing cell cycle arrest in the G1 phase and induced apoptosis, which inhibits the proliferation of CDK4/6-overexpressing tumor cells. In patients with CDK4/6-independent tumor cells, G1T28 may protect against multi-lineage chemotherapy-induced myelosuppression (CIM) by transiently and reversibly inducing G1 cell cycle arrest in hematopoietic stem and progenitor cells (HSPCs) and preventing transition to the S phase. Per the applicant, this protects all hematopoietic lineages, including red blood cells, platelets, neutrophils and lymphocytes, from the DNA-damaging effects of certain chemotherapeutics and preserves the function of the bone marrow and the immune system.
                    </P>
                    <P>
                        The applicant stated that the cell cycle consists of four distinct phases, Gap 1 phase (G
                        <E T="52">1</E>
                        ), S phase, Gap 2 (G
                        <E T="52">2</E>
                        ) post-synthesis phase, and the M phase.
                        <SU>137</SU>
                        <FTREF/>
                         Regulation of this process is maintained by a series of highly conserved proteins referred to as cyclins, and their catalytic binding partners, CDKs. The CDKs are a family of enzymes that control several cellular processes in mammalian cells, including the modulation of the cell cycle via binding to cyclins A-E, which results in the activation of transcription factors that regulate the cellular transition from G1 (growth phase) to S (DNA replication) and G2 (growth phase) to M (mitosis).
                        <SU>138</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>137</SU>
                             Ferrarotto R, Anderson I, Medgyasszay B, et al. Trilaciclib reduces the need for growth factors and red blood cell transfusions to manage chemotherapy-induced myelosuppression. Poster presented at: IASLC: 2020 North America Conference on Lung Cancer; October 16-17, 2020; Virtual congress.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>138</SU>
                             Asghar U, Witkiewicz AK, Turner NC, Knudsen ES. The history and future of targeting cyclin-dependent kinases in cancer therapy. Nat Rev Drug Discov. 2015;14(2):130-146.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, the G1-to-S checkpoint is a critical restriction point in the process of cell division. Cells are maintained in a quiescent state until the proper signal is achieved for reentry into the cell cycle. Throughout G1, expression of the D-type cyclins (D1, D2, D3) increases until active complexes with CDK4/6 are formed. Active CDK4/6 complexes partially phosphorylate RB, which allows partial depression of the transcription factor E2F. This induces additional transcript production of cyclin E1, which binds CDK2 to form active complexes that result in the hyperphosphorylation of RB and drives the cells through late G1 into S phase. Inhibition of cyclin D-CDK4/6 by the tumor suppressor CDKN2A leads to a G1 arrest and cell-cycle progression is halted.
                        <SU>139</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>139</SU>
                             Donjerkovic D, Scott DW. Regulation of the G1 phase of the mammalian cell cycle. Cell Res. 2000;10(1):1-16.
                        </P>
                    </FTNT>
                    <P>With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant asserted that trilaciclib will be assigned the same MS-DRG as existing technologies. The applicant did not explicitly state to which MS-DRG(s) trilaciclib would be assigned, but included MS-DRGs 180 (Respiratory Neoplasms with MCC), 181 (Respiratory Neoplasms with CC), and 182 (Respiratory Neoplasms without CC/MCC) in its cost analysis.</P>
                    <P>
                        With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population when compared to an existing technology, the applicant stated that trilaciclib is the only proactive (preventive) multilineage (erythrocytes, leukocytes, and thrombocytes, neutrophils and lymphocytes) therapy given as a 30-minute infusion administered prior to chemotherapy on each day of chemotherapy. Due to its mechanism of action, trilaciclib's benefit is coupled to its administration schedule (that is, trilaciclib must be administered prior to chemotherapy to ensure G1 arrest of HSPCs when those cells are exposed to cytotoxic chemotherapy). According to the applicant, this therapeutic paradigm contrasts with standard available treatment options and interventions that are administered after chemotherapy to reactively reduce or treat chemotherapy side effects. The applicant asserted that typical supportive care rescue interventions such as growth factors (G-CSFs, ESAs) and red blood cell (RBC) transfusions are used after chemotherapy causes damage to stem cells. Current supportive care therapies are used reactively to treat single cell lineage specific (leukocytes and erythrocytes) complications,
                        <SU>140</SU>
                        <FTREF/>
                         such as neutropenia and anemia. Additionally, the applicant indicated that growth factor and RBC transfusion use are known to carry a number of risks and cause complications and adverse events.
                    </P>
                    <FTNT>
                        <P>
                            <SU>140</SU>
                             National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Hematopoietic Growth Factors. Version 1.2020. 27 January. 2020.
                        </P>
                    </FTNT>
                    <P>We note that the information provided by the applicant in response to whether trilaciclib treats the same or similar type of disease or the same or similar patient population, appears to only speak to the first criterion and whether trilaciclib has a mechanism of action that is different than existing technologies; however, we believe trilaciclib appears to treat the same patient population and disease as existing therapies. We are inviting public comments on whether trilaciclib is substantially similar to an existing technology and whether it meets the newness criterion.</P>
                    <P>
                        With respect to the cost criterion, the applicant conducted the following analysis to demonstrate that trilaciclib meets the cost criterion. In identifying the cost of trilaciclib, the applicant stated that dosing is based on body surface area, 240 mg/m
                        <SU>2</SU>
                         with an average of two vials (300mg each) per patient per dose. To identify cases that may be eligible for the use of trilaciclib, the applicant searched the FY 2019 MedPAR LDS file for claims reporting an ICD-10-PCS code of category C34 through C34.92 (Malignant neoplasm related to the bronchus, lobe, or lung) as noted in the following table.
                    </P>
                    <GPH SPAN="3" DEEP="170">
                        <PRTPAGE P="25241"/>
                        <GID>EP10MY21.147</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="414">
                        <GID>EP10MY21.148</GID>
                    </GPH>
                    <P>
                        According to the applicant, based on the advice of clinical experts, it limited case selection criteria to claims that included one of MS-DRGs 180, 181, or 182. The applicant then randomly selected 15% of the claims from the sample to account for the fact that SCLC comprises 15% of lung cancer cases.
                        <SU>141</SU>
                        <FTREF/>
                         Based on the FY 2019 MedPAR LDS file, the applicant identified 3,500 cases. The applicant noted that 2,346 cases mapped to MS-DRG 180; 1,085 cases 
                        <PRTPAGE P="25242"/>
                        mapped to MS-DRG 181; and 69 cases mapped to MS-DRG 182.
                    </P>
                    <FTNT>
                        <P>
                            <SU>141</SU>
                             Govindan R, et al. 
                            <E T="03">J Clin Oncol.</E>
                             2006;24:4539-44. Byers LA, Rudin CM. 
                            <E T="03">Cancer.</E>
                             2015;121:664-72.
                        </P>
                    </FTNT>
                    <P>Using these 3,500 cases, the applicant then calculated the unstandardized average charges per case for each MS-DRG. Because the use of trilaciclib results in approximately half of patients no longer needing drugs used to counter the effects of chemotherapy during the inpatient stay, the applicant removed 50% of the drug charges for the technology being replaced.</P>
                    <P>The applicant then standardized the charges using the 2019 IPPS/LTCH PPS final rule impact file and inflated the charges by 1.13218 or 13.2 percent, the same inflation factor used by CMS to update the outlier threshold in the FY 2021 IPPS/LTCH PPS final rule. The applicant then added the charges for trilaciclib by converting the costs to a charge by dividing the cost by the national average cost-to-charge ratio of 0.187 for pharmacy from the FY 2021 IPPS/LTCH PPS final rule.</P>
                    <P>Using the data file thresholds associated with the FY 2021 IPPS/LTCH PPS final rule correction notice, the average case-weighted threshold amount was $57,031. In the applicant's analysis, the final inflated average case-weighted standardized charge per case was $95,701. Because the final inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount, the applicant maintained that the technology meets the cost criterion.</P>
                    <P>With respect to the cost criterion, we note that in listing the codes it used to identify cases that may be eligible for the use of trilaciclib, the applicant provided several ICD-10 codes that lack four digits and thus, are considered invalid. We would be interested in understanding the basis for the applicant's choice of codes. We also note that in its analysis, the applicant randomly selected 15% of the claims from the sample to account for the fact that SCLC comprises 15% of lung cancer cases. In so doing, the applicant is making the assumption that SCLC cases are randomly distributed amongst all cases from which the applicant sampled. By randomly sampling the population, the applicant is selecting a subsample that is ideally similar to the population with less variance. It may be the case that SCLC cases are systematically different from other cases in the population. If this is true, then a random sample may not be appropriate. Accordingly, we question the appropriateness of the sampling used and whether it accurately represents cases that would use the technology.</P>
                    <P>Finally, with respect to pricing, it appears that the applicant's final inflated average case-weighted standardized charge per case reflects pricing prior to the availability of more current total wholesale acquisition cost. We therefore request that the applicant update its cost analysis to reflect the final inflated average case weighted standardized charge per case based on this more current information. We are inviting public comment on whether trilaciclib meets the cost criterion.</P>
                    <P>
                        With respect to the substantial clinical improvement criterion, the applicant asserted that trilaciclib represents a substantial clinical improvement over existing technologies because it offers a treatment option for patients unresponsive to or ineligible for currently available treatments and improves clinical outcomes for a patient population as compared to currently available treatments. The applicant stated that chemotherapy-induced myelosuppression (CIM) is typically managed with treatment dose delays and reductions due to the slow recovery of bone marrow after a course of chemotherapy.
                        <SU>142</SU>
                        <FTREF/>
                         The applicant also stated that CIM is managed with rescue interventions including hematopoietic growth factors (G-CSFs and ESAs) and by RBC and platelet transfusions.
                        <E T="51">143 144</E>
                        <FTREF/>
                         Per the applicant, despite the availability and use of these treatment options, CIM continues to be of clinical significance and remains a central concern in the delivery of chemotherapy.
                        <E T="51">145 146</E>
                        <FTREF/>
                         The applicant further stated that myelosuppression results in dose reductions, dose delays, and/or dose discontinuations, affecting the dose intensity and intended antitumor efficacy of chemotherapy.
                        <SU>147</SU>
                        <FTREF/>
                         Per the applicant, the supportive care interventions for treatment of myelosuppression are suboptimal and are often administered reactively, do not protect the bone marrow from chemotherapy-induced cytotoxic effects, are specific to single hematopoietic lineages, and impart their own risks for adverse reactions.
                        <SU>148</SU>
                        <FTREF/>
                         The applicant concluded by stating that new approaches that proactively prevent chemotherapy-induced damage and its associated consequences, whilst not decreasing the efficacy of chemotherapy, are urgently needed to improve care of patients with ES-SCLC.
                        <SU>149</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>142</SU>
                             Crawford J, Dale DC, Lyman GH. Chemotherapy-induced neutropenia: Risks, consequences, and new directions for its management. Cancer. 2004;100(2):228.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>143</SU>
                             Kurtin S. Myeloid Toxicity of Cancer Treatment. 
                            <E T="03">J Adv Pract Oncol</E>
                             2012;3:209-24.
                        </P>
                        <P>
                            <SU>144</SU>
                             Asghar U, Witkiewicz AK, Turner NC, Knudsen ES. The history and future of targeting cyclin-dependent kinases in cancer therapy. Nat Rev Drug Discov. 2015;14(2):130-46.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>145</SU>
                             Crawford J, Dale DC, Lyman GH. Chemotherapy-induced neutropenia: Risks, consequences, and new directions for its management. Cancer. 2004;100(2):228.
                        </P>
                        <P>
                            <SU>146</SU>
                             Lyman GH. Chemotherapy dose intensity and quality cancer care. Oncology (Williston Park). 2006;20(14 Suppl 9):16-25.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>147</SU>
                             Smith RE. Trends in recommendations for myelosuppressive chemotherapy for the treatment of solid tumors. J Natl Compr Canc Netw. 2006;4(7):649-58.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>148</SU>
                             Bisi JE, Sorrentino JA, Roberts PJ, Tavares FX, Strum JC. Preclinical characterization of G1T28: a novel CDK4/6 inhibitor for reduction of chemotherapy-induced myelosuppression. Mol Cancer Ther. 2016;15(5):783-93.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>149</SU>
                             Nurgali K, Jagoe T, Raquel Abalo R. Editorial: Adverse Effects of Cancer Chemotherapy: Anything New to Improve Tolerance and Reduce Sequelae? Front Pharmacol. 2018;9:245.
                        </P>
                    </FTNT>
                    <P>
                        In regard to the claim that the use of trilaciclib significantly improves clinical outcomes for a patient population as compared to currently available treatments, the applicant stated that the administration of trilaciclib prior to chemotherapy in patients with SCLC prevented chemotherapy-induced neutropenia, reduced chemotherapy-induced anemia, reduced CIM or sepsis-related hospitalizations, and has the potential to improve the management and quality of life of patients receiving myelosuppressive chemotherapy as compared to placebo.
                        <SU>150</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>150</SU>
                             Ferrarotto R, Anderson I, Medgyasszay B, et al. Trilaciclib reduces the need for growth factors and red blood cell transfusions to manage chemotherapy-induced myelosuppression. Poster presented at: IASLC: 2020 North America Conference on Lung Cancer; October 16-17, 2020; Virtual congress.
                        </P>
                    </FTNT>
                    <P>The applicant presented eight claims in support of the assertion that trilaciclib represents substantial clinical improvement over existing technologies in the mitigation of clinically significant chemotherapy-induced myelosupression in adult patients with SCLC.</P>
                    <P>
                        In its first and second claims, the applicant asserted that trilaciclib reduces the mean duration of severe G4 neutropenia in cycle 1 of chemotherapy and reduces the proportion of patients experiencing severe G4 neutropenia in comparison to placebo. The applicant submitted three sources in support of these claims. First, the applicant submitted a poster presentation from Daniel, et. al., describing a global, randomized, double-blind, placebo-controlled, multicenter, phase 2 study that assessed the potential of trilaciclib to reduce the incidence and consequences of chemotherapy-induced myelosuppression in patients with newly diagnosed ES-SCLC treated with etoposide, carboplatin, and atezolizumab. One hundred seven eligible patients were randomized to 
                        <PRTPAGE P="25243"/>
                        receive trilaciclib (n = 53) or placebo (n = 54). The primary endpoints were mean duration of severe neutropenia (SN) in cycle 1 and percent of patients with grade 4 SN. Results summarized mean duration of SN in cycle 1 as 0 days with trilaciclib and 4 days with placebo, and percent of patients with grade 4 SN as 1.9% vs 49.1%, respectively.
                        <SU>151</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>151</SU>
                             Daniel D, Kuchava V, Bondarenko I et al. Trilaciclib Decreases Myelosuppression in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Patients Receiving First-Line Chemotherapy Plus Atezolizumab [Poster Presentation]. European Society of Medical Oncology (ESMO). October, 2019; Barcelona, Spain.
                        </P>
                    </FTNT>
                    <P>
                        Second, the applicant submitted an article by Weiss, et. al., summarizing a phase II randomized, double-blind placebo-controlled study of the safety, efficacy and pharmacokinetics (PK) of trilaciclib in combination with etoposide/carboplatin (E/P) therapy for treatment-naive extensive-stage small-cell lung cancer patients. Thirty-nine patients were included in the trilaciclib group versus 38 in the placebo group. The applicant stated that treatment with trilaciclib resulted in a reduced mean duration of severe G4 neutropenia in cycle 1 (0 days versus 3 days in placebo) and reduced proportion of patients experiencing severe G4 neutropenia for trilaciclib (5% versus 43%).
                        <SU>152</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>152</SU>
                             Weiss JM, Csoszi T, Maglakelidze M et al. Myelopreservation with the CDK4/6 inhibitor Trilaciclib in Patients with Small-Cell Lung Cancer Receiving First-Line Chemotherapy: A Phase Ib/Randomized Phase II Trial. Ann Oncol. 2019 ;30(10):1613-1621.
                        </P>
                    </FTNT>
                    <P>
                        Third, the applicant submitted a presentation from Hart, et. al., describing a randomized, double-blind, placebo-controlled, phase 2 study to compare the results of 32 patients receiving Trilaciclib versus 28 receiving placebo in patients being treated with topotecan for previously treated ES-SCLC. Primary endpoints were mean duration of SN in cycle 1 and the percentage of patients with SN. Results demonstrated that the mean duration of severe G4 neutropenia in cycle 1 was reported at 2 days for trilaciclib versus eight days for placebo. The proportion of patients experiencing severe G4 neutropenia was reported at 41% for trilaciclib versus 76% for placebo.
                        <SU>153</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>153</SU>
                             Hart LL, Andric ZG, Hussein MA et al. Effect of Trilaciclib, a CDK4/6 Inhibitor, on Myelosuppression in Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer [Oral Presentation]. Presented at: American Society of Clinical Oncology (ASCO). June 2019; Chicago, US.
                        </P>
                    </FTNT>
                    <P>
                        In the third claim, the applicant asserted that trilaciclib reduces the proportion of patients experiencing febrile neutropenia treatment emergent adverse events (TEAE) in comparison to placebo. In the fourth claim, the applicant asserted that trilaciclib decreases the rate of therapeutic intervention with G-CSF in comparison to placebo, noting that growth factors are known to carry a number of risks, cause complications and adverse events. In the fifth claim, the applicant asserted that trilaciclib reduces the proportion of patients experiencing grade 3/4 anemia in comparison to placebo. In the sixth claim, the applicant asserted that trilaciclib decreases the rate of therapeutic intervention with red blood cell transfusions in comparison to placebo. To support these claims, the applicant submitted a 2020 poster presentation from Weiss, et. al., describing a pooled analysis across three RCTs that compared the proportion of ES-SCLC patients experiencing febrile neutropenia between trilaciclib and placebo. The trilaciclib group included 122 patients and the placebo group included 118 patients. The presentation reflected the following results: The proportion of patients experiencing febrile neutropenia for trilaciclib was 3% versus placebo at 9%; the rate of therapeutic intervention with G-CSF for trilaciclib at 29% versus 56% for placebo; the proportion of patients experiencing grade 3/4 anemia for trilaciclib at 20% versus 32% for placebo; and the rate of therapeutic intervention with red blood cell transfusions for trilaciclib at 15% versus 26% for placebo.
                        <SU>154</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>154</SU>
                             Weiss J, Goldschmidt J, Andric Z et al. Myelopreservation and Reduced Use of Supportive Care with Trilaciclib in Patients with Small Cell Lung Cancer [Poster Presentation]. Presented at: American Society of Clinical Oncology (ASCO). May 2020.
                        </P>
                    </FTNT>
                    <P>
                        In the seventh claim, the applicant asserted that trilaciclib delays time to deterioration in symptoms and functioning domains of patient-reported quality of life measures on Functional Assessment of Cancer Therapy (FACT) scores. The applicant submitted a 2019 presentation from Weiss, et. al., describing a pooled analysis across three RCTs. The applicant stated that trilaciclib delays time to confirmed deterioration in a variety of symptoms and functioning domains compared to placebo, for example: median of 4.7 months delay to deterioration for fatigue; median of 3.5 months delay for anemia; and median of 4 months delay for functional well-being.
                        <SU>155</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>155</SU>
                             Weiss J, Skaltsa K, Gwaltney C, et al: Results from three phase 2 randomized, double-blind, placebo-controlled small cell lung cancer trials. 2019 Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology International Symposium on Supportive Care in Cancer. Abstract eP723. Presented June 21, 2019.
                        </P>
                    </FTNT>
                    <P>
                        In the eighth claim, the applicant asserted that trilaciclib decreases the number of hospitalizations due to myelosuppression or sepsis. The applicant submitted a conference agenda referring to an oral presentation by Ferrarotto, et. al., at the North America Conference on Lung Cancer, October 16, 2020. The applicant stated that hospitalizations due to myelosuppression or sepsis occurred in significantly fewer patients and significantly less often among patients receiving trilaciclib prior to chemotherapy versus placebo though we were unable to locate support for this claim in the conference agenda submitted with the application.
                        <SU>156</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>156</SU>
                             Ferrarotto R, Anderson I, Medgyasszay B, et al. Trilaciclib reduces the need for growth factors and red blood cell transfusions to manage chemotherapy-induced myelosuppression. [Oral Presentation]. Presented at: North America Conference on Lung Cancer, October 2020. 
                            <E T="03">https://naclc2020.iaslc.org/program-at-a-glance/.</E>
                        </P>
                    </FTNT>
                    <P>
                        With respect to the substantial clinical improvement criterion, we note that the data submitted by the applicant included one published peer reviewed article from Weiss, et. al.,
                        <SU>157</SU>
                        <FTREF/>
                         abstracts from Daniel, et. al.,
                        <SU>158</SU>
                        <FTREF/>
                         and Hart, et. al.,
                        <SU>159</SU>
                        <FTREF/>
                         and references to trials exploring broader cohorts of small cell lung cancer, breast cancer and colon cancer patients. In addition, as summarized previously, we note that most of the studies submitted by the applicant had sample sizes fewer than 100 participants which may limit generalizability of the studies. With respect to the Weiss, et. al., study, we note that trilaciclib was compared with placebo at a significance level of two-sided α = 0.2 which is much lower than the typical cutoff of 0.05 and may have increased the risk of false positives and interfered with the ability to draw conclusions that are based on statistical methods. We also note the lack of any statistical correction for multiple comparisons. We note that 
                        <PRTPAGE P="25244"/>
                        in sources provided by the applicant, mean duration of severe neutropenia was assessed in day increments.
                        <E T="51">160 161 162 163</E>
                        <FTREF/>
                         However, it is not clear that zero days would indicate that those patients experienced no severe neutropenia. Specifically, we question whether mean hours in severe neutropenia was evaluated or whether, in addition to the groupings by days, one day or less would be an appropriate value for inclusion. Finally, while the applicant referred to decreases in the number of hospitalizations, we note that the source provided was limited to a conference agenda that only linked to an abstract pertaining to reductions in utilization of supportive care interventions but did not reflect hospitalization rates.
                        <SU>164</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>157</SU>
                             Weiss JM, Csoszi T, Maglakelidze M, et al. Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: A phase Ib/randomized phase II trial. Ann Oncol. 2019;30(10):1613-1621.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>158</SU>
                             Daniel D, Kuchava V, Bondarenko I, et al. Trilaciclib (T) decreases myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) patients receiving first-line chemotherapy plus atezolizumab. Ann Oncol. 2019;30:v713, Abstract 1742PD. 
                            <E T="03">https://www.g1741therapeutics.com/file.cfm/1734/docs/tr-G1741_ESMO2019_Daniel.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>159</SU>
                             Hart LL, Andric ZG, Hussein MA, et al. Effect of trilaciclib, a CDK 
                            <FR>4/6</FR>
                             inhibitor, on myelosuppression in patients with previously treated extensive-stage small cell lung cancer receiving topotecan. J Clin Oncol. 2019;37(15_suppl): Abstract 8505: 
                            <E T="03">https://www.g8501therapeutics.com/file.cfm/8534/docs/tr-G8501T8528-8503%8520ASCO%202019%202020Oral%202020Presentation%20060119-20060111.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>160</SU>
                             Weiss JM, Csoszi T, Maglakelidze M, et al. Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: A phase Ib/randomized phase II trial. Ann Oncol. 2019;30(10):1613-1621.
                        </P>
                        <P>
                            <SU>161</SU>
                             Daniel D, Kuchava V, Bondarenko I, et al. Trilaciclib (T) decreases myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) patients receiving first-line chemotherapy plus atezolizumab. Ann Oncol. 2019;30:v713, Abstract 1742PD: 
                            <E T="03">https://www.g1741therapeutics.com/file.cfm/1734/docs/tr-G1741_ESMO2019_Daniel.pdf</E>
                            .
                        </P>
                        <P>
                            <SU>162</SU>
                             Hart LL, Andric ZG, Hussein MA et al. Effect of Trilaciclib, a CDK4/6 Inhibitor, on Myelosuppression in Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer [Oral Presentation]. Presented at: American Society of Clinical Oncology (ASCO). June 2019; Chicago, US.
                        </P>
                        <P>
                            <SU>163</SU>
                             Weiss J, Goldschmidt J, Andric Z et al. Myelopreservation and Reduced Use of Supportive Care with Trilaciclib in Patients with Small Cell Lung Cancer [Poster Presentation]. Presented at: American Society of Clinical Oncology (ASCO). May 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>164</SU>
                             Ferrarotto R, Anderson I, Medgyasszay B, et al. Trilaciclib reduces the need for growth factors and red blood cell transfusions to manage chemotherapy-induced myelosuppression. [Oral Presentation]. Presented at: North America Conference on Lung Cancer, October 2020. 
                            <E T="03">https://naclc2020.iaslc.org/program-at-a-glance/.</E>
                        </P>
                    </FTNT>
                    <P>We invite public comments as to whether trilaciclib meets the substantial clinical improvement criterion.</P>
                    <P>
                        We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for trilaciclib.
                    </P>
                    <HD SOURCE="HD3">f. Ellipsys® Vascular Access System</HD>
                    <P>Avenu Medical, Inc. submitted an application for new technology add-on payments for the Ellipsys® Vascular Access System (“Ellipsys”) for FY 2022. Ellipsys is a device that enables percutaneous creation of an arteriovenous fistula (AVF), which is used to access the bloodstream for hemodialysis for the treatment of end-stage renal disease (ESRD). According to the applicant, to create the fistula, a physician inserts a crossing needle through the perforating vein and into the proximal radial artery in the forearm. A specialized catheter is then used to bring the artery and vein together. The two vessels are “welded” together with thermal resistance energy, creating an anastomosis. According to the applicant, the only means of creating an AVF was through open surgery before the approval of Ellipsys, and percutaneous AVF (pAVF) offers a number of advantages over surgical AVF (sAVF).</P>
                    <P>
                        With respect to the newness criterion, the applicant for Ellipsys received 510(k) clearance from the FDA on August 9, 2019, with an indication for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.
                        <SU>165</SU>
                        <FTREF/>
                         The subject of this 510(k) clearance was an update to the Instructions for Use (IFU) to allow an additional procedural step for balloon dilation of the anastomosis junction at the radial artery and adjacent outflow vein of the AVF immediately after creation with the Ellipsys catheter. Per the applicant, the device was immediately available on the market. The applicant further stated that the device was originally approved under a De Novo clearance on June 22, 2018. Ellipsys also received two additional 510(k) clearances dated January 25, 2019 (minor change in the packaging of components) and October 5, 2018 (minor technological differences in the power control unit and minor enhancements to the catheter design) but the applicant states they are not regarded as material for this application. The FDA has classified Ellipsys as a Class II device under the generic name percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. The applicant stated that currently, two ICD-10-PCS codes identify procedures using Ellipsys: 031B3ZF (Bypass right radial artery to lower arm vein, percutaneous approach); and 031C3ZF (Bypass left radial artery to lower arm vein, percutaneous approach). However, since these codes also identify the WavelinQ
                        <E T="51">TM</E>
                         EndoAVF System (“WavelinQ”), another percutaneous fistula device, Avenu Medical submitted a code request for a unique ICD-10-PCS code to distinctly identify Ellipsys beginning in FY 2022. The applicant stated this technology was first assigned HCPCS code C9754 on January 1, 2019, which was then replaced by HCPCS code G2170 on July 1, 2020. Per the applicant, WavelinQ was assigned HCPCS codes (C9755 replaced by G2171) with the same timing, and the codes for the 2 pAVF technologies are differentiated by the use of thermal resistance energy for Ellipsys and the use of radiofrequency energy for WavelinQ.
                    </P>
                    <FTNT>
                        <P>
                            <SU>165</SU>
                             U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. 510(k) Summary No. K1191114. 2019. Retrieved from: 
                            <E T="03">https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191114.pdf.</E>
                        </P>
                    </FTNT>
                    <P>The applicant stated that hemodialysis access for the treatment of ESRD can be provided by catheter, graft, or AVF, of which AVF is generally preferred for patients whose vascular anatomy and condition permit it. Per the applicant, the only method for creating an AVF was through an open surgical approach until the introduction of Ellipsys and WavelinQ, two devices that use a percutaneous approach.</P>
                    <P>As discussed earlier, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>With regard to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, the applicant asserted that Ellipsys uses a new mechanism of action compared to its initial clearance. Per the applicant, the current device included an additional step in the IFU, creating a different procedure profile and a different mechanism of action. The applicant states that the addition of this step, a balloon angioplasty performed within the same operative session as the creation of the pAVF, instead of days or weeks later, typically contributes to decreased time to maturation, improved initial flow, and helps avoid early thrombosis of the newly-created access, in addition to decreasing the number of secondary procedures required for maturation and maintenance. According to the applicant, the explicit inclusion of the step in the IFU, where it was not previously explicitly included, represents a new mechanism of action.</P>
                    <P>
                        With respect to the second criterion, whether a product is assigned to the same or different MS-DRG, the applicant generally stated that Ellipsys is assigned to the same MS-DRGs as existing technologies. According to information provided by the applicant, 
                        <PRTPAGE P="25245"/>
                        these MS-DRGs appear to be MS-DRGs 264, 356, 357, 358, 628, 629, 630, 673, 674, 675, 907, 908, 909, 981, 982, and 983. With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant generally stated that Ellipsys will be used to treat the same or similar type of disease and the same or similar patient population as the current standard-of-care treatments.
                    </P>
                    <P>
                        In summary, the applicant believes that Ellipsys is not substantially similar to other currently available therapies and/or technologies because it uses a new mechanism of action and that therefore, the technology meets the “newness” criterion. However, we believe that the mechanism of action for Ellipsys may be the same or similar to the original version of the Ellipsys system, which received FDA approval on June 22, 2018. Though the current IFU includes an additional procedure as part of the index procedure, it is not clear that this step of balloon angioplasty done concurrently changes the mechanism of action of the Ellipsys system. Per the FDA's 510(k) summary, compared to the predicate device, there were no changes to the device or the manner in which it creates a percutaneous anastomosis, and other than the additional procedural step of balloon dilation, all characteristics remain unchanged.
                        <SU>166</SU>
                        <FTREF/>
                         In addition, clinicians were not precluded from performing this step before the change in the IFU, and in fact, balloon dilation was already performed during the index procedure in some cases.
                        <SU>167</SU>
                        <FTREF/>
                         Though the applicant maintains that performing this additional step in all cases, as opposed to some, leads to superior clinical outcomes, we are unclear if this has any bearing on newness for this technology or if it represents a change in the mechanism of action of this device. We note that if the current device is substantially similar to the original version of Ellipsys, we believe the newness period for this technology would begin on June 22, 2018 with the De Novo approval date and, therefore, because the 3-year anniversary date of the technology's entry onto the U.S. market (June 22, 2021) would occur in FY 2021, the technology would no longer be considered new and would not be eligible for new technology add-on payments for FY 2022. We welcome public comments on whether the change in the Ellipsys IFU represents a change to the device's mechanism of action.
                    </P>
                    <FTNT>
                        <P>
                            <SU>166</SU>
                             U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. 510(k) Summary No. K1191114. 2019. Retrieved from: 
                            <E T="03">https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191114.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>167</SU>
                             Hull JE, Jennings W, 
                            <E T="03">et al.,</E>
                             “The Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation for Hemodialysis Access,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2018; 29: 149-158.
                        </P>
                    </FTNT>
                    <P>We also note that differences in mechanism of action between Ellipsys and WavelinQ were not included. We note that CMS stated in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58702) that WavelinQ uses a unique mechanism of action that differed from that of other commercially available devices.</P>
                    <P>We are inviting public comments on whether Ellipsys is substantially similar to other currently available therapies and/or technologies and whether this technology meets the newness criterion.</P>
                    <P>With regard to the cost criterion, the applicant conducted the following analysis to demonstrate that the technology meets the cost criterion.</P>
                    <P>The applicant searched the FY 2019 MedPAR claims data file with the FY 2019 IPPS/LTCH PPS final rule correction notice IPPS Impact File to identify potential cases representing patients who may be eligible for treatment using the Ellipsys. The applicant stated that currently, there are two ICD-10-PCS procedure codes that describe percutaneous AVF in the radial artery: 031B3ZF (Bypass right radial artery to lower arm vein, percutaneous approach) and 031C3ZF (Bypass left radial artery to lower arm vein, percutaneous approach). The applicant stated that these codes are not specific to percutaneous AVF formation using thermal energy. We note that the applicant submitted a request for approval for a unique ICD-10-PCS code for the use of the Ellipsys beginning FY 2022. The applicant stated that if the procedure were reported with the previously mentioned procedure codes, Ellipsys would be mapped to the following MS-DRGs:</P>
                    <GPH SPAN="3" DEEP="200">
                        <GID>EP10MY21.149</GID>
                    </GPH>
                    <P>The applicant added that ICD-10 codes 031B3ZF and 031C3ZF were new effective October 1, 2019 and therefore do not appear in the 2019 claims data. According to the applicant, the most common MS-DRGs for patients admitted with chronic kidney disease and who received an open procedure for creation of an AVF are shown below.</P>
                    <GPH SPAN="3" DEEP="69">
                        <PRTPAGE P="25246"/>
                        <GID>EP10MY21.150</GID>
                    </GPH>
                    <P>The applicant has not made a request for Ellipsys to be mapped to a new MS-DRG for FY 2022.</P>
                    <P>The applicant stated that claims which had a diagnosis code for Chronic Kidney Disease (CKD) stage IV, CKD stage V, or ESRD and which included an open bypass of the subclavian artery to upper arm vein or the radial artery to lower arm vein during the same stage were included in the cost analysis. The applicant stated they used the following ICD-10 codes in their analysis to identify claims.</P>
                    <GPH SPAN="3" DEEP="145">
                        <GID>EP10MY21.151</GID>
                    </GPH>
                    <P>Cases mapping to the top five MS-DRGs by volume were selected, which resulted in 689 cases or 79% of case volume.</P>
                    <P>The applicant determined an average unstandardized case weighted charge per case of $91,190.</P>
                    <P>The applicant did not remove charges for prior technology because the cases identified included an open procedure that is not performed using a specific device. However, the applicant stated that all charges for the operating room (OR) were removed as the procedures involving the technology would not always be performed in an OR. The applicant stated that departmental charges were standardized using the factors from the standardization file released with the FY 2021 final rule. The applicant then standardized the charges using the FY 2019 Final Rule with Correction Notice Impact File. Next, the applicant applied the 2-year inflation factor used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier threshold charges (1.13218). To calculate the charges for the technology, the applicant used the national average CCR for the Supplies and Equipment cost center of 0.297 from the FY 2021 IPPS/LTCH PPS final rule. The applicant added charges for other items and services related to the technology; half of the average departmental charges for the OR removed in a prior step were added back to the per case charge, by MS-DRG, as procedures using the technology would sometimes be performed in an OR. The applicant calculated a final inflated average case-weighted standardized charge per case of $119,158, which exceeded the average case-weighted threshold amount of $91,190 by $27,967. The applicant stated that because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount, the therapy meets the cost criterion.</P>
                    <P>We note that the applicant used claims with open subclavian artery bypass to upper arm vein, in addition to radial lower arm fistulas, as a proxy for Ellipsys cases. The applicant stated that Ellipsys may provide an alternative to these cases in some instances where AVF placement in the radial arteries is possible but the surgeons are unfamiliar with the procedure. However, we question if these are the most appropriate proxy, as Ellipsys should not replace radiocephalic fistulas, per standard guidelines that recommend wrist fistulas first; and it would be more likely that surgeons would use Ellipsys over upper arm fistulas than a subclavian fistula, which is used rarely in standard practice.</P>
                    <P>We are inviting public comments on whether the Ellipsys® Vascular Access System meets the cost criterion.</P>
                    <P>
                        With respect to the substantial clinical improvement criterion, the applicant asserted that the Ellipsys® Vascular Access System represents a substantial clinical improvement over existing technologies. Broadly, the applicant outlined three comparators with respect to which it asserted Ellipsys provides a substantial clinical improvement: (1) Percutaneous AVF with the WavelinQ
                        <E T="51">TM</E>
                         (4F) EndoAVF System; (2) percutaneous AVF (pAVF) with the prior version of Ellipsys; and (3) surgical AVF (sAVF).
                    </P>
                    <P>With respect to the first comparison, Ellipsys as compared to WavelinQ, the applicant stated that Ellipsys has improved outcomes including technical success and cumulative patency. The applicant cited the following to support superiority of Ellipsys over WavelinQ: (1) Higher fraction of cases with clinically functional AVFs; (2) speedier maturation; (3) more durable AVFs; and (4) smaller failure rate. According to the applicant, no head-to-head clinical trial is available, but they provided one retrospective study that provides a direct comparison between the two pAVF systems to support their claims.</P>
                    <P>
                        Shahverdyan et al. performed a retrospective review of 100 patients undergoing percutaneous fistula creation at a single site in Germany between December 2017 and December 2019 to compare outcomes with pAVF 
                        <PRTPAGE P="25247"/>
                        creation using the Ellipsys and WavelinQ systems.
                        <SU>168</SU>
                        <FTREF/>
                         In this single-operator, comparative case series, 65 Ellipsys procedures and 35 WavelinQ procedures were completed, following a procedure sequence algorithm for selecting the type of vascular access. Per the study, wrist sAVF was the first choice as per standard practice guidelines, followed by proximal forearm pAVF, resulting in 100 pAVFs using Ellipsys (n=65) and WavelinQ (n=35). Demographics for the study patients included 69 percent male and median age of 64.1 years. There were no significant differences between WavelinQ and Ellipsys patients in age, Body Mass Index (BMI), Chronic Kidney Disease (CKD) status, AVF history, or presence of diabetes, though the WavelinQ group had a higher proportion of males. The primary endpoints were technical success, time to maturation, functional patency, and time to first clinical use, and median follow-up was 186.5 days. The study reported technical success, defined as post-procedure ultrasound examination demonstrating a patent anastomosis and fistula flow, with Ellipsys at 100 percent vs. 97 percent with WavelinQ (p=0.35). Interventions were performed in approximately 27 percent of cases for both technologies, and the number of interventions per patient-year was 0.96 vs. 0.46, respectively.
                    </P>
                    <FTNT>
                        <P>
                            <SU>168</SU>
                             Shahverdyan et al., “Comparison of Outcomes of Percutaneous Arteriovenous Fistulae Creation by Ellipsys and WavelinQ Devices,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2020; 31(9): 1365-1372. (Published on-line August 11, 2020.)
                        </P>
                    </FTNT>
                    <P>Per the applicant, the study demonstrated a higher fraction of cases with clinically functional AVFs using Ellipsys, as fistula maturation at four weeks was 68.3 percent with Ellipsys vs. 54.3 percent with WavelinQ (p=0.1709), and at the end of the study period, 83.3% and 71.4% respectively. In addition, the applicant stated that successful dialysis access was achieved in 79.5 percent of Ellipsys cases vs. 60.9 percent for WavelinQ cases among patients on dialysis (p=0.0711). The applicant also stated that the study demonstrated that Ellipsys results in speedier maturation with Ellipsys demonstrating a median time to cannulation of 60 days vs. 90 days with WavelinQ (p=0.3676). Next, the applicant stated that use of Ellipsys demonstrated more durable AVFs, with a secondary patency rate (the time from fistula creation to fistula abandonment, including any interventions) at 12 months of 82 percent as compared to 60 percent with WavelinQ, and a functional patency rate of 100% vs 85.7%, respectively. We note that primary patency (the time from fistula creation to the first intervention) between groups was not significantly different. Lastly, access failure occurred in 15.4 percent of Ellipsys patients vs 37.1 percent of WavelinQ patients (p=0.0137), which demonstrated that use of Ellipsys results in a smaller failure rate, according to the applicant.</P>
                    <P>With regard to the second comparison, Ellipsys compared to the previous version of the technology, the applicant states that since the IFU dated 8/9/19 now states that balloon angioplasty should be performed at the time of the creation procedure, they believe that Ellipsys should be considered a different device. Per the applicant, this subtle difference is of key clinical importance to successful use of Ellipsys, as this method decreases the time to two-needle cannulation (2NC) and also improves initial flow, resolving vascular spasm at the time of the procedure and reducing early thrombosis. The applicant further states that performing balloon angioplasty 100 percent of the time also decreases the number of secondary procedures. To support these claims, the applicant compared results from the Ellipsys pivotal trial that used the earlier IFU, in which angioplasty was performed simultaneously on 19% of patients, with the Ellipsys post-market registry that implemented the change and performed the additional step on 100% of patients.</P>
                    <P>
                        Ellipsys's pivotal trial was a prospective, single-arm, non-inferiority study of 107 patients at five sites to compare Ellipsys with a 90-day performance goal based on a meta-analysis of surgical results from the literature.
                        <SU>169</SU>
                        <FTREF/>
                         Inclusion criteria included vascular anatomy specific to the indications for Ellipsys, age between 18 and 80 years old, and CKD stage IV or V. Exclusion criteria included recent surgery or major illness within 6 weeks, acute or active infection, and use of immunosuppressive medication. Of 261 patients evaluated, a total of 117 met inclusion and exclusion criteria, with 28 percent excluded due to unsuitable anatomy. 107 were included in the intent to treat (ITT) population after each study site completed 2 proctored procedures. Demographics included 73 percent male, mean patient age of 56.7 years, and mean BMI of 31.2 percent. All patients in the ITT population received a pAVF with Ellipsys between the proximal radial artery and perforating vein, followed by separate maturation procedures. The primary efficacy endpoint of the study was maturation success, defined as brachial artery flow volume greater than or equal to 500ml/min and target vein diameter greater than or equal to 4mm in more than 49 percent of patients at 90 days. This performance goal was obtained from a meta-analysis of 8 studies of open sAVF, where the weighted least squares mean success rate was 62 percent, and the lower bound from a 2-sided 95 percent lower confidence interval was 49 percent. The primary safety endpoint was the absence of device-related complications at 90 days. Access failure occurred in 4/107, with a technical success rate of 95 percent. The primary endpoint was met by 86 percent at 90 days (the 97.5 percent lower confidence interval was 77.9 percent), exceeding the 49 percent performance goal (p&lt;0.0001). Cumulative patency was 91.6 percent at 90 days and 86.7 percent at 1 year. During the 12-month study, 88 percent of the patients on hemodialysis (71 of 81) had successful 2-needle cannulation, including 63 patients on dialysis at enrollment and 18 who initiated dialysis during the study. The mean time to cannulation was 114.3 days ± 66.2 (34-345 days). Per the authors, spasm of the perforating vein was easily treated with vasodilators and balloon dilation as a matter of routine care. Nineteen percent of patients (20/107) received balloon dilation during the index procedure, and second stage maturation procedures included 113 balloon dilations in 77 patients. A total of 205 maturation procedures were performed on 99 patients at a mean of 35.1 days. An additional 66 maintenance procedures were performed in 35 patients at a mean of 17 days, for a total of 271 secondary procedures during the 12 months of the study (2.7 per patient year).
                    </P>
                    <FTNT>
                        <P>
                            <SU>169</SU>
                             Hull JE, Jennings W, et al., “The Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation for Hemodialysis Access,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2018; 29: 149-158.et al.,
                        </P>
                    </FTNT>
                    <P>
                        The Ellipsys post-market registry by Hull et al. was a prospective single-operator study of 60 patients receiving a pAVF with Ellipsys at a single outpatient US site in an attempt to understand patient selection, maturation, and cannulation with pAVFs.
                        <SU>170</SU>
                        <FTREF/>
                         Patient demographics included 57 percent male, mean age of 64, and mean BMI of 30.7. 123 patients with ESRD stages IV and V were evaluated by ultrasound to determine suitability for AVF. Ninety-two percent were eligible for sAVF and 61 percent 
                        <PRTPAGE P="25248"/>
                        were eligible for pAVF. Of the 95 patients who received an AVF, 63 percent (60) received pAVF and 37 percent (35) received sAVF. All 60 pAVF patients underwent pAVF creation under ultrasound guidance, followed by balloon dilation, as compared to the pivotal trial where only 19 percent had balloon dilation as part of the index procedure. After 4 weeks, maturation and suitability for dialysis were assessed. The fistulas were considered suitable when palpable on examination and the target vein had 500ml/min flow volume and 5mm diameter. Fifty-two additional maturation procedures, including balloon dilation in 62 percent, were performed in 40 of 60 patients to achieve adequate flow volume and diameter in the target vein. Physiologic maturation was achieved in 93 percent (56 of 60 patients) with a mean time of 40.4 days ± 4.3, and of the remaining 4 patients, one thrombosed and three died prior to maturation. In the 54 patients requiring dialysis, 87 percent achieved 2NC at a mean of 76.8 days. Six month cumulative patency and functional patency were both 94 percent. 70 maintenance procedures were performed in 63 percent. Only 2 patients achieved 2NC without an additional procedure. The authors noted that this study is limited by a modest sample size and single-site study with surgeons experienced in pAVF creation, and that results were not compared to surgery.
                    </P>
                    <FTNT>
                        <P>
                            <SU>170</SU>
                             Hull JE, Deitrick J, Groome K, “Maturation for Hemodialysis in the Ellipsys® EndoAVF Post-Market Registry,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2020; 31(9): 1373-1381. (Published on-line August 13, 2020.)
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, the post-market registry demonstrated the significant clinical differences between performing balloon angioplasty as part of the index procedure 19 percent of the time (as seen in the pivotal trial) compared to 100 percent of the time. The results showed that the average time to 2NC decreased from 100 days to 70 days. The study also compared initial AVF flow between the studies, which increased to 649 ml/min from 330.4 ml/min, attributed to the reduction in instances of venospasm due to balloon dilation.
                        <SU>171</SU>
                        <FTREF/>
                         According to the study investigators, this decrease in venospasm and higher flow led to a reduction in early thrombosis from 11 percent to 2 percent. Lastly, the applicant compared the number of secondary procedures between the two studies with the following table:
                    </P>
                    <FTNT>
                        <P>
                            <SU>171</SU>
                             Hull JE, Deitrick J, Groome K, “Maturation for Hemodialysis in the Ellipsys® EndoAVF Post-Market Registry,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2020; 31(9): 1373-1381. (Published on-line August 13, 2020.)
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="60">
                        <GID>EP10MY21.152</GID>
                    </GPH>
                    <P>Per the applicant, despite the higher standard for maturation in the second study (5mm target vein diameter vs 4mm in the pivotal study), the number of maturation procedures decreased, while maintenance procedures increased. Overall, secondary procedures decreased with the new protocol, as described in the table submitted by the applicant.</P>
                    <P>With respect to the third comparison, Ellipsys as compared to sAVF, the applicant stated that Ellipsys creates a side-to-side fistula with a percutaneous approach while sAVFs for the most part create end-to-side fistulas. According to the applicant, in patients that have suitable anatomy for pAVF creation, this method of fistula creation contributes to improved outcomes in five ways: (1) Higher fraction of cases with clinically functional AVFs; (2) decreased time to two-needle cannulation; (3) more durable AVFs; (4) decreased need for secondary interventions; and (5) patient satisfaction with Ellipsys AVFs. According to the applicant, no head-to-head studies or randomized trials between Ellipsys and sAVFs are available, and instead, results of key variables of interest were compared using studies with comparable results for sAVFs from published literature. The applicant provided 2 prospective single-arm studies and 5 retrospective studies, including the studies previously discussed, to support these claims. They also submitted data from one unpublished study. Aside from the Ellipsys pivotal trial, the Ellipsys post-market registry, and the comparison study with WavelinQ already summarized, the remaining studies are summarized below.</P>
                    <P>
                        The 2-year results of the pivotal trial were analyzed retrospectively by Beathard.
                        <SU>172</SU>
                        <FTREF/>
                         105 patients with 2 year follow-up data were included, and of these, 103 had functioning fistulas and all were receiving dialysis except 3. Cumulative patency at 18 and 24 months was 92.8 percent and 91.6 percent, respectively. Patient experience with pAVF was assessed among those who had received a previous access procedure (
                        <FR>1/3</FR>
                        ). When compared to their previous procedure, patients rated Ellipsys as the same in 68 percent, better or much better in 29 percent, and worse in 3 percent. Patients mentioned difficulty with cannulation due to unfamiliarity of dialysis staff with pAVF, but commented on the lack of surgical scar and short recovery time. Among all patients who responded, 93 percent rated their access as very good or excellent.
                    </P>
                    <FTNT>
                        <P>
                            <SU>172</SU>
                             Beathard et al., “Two-year cumulative patency of endovascular AVF” JVA 2020; 21: 350-356.
                        </P>
                    </FTNT>
                    <P>
                        A retrospective review of 34 patients who received pAVF between May 2017 and November 2018 at a clinic in France was submitted.
                        <SU>173</SU>
                        <FTREF/>
                         Patients included had ESRD, were not candidates for wrist fistulas, and met the anatomic criteria for use of Ellipsys. Demographics included patients that were 58 percent male, 65 percent Caucasian and 35 percent African, and a mean age of 62 years old. After fistula creation with Ellipsys, all anastomoses received balloon dilation. Twenty-four of 34 patients had successful 2NC within 6 weeks. Forty-four percent of patients did not require secondary interventions, and 12 percent required additional dilation within 4 weeks to improve maturation. Two patients converted to a surgical fistula due to cannulation difficulties. No patients developed steal syndrome or aneurysmal changes in the one year follow-up period. Study authors noted that one benefit of pAVF over sAVF is the potential for multiple outflow cannulation veins, as compared to a sAVF in the same location, where the median cubital vein is ligated to augment flow into a single vessel.
                    </P>
                    <FTNT>
                        <P>
                            <SU>173</SU>
                             Hebibi et al, “Clinical hemodialysis experience with percutaneous arteriovenous fistulas created using the Ellipsys® vascular access system,” 
                            <E T="03">Hemodialysis International</E>
                             2019; 23(2): 168-172.
                        </P>
                    </FTNT>
                    <P>
                        Another study provided was a retrospective cohort study of 232 
                        <PRTPAGE P="25249"/>
                        consecutive patients who underwent pAVF creation with Ellipsys at a single center in France.
                        <SU>174</SU>
                        <FTREF/>
                         An Ellipsys pAVF was the second choice after a radiocephalic surgical wrist fistula. Patients were 63 percent male, with a mean age of 64 years old (25-92). Balloon angioplasty was considered part of the index procedure and performed in all cases. Technical success was achieved in 99 percent. At 1 year, the primary patency rate was 54 percent and the secondary patency rate was 96 percent with a mean follow up of 252 days. The most frequent intervention (35 percent of patients) was additional balloon angioplasty. Eleven percent of patients underwent procedures for superficialization of deep veins. Average maturation time by clinical or ultrasound criteria was 4 weeks, and successful cannulation was established in less than 2 weeks in 10 percent of patients. No significant adverse events related to the procedures occurred. Three patients (1 percent) required later conversion to sAVF, two due to occlusion of the anastomosis and one due to rupture of the perforator during an angioplasty procedure and pseudoaneurysm. The authors conclude that pAVFs have reduced need for reinterventions and result in a moderate-flow fistula with shared venous drainage. They further state that minimally invasive AVF creation with the low risk of complications seen using Ellipsys can be particularly beneficial in older patients, especially since the lower flow fistula as compared to brachial artery inflow AVFs decreases the risk of cardiac issues. They conclude that large-scale randomized studies are needed to confirm their findings.
                    </P>
                    <FTNT>
                        <P>
                            <SU>174</SU>
                             Mallios et al., “Mid-term results of percutaneous arteriovenous fistula creation with Ellipsys vascular access system, technical recommendations and an algorithm for maintenance,” 
                            <E T="03">Journal of Vascular Surgery</E>
                             2020; 72(6): 2097-2106. (Published on-line April 7, 2020.).
                        </P>
                    </FTNT>
                    <P>
                        In another study, a case series of 14 patients who achieved early cannulation with an Ellipsys pAVF underwent retrospective review at an outpatient department in Europe.
                        <SU>175</SU>
                        <FTREF/>
                         In these patients, cannulation within 14 days post creation was performed using plastic cannulas in order to avoid catheter insertion or replacement for dialysis. The procedure was successful in all except one case. Primary patency at 12 months was 66 percent and cumulative patency was 100 percent, with the authors concluding that this success suggests that pAVF could serve as an alternative to catheter for immediate dialysis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>175</SU>
                             Mallios et al., “Early cannulation of percutaneously created AVFs”, 
                            <E T="03">Journal of Vascular Access</E>
                             2020; 21(6): 997-1002. (Published on-line December 19, 2019.)
                        </P>
                    </FTNT>
                    <P>The applicant also submitted preliminary unpublished results from a 3-year follow up of 99 of the pivotal trial patients, stating that while Ellipsys AVFs required more maturation procedures, in the 2 years following creation they required fewer maintenance procedures as compared to results for sAVF reported in the literature, with an average of 0.83 vs. 3.41, respectively. Additionally, they stated that at every follow-up period, Ellipsys showed improved cumulative patency over sAVF results from the literature, with rates of 90 percent vs 46 percent at 36 months.</P>
                    <P>
                        The applicant summarized results from all of the studies to support each claim of Ellipsys's superiority over sAVF by comparing to historical controls in the literature. For the claim of more clinically functional AVFs, the applicant summarized results from 4 studies, demonstrating 2NC in 88 percent at one year and 95 percent at 2 years, 87 percent with an average follow up of 282 days, and 82 percent within 6 weeks.
                        <E T="51">176 177 178 179</E>
                        <FTREF/>
                         This was compared to a value of 53.4 percent successful cannulation for sAVF from a study that looked at the effect of age over 65 on clinical outcomes for radiocephalic and brachiocephalic AVF.
                        <SU>180</SU>
                        <FTREF/>
                         For the claim of decreased time to 2NC, the applicant summarized the results from 5 studies, demonstrating a mean time to 2NC for Ellipsys of 100.2 days, 65.5 ± 45.7 days, a range of 10 days to 6 weeks, 4 weeks, and 60 days.
                        <E T="51">181 182 183 184 185</E>
                        <FTREF/>
                         This was compared to a mean of 136 days for sAVFs, taken from the United States Renal Data System.
                        <SU>186</SU>
                        <FTREF/>
                         For the claim of more durable AVFs, the applicant summarized results from 5 studies demonstrating Ellipsys's cumulative patency at 12 months, ranging from 82 percent to 100 percent, and 91.6 percent at 24 months.
                        <E T="51">187 188 189 190</E>
                        <FTREF/>
                         The applicant compared these results to a patency rate of 65 percent for sAVFs found in the USRDS database.
                        <SU>191</SU>
                        <FTREF/>
                         The applicant further stated that preliminary results from the pivotal trial 3 year follow-up reinforce this claim, as they found that the cumulative patency using Ellipsys was 90 percent at 36 months, compared to a historical value of 46 percent for sAVFs. For the claim of decreased secondary interventions (including maturation and maintenance procedures), the applicant summarized outcomes from 3 studies demonstrating 0.96 secondary interventions per patient year in the study by Shahverdyan et al.; 2.63 interventions per year in the pivotal trial; and an average of 0.83 maintenance inventions per patient in the 2 years following creation in the preliminary results of the 3 year follow-up by Hull et al. The applicant stated that a comparable value for sAVFs is 
                        <PRTPAGE P="25250"/>
                        3.41 over 2 years.
                        <SU>192</SU>
                        <FTREF/>
                         Finally, for the claim of patient satisfaction, the applicant cited results of the patient survey performed by Beathard et al., stating that the survey indicated a high level of satisfaction with Ellipsys, with 93 percent rating their access as very good or excellent, and 95 percent rating their lack of pain as very good or excellent. Additionally, patients noted the lack of scar, short recovery time, and ease of use with Ellipsys.
                        <SU>193</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>176</SU>
                             Hull JE, Jennings W, 
                            <E T="03">et al.,</E>
                             “The Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation for Hemodialysis Access,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2018; 29: 149-158.
                        </P>
                        <P>
                            <SU>177</SU>
                             Beathard GA, 
                            <E T="03">et al.,</E>
                             “Two-year cumulative patency of endovascular arteriovenous fistula,” 
                            <E T="03">Journal of Vascular Access</E>
                             2020; 21: 350-356.
                        </P>
                        <P>
                            <SU>178</SU>
                             Hull JE, Deitrick J, Groome K, “Maturation for Hemodialysis in the Ellipsys® EndoAVF Post-Market Registry,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2020; 31(9): 1373-1381. (Published on-line August 13, 2020.)
                        </P>
                        <P>
                            <SU>179</SU>
                             Hebibi H, 
                            <E T="03">et al.,</E>
                             “Clinical hemodialysis experience with percutaneous arteriovenous fistulas created using the Ellipsys® vascular access system,” 
                            <E T="03">Hemodialysis International</E>
                             2019; 23(2): 16 8-172.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>180</SU>
                             Weale A, 
                            <E T="03">et al.,</E>
                             “Radiocephalic and Brachiocephalic Arteriovenous Fistula Outcomes in the Elderly,” 
                            <E T="03">Journal of Vascular Surgery</E>
                             2008; 47(1): 144-150.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>181</SU>
                             Hull JE, Jennings W, 
                            <E T="03">et al.,</E>
                             “The Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation for Hemodialysis Access,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2018; 29: 149-158.
                        </P>
                        <P>
                            <SU>182</SU>
                             Hull JE, Deitrick J, Groome K, “Maturation for Hemodialysis in the Ellipsys® EndoAVF Post-Market Registry,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2020; 31(9): 1373-1381. (Published on-line August 13, 2020.)
                        </P>
                        <P>
                            <SU>183</SU>
                             Hebibi H, 
                            <E T="03">et al.,</E>
                             “Clinical hemodialysis experience with percutaneous arteriovenous fistulas created using the Ellipsys® vascular access system,” 
                            <E T="03">Hemodialysis International</E>
                             2019; 23(2): 168-172.
                        </P>
                        <P>
                            <SU>184</SU>
                             Mallios A, Bourquelot P, Franco G, 
                            <E T="03">et al.,</E>
                             “Mid-term results of percutaneous arteriovenous fistula creation with Ellipsys vascular access system, technical recommendations and an algorithm for maintenance,” 
                            <E T="03">Journal of Vascular Surgery</E>
                             2020; 72(6): 2097-2106. (Published on-line April 7, 2020.)
                        </P>
                        <P>
                            <SU>185</SU>
                             Shahverdyan R, 
                            <E T="03">et al.,</E>
                             “Comparison of Outcomes of Percutaneous Arteriovenous Fistulae Creation by Ellipsys and WavelinQ Devices,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2020; 31(9): 1365-1372. (Published on-line August 11, 2020.)
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>186</SU>
                             United States Renal Data System. 2016 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2016.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>187</SU>
                             Beathard GA, 
                            <E T="03">et al.,</E>
                             “Two-year cumulative patency of endovascular arteriovenous fistula,” 
                            <E T="03">Journal of Vascular Access</E>
                             2020; 21: 350-356.
                        </P>
                        <P>
                            <SU>188</SU>
                             Mallios A, Bourquelot P, Franco G, 
                            <E T="03">et al.,</E>
                             “Mid-term results of percutaneous arteriovenous fistula creation with Ellipsys vascular access system, technical recommendations and an algorithm for maintenance,” 
                            <E T="03">Journal of Vascular Surgery</E>
                             2020; 72(6): 2097-2106. (Published on-line April 7, 2020.)
                        </P>
                        <P>
                            <SU>189</SU>
                             Shahverdyan R, 
                            <E T="03">et al.,</E>
                             “Comparison of Outcomes of Percutaneous Arteriovenous Fistulae Creation by Ellipsys and WavelinQ Devices,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2020; 31(9): 1365-1372. (Published on-line August 11, 2020.)
                        </P>
                        <P>
                            <SU>190</SU>
                             Mallios A, 
                            <E T="03">et al.,</E>
                             “Early cannulation of percutaneously created arteriovenous hemodialysis fistulae,” 
                            <E T="03">Journal of Vascular Access</E>
                             2020; 21(6): 997-1002. (Published on-line December 19, 2019.)
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>191</SU>
                             Al-Jaishi, Ahmed A., et al. “Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis.” 
                            <E T="03">American Journal of Kidney Diseases</E>
                             (2014) 63(3): 464-47.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>192</SU>
                             Lee T, 
                            <E T="03">et al.,</E>
                             “Long-Term Outcomes of Arteriovenous Fistulas with Unassisted versus Assisted Maturation: A Retrospective National Hemodialysis Cohort Study,” 
                            <E T="03">Journal on American Nephrology</E>
                             2019; 30(11):2209-2218.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>193</SU>
                             Beathard GA, 
                            <E T="03">et al.,</E>
                             “Two-year cumulative patency of endovascular arteriovenous fistula,” 
                            <E T="03">Journal of Vascular Access</E>
                             2020; 21: 350-356.
                        </P>
                    </FTNT>
                    <P>We note that only one of the studies submitted by the applicant in support of a finding of substantial clinical improvement for Ellipsys has a comparator arm (retrospective comparison), and none were created with a methodology to demonstrate superiority. In addition, some studies may be limited by potential bias due to single operator and/or single site design, and comparisons to sAVF were made using various historical controls from different studies with no statistical analyses, making it difficult to account for confounding variables. We further note that the studies used physiologic endpoints as a surrogate outcome for fistula maturity instead of a clinically functional fistula as determined by successful 2-needle cannulation. Of interest, a number of the studies submitted concluded that there is a further need for head-to-head, larger scale, or longer trials to confirm claims of superiority of pAVF over surgical AVF and other pAVF devices. We note that the applicant provided one retrospective study with a small sample size to support the claim of superiority of Ellipsys over WavelinQ. Though this study by Shahverdyan et al. demonstrated numerically better outcomes for multiple endpoints with Ellipsys, we note that outcomes did not reach statistical significance for primary patency, technical success, maturation rates, time to cannulation, or fistula success, and we note the potential for bias with the single operator/single site study design.</P>
                    <P>
                        We note that the decreased interventions and time to 2NC using Ellipsys were reported from studies performed outside of the US, where practice patterns are different. Per the Hull et al. study, practice in the US is to direct flow into a single upper arm vein to meet established guidelines for fistula flow diameter depth and length, whereas in the European studies, multiple outflow veins were accepted.
                        <SU>194</SU>
                        <FTREF/>
                         The authors further state that allowing multiple outflow veins decreases the number of secondary maturation procedures used to direct flow, but requires advanced cannulation techniques, ultrasound guidance, and plastic access cannulas that are not available in the US. These techniques and the use of plastic cannulas also allow for early cannulation of the fistula in European studies. For these reasons, we question whether the European results are generalizable to the US population.
                    </P>
                    <FTNT>
                        <P>
                            <SU>194</SU>
                             Hull et al., “Maturation for Hemodialysis in the Ellipsys EndoAVF Post-Market Registry,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2020; 31(9): 1373-1381. (Published on-line August 13, 2020.)
                        </P>
                    </FTNT>
                    <P>When comparing the new protocol for Ellipsys (always performing balloon angioplasty) to the De Novo protocol (sometimes performing balloon angioplasty), Ellipsys demonstrated a reduced number of maturation procedures and faster time to cannulation; however, more maintenance procedures were required than the De Novo protocol. In addition, the investigators did not account for potential confounding variables between the different studies, which could have affected outcomes in order to compare the two studies used to claim superiority. We further note that previously, balloon angioplasty was nearly always performed, whether as part of the index procedure, as a maturation procedure, or as a maintenance procedure, and it continued to be a necessary secondary intervention after adoption of the new procedural step.</P>
                    <P>We are inviting public comments on whether the Ellipsys® Vascular Access System demonstrates improvement over each of the three comparators and meets the substantial clinical improvement criterion.</P>
                    <P>We received public comments in response to the New Technology Town Hall meeting regarding the application of the Ellipsys® Vascular Access System for new technology add-on payments.</P>
                    <P>
                        <E T="03">Comment:</E>
                         The applicant submitted a public comment providing an additional study and addressing questions posed at the town hall meeting. The study provided is a single-center retrospective comparison article in press of Ellipsys and sAVF by Harika et al. 107 patients who received pAVF with Ellipsys at this center between May 2017 and May 2018 were compared to an equal number of consecutive patients who received a surgical fistula in the same time period. Patients with grafts or lower extremity fistulae were excluded and baseline characteristics and demographics were comparable between groups. All pAVFs were created by a single surgeon, while the sAVFs were created by 4 surgeons. Primary outcomes were primary and secondary patency rates, as well as maturation as determined by AVF utilization, or &gt;4mm diameter and &gt;500ml/lt flow for pre-dialysis patients. Secondary outcomes assessed secondary interventions and rate of complications. Per the applicant, at 6 weeks, pAVF maturation rates were higher compared to the sAVF arm (65 percent vs 50 percent, p=0.01). In addition, primary patency in the sAVF group was higher than pAVF at 12 months (86 percent vs 61 percent, p&lt;0.01) but comparable at 24 months (52 percent vs 55 percent, p=0.48), and secondary patency rates were not significantly different between groups at 12 or 24 months. Rates of secondary interventions were divided between percutaneous and surgical interventions. At 2 years, the rate of percutaneous reinterventions was similar but the sAVFs required more surgical revisions (36% vs. 17%). Differences in total interventions between groups did not reach statistical significance at 12 and 24 months. The study authors conclude that pAVF's better aesthetic result, short procedure time, and ability to perform easily in an outpatient office procedure center indicates that Ellipsys has many benefits, but large prospective randomized multicenter studies are needed to confirm the outcomes demonstrated in this study.
                        <SU>195</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>195</SU>
                             Harika G, et al., “Comparison of surgical versus percutaneously created arteriovenous hemodialysis fistulae,” 
                            <E T="03">Journal of Vascular Surgery</E>
                             2020; accepted for publication December 5, 2020, in press.
                        </P>
                    </FTNT>
                    <P>
                        In response to a question regarding the need for a head-to-head comparison between WavelinQ and Ellipsys to determine superiority, the applicant stated that there are no randomized controlled trials available but the study (summarized previously) by Shahverdyan et al. provides a reasonable comparison of the two. Per the applicant, the algorithm to choose which procedure to perform reflected “real-world” choices, and the results demonstrated that Ellipsys offers substantial clinical improvement over WavelinQ. In response to a comment questioning the available 2-year data using the current version of Ellipsys, the applicant stated that the 2-year follow up study (Beathard et al.) of the pivotal trial captured results of patients treated with immediate angioplasty, as that was done in 19 percent of patients even 
                        <PRTPAGE P="25251"/>
                        before the procedural change. The applicant further stated that the current version of Ellipsys differs only by the addition of this procedural step, and studies after the pivotal trial adopted this practice to better results, with this combination of results indicating that the balloon angioplasty step improves outcomes over a multi-year period. In addition, the applicant stated that the Harika et al. study (summarized previously) had a 2-year study period, and all patients had immediate balloon angioplasty. In response to a question regarding the comparability of pAVF in the proximal radial artery with a sAVF in the same location, the applicant stated though they are created differently, they are functionally comparable once mature, and neither typically requires superficialization.
                    </P>
                    <P>
                        Next, in response to a question regarding what the fewer short-term complications using Ellipsys are as compared to sAVF, the applicant stated that these include lower wound morbidity due to minimal incisions, fewer aneurysms, avoidance of vasospasm, and lower incidence of clinically significant steal syndrome. The applicant stated that in sAVF, clinically significant steal syndrome can occur in as many as 11 percent of cases, but it is rare in reports of pAVFs placed with Ellipsys. The applicant summarized information on complications with Ellipsys from the studies previously discussed and stated that (1) Harika et al 
                        <SU>196</SU>
                        <FTREF/>
                         reported that sAVFs had a substantially higher rate of wound healing and infections, as well as more occurrences of steal syndrome and aneurysm; (2) Hull et al's prospective safety and efficacy study 
                        <SU>197</SU>
                        <FTREF/>
                         examined possible complications in detail and most complications did not appear at all; (3) the Ellipsys pivotal trial 
                        <SU>198</SU>
                        <FTREF/>
                         reported no complications due to vessel perforation, dissection, or distal embolization were reported; (4) in the Hull et al. Maturation Study,
                        <SU>199</SU>
                        <FTREF/>
                         several adverse events were reported including one hematoma, one arm swelling, and one case of steal syndrome; and (5) Mallios et al's report on mid-term results 
                        <SU>200</SU>
                        <FTREF/>
                         reported no complications, other than cases treated with balloon angioplasty and one case of arm swelling.
                    </P>
                    <FTNT>
                        <P>
                            <SU>196</SU>
                             Harika G, et al., “Comparison of surgical versus percutaneously created arteriovenous hemodialysis fistulae,” 
                            <E T="03">Journal of Vascular Surgery</E>
                             2020; accepted for publication December 5, 2020, in press.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>197</SU>
                             Hull JE, Elizondo-Riojas G, 
                            <E T="03">et al.,</E>
                             “Thermal resistance anastomosis device for the percutaneous creation of arteriovenous fistulae for hemodialysis,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2017; 28: 380-387.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>198</SU>
                             Hull JE, Jennings W, 
                            <E T="03">et al.,</E>
                             “The Pivotal Multicenter Trial of Ultrasound-Guided Percutaneous Arteriovenous Fistula Creation for Hemodialysis Access,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2018; 29: 149-158.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>199</SU>
                             Hull et al., “Maturation for Hemodialysis in the Ellipsys EndoAVF Post-Market Registry,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2020; 31(9): 1373-1381. (Published on-line August 13, 2020.)
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>200</SU>
                             Mallios et al., “Mid-term results of percutaneous arteriovenous fistula creation with Ellipsys vascular access system, technical recommendations and an algorithm for maintenance,” 
                            <E T="03">Journal of Vascular Surgery</E>
                             2020; 72(6): 2097-2106. (Published on-line April 7, 2020.)
                        </P>
                    </FTNT>
                    <P>The applicant also addressed a final question in its public comment regarding the definition of improved durability. The applicant stated that this is an umbrella term used to reflect the useful life of an AVF for dialysis, and can include different patency measures.</P>
                    <P>
                        <E T="03">Response:</E>
                         We thank the applicant for its comments and will take this information into consideration when deciding whether to approve new technology add-on payments for the Ellipsys® Vascular Access System. With regard to the Harika et al. study provided, we note that prespecified subgroup analyses of pAVF vs elbow fistulae (e-AVF) and pAVF vs wrist fistulae were also compared, with elbow fistula considered to be the most similar comparator to “real world” vascular access practice patterns. When comparing outcomes between e-AVF and p-AVF groups in this study, differences in total interventions, maturation at 6 weeks, and secondary patency rates were not significantly different. e-AVF also demonstrated higher 12 month primary patency (p=0.02). We further note that though the applicant asserted that Ellipsys decreases the need for secondary interventions as compared to sAVF, this study did not demonstrate a statistically significant difference between arms for total interventions at 12 or 24 months, and we are concerned that this may not demonstrate a substantial clinical improvement for Ellipsys over sAVF.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Another public comment was submitted in response to the Town Hall meeting. The commenter stated that during the FY 2022 New Technology Town Hall Meeting, Avenu Medical relied upon a single published study to support claims of substantial clinical improvement for Ellipsys over WavelinQ. Per the commenter, this study indicated that limitations of the review include those of any retrospective analysis on nonrandomized data and possible selection bias.
                        <SU>201</SU>
                        <FTREF/>
                         Per the commenter, the authors of the study concluded that both of the devices had high technical success rates and adequate flow volumes, as well as no significant difference in primary patency, and that the devices may serve different patient populations, since patients can be anatomically eligible for one or the other. The commenter concludes that it is important that both technologies are available as treatment options for Medicare beneficiaries and they believe CMS should consider new technology add-on payments for the two pAVF systems together. They also stated that CMS should designate a new technology add-on payment category for devices used in percutaneous creation of an AVF.
                    </P>
                    <FTNT>
                        <P>
                            <SU>201</SU>
                             Shahverdyan R., et al. “Comparison of Outcomes of Percutaneous Arteriovenous Fistulae Creation by Ellipsys and WavelinQ Devices,” 
                            <E T="03">Journal of Vascular and Interventional Radiology</E>
                             2020; 31(9): 1365-1372. (Published on-line August 11, 2020.)
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Response:</E>
                         We thank the commenter for their input and will take this information into consideration when deciding whether to approve new technology add-on payments for the Ellipsys® Vascular Access System. We note that we are unclear with regard to the commenter's request for a new technology add-on payment category, as the IPPS payment system does not utilize categories, and this request may be referring to another payment system.
                    </P>
                    <HD SOURCE="HD3">
                        g. ENSPRYNG
                        <SU>TM</SU>
                         (satralizumab-mwge)
                    </HD>
                    <P>
                        Genentech, Inc. submitted an application for new technology add-on payments for the ENSPRYNG
                        <SU>TM</SU>
                         (satralizumab-mwge) injection (ENSPRYNG) for FY 2022. According to the applicant, ENSPRYNG is indicated by the FDA for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. ENSPRYNG is the first subcutaneous, first self-administered, and third FDA-approved drug for the treatment of this severe chronic autoimmune disease of the central nervous system.
                        <SU>202</SU>
                        <FTREF/>
                         The applicant states, due to the severity of relapses, relapse prevention is a key disease management priority. Patients who relapse are often admitted to the hospital for acute treatment. According to the applicant, with every relapse, patients are at risk of becoming blind or paralyzed, and thus it is critical to minimize the risk of future relapses by initiating maintenance treatment with a therapy such as ENSPRYNG in a timely manner while the patient is still 
                        <PRTPAGE P="25252"/>
                        admitted. Therefore, according to the applicant, ENSPRYNG should be approved for new technology add-on payments in order to maximize the likelihood that this especially sick patient population can start the treatment they need while in the inpatient setting.
                    </P>
                    <FTNT>
                        <P>
                            <SU>202</SU>
                             ENSPRYNG (satralizumab) [prescribing information]. South San Francisco, CA: Genentech USA, Inc.; 2020. SOLIRIS (eculizumab) [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; 2019. UPLIZNA (inebilizumab) [prescribing information]. Gaithersburg, MD: Viela Bio, Inc.; 2020.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, NMOSD is a rare, inflammatory, potentially life-threatening autoimmune central nervous system (CNS) disorder characterized primarily by severe, unpredictable relapses of optic neuritis and/or acute longitudinally extensive transverse myelitis (LETM).
                        <SU>203</SU>
                        <FTREF/>
                         The applicant asserts that NMOSD has an estimated prevalence of 0.1-10 per 100,000 individuals, affecting nearly 15,000 individuals in the United States.
                        <SU>204</SU>
                        <FTREF/>
                         NMOSD occurs in children 
                        <SU>205</SU>
                        <FTREF/>
                         and adults 
                        <SU>206</SU>
                        <FTREF/>
                         of all races 
                        <SU>207</SU>
                        <FTREF/>
                         and disproportionately affects African and Asian females aged 30 to 40 years.
                        <SU>208</SU>
                        <FTREF/>
                         According to the applicant, the (bilateral) optic neuritis and/or LETM that are characteristic of NMOSD result from inflammation of the optic nerve, spinal cord,
                        <SU>209</SU>
                        <FTREF/>
                         and brainstem,
                        <SU>210</SU>
                        <FTREF/>
                         but other regions of the CNS may be affected as well. The vast majority of patients (80%-90%) experience repeated relapses, and disability accumulates with each relapse.
                        <SU>211</SU>
                        <FTREF/>
                         Around 60% of patients relapse within one year of diagnosis, and 90% relapse within 3 years.
                        <SU>212</SU>
                        <FTREF/>
                         Compared with patients who experience an isolated attack, patients with relapsing disease have greater disease-related clinical burden, and upward of 83% of patients do not fully recover after subsequent relapses.
                        <SU>213</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>203</SU>
                             Jarius S, Ruprecht K, Wildemann B, et al. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: A multicentre study of 175 patients. J. Neuroinflammation 2012;9(1) doi:10.1186/1742-2094-9-14.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>204</SU>
                             Flanagan EP, Cabre P, Weinshenker BG, et al. Epidemiology of Aquaporin-4 Autoimmunity And Neuromyelitis Optica Spectrum. Ann Neurol. 2016;79(5):775-783. doi:10.1002/ana.24617.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>205</SU>
                             Siegel Rare Neuroimmune Association. Neuromyelitis Optica Spectrum Disorder (NMOSD). 
                            <E T="03">https://wearesrna.org/living-with-myelitis/disease-information/neuromyelitis-optica-spectrum-disorder/diagnosis/#nmosd.</E>
                             Accessed August 19, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>206</SU>
                             Etemadifar M, Nasr Z, Khalili B, Taherioun M, Vosoughi R. Epidemiology of Neuromyelitis Optica in the World: A Systematic Review and Meta-analysis. Mult Scler Int. 2015;2015:174720. doi:10.1155/2015/174720.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>207</SU>
                             Simon KC, Schmidt H, Loud S, Ascherio A. Risk Factors For Multiple Sclerosis, Neuromyelitis Optica And Transverse Myelitis. Mult Scler. 2015;21(6):703-709. doi:10.1177/1352458514551780.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>208</SU>
                             Wingerchuk DM, Lennon VA, Lucchinetti CF, et al. The spectrum of neuromyelitis optica. Lancet Neurol. 2007;6(9)805-815. doi:10.1016/s1474-4422(07)70216-8.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>209</SU>
                             Siegel Rare Neuroimmune Association. Neuromyelitis Optica Spectrum Disorder (NMOSD). 
                            <E T="03">https://wearesrna.org/living-with-myelitis/disease-information/neuromyelitis-optica-spectrum-disorder/diagnosis/#nmosd.</E>
                             Accessed August 19, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>210</SU>
                             National Organization for Rare Disorders (NORD®). Neuromyelitis Optica Spectrum Disorder. 
                            <E T="03">https://rarediseases.org/rare-diseases/neuromyelitis-optica/</E>
                            . Accessed August 19, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>211</SU>
                             Wingerchuk DM. Diagnosis and Treatment of Neuromyelitis Optica. Neurologist 2007;13(1)2-11. doi:10.1097/01.nrl.0000250927.21903.f8.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>212</SU>
                             Wingerchuk DM, Lennon VA, Lucchinetti CF, et al. The spectrum of neuromyelitis optica. Lancet Neurol. 2007;6(9)805-815. doi:10.1016/s1474-4422(07)70216-8.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>213</SU>
                             Jarius S, Ruprecht K, Wildemann B, et al. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: A multicentre study of 175 patients. J. Neuroinflammation 2012;9(1) doi:10.1186/1742-2094-9-14.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, the negative impact of NMOSD on patient quality of life (QoL) is predominantly a result of physical disability, pain, vision impairment, and bowel and bladder dysfunction.
                        <SU>214</SU>
                        <FTREF/>
                         Disease-induced disability and symptoms have a considerable impact on patients' ability to work and thrive in social activities and personal relationships.
                        <SU>215</SU>
                        <FTREF/>
                         The applicant added that the loss of motor and sensory function leads to approximately 50% of patients requiring a wheelchair 
                        <SU>216</SU>
                        <FTREF/>
                         and 62% of patients becoming functionally blind 
                        <SU>217</SU>
                        <FTREF/>
                         within 5 years of diagnosis.
                        <SU>218</SU>
                        <FTREF/>
                         Therefore, according to the applicant, it is critical that treatments that consistently and effectively reduce the risk of relapse are initiated rapidly in patients diagnosed with NMOSD.
                    </P>
                    <FTNT>
                        <P>
                            <SU>214</SU>
                             Beekman J, Keisler A, Pedraza O, et al. Neuromyelitis optica spectrum disorder. Neurol.-Neuroimmunol. Neuroinflammation 2019;6(4)e580. doi:10.1212/nxi.0000000000000580.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>215</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>216</SU>
                             Kessler RA, Mealy MA, Levy M. Treatment of Neuromyelitis Optica Spectrum Disorder: Acute, Preventive, and Symptomatic. Curr. Treat. Options Neurol. 2015;18(1) doi:10.1007/s11940-015-0387-9.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>217</SU>
                             Wingerchuk DM, Hogancamp WF, O'Brien PC, et al. The clinical course of neuromyelitis optica (Devic's syndrome). Neurology 2012;53(5)1107-1107. doi:10.1212/wnl.53.5.1107.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>218</SU>
                             Wingerchuk DM, Weinshenker BG. Neuromyelitis optica: Clinical predictors of a relapsing course and survival. Neurology 2012;60(5)848-853. doi:10.1212/01.wnl.0000049912.02954.2c.
                        </P>
                    </FTNT>
                    <P>
                        With respect to the newness criterion, ENSPRYNG received FDA BLA approval on August 14, 2020. The applicant added that ENSPRYNG was granted Fast Track designation 
                        <SU>219</SU>
                        <FTREF/>
                         and Breakthrough Therapy designation 
                        <SU>220</SU>
                        <FTREF/>
                         by the FDA. The applicant stated that ENSPRYNG was not commercially available until August 24, 2020 because the applicant had to wait for final approval for printing and labeling as well as customs and importation. The recommended loading dosage of ENSPRYNG for the first three administrations is 120 mg by subcutaneous injection at Weeks 0, 2, and 4, followed by a maintenance dosage of 120 mg every four weeks. The applicant submitted a request for an ICD-10-PCS code to uniquely identify the administration of ENSPRYNG beginning FY 2022.
                    </P>
                    <FTNT>
                        <P>
                            <SU>219</SU>
                             US Department of Health and Human Services. FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord. 
                            <E T="03">https://www.fda.gov/news-events/press-announcements/fda-approves-treatment-rare-disease-affecting-optic-nerves-spinal-cord</E>
                            . Accessed September 10, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>220</SU>
                             Genentech, USA Inc. FDA Approves Genentech's Enspryng for Neuromyelitis Optica Spectrum Disorder. 
                            <E T="03">https://www.gene.com/media/press-releases/14873/2020-08-14/fda-approves-genentechs-enspryng-for-neu</E>
                            . Accessed September 10, 2020.
                        </P>
                    </FTNT>
                    <P>
                        As discussed earlier, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposed of new technology add-on payments. The applicant stated that there are limited treatment guidelines available for NMOSD with the most recent US guidelines published in 2012. These US NMOSD treatment guidelines exclusively recommend off-label drugs: Azathioprine, with or without prednisone; mycophenolate mofetil, with or without prednisone; rituximab; or prednisone alone.
                        <SU>221</SU>
                        <FTREF/>
                         The applicant stated that there are presently two other FDA-approved therapies for patients with AQP4-IgG positive NMOSD: SOLIRIS (eculizumab),
                        <SU>222</SU>
                        <FTREF/>
                         which was approved in 2019, and UPLIZNA (inebilizumab-cdon), which was approved in 2020.
                        <SU>223</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>221</SU>
                             Kimbrough DJ, Fujihara K, Jacob A, et al. Treatment of Neuromyelitis Optica: Review And Recommendations. Mult Scler Relat Disord. 2012;1(4):180-187. doi:10.1016/j.msard.2012.06.002.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>222</SU>
                             SOLIRIS (eculizumab) [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; 2019.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>223</SU>
                             UPLIZNA (inebilizumab) [prescribing information]. Gaithersburg, MD: Viela Bio, Inc.; 2020.
                        </P>
                    </FTNT>
                    <P>
                        With regard to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, the application stated that ENSPRYNG is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of NMOSD in adult patients who are AQP4-IgG positive.
                        <SU>224</SU>
                        <FTREF/>
                         According to the applicant, ENSPRYNG targets soluble and membrane-bound IL-6 receptors to inhibit IL-6 signaling and subsequently disrupt downstream inflammatory 
                        <PRTPAGE P="25253"/>
                        effects that contribute to the pathophysiology of NMOSD; 
                        <SU>225</SU>
                        <FTREF/>
                         ENSPRYNG dissociates from the IL-6 receptor at an acidic pH within endosomes and is recycled to circulation, prolonging the plasma half-life of the drug.
                        <SU>226</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>224</SU>
                             ENSPRYNG (satralizumab) [prescribing information]. South San Francisco, CA: Genentech USA, Inc.; 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>225</SU>
                             Yamamura T, Kleiter I, Fujihara K, et al. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J. Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>226</SU>
                             Igawa T, Ishii S, Tachibana T, et al. Antibody Recycling By Engineered Ph-Dependent Antigen Binding Improves The Duration of Antigen Neutralization. Nat Biotechnol. 2010;28(11):1203-1207. doi:10.1038/nbt.1691. Heo Y. Satralizumab: First Approval. Drugs 2020;80(14)1477-1482. doi:10.1007/s40265-020-01380-2.
                        </P>
                    </FTNT>
                    <P>
                        The applicant next identified other drugs used to treat NMOSD and their corresponding mechanisms of action. According to the applicant, these current treatments include: SOLIRIS, for which a precise mechanism of action is unknown but is presumed to involve inhibition of AQP4-IgG-induced terminal complement C5b-9 deposition; 
                        <SU>227</SU>
                        <FTREF/>
                         UPLIZNA, for which a precise mechanism of action is unknown but is presumed to involve binding to CD19, a surface antigen present on pre-B and mature B cells; 
                        <SU>228</SU>
                        <FTREF/>
                         azathioprine, for which a precise mechanism of action is unknown; 
                        <SU>229</SU>
                        <FTREF/>
                         Rituxan, which targets CD20 antigen on B cells and leads to profound B cell depletion, principally over an antibody-dependent cell cytotoxicity mechanism; 
                        <SU>230</SU>
                        <FTREF/>
                         mycophenolate mofetil, which is an immunosuppressive and an inhibitor of inosine monophosphate dehydrogenase and therefore of the guanosine nucleotide synthesis pathway upon which T and B cells depend; 
                        <SU>231</SU>
                        <FTREF/>
                         and prednisone, which is a synthetic adrenocortical steroid drug with predominately corticosteroid properties.
                        <SU>232</SU>
                        <FTREF/>
                         The applicant concluded that none of these current drugs are characterized by their binding and blocking of soluble and membrane-bound IL-6 receptors to inhibit IL-6 signaling. Therefore, the applicant believes ENSPRYNG has a unique and distinct mechanism of action.
                    </P>
                    <FTNT>
                        <P>
                            <SU>227</SU>
                             SOLIRIS (eculizumab) [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; 2019.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>228</SU>
                             UPLIZNA (inebilizumab) [prescribing information]. Gaithersburg, MD: Viela Bio, Inc.; 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>229</SU>
                             IMURAN (azathioprine) [prescribing information]. Roswell, GA: Sebela Pharmaceuticals Inc.; 2018.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>230</SU>
                             RITUXAN (rituximab) [prescribing information]. South San Francisco, CA: Genentech, Inc.; 2019.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>231</SU>
                             Allison AC, Eugui EM. Mycophenolate Mofetil And Its Mechanisms of Action. Immunopharmacology 2000;47(2-3)85-118. doi:10.1016/s0162-3109(00)00188-0.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>232</SU>
                             RAYOS (prednisone) [prescribing information]. Lake Forest, IL: Horizon Therapeutics USA, Inc.; 2019.
                        </P>
                    </FTNT>
                    <P>
                        With respect to the second criterion, whether a product is assigned to the same or different MS-DRG, the applicant acknowledged that ENSPRYNG may be assigned to the same MS-DRG when compared to existing technology. Per the applicant, cases representing patients who may be eligible for treatment with ENSPRYNG map to MS-DRGs 058, 059, and 060. With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant stated that the use of ENSPRYNG may not involve the treatment of the same or similar patient population when compared with an existing technology because: (1) Current technologies such as SOLIRIS may be contraindicated in patients with unresolved serious 
                        <E T="03">Neisseria meningitidis</E>
                         infections; and (2) SOLIRIS and UPLIZNA are administered as IV infusions which not all patients may be willing to receive.
                    </P>
                    <P>
                        In summary, the applicant asserts ENSPRYNG meets the newness criterion because it is the only treatment for NMOSD that works specifically by suppressing IL-6 signaling, and because it may not involve the treatment of the same or similar patient population as existing technology. We note that the applicant states that the use of ENSPRYNG may not involve treatment of the same or similar patient population when compared to SOLIRIS with regard to the treatment of patients with unresolved serious 
                        <E T="03">Neisseria meningitidis</E>
                         infection and with regard to the treatment of patients unwilling to receive an IV infusion. However, we question if UPLIZNA may also be a treatment option for patients with meningococcal disease. We further question whether patients who are unwilling to receive an IV infusion would constitute a new patient population for NMOSD. We invite public comment on whether ENSPRYNG involves the treatment of the same or similar patient population when compared to existing technologies.
                    </P>
                    <P>We are inviting public comments on whether ENSPRYNG is substantially similar to other technologies and whether ENSPRYNG meets the newness criterion. With regard to the cost criterion, the applicant provided two cost analyses, with the first being an update of the analysis used in FY 2021 by the applicant for SOLIRIS, which is also indicated for NMOSD, and the second which is specific to ENSPRYNG.</P>
                    <P>Under the first analysis, the applicant searched the FY 2019 MedPAR database for cases reporting ICD-10-CM code G36.0 in the primary and/or admitting position, which resulted in 583 cases. The applicant imputed one case where an MS-DRG had a case volume lower than 11, resulting in 556 cases mapping to 30 MS-DRGs. The applicant stated that it restricted the analysis to MS-DRGs 058, 059, and 060, which accounted for 92.1% of all cases identified. The applicant also excluded cases that were not included in the FY 2021 Proposed Rule Impact File from this analysis, resulting in a final case count of 466 cases mapping to three MS-DRGs. Using a CCR of 0.343 (national other services average CCR), the applicant then removed all charges in the drug cost center, all charges in the blood cost center, and an additional $12,000 of cost for plasma exchange procedural costs for cases with non-zero charges in the blood cost center, for charges for related and prior technologies. The applicant applied an inflation factor of 13.1%, which per the applicant is the outlier charge inflation factor used in the FY 2021 IPPS/LTCH PPS final rule, to update the standardized charges from FY 2019 to FY 2021. We note that the applicant appears to have used the FY 2021 IPPS/LTCH PPS proposed rule inflation factor rather than the 2-year inflation factor from the FY 2021 IPPS/LTCH PPS final rule of 13.2 percent (85 FR 59038), which would have increased the inflated charges. Finally, the applicant added charges for the technology by multiplying the cost of ENSPRYNG, based on an average of 1.22 doses per patient, by the inverse of the national average drug CCR of 0.187 from the FY 2021 IPPS/LTCH PPS final rule (85 FR 58601). The applicant calculated a final inflated average case-weighted standardized charge per case of $150,154, which exceeds the case-weighted threshold of $47,813.</P>
                    <P>
                        For the second analysis, the applicant used the same sample of cases (466) from the first analysis, as identified in the FY 2019 MedPAR database with the ICD-10-CM code G36.0 and with the same sample restrictions. In this analysis, the applicant did not remove charges for related or prior technologies because, per the applicant, ENSPRYNG is anticipated to neither replace plasma exchange nor be used as a monotherapy in all patients. The applicant standardized and inflated the charges, as well as added charges for ENSPRYNG using the same methodology as the first analysis, described previously. The applicant calculated a final inflated 
                        <PRTPAGE P="25254"/>
                        average case-weighted standardized charge per case of $175,021, which exceeded the case-weighted threshold of $47,813. The applicant asserted that ENSPRYNG meets the cost criterion based on these analyses.
                    </P>
                    <P>Based on the information provided by the applicant, it is uncertain to us why the national other services average CCR was used to inflate costs to charges in the first analysis when the applicant indicated that it removed charges from the drugs cost center and blood cost center. We are seeking public comment on whether this or another CCR, such as a CCR for drugs or blood and blood products, would be more appropriate. Furthermore, in the event that a MS-DRG has fewer than 11 cases, the applicant should impute a minimum case number of 11. We are inviting public comments on whether ENSPRYNG meets the cost criterion, including whether the use of another CCR would substantially alter the results of the applicant's analysis.</P>
                    <P>
                        With regard to the substantial clinical improvement criterion, the applicant asserts that ENSPRYNG represents a substantial clinical improvement in the following ways: (1) It significantly improves clinical outcomes relative to services or technologies previously available for the treatment of NMOSD in adult patients who are AQP4-IgG positive; (2) these improvements are not accompanied by serious safety concerns; (3) ENSPRYNG is the only FDA-approved treatment for NMOSD that is subcutaneously administered; 
                        <SU>233</SU>
                        <FTREF/>
                         and (4) the totality of circumstances demonstrates ENSPRYNG, relative to technologies previously available, substantially improves the treatment of Medicare beneficiaries. The applicant submitted two recent studies to support their claims of substantial clinical improvement over existing technologies.
                    </P>
                    <FTNT>
                        <P>
                            <SU>233</SU>
                             ENSPRYNG (satralizumab) [prescribing information]. South San Francisco, CA: Genentech USA, Inc.; 2020.
                        </P>
                    </FTNT>
                    <P>
                        The SAkuraStar (NCT02073279) 
                        <SU>234</SU>
                        <FTREF/>
                         study was a Phase 3, double-blind, placebo-controlled, parallel-group trial at 44 investigational sites in 13 countries to assess the safety and efficacy of ENSPRYNG monotherapy in patients with NMOSD. 95 (57%) of 168 screened participants aged 18-74 years with AQP4-IgG positive or negative NMOSD met the inclusion criteria and were randomly assigned (2:1) to treatment with ENSPRYNG 120mg (n=63) or visually matched placebo (n=32). Inclusion criteria included participants who had experienced at least one documented NMOSD attack or relapse in the previous 12 months and had a score of 6.5 or less on the Expanded Disability Status Scale, while exclusion criteria included clinical relapse 30 days or fewer before baseline. The primary endpoint was time to the first protocol-defined relapse, based on the intention-to-treat (ITT) population (AQP4-IgG positive and negative) (n=95), and analyzed with stratification for two randomization factors (previous therapy for prevention of attacks and nature of the most recent attack). Treatment in both arms was given subcutaneously at weeks 0, 2, 4, and every 4 weeks thereafter. The double-blind phase was due to last until 44 protocol-defined relapses occurred or 1.5 years after random assignment of the last patient enrolled, whichever occurred first. Participants could enter an open-label phase after the occurrence of a protocol-defined relapse or at the end of the double-blind phase. Protocol-defined relapses occurred in 19 (30%) patients receiving satralizumab and 16 (50%) receiving placebo (hazard ratio 0.45, 95% CI 0.23-0.89; p=0.018). 473.9 adverse events per 100 patient-years occurred in the satralizumab group and 495.2 per 100 patient-years in the placebo group. The authors noted that the incidence of serious adverse events and adverse events leading to withdrawal was similar between groups.
                    </P>
                    <FTNT>
                        <P>
                            <SU>234</SU>
                             Traboulsee A, Greenberg BM, Bennett JL, et al. Safety And Efficacy of Satralizumab Monotherapy In Neuromyelitis Optica Spectrum Disorder: A Randomised, Double-Blind, Multicentre, Placebo-Controlled Phase 3 Trial. Lancet Neurol. 2020;19(5):402-412. doi:10.1016/S1474-4422(20)30078-8.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, this study demonstrated that the time to the first relapse was significantly longer in ENSPRYNG-treated patients compared with patients who received a placebo (risk reduction, 55%; hazard ratio, 0.45 (95% CI 0.23, 0.89); p = 0.0184). In the AQP4-IgG positive population, there was a 74% risk reduction and a hazard ratio of 0.26 (95% CI 0.11, 0.63; p = 0.0014). The results in the subgroup of AQP4-IgG negative patients were not statistically significant.
                        <E T="51">235 236</E>
                        <FTREF/>
                         The annualized relapse rate for AQP4-IgG positive patients was 0.1 (95% CI, 0.05-0.2) in the ENSPRYNG group and 0.5 (95% CI, 0.3-0.9) in the placebo group.
                        <SU>237</SU>
                        <FTREF/>
                         The proportion of relapse-free AQP4-IgG positive patients at week 96 was 77% in the ENSPRYNG group and 41% in the placebo group.
                        <SU>238</SU>
                        <FTREF/>
                         According to the applicant, the study concluded that ENSPRYNG monotherapy reduced the rate of NMOSD relapse compared with placebo in the overall trial population and had a favorable safety profile.
                    </P>
                    <FTNT>
                        <P>
                            <SU>235</SU>
                             ENSPRYNG (satralizumab) [prescribing information]. South San Francisco, CA: Genentech USA, Inc.; 2020. Traboulsee A, et al. Efficacy of satralizumab monotherapy in prespecified subgroups of SAkuraStar, a phase 3 study in patients with neuromyelitis optica spectrum disorder. Oral Presentation at: Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum; West Palm Beach, FL, USA; February 27-29, 2020.
                        </P>
                        <P>
                            <SU>236</SU>
                             ENSPRYNG (satralizumab) [prescribing information]. South San Francisco, CA: Genentech USA, Inc.; 2020. Traboulsee A, et al. Efficacy of satralizumab monotherapy in prespecified subgroups of SAkuraStar, a phase 3 study in patients with neuromyelitis optica spectrum disorder. Oral Presentation at: Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum; West Palm Beach, FL, USA; February 27-29, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>237</SU>
                             Traboulsee A, et al. Efficacy of satralizumab monotherapy in prespecified subgroups of SAkuraStar, a phase 3 study in patients with neuromyelitis optica spectrum disorder. Oral Presentation at: Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum; West Palm Beach, FL, USA; February 27-29, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>238</SU>
                             Traboulsee A, Greenberg BM, Bennett JL, et al. Safety And Efficacy of Satralizumab Monotherapy In Neuromyelitis Optica Spectrum Disorder: A Randomised, Double-Blind, Multicentre, Placebo-Controlled Phase 3 Trial. Lancet Neurol. 2020;19(5):402-412. doi:10.1016/S1474-4422(20)30078-8.
                        </P>
                    </FTNT>
                    <P>
                        In the second Phase 3, randomized, double-blind, placebo controlled study submitted by the applicant, the SAkuraSky (NCT02028884) 
                        <SU>239</SU>
                        <FTREF/>
                         trial, 83 patients with NMOSD who were seropositive or seronegative for AQP4-IgG were randomly assigned (1:1) to receive either 120 mg of satralizumab (n=41) or placebo (n=42) administered subcutaneously at weeks 0, 2, and 4 and every 4 weeks thereafter, in addition to stable IST. The primary end point was the first protocol-defined relapse in a time-to-event analysis. Key secondary end points were the change from baseline to week 24 in the visual-analogue scale (VAS) pain score (range, 0 to 100, with higher scores indicating more pain) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score (range, 0 to 52, with lower scores indicating more fatigue). Safety was also assessed.
                    </P>
                    <FTNT>
                        <P>
                            <SU>239</SU>
                             US Department of Health and Human Services. Active Study | Neuromyelitis Optica Spectrum Disorder. 
                            <E T="03">https://clinicaltrials.gov/ct2/results?cond=&amp;term=NCT02028884&amp;cntry=&amp;state=&amp;city=&amp;dist=</E>
                            . Accessed August 14, 2020.
                        </P>
                    </FTNT>
                    <P>
                        The results of the SAkuraSky trial demonstrated that the median treatment duration with satralizumab in the double-blind period was 107.4 weeks. Relapse occurred in 8 patients (20%) receiving satralizumab and in 18 (43%) receiving placebo (hazard ratio, 0.38; 95% confidence interval [CI], 0.16 to 0.88). Multiple imputations for censored data (including patients who discontinued the trial, received rescue therapy, had a change in baseline treatment, or were continuing in the 
                        <PRTPAGE P="25255"/>
                        trial at the data-cutoff date) resulted in hazard ratios ranging from 0.34 to 0.44 (with corresponding P values of 0.01 to 0.04). Among the 55 AQP4-IgG-seropositive patients, relapse occurred in 11% of those in the satralizumab group and in 43% of those in the placebo group (hazard ratio, 0.21; 95% CI, 0.06 to 0.75); among 28 AQP4-IgG-seronegative patients, relapse occurred in 36% and 43%, respectively (hazard ratio, 0.66; 95% CI, 0.20 to 2.24). The between-group difference in the change in the mean VAS pain score was 4.08 (95% CI, −8.44 to 16.61); the between-group difference in the change in the mean FACIT-F score was −3.10 (95% CI, −8.38 to 2.18). The rates of serious adverse events and infections did not differ between groups.
                    </P>
                    <P>
                        In support of the applicant's claim that ENSPRYNG significantly improves clinical outcomes relative to services or technologies previously available for the treatment of NMOSD in adult patients who are AQP4-IgG positive, the applicant stated that patients treated with ENSPRYNG plus IST exhibited a significantly longer time to first relapse when compared to placebo. This also included a risk reduction of 62% in patients treated with ENSPRYNG plus IST when compared with patients who received a placebo plus IST and a 79% risk reduction in the AQP4-IgG positive population. Results in the AQP4-IgG negative patient subgroup were not statistically significant.
                        <SU>240</SU>
                        <FTREF/>
                         The proportion of relapse free AQP4-IgG positive patients at week 96 was 92% in ENSPRYNG plus IST group and 53% in the placebo plus IST group.
                        <SU>241</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>240</SU>
                             ENSPRYNG (satralizumab) [prescribing information]. South San Francisco, CA: Genentech USA, Inc.; 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>241</SU>
                             Yamamura T, Kleiter I, Fujihara K, et al. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J. Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant's second claim, substantial improvements in clinical efficacy are not accompanied by serious concerns. In the SAkuraSky trial, 90% of patients in the ENSPRYNG plus IST group had at least one adverse event compared to 95% in the placebo plus IST group.
                        <SU>242</SU>
                        <FTREF/>
                         The safety profile of ENSPRYNG in the OST period was consistent with the double-blind period. There were no deaths or anaphylactic reactions, rates of AEs and serious AEs did not increase with longer exposure to ENSPRYNG; and the most frequently reported AEs in the OST period were consistent with the double-blind period.
                        <SU>243</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>242</SU>
                             Yamamura T, Kleiter I, Fujihara K, et al. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J. Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>243</SU>
                             Greenberg B, Seze JD, Fox E. et al. Safety of satralizumab in neuromyelitis optica spectrum disorder (NMOSD): Results from the open-label extension periods of SAkuraSky and SAkuraStar Presentation at: Americas Committee for treatment and research in Multiple Sclerosis (ACTRIMS); September 2020; Virtual.
                        </P>
                    </FTNT>
                    <P>
                        The applicant's third claim concerns the flexibility provided to patients by the option to self-administer ENSPRYNG. According to the applicant, ENSPRYNG is the only FDA-approved treatment for NMOSD that is administered subcutaneously.
                        <SU>244</SU>
                        <FTREF/>
                         Once treatment is initiated during inpatient hospital admission, upon discharge and having received adequate training on how to perform the injection, an adult patient/caregiver may administer all subsequent doses of ENSPRYNG at home if the treating physician determines that it is appropriate and the adult patient/caregiver can perform the injection technique. According to the applicant, self-administration provides the patient the option to continue the therapy initiated in the hospital while in the convenience of their own home, with reduced disruption to daily life. The applicant states that additionally, the option to self-administer provides flexibility to patients, as they can bring their medication with them while traveling without having to worry if there is an infusion site nearby. The applicant claims this may potentially reduce the rate of hospital readmissions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>244</SU>
                             ENSPRYNG (satralizumab) [prescribing information]. South San Francisco, CA: Genentech USA, Inc.; 2020.
                        </P>
                    </FTNT>
                    <P>
                        In their fourth claim, the applicant states the totality of circumstances otherwise demonstrate that ENSPRYNG, relative to technologies previously available, substantially improves the treatment of Medicare beneficiaries. The applicant asserts that a cross trial comparison between ENSPRYNG and SOLIRIS (approved for new technology add-on payment in FY 2021) cannot be made due to differences in trial design and study population. However, the applicant noted the following distinctions between ENSPRYNG and SOLIRIS and their clinical trials. Per the applicant, the first distinction is that in the registrational study for SOLIRIS, a higher proportion of patients receiving SOLIRIS than those receiving a placebo discontinued their participation in the clinical trial (17% vs 6%).
                        <SU>245</SU>
                        <FTREF/>
                         During the double-blind period of SAkuraSky trial, however, a total of three patients (7%) in the ENSPRYNG group and 10 patients (24%) in the placebo group discontinued the trial agent.
                        <SU>246</SU>
                        <FTREF/>
                         The applicant states that discontinuation of SOLIRIS may be associated with relapse and hospitalization. The second distinction made by the applicant is that the prescribing information for ENSPRYNG 
                        <SU>247</SU>
                        <FTREF/>
                         does not bear a black-box warning, in contrast to that of SOLIRIS.
                        <SU>248</SU>
                        <FTREF/>
                         The third distinction is that patients must be vaccinated against 
                        <E T="03">Neisseria meningitidis</E>
                         before receiving SOLIRIS 
                        <SU>249</SU>
                        <FTREF/>
                         and no such requirement applies to ENSPRYNG.
                        <SU>250</SU>
                        <FTREF/>
                         The fourth and final distinction made by the applicant highlights duration of treatment. In the SAkuraSky trial, the mean period of treatment in the double-blind period was 94.1±72.6 weeks in the ENSPRYNG group and 66.0±61.4 weeks in the placebo group.
                        <SU>251</SU>
                        <FTREF/>
                         However, the median trial durations were shorter in the SOLIRIS trial, at 90.93 and 43.14 weeks (minimum-maximum, 6.4-211.1 and 8.0-208.6) for the SOLIRIS and placebo groups, respectively.
                        <SU>252</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>245</SU>
                             Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. N. Engl. J. Med. 2019;381(7)614-625. doi:10.1056/nejmoa1900866.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>246</SU>
                             Yamamura T, Kleiter I, Fujihara K, et al. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J. Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>247</SU>
                             ENSPRYNG (satralizumab) [prescribing information]. South San Francisco, CA: Genentech USA, Inc.; 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>248</SU>
                             SOLIRIS (eculizumab) [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; 2019.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>249</SU>
                             SOLIRIS (eculizumab) [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; 2019.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>250</SU>
                             ENSPRYNG (satralizumab) [prescribing information]. South San Francisco, CA: Genentech USA, Inc.; 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>251</SU>
                             Yamamura T, Kleiter I, Fujihara K, et al. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J. Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>252</SU>
                             Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. N. Engl. J. Med. 2019;381(7)614-625. doi:10.1056/nejmoa1900866.
                        </P>
                    </FTNT>
                    <P>
                        In connection with the applicant's fourth claim to support substantial clinical improvement, the applicant stated that both the SAkuraStar 
                        <SU>253</SU>
                        <FTREF/>
                         and SAkuraSky 
                        <SU>254</SU>
                        <FTREF/>
                         clinical trials included comparator arms. In SAkuraStar, an exclusion criterion was IST use, whereas in SAkuraSky, patients were permitted to continue baseline treatment with a stable dose of the IST agents in addition to the trial drug. This allowed the efficacy of ENSPRYNG to be assessed both in patients who were 
                        <PRTPAGE P="25256"/>
                        receiving one of the IST agents for their NMOSD and in the others who were receiving nothing at all. The applicant stated that in contrast, SOLIRIS was tested only in a single Phase 3 clinical trial where the primary end point was the first adjudicated relapse in the population of patients taking stable-dose IST and either SOLIRIS or placebo; the efficacy of SOLIRIS monotherapy was a sub analysis,
                        <SU>255</SU>
                        <FTREF/>
                         and UPLIZNA was tested only in a single Phase 3 clinical trial as a monotherapy with only a 28-week randomized, controlled period.
                        <SU>256</SU>
                        <FTREF/>
                         According to the applicant, ENSPRYNG has received approval by regulatory authorities in Japan,
                        <SU>257</SU>
                        <FTREF/>
                         Canada, and Switzerland 
                        <SU>258</SU>
                        <FTREF/>
                         for the treatment of both adults and adolescents (12-17 years of age) with NMOSD. The applicant asserts that patients in the ENSPRYNG clinical trials likely are representative of Medicare patients despite their mean ages (45.3 years for the ENSPRYNG arm of SAkuraStar 
                        <SU>259</SU>
                        <FTREF/>
                         and 40.8 years for the ENSPRYNG arm of SAkuraSky 
                        <SU>260</SU>
                        <FTREF/>
                        ) being less than 65, as NMOSD is so severe that patients may qualify for disability accompanied by Medicare benefits regardless of their age.
                        <SU>261</SU>
                        <FTREF/>
                         The applicant explained that a severe onset attack causing increased disability is reported to occur in 45% of patients with NMOSD 
                        <SU>262</SU>
                        <FTREF/>
                         and that 52.4% of US-based NMOSD patients report severe problems with mobility,
                        <SU>263</SU>
                        <FTREF/>
                         which is consistent with definitions of disability used by the Social Security Administration (SSA).
                        <SU>264</SU>
                        <FTREF/>
                         Per the applicant, SSA maintains a list of impairments considered severe enough to prevent gainful activity. Though NMOSD is not listed, multiple sclerosis (MS) is,
                        <SU>265</SU>
                        <FTREF/>
                         and the two conditions are frequently confused due to similarities between clinical presentations.
                        <SU>266</SU>
                        <FTREF/>
                         According to the applicant, the SSA is open to allowing people to qualify for disability by showing their condition is as severe as one that is on the list.
                        <SU>267</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>253</SU>
                             Traboulsee A, Greenberg BM, Bennett JL, et al. Safety And Efficacy of Satralizumab Monotherapy In Neuromyelitis Optica Spectrum Disorder: A Randomised, Double-Blind, Multicentre, Placebo-Controlled Phase 3 Trial. Lancet Neurol. 2020;19(5):402-412. doi:10.1016/S1474-4422(20)30078-8.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>254</SU>
                             Yamamura T, Kleiter I, Fujihara K, et al. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J. Med. 2019; 381(22)2114-2124. doi:10.1056/nejmoa1901747.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>255</SU>
                             Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. N. Engl. J. Med. 2019;381(7)614-625. doi:10.1056/nejmoa1900866.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>256</SU>
                             Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet 2019;394(10206)1352-1363. doi:10.1016/s0140-6736(19)31817-3.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>257</SU>
                             F. Hoffmann-La Roche Ltd. Roche's ENSPRYNG (satralizumab) Approved In Japan For Adults And Children With Neuromyelitis Optica Spectrum Disorder. 
                            <E T="03">https://www.roche.com/media/releases/med-cor-2020-06-29.htm</E>
                            . Accessed August 14, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>258</SU>
                             Heo Y. Satralizumab: First Approval. Drugs 2020;80(14)1477-1482. doi:10.1007/s40265-020-01380-2.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>259</SU>
                             Traboulsee A, Greenberg BM, Bennett JL, et al. Safety And Efficacy of Satralizumab Monotherapy In Neuromyelitis Optica Spectrum Disorder: A Randomised, Double-Blind, Multicentre, Placebo-Controlled Phase 3 Trial. Lancet Neurol. 2020;19(5):402-412. doi:10.1016/S1474-4422(20)30078-8.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>260</SU>
                             Yamamura T, Kleiter I, Fujihara K, et al. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. N. Engl. J. Med. 2019;381(22)2114-2124. doi:10.1056/nejmoa1901747.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>261</SU>
                             Social Security Administration. Medicare Information. 
                            <E T="03">https://www.ssa.gov/disabilityresearch/wi/medicare.htm</E>
                            . Accessed September 10, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>262</SU>
                             Kim S, Mealy MA, Levy M, et al. Racial differences in neuromyelitis optica spectrum disorder. Neurology 2018;91(22)e2089-e2099. doi:10.1212/wnl.0000000000006574.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>263</SU>
                             Mealy MA, Boscoe A, Caro J, et al. Assessment of Patients with Neuromyelitis Optica Spectrum Disorder Using the EQ-5D. Int. J. MS Care 2018; 21(3)129-134. doi:10.7224/1537-2073.2017-076.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>264</SU>
                             Social Security Administration. How You Qualify. 
                            <E T="03">https://www.ssa.gov/benefits/disability/qualify.html</E>
                            . Accessed October 2, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>265</SU>
                             Social Security Administration. Disability Evaluation Under Social Security. 
                            <E T="03">https://www.ssa.gov/disability/professionals/bluebook/11.00-Neurological-Adult.htm#11_09</E>
                            . Accessed September 10, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>266</SU>
                             Etemadifar M, Nasr Z, Khalili B, Taherioun M, Vosoughi R. Epidemiology of Neuromyelitis Optica In The World: A Systematic Review And Meta-Analysis. Mult Scler Int. 2015;2015:174720. doi:10.1155/2015/174720.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>267</SU>
                             Social Security Administration. How You Qualify. 
                            <E T="03">https://www.ssa.gov/benefits/disability/qualify.html</E>
                            . Accessed October 2, 2020.
                        </P>
                    </FTNT>
                    <P>After reviewing the information submitted by the applicant as part of its FY 2022 new technology add-on payment application for ENSPRYNG, we note that while the applicant provided data comparing ENSPRYNG to placebo with or without IST, the applicant did not provide data to demonstrate improved outcomes over existing FDA approved treatments for NMOSD. While the applicant states reasons why a comparison could not be made, additional information would help inform our assessment of whether ENSPRYNG demonstrates a significant clinical improvement over existing technologies for outcomes such as time to first relapse and annual relapse rate. In addition, while we understand that there may be potential benefits related to the self-administrative delivery of ENSPRYNG, we question if the benefits are related only to the outpatient administration of the medication and whether they would demonstrate improved clinical outcomes that represent a substantial clinical improvement in the inpatient setting. We are inviting public comments on whether ENSPRYNG meets the substantial clinical improvement criterion.</P>
                    <P>
                        We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for ENSPRYNG.
                    </P>
                    <HD SOURCE="HD3">h. ABECMA® (idecabtagene vicleucel)</HD>
                    <P>Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb (BMS), submitted an application for new technology add-on payment for idecabtagene vicleucel for FY 2022. Idecabtagene viclecuel is a, B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell immunotherapy for the treatment of adult patients with relapsed or refractory (RR) multiple myeloma (MM) (RRMM) who have received at least four prior therapies including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody (for example, triple-class-exposed). Idecabtagene vicleucel is expected to be a 5th line plus (5L+) treatment.</P>
                    <P>Multiple myeloma (MM) is typically characterized by the neoplastic proliferation of plasma cells producing a monoclonal immunoglobulin. The plasma cells proliferate in the bone marrow and can result in extensive skeletal destruction with osteolytic lesions, osteopenia, and/or pathologic fractures. The diagnosis of MM is often suspected because of one (or more) of the following clinical presentations:</P>
                    <FP SOURCE="FP-1">• Bone pain with lytic lesions discovered on routine skeletal films or other imaging modalities</FP>
                    <FP SOURCE="FP-1">• An increased total serum protein concentration and/or the presence of a monoclonal protein in the urine or serum</FP>
                    <FP SOURCE="FP-1">• Systemic signs or symptoms suggestive of malignancy, such as unexplained anemia</FP>
                    <FP SOURCE="FP-1">• Hypercalcemia, which is either symptomatic or discovered incidentally</FP>
                    <FP SOURCE="FP-1">• Acute renal failure with a bland urinalysis or rarely nephrotic syndrome due to concurrent immunoglobulin light chain (AL) amyloidosis</FP>
                    <P>
                        It is important to distinguish MM both from other causes of these clinical presentations and from other plasma cell dyscrasias for the purposes of prognosis and treatment.
                        <SU>268</SU>
                        <FTREF/>
                         Data from the U.S. Surveillance, Epidemiology, and End Results (SEER) registry estimate 32,000 new cases of MM and 
                        <PRTPAGE P="25257"/>
                        13,000 deaths from MM annually in the U.S. This correlates with an annual incidence of approximately 7 per 100,000 men and women per year. MM is largely a disease of older adults. The median age at diagnosis is 65 to 74 years. MM is also slightly more frequent in men than in women (approximately 1.4:1). MM is associated with substantial morbidity and mortality 
                        <SU>269</SU>
                        <FTREF/>
                         and approximately 25% of patients have a median survival of 2 years or less.
                        <SU>270</SU>
                        <FTREF/>
                         With respect to the newness criterion, idecabtagene vicleucel received FDA approval on March 26, 2021, and has marketing authorization under the name of Abecma® and is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. A single dose of idecabtagene vicleucel contains a cell suspension of 300 to 460 × 106 CAR T-cells.
                    </P>
                    <FTNT>
                        <P>
                            <SU>268</SU>
                             Laubauch, J.P. (2021). Multiple myeloma: Clinical features, laboratory manifestations, and diagnosis. UptoDate. Available from 
                            <E T="03">https://www.uptodate.com/contents/multiple-myeloma-clinical-features-laboratory-manifestations-and-diagnosis?search=multiple%20myeloma&amp;;source=search_result&amp;selectedTitle=1~150&amp;usage_type=default&amp;display_rank=1.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>269</SU>
                             R?owan AJ, Allen C, Barac A, et al. Global Burden of Multiple Myeloma: A Systematic Analysis for the Global Burden of Disease Study 2016. JAMA Oncol. 2018;4(9):1221-1227. doi:10.1001/jamaoncol.2018.2128.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>270</SU>
                             Biran, N., Jagannath, S., Risk Stratification in Multiple Myeloma, Part 1: Characterization of High-Risk Disease 2013. Clinical Adv in Hematology &amp; Oncology 11(8); 489-503.
                        </P>
                    </FTNT>
                    <P>The applicant submitted a request for unique ICD-10-PCS codes that describe the administration of idecabtagene vicleducel at the September 2020 Coordination and Maintenance Committee meeting. The following codes were approved to describe procedures involving the administration of idecabtagene vicleucel: XW033L7 (Introduction of idecabtagene vicleucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7) and XW043L7 (Introduction of idecabtagene vicleucel immunotherapy into central vein, percutaneous approach, new technology group 7). These codes will be effective starting October 1, 2021.</P>
                    <P>As previously stated, if a technology meets all three of the substantial similarity criteria as previously described, it would be considered substantially similar to an existing technology and therefore would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>With respect to whether a product uses the same or a similar mechanism of action when compared to an existing technology to achieve a therapeutic outcome, the applicant asserts that idecabtagene viceleucel does not use the same or similar mechanism of action as other therapies approved to treat 4L+ RRMM or CAR T-cell therapies approved to treat different diseases. According to the applicant, with regard to its mechanism of action, idecabtagene viceleucel is a chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The CAR construct includes an anti-BCMA scFv-targeting domain for antigen specificity, a transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain. Antigen-specific activation of idecabtagene viceleucel results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.</P>
                    <P>According to the applicant, with respect to the non-CAR T-cell therapies to treat 4L+ RRMM, specifically Xpovio®, Blenrep, and chemotherapy, idecabtagene vicleucel's mechanism of action is different because it is a CAR T-cell therapy. The applicant states that the mechanism of action for Xpovio® is reversible inhibition of nuclear export of tumor suppressor proteins (TSPs), growth regulators, and mRNAs of oncogenic proteins by blocking exportin 1 (XPO1). XPO1 inhibition by Xpovio® leads to accumulation of TSPs in the nucleus, reductions in several oncoproteins, such as c-myc (a “master regulator” which controls many aspects of cellular growth regulation and cellular metabolism) and cyclin D1, cell cycle arrest, and apoptosis of cancer cells. The applicant states that Blenrep's mechanism of action is cell destruction via microtubule inhibition, where the microtubule inhibitor is conjugated to a BCMA-specific antibody (antibody-drug conjugate). The applicant further states that the mechanism of action for chemotherapy regimens generally is disruption of normal processes required for cell survival, such as deoxyribonucleic acid (DNA) replication and protein synthesis or degradation.</P>
                    <P>With respect to the mechanism of action of other currently FDA approved CAR T-cell therapies, according to the applicant, there are no other FDA approved CAR T-cell therapies that are indicated for treatment of RRMM with the same or similar mechanism of action as idecabtagene vicleucel. The applicant stated that CAR T-cell therapies employ a unique mechanism of action which modifies the patient's own T-cell to express a chimeric antigen receptor (CAR) that programs T-cells to destroy cells that express a specific target. In the case of idecabtagene vicleucel, this target is BCMA, which is a protein that is highly expressed on the surface of MM cells making it an ideal target for the treatment of MM. The applicant asserts that the key feature that distinguishes idecabtagene vicleucel from CD-19 directed CAR T-cell therapies is the BCMA targeting domain. According to the applicant, idecabtagene vicleucel's BCMA targeting domain means that idecabtagene vicleucel has a completely different mechanism of action from other currently FDA approved CAR T-cell therapies. In its application, the applicant asserted that since there are currently no FDA approved anti-BCMA CAR T-cell therapies, if approved, idecabtagene vicleucel is the first CAR T-cell therapy approved for the treatment of RRMM and the only approved CAR T-cell therapy with a BCMA targeting domain which makes it unique as compared to other currently approved FDA therapies used to treat RRMM.</P>
                    <P>With regard to whether a product is assigned to the same DRG when compared to an existing technology, the applicant stated that it expects that cases involving the administration idecabtagene vicleucel will be assigned to the same MS-DRG, MS-DRG 018 (Chimeric Antigen Receptor (CAR) T-cell Immunotherapy), as other CAR T-cell therapies.</P>
                    <P>With regard to whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population when compared to an existing technology, the applicant asserted that, if FDA approved, idecabtagene vicleucel will be the first and only anti-BCMA CAR T-cell therapy available to treat RRMM. The applicant further asserted that idecabtagene vicleucel would be indicated for a broader population than other currently FDA-approved available therapies, specifically multiple myeloma patients having received four prior therapies.</P>
                    <P>
                        In summary, according to the applicant, because idecabtagene vicleucel has a unique mechanism of action when compared to other currently FDA approved treatments for RRMM, and does not involve the treatment of the same or similar type of disease (RRMM) or the same or similar patient population (triple-class-exposed adult patients with RRMM), the technology is not substantially similar to an existing technology and therefore meets the newness criterion. However, we question whether idecabtagnene vicleucel's mechanism of action may be similar to that of ciltacabtagene autoleucel, another CAR T-cell therapy for which an application for new technology add-on payments was 
                        <PRTPAGE P="25258"/>
                        submitted for FY 2022 as discussed previously. Both idecabtagene vicleucel and ciltacabtagene autoleucel seem to be intended for similar patient populations; multiple myeloma patients with three or more prior therapies, and would involve the treatment of the same conditions; adult patients with relapsed or refractory multiple myeloma. We are interested in information on how these two technologies may differ from each other with respect to the substantial similarity criteria and newness criterion, to inform our analysis of whether idecabtagene vicleucel and ciltacabtagne autoleucel, if approved by July 1, 2021, are substantially similar to each other and therefore should be considered as a single application for purposes of new technology add-on payments.
                    </P>
                    <P>We are inviting public comments on whether idecabtagene vicleucel is substantially similar to an existing technology and whether it meets the newness criterion.</P>
                    <P>With regard to the cost criterion, the applicant searched the FY 2019 MedPAR correction notice (December 1, 2020) file to identify potential cases representing patients who may be eligible for treatment using idecabtagene vicleucel. In its analysis, the applicant identified a primary cohort to assess whether this therapy met the cost criterion. The following ICD-10-CM diagnosis codes were used to identify claims involving multiple myeloma procedures.</P>
                    <GPH SPAN="3" DEEP="44">
                        <GID>EP10MY21.153</GID>
                    </GPH>
                    <P>The applicant chose to limit its analysis to MS-DRG 016 (Autologous Bone Marrow Transplant W CC/MCC or T-Cell Immunotherapy, MS-DRG 840 (Lymphoma &amp; Non-Acute Leukemia W MCC) and MS-DRG 841 (Lymphoma &amp; Non-Acute Leukemia W CC). The claim search conducted by the applicant resulted in 1,955 claims mapped to MS-DRG 016, MS-DRG 840 and MS-DRG 841 using the FY 2019 MedPAR. The applicant determined an average unstandardized case weighted charge per case of $1,237,393. The applicant used the MS-DRG-018 New Technology Threshold for FY 2022 from the FY 2021 IPPS/LTCH PPS final rule.</P>
                    <P>The applicant removed all charges in the drug cost center for the prior technology because, according to the applicant, it is not possible to differentiate between different drugs on inpatient claims. The applicant added that this is likely an overestimate of the charges that would be replaced by the use of idecabtagene vicleucel. The applicant then standardized the charges using the FY 2019 final rule impact file. Next, the applicant applied the 2-year inflation factor used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier threshold charges (1.13218). To calculate the charges for the new technology, the applicant used a national average CCR for the CAR T-cell therapies of 0.295. To determine this alternative CCR for CAR T-cell therapies, the applicant referred to the FY 2021 IPPS/LTCH PPS final rule AOR/BOR file and calculated an alternative markup percentage by dividing the AOR drug charges within DRG 018 by the number of cases to determine a per case drug charge. The applicant then divided the drug charges per case by $373,000, the acquisition cost of YESCARTA and KYMRIAH. The applicant calculated a final inflated average case-weighted standardized charge per case of $1,329,540, which exceeded the average case-weighted threshold amount of $1,251,127 by $78,413. The applicant stated that because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount, the therapy meets the cost criterion.</P>
                    <P>As noted in previous discussions, the submitted costs for CAR T-cell therapies vary widely due to differences in provider billing and charging practices for this therapy. Therefore, with regard to the use of this data for purposes of calculating a CAR T-cell CCR, we are uncertain how representative this data is for use in the applicant's cost analyses given the potential for variability.</P>
                    <P>We continue to be interested in public comments regarding the eligibility of CAR T-cell technologies for new technology add-on payments when assigned to MS-DRG 018. As we have noted in prior rulemaking with regard to the CAR T-cell therapies (83 FR 41172 and 85 FR 58603 through 58608), if a new MS-DRG were to be created, then consistent with section 1886(d)(5)(K)(ix) of the Act, there may no longer be a need for a new technology add-on payment under section 1886(d)(5)(K)(ii)(III) of the Act.</P>
                    <P>We invite public comment on whether idecabtagene vicleucel meets the cost criterion.</P>
                    <P>With regard to the substantial clinical improvement criterion, the applicant asserted that it believes that idecabtagene vicelucel represents a substantial clinical improvement over existing technologies because: (1) The totality of the circumstances regarding idecabtagene vicleucel's clinical efficacy, safety, and data make clear that idecabtagene vicleucel substantially improves, relative to services or technologies currently available, the treatment of Medicare beneficiaries with RRMM; (2) idecabtagene vicleucel has superior effectiveness compared to existing therapies; (3) idecabtagene vicleucel fills an unmet need as demonstrated by the patient population in its registrational study, which is reflective of real-world RRMM patients and (4) idecabtagene vicleucel improves quality of life for patients with RRMM.</P>
                    <P>
                        In support of its assertion that the totality of the circumstances regarding idecabtagene vicleucel's clinical efficacy, safety, and data make clear that idecabtagene vicleucel substantially improves, relative to services or technologies currently available, the treatment of Medicare beneficiaries with RRMM, the applicant cited results from the KarMMA study, a single-arm, open-label, phase 2 trial of idecabtagene vicleucel. The primary outcome measure for the KarMMA study was overall response rate (ORR). Secondary endpoints were; complete response rate (CRR) (key secondary; null hypothesis ≤10%), safety, duration of response (DOR), progression-free survival (PFS), overall survival (OS), pharmacokinetics (PK), minimum residual disease (MRD), quality of life (QOL) and health economics and outcomes research (HEOR). The study enrolled 140 patients and 128 received treatment. Patients were treated at target dose between 150 and 450 x 10 
                        <SU>6</SU>
                         CAR T-cells. Treated patients had received three or more prior lines of therapy including an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody. All patients were refractory to the last regimen (94% were refractory to anti-CD38 and 84% were 
                        <PRTPAGE P="25259"/>
                        refractory to triple therapy). Efficacy results showed an ORR of 50% for patients (n=4) receiving the target idecabtagene vicleucel dose of 150 x10
                        <SU>6</SU>
                        ; 68.6% for patients (n=70) receiving the target dose of 300 x10
                        <SU>6</SU>
                        ; 81.5% for patients (n=54) receiving the target dose of 450 x 10
                        <SU>6</SU>
                        . The overall ORR for all patients (n=128) who received idecabtagene vicleucel was 73.4%.
                    </P>
                    <P>
                        The applicant asserts that in the KarMMA study, patients who received idecabtagene vicleucel achieved numerically superior response rates, duration of response, and overall survival compared with outcomes seen for alternative therapies (belantamab-mafodotin and selinexor) in other trials.
                        <E T="51">271 272 273 274 275 276</E>
                        <FTREF/>
                         Response rates, according to the applicant, were also high even in patients refractory to five therapies (defined as 2 IMiD agents, 2 PIs, and 1 anti-CD38 antibody), reflecting the novel mechanism of action, according to the applicant. The applicant asserts that compared with anti-CD-19 CAR T-cell therapies, the adverse event profile revealed low rates of grade 3+ CRS (5%) and neurotoxicity (NT) (3%).
                        <SU>277</SU>
                        <FTREF/>
                         According to the applicant, these safety results confirm that idecabtagene vicleucel has the potential to offer a meaningful benefit to Medicare beneficiaries. The applicant also asserts that idecabtagene vicluecel has been demonstrated to be effective and with a manageable safety profile for patients with a high-unmet need (older age, aggressive disease). The applicant asserts that the results from the pivotal KarMMa study confirm the clinical benefit of idecabtagene vicleucel in a heavily pre-treated RRMM patient population.
                    </P>
                    <FTNT>
                        <P>
                            <SU>271</SU>
                             Munshi NC, Anderson, Jr LD, Shah N, et al. Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T-cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): Initial KarMMa results. J Clin Oncol. 2020;38(15_suppl):8503-8503. doi:10.1200/JCO.2020.38.15_suppl.8503.
                        </P>
                        <P>
                            <SU>272</SU>
                             Rodriguez-Otero P, Weisel K, Davies F, et al. Matching-adjusted indirect comparisons of efficacy outcomes for idecabtagene vicleucel from the KARMMA study vs selinexor plus dexamethasone (STORM part 2) and belantamab mafodotin (DREAMM-2). In: European Hematology Association.; 2020.
                        </P>
                        <P>
                            <SU>273</SU>
                             Jagannath S, Lin Y, Goldschmidt H, et al. KarMMa-RW: A study of real-world treatment patterns in heavily pretreated patients with relapsed and refractory multiple myeloma (RRMM) and comparison of outcomes to KarMMa. J Clin Oncol. 2020;38(15_suppl):8525-8525. doi:10.1200/jco.2020.38.15_suppl.8525.
                        </P>
                        <P>
                            <SU>274</SU>
                             Raje N, Berdeja J, Lin Y, et al. Anti-BCMA CAR T-cell therapy bb2121 in relapsed or refractory multiple myeloma. N Engl J Med. 2019;380(18):1726-1737. doi:10.1056/NEJMoa1817226.
                        </P>
                        <P>
                            <SU>275</SU>
                             Lonial S, Lee HC, Badros A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020;21(2):207-221. doi:10.1016/S1470-2045(19)30788-0.
                        </P>
                        <P>
                            <SU>276</SU>
                             Chari A, Vogl DT, Gavriatopoulou M, et al. Oral Selinexor-Dexamethasone for Triple-Class Refractory Multiple Myeloma. N Engl J Med. 2019;381(8):727-738. doi:10.1056/nejmoa1903455.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>277</SU>
                             Munshi NC, Anderson, Jr LD, Shah N, et al. Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T-cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): Initial KarMMa results. 
                            <E T="03">J Clin Oncol.</E>
                             2020;38(15_suppl):8503-8503.
                        </P>
                    </FTNT>
                    <P>
                        We note that in contrast with anti-CD-19 CAR T-cell therapies (for leukemia or lymphoma) where a high fraction of responders remained in remission even after 5 years, idecabtagene vicleucel does not appear to result in long-term remission. In the KarMMA study, among responding patients, over 75% relapsed by 20 months, with no plateauing of the response curve.
                        <SU>278</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>278</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        To support its assertion that idecabtagene vicleucel has superior effectiveness compared to existing therapies, the applicant provided results from the KarMMa-RW study,
                        <SU>279</SU>
                        <FTREF/>
                         a single-arm, open-label, phase 2 trial, examining real-world treatment patterns in heavily pretreated patients with RRMM. The study also provides a comparison against outcomes in the KarMMa study. The KarMMa-RW study was conducted to assess treatment patterns in real-world RRMM patients with characteristics similar to the KarMMa population and to compare outcomes with currently available therapies in this synthetic cohort vs idecabtagene vicleucel therapy in the KarMMa study. The primary endpoint of the KarMMA-RW study was overall response rate (ORR). Secondary endpoints of the study were complete response rate (CRR), very good partial response (VGPR) rate, progression free survival (PFS) and overall survival (OS). Subgroup analyses by age, sex, double-class refractory (IMiD agents and PIs) and number of prior anti-myeloma regimens per year (≤1 per year or &gt;1) were conducted to compare ORR and PFS between the KarMMa cohort and eligible RRMM cohort. Since complete response assessment requires a bone marrow biopsy evaluation, per International Myeloma Working Group (IMWG) uniform response criteria for multiple myeloma, when data to assess a complete response were not available in eligible RRMM cohort, analyses were summarized for VGPR or better (≥VGPR) to avoid underestimating the response in the eligible RRMM cohort.
                    </P>
                    <FTNT>
                        <P>
                            <SU>279</SU>
                             Jagannath S, Lin Y, Goldschmidt H, et al. KarMMa-RW: A study of real-world treatment patterns in heavily pretreated patients with relapsed and refractory multiple myeloma (RRMM) and comparison of outcomes to KarMMa. 
                            <E T="03">J Clin Oncol.</E>
                             2020;38(15_suppl):8525-8525.
                        </P>
                    </FTNT>
                    <P>Of 1,949 real-world RRMM patients, 1,171 were refractory to their last treatment regimen at baseline. Patients who had exposure to any BCMA-directed therapy or gene-modified therapy were excluded. Of the 1,171 patients in the refractory RRMM cohort, 528 received the next line of therapy; 643 patients were excluded due to no new treatment due to death (n = 441) and no new treatment due to no follow-up (n = 202). Of the remaining 528 patients, 190 triple class exposed patients were selected as the eligible RRMM cohort based on the KarMMa eligibility criteria. The ORR in the KarMMa and eligible RRMM cohorts was 76% and 32% (p= &lt;0.0001), respectively. The VGPR in the KarMMa and eligible RRMM cohorts was 57% and 14% (p= &lt;0.0001), respectively.</P>
                    <P>
                        A matched-paired analysis was conducted and ORR was adjusted for matching. Results from the matched-paired analysis were consistent with the primary analysis: the ORR for the matched KarMMa cohort (n = 76-80) and matched eligible RRMM (n = 76-80) was 72% and 29% (p=&lt;0.0001), respectively. According to the applicant, PFS was significantly improved in KarMMa vs the eligible RRMM cohort; median PFS was 11.3 months and 3.5 months in the KarMMa and Eligible RRMM cohorts, respectively (p= &lt;0.0001). Median follow-up was 11.3 months (KarMMa) and 10.2 months (eligible RRMM cohort) at data cutoff. According to the applicant, OS was significantly improved in KarMMa vs the eligible RRMM cohort. OR was 18.2 months for the KarMMa cohort (across all target doses from 150-450 × 10
                        <SU>6</SU>
                         CAR T-cells) and 14.7 months for the eligible RRMM cohort. The estimated 12-month probability of surviving was 80% in the KarMMa cohort and 56% in the eligible RRMM cohort. Median follow-up was 12.0 months (KarMMa) and 15.0 months (eligible RRMM cohort) among surviving patients at data cutoff.
                    </P>
                    <P>
                        The applicant asserts that the results from the KarMMa-RW study confirm that there is no clear standard of care for RRMM patients who received at least 3 prior therapies, including IMiD agents, PIs, and anti-CD38 antibodies. Patients in the eligible RRMM cohort received 94 different treatment regimens as next-line therapy and according to the applicant, outcomes were sub-optimal with currently available therapies in the real-world RRMM patients. The applicant asserts that significantly improved outcomes were demonstrated with idecabtagene vicleucel treatment in the KarMMa cohort vs the similar real-
                        <PRTPAGE P="25260"/>
                        world population (eligible RRMM cohort). The applicant noted that the real world myeloma patient population is older (MM incidence is known to increase with age, with over 60 percent of all new cases occurring in adults aged 65+years).
                        <SU>280</SU>
                        <FTREF/>
                         The applicant asserts that results were consistent across subgroups including patients aged ≥65 years.
                    </P>
                    <FTNT>
                        <P>
                            <SU>280</SU>
                             Cancer Stat Facts: Myeloma, NCI SEER, 
                            <E T="03">https://seer.cancer.gov/statfacts/html/mulmy.html</E>
                             (last visited October. 7, 2020).
                        </P>
                    </FTNT>
                    <P>The applicant also provided a comparison of the efficacy of idecabtagene and Xpovio® from the STORM study and Blenrep from the DREAMM-2 study. STORM is a prospective, multicenter phase 2 study of Xpovio® and dexamethasone in patients with RRMM (n=122) in the 4L+ setting. The STORM trial served as the basis for regulatory approval in the US and demonstrated the clinical efficacy and safety of Xpovio®. The ORR was 26% for patients in the STORM study vs 73% for patients treated with idecabtagene vicleucel in the KarMMa study, CR was 1% for patients in the STORM study vs 33% for patients treated with idecabtagene vicleucel in the KarMMa study, medium duration of response (mDOR) was 4.4 months for patients in the STORM study vs 10.7 months for patients treated with idecabtagene vicleucel in the KarMMa study, and PFS was 3.7 months for patients in the STORM study vs 8.8 months for patients treated with idecabtagene vicleucel in the KarMMa study. The DREAMM-2 study is a prospective, multicenter Phase 2 study of Blenrep in patients with RRMM (n=122) in the 4L+ setting. The ORR was 31% for patients in the DREAMM-2 study vs 73% for patients treated with idecabtagene vicleucel in the KarMMa study, CR was 3% for patients in the DREAMM-2 study vs 33% for patients treated with idecabtagene vicleucel in the KarMMa study, medium duration of response (mDOR) was not reached in the Blenrep group whereas it was 10.7 months for patients treated with idecabtagene vicleucel in the KarMMa study, and PFS was 2.9 months for patients in the DREAMM-2 study vs 8.8 months for patients treated with idecabtagene vicleucel in the KarMMa study.</P>
                    <P>Because idecabtagne vicleucel showed improved ORR, CR, medDOR and PFS when compared to Xpovio® and Blenrep, the applicant asserts that idecabtagne vicleucel provides a substantial clinical improvement over these existing therapies.</P>
                    <P>
                        To support that idecabtagene vicleucel fills an unmet need as demonstrated by the patient population in its registrational study, the Phase 2 KarMMa study, the applicant asserts that in addition to showing deep and durable responses and a manageable safety profile in heavily pretreated, highly refractory RRMM patients in the context of controlled clinical studies, comparisons of outcomes in real world patients (that is, patients not enrolled in clinical trials) support the assertion that idecabtagene vicleucel offers significantly improved outcomes for RRMM compared with currently available therapies. The applicant asserts that when compared to myeloma patients generally included in clinical studies, the real world myeloma patient population is older (MM incidence is known to increase with age, with over 60 percent of all new cases occurring in adults aged ≥65 years) 
                        <SU>281</SU>
                        <FTREF/>
                         and sicker (due to the high proportion of elderly patients in this population, those with MM commonly also have additional comorbidities associated with increased age, including conditions such as osteoporosis, arthritis, diabetes, additional malignancies, cardiovascular disease, and renal dysfunction, amongst others).
                        <SU>282</SU>
                        <FTREF/>
                         The applicant provided an abstract from the MAMMOTH study, a noninterventional, retrospective cohort analysis conducted to assess outcomes in patients after they become refractory to anti-CD38 monoclonal antibodies, including a subset of patients who were triple-class-exposed. Patients in STORM (analyzing Xpovio® plus dexamethasone) had an ORR of 32.8% versus 25% for patients receiving conventional care in MAMMOTH (p=0.078) and STORM patients had better OS than patients in MAMMOTH (median 10.4 vs 6.9 months) (p=0.043). The applicant asserts that these results highlight a high unmet need in a patient population refractory to anti-CD38 monoclonal antibody, including a subset of triple-class exposed patients.
                    </P>
                    <FTNT>
                        <P>
                            <SU>281</SU>
                             Cancer Stat Facts: Myeloma, NCI SEER, 
                            <E T="03">https://seer.cancer.gov/statfacts/html/mulmy.html</E>
                             (last visited Oct. 7, 2020).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>282</SU>
                             Hari P et al. The impact of age and comorbidities on practice patterns and outcomes in patients with relapsed/refractory multiple myeloma in the era of novel therapies. Journal of Geriatric Oncology. 2018;9(2):138-144 (Hari, 2018).
                        </P>
                    </FTNT>
                    <P>
                        To support the assertion that idecabtagene vicleucel improves quality of life for patients with RRMM, the applicant referenced idecabtagene vicleucel's impact on Health-related quality of life (HRQoL) as assessed in the KarMMa study as a secondary endpoint. HRQoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life C30 Questionnaire (QLQ-C30) and the EORTC Multiple Myeloma Module (MY20). The QLQ-C30 consists of 30 questions addressing 5 functional domain scales, 3 symptom scales, a Global ealth/QoL scale, and 6 single item measures.
                        <SU>283</SU>
                        <FTREF/>
                         The QLQ-MY20 consists of 20 questions addressing 4 myeloma-specific HRQoL domains (disease symptoms, side effects of treatment, future perspectives, and body image).
                        <SU>283</SU>
                         Primary subscales of interest were QLQ-C30 Fatigue, Pain, Physical Functioning, Cognitive Functioning, and Global Health/QoL subscales and QLQ-MY20 Symptom and Side Effects subscales. Subscales were preselected based on their relevance to this patient population. The data are based on a minimum of 10 months post-infusion. Median follow-up durations at the target dose levels of 150, 300, and 450 × 10
                        <SU>6</SU>
                         CAR T-cells were 17.8, 13.9, and 9.7 months, respectively. Of 140 patients enrolled in KarMMa, 128 received idecabtagene vicleucel, of whom 121 (94.5%) and 120 (93.8%) were evaluable for HRQoL by QLQ-C30 and QLQ-MY20, respectively. At baseline, idecabtagene vicleucel treated patients had less favorable scores for all QLQ-C30 domains of interest (fatigue, pain, Global Health/QoL, physical functioning and cognitive functioning) than the general population. From baseline at multiple time points through month 9 post-infusion, the applicant asserts that clinically meaningful improvements were observed in QLQ-C30 Fatigue, Pain, Physical Functioning, and Global Health subscale scores relative to baseline, as the mean score from baseline showed improvement in all domains. The applicant asserts that these results support that idecabtagene vicleucel provides meaningful improvements in HRQoL and self-reported symptoms associated with heavily pretreated RRMM and demonstrate that idecabtagene vicleucel provides meaningful improvement in both global function and symptoms related to MM.
                    </P>
                    <FTNT>
                        <P>
                            <SU>283</SU>
                             Helena Maes &amp; Michel Delforge (2015) Optimizing quality of life in multiple myeloma patients: current options, challenges and recommendations, Expert Review of Hematology, 8:3, 355-366, DOI: 10.1586/17474086.2015.1021772.
                        </P>
                    </FTNT>
                    <P>
                        After reviewing the information submitted by the applicant as part of its FY 2022 new technology add-on payment application for idecabtagene vicleucel, we question whether, due to the lack of randomization, there is sufficient evidence to establish the efficacy of idecabtagene vicleucel compared with current alternatives. It is unknown whether the superior 
                        <PRTPAGE P="25261"/>
                        outcomes for idecabtagene vicleucel in the KarMMA study, which has not been peer-reviewed, were due to more effective therapy or other factors, such as differences in patient population or treating oncologist. We also note that the applicant chose to use ORR data as a measure of substantial clinical improvement rather than the more clinically relevant and available OS data.
                    </P>
                    <P>We are inviting public comment on whether idecabtagene vicleucel meets the substantial clinical improvement criterion.</P>
                    <P>
                        We did not receive any written comments in response to the New Techology Add-on Payment Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for idecabtagene vicleucel.
                    </P>
                    <HD SOURCE="HD3">i. INDIGO Aspiration System With Lightning Aspiration Tubing</HD>
                    <P>Penumbra, Inc. submitted an application for the INDIGO® Aspiration System with Lightning Tubing (“INDIGO® with Lightning”) for FY 2022. Per the applicant, INDIGO® with Lightning is a mechanical thrombectomy aspiration system used in the treatment of pulmonary embolism, deep vein thrombosis and peripheral arterial thromboembolism that optimizes thrombus removal by differentiating between thrombus and blood.</P>
                    <P>According to the applicant, INDIGO® with Lightning performs clot detection and removal via smart technology which enables the physician to determine when the catheter is in thrombus and when it is in patent flow resulting in blood loss reduction through intermittent aspiration mechanical thrombectomy. The applicant stated that INDIGO® with Lightning is used for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. The applicant stated that the INDIGO® with Lightning is composed of a mechanical thrombectomy aspiration pump (known as the Penumbra Engine) that is packaged with INDIGO® CAT12 (12 French) and CAT8 (8 French) catheters as well as Lightning, a clot detection/blood loss reduction technology embedded in the Penumbra Engine pump and tubing.</P>
                    <P>
                        Arterial thromboembolism can result in acute limb ischemia (ALI) which requires emergent treatment. Venous thromboembolism is a condition which includes both deep vein thrombosis (DVT) and pulmonary embolism (PE) and occurs in 1 to 2 individuals per 1000 per year and is predominantly a disease of older age.
                        <SU>284</SU>
                        <FTREF/>
                         The 2020 American Society of Hematology guidelines for venous thromboembolism include recommendations for the treatment of patients with both pulmonary embolism and deep vein thrombosis, and recommended treatments include home care, systemic pharmacological thrombolysis, and procedural care.
                        <SU>285</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>284</SU>
                             Heit, John A. “Epidemiology of venous thromboembolism.” 
                            <E T="03">Nature reviews. Cardiology</E>
                             vol. 12,8 (2015): 464-74. doi:10.1038/nrcardio.2015.83
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>285</SU>
                             Thomas L. Ortel, Ignacio Neumann, Walter Ageno, Rebecca Beyth, Nathan P. Clark, Adam Cuker, Barbara A. Hutten, Michael R. Jaff, Veena Manja, Sam Schulman, Caitlin Thurston, Suresh Vedantham, Peter Verhamme, Daniel M. Witt, Ivan D. Florez, Ariel Izcovich, Robby Nieuwlaat, Stephanie Ross, Holger J. Schünemann, Wojtek Wiercioch, Yuan Zhang, Yuqing Zhang; American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism. 
                            <E T="03">Blood Adv</E>
                             2020; 4 (19): 4693-4738. doi: 
                            <E T="03">https://doi.org/10.1182/bloodadvances.2020001830.</E>
                        </P>
                    </FTNT>
                    <P>
                        Procedural care may include open procedures as well as catheter-directed thrombolysis and percutaneous mechanical thrombectomy.
                        <SU>286</SU>
                        <FTREF/>
                         In catheter-directed thrombolysis, a thrombolytic agent is infused intravascularly adjacent to the clot burden through a percutaneous transcatheter.
                        <SU>287</SU>
                        <FTREF/>
                         In percutaneous mechanical thrombectomy, the thrombus is lysed or removed mechanically. The therapies may be used separately or in conjunction with one another.
                        <SU>288</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>286</SU>
                             Karthikesalingam A, Young EL, Hinchliffe RJ, Loftus IM, Thompson MM, Holt PJ. A systematic review of percutaneous mechanical thrombectomy in the treatment of deep venous thrombosis. 
                            <E T="03">Eur J Vasc Endovasc Surg.</E>
                             2011 Apr;41(4):554-65. doi: 10.1016/j.ejvs.2011.01.010. Epub 2011 Feb 1. PMID: 21288745.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>287</SU>
                             Brown KN, Devarapally SR, Lee L, et al. Catheter Directed Thrombolysis Of Pulmonary Embolism. [Updated 2020 Apr 10]. In: StatPearls [internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan. 
                            <E T="03">https://www.ncbi.nlm.nih.gov/books/NBK536918/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>288</SU>
                             Karthikesalingam A, Young EL, Hinchliffe RJ, Loftus IM, Thompson MM, Holt PJ. A systematic review of percutaneous mechanical thrombectomy in the treatment of deep venous thrombosis. 
                            <E T="03">Eur J Vasc Endovasc Surg.</E>
                             2011 Apr;41(4):554-65. doi: 10.1016/j.ejvs.2011.01.010. Epub 2011 Feb 1. PMID: 21288745.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that mechanical thrombectomy may be performed with a variety of devices. These methods include aspiration thrombectomy, rheolytic thrombectomy, and fragmentation thrombectomy.
                        <SU>289</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>289</SU>
                             Haude, M. Mechanical thrombectomy catheter systems. 
                            <E T="03">Interventional Cardiology</E>
                             2007;2(1):58-60.
                        </P>
                    </FTNT>
                    <P>The applicant stated that INDIGO® with Lightning differs from other mechanical thrombectomy devices on the basis of the use of a mechanical pump to generate a vacuum for aspiration and “intelligent aspiration” which differentiates clots and patient blood flow, thereby limiting blood loss. The applicant states that other endovascular mechanical thrombectomy devices do not provide aspiration using a vacuum. According to the applicant, the Lightning tubing performs clot detection using a proprietary algorithm. According to the applicant, once this “smart technology” detects free-flowing blood, it indicates patent flow to the physician and begins intermittent aspiration resulting in less blood loss during the procedure.</P>
                    <P>The applicant indicated that there is no unique ICD-10-PCS procedure code to describe the use of INDIGO® with Lightning. The applicant submitted a request for a unique ICD-10-PCS code to identify the technology beginning FY 2022.</P>
                    <P>INDIGO® with Lightning is a system with multiple components which have been reviewed by FDA both separately and as part of an overall system which includes catheters, tubing, and a vacuum pump. For the catheter portion of the system, INDIGO® aspiration catheter 12 (12 French) and separator 12 received FDA 510(k) clearance on May 28, 2020 for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems under FDA submission number K192981. The applicant states that they submitted an application for FDA 510(k) clearance for that same technology (with a predicate which received clearance mentioned previously under submission number K192981) for indication of pulmonary embolism under FDA submission number K202821 for which clearance was completed on November 18, 2020. The INDIGO® aspiration catheter 12 and separator 12 received FDA 510(k) clearance for the peripheral arterial and venous system on the basis of similarity to an earlier version of the same catheter and separator, which itself received FDA 510(k) clearance on May 26, 2015 under FDA 510(k) number K142870 as part of the Penumbra Embolectomy System for the same indication. We note that the overall system received a second 510(k) clearance on December 20, 2019 under FDA 510(k) number K192833 for the added indication of PE.</P>
                    <P>
                        With respect to the newness criterion for the tubing, the Lightning tubing received FDA 510(k) authorization for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems on March 13, 2020 under FDA 510(k) number K193244. The same tubing received FDA 510(k) authorization for pulmonary embolism on April 22, 2020 under FDA 
                        <PRTPAGE P="25262"/>
                        510(k) number K200771, which was granted based on substantial similarity to the same manufacturer's device. The predicate device for the peripheral arterial and venous system was an earlier version of the tubing without Lighting which itself received FDA 510(k) authorization on May 3, 2018 under FDA 510(k) number K180939.
                    </P>
                    <P>With respect to the newness criterion for the vacuum pump, the Penumbra Engine Pump and Canister received FDA 510(k) clearance for use in the peripheral arterial and venous systems (PAVS) on March 8, 2018 under FDA 510(k) number K180105. The following table summarizes the FDA approval information listed in this section.</P>
                    <GPH SPAN="3" DEEP="120">
                        <GID>EP10MY21.154</GID>
                    </GPH>
                    <P>The applicant has applied for new technology add-on payments for INDIGO® with Lightning when used for the treatment of venous thromboembolism, arterial thromboembolism, and pulmonary thromboembolism.</P>
                    <P>As discussed previously, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>With regard to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, the applicant stated that INDIGO® with Lightning does not use the same or a similar mechanism of action when compared to an existing technology to achieve a therapeutic outcome. The applicant described differences between INDIGO® with Lightning and existing technologies based on the use of a mechanical pump to generate a vacuum for aspiration and the Lightning tubing, which the applicant stated limits blood loss and indicates clot versus patent flow. For pulmonary embolism and the peripheral system, the applicant identified Inari Flowtriever as an existing technology and noted that any aspiration provided using this system is provided via syringe as opposed to a vacuum pump. For the peripheral system, the applicant also identified Inari Flowtriever as using the same syringe method of aspiration. The applicant also identified two additional aspiration thrombectomy catheters, Angiojet® and Angiovac®, used in the peripheral system and suggested that Angiojet® also uses a syringe for aspiration and that Angiovac® utilizes an extracorporeal bypass circuit that is created outside the body consisting of an outflow line, a centrifugal pump, a filter and an inflow line.</P>
                    <P>With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant stated that services provided using this device would be captured under MS-DRGs 163-165 and 270-272. MS-DRGs 163-165 address major chest procedures and MS-DRGs 270-272 address other major cardiovascular procedures.</P>
                    <P>With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population when compared to an existing technology, the applicant did not address this criterion directly in the application, but stated that the new use of the INDIGO® System with Lighting is for the most recent FDA indication (April 2020) in PE. The applicant further states that PE is not the same disease as arterial and venous thromboembolism; the patient populations may overlap, but are not identical.</P>
                    <P>We have the following concerns regarding whether the technology meets the substantial similarity criteria and whether it should be considered new. While the applicant discussed the differences between INDIGO® with Lighting and products made by other manufacturers, the applicant does not provide enough information regarding how INDIGO® with Lightning differs in its components from the existing aspiration thrombectomy catheters on the market to determine whether the technology uses a unique mechanism of action. We question whether the mechanism of action of the pump is different than that of the existing aspiration thrombectomy systems that also use a pump rather than a syringe, and how the mechanism of action of the separator, which is part of the catheter portion of the device, is different from that of existing thrombectomy systems that deploy a device through the lumen of the catheter to break up the thrombus. It is also unclear what mechanism of action is used within the “smart technology” and how it may differ from other products which are intended to similarly reduce blood loss during the procedure. It is unclear if the “smart technology” resides within the pump, which was cleared by FDA 510(k) on March 8, 2018, or within the tubing, which was most recently cleared by FDA 510(k) on April 22, 2020. We note that while the applicant did not directly address the third criterion within the application, based on the clinical uses of the device described in the application, we believe the INDIGO® with Lightning is intended for a patient population that is similar to the patient population treated by existing thrombectomy devices, including patients who receive percutaneous interventions for PE and peripheral arterial thromboembolism.</P>
                    <P>
                        We note that the predicate device for the vacuum pump, the Penumbra Engine Pump and Canister, received FDA 510(k) clearance for use in the peripheral arterial and venous systems on March 8, 2018 under FDA 510(k) number K180105 and therefore appears to no longer be considered new. We further note that the catheter and tubing, as described in the 510(k) applications, appear to only have minor differences from their predicate devices such as length of tubing and shelf life, as opposed to elements that would affect the mechanism of action. If we determine that the catheter and tubing are substantially similar to the predicate 
                        <PRTPAGE P="25263"/>
                        devices cleared under FDA 510(k) numbers K142870 (May 26, 2015) and K180939 (May 3, 2018), respectively, the newness date of the INDIGO® with Lightning would correspond to the dates listed and therefore may no longer be considered new. We also note that it is unclear whether the components of the system may be substantially similar to the overall system and whether the applicable newness date for each indication would therefore be the date of the overall system clearance for each indication, specifically May 26, 2015 for peripheral arterial and venous systems and December 20, 2019 for pulmonary embolism.
                    </P>
                    <P>We invite public comment on whether INDIGO® with Lightning is substantially similar to other technologies and whether INDIGO® with Lightning meets the newness criterion.</P>
                    <P>With regard to the cost criterion, the applicant searched the FY 2019 MedPAR claims data file with the FY 2019 Final Rule with Correction Notice IPPS Impact File to identify potential cases representing patients who may be eligible for treatment using the INDIGO® System. The applicant identified claims with any one of the following ICD-10-PCS codes for percutaneous mechanical thrombectomy:</P>
                    <GPH SPAN="3" DEEP="592">
                        <PRTPAGE P="25264"/>
                        <GID>EP10MY21.155</GID>
                    </GPH>
                    <P>In its analysis, the applicant identified a primary cohort to assess whether this therapy met the cost criterion. The previously listed ICD-10-PCS procedure codes were used to identify claims involving percutaneous procedures. The claim search conducted by the applicant resulted in 15,580 claims mapping to six MS-DRGs: 270 (Other Major Cardiovascular Procedures with MCC), 271 (Other Major Cardiovascular Procedures with CC), 272 (Other Major Cardiovascular Procedures without CC/MCC), 163 (Major Chest Procedures with MCC), 164 (Major Chest Procedures with CC), and 165 (Major Chest Procedures without CC/MCC).</P>
                    <P>
                        The applicant determined an average unstandardized case weighted charge per case of $126,211.
                        <PRTPAGE P="25265"/>
                    </P>
                    <P>The applicant did not remove charges for prior technology. The applicant stated that no prior technology is being replaced. The applicant then standardized the charges using the FY 2019 Final Rule with Correction Notice Impact File. Next, the applicant applied the 2-year inflation factor used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier threshold charges (1.13218). To calculate the charges for the new technology, the applicant used what it stated was the national average CCR for the Supplies and Equipment cost center of 0.299 from the FY 2021 IPPS final rule. However, we note that the actual value for this cost center for FY 2021 was 0.297. The applicant calculated a final inflated average case-weighted standardized charge per case of $180,036, which exceeded the average case-weighted threshold amount of $126,211 by $53,825. The applicant stated that because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount, the therapy meets the cost criterion.</P>
                    <P>We invite public comment on whether INDIGO® with Lightning meets the cost criterion.</P>
                    <P>With respect to the substantial clinical improvement criterion, the applicant asserted that the INDIGO® with Lightning represents a substantial clinical improvement over existing technologies because it results in lower rates of aspirated blood loss during the procedure, low major bleeding event rate, reduces blood loss, reduces ICU stays, and reduces procedure time. The applicant also suggested that the technology allows for revascularization without thrombolytics and no recurrence of pulmonary embolism after 30 days.</P>
                    <P>To support its application, the applicant submitted a reference to the EXTRACT-PE prospective, single-arm study across 22 sites comparing the use of INDIGO® without Lightning to systemic thrombolysis in 119 patients with PE who had not been previously treated with anti-thrombolytics or an adjunctive device within 48 hours. The applicant stated that this study was completed under FDA Investigational Device Exception (IDE) G170064. The applicant claimed that the EXTRACT-PE study showed the INDIGO® without Lightning led to a significant mean reduction of 0.43 in right ventricle/left ventricle (RV/LV) ratio (a measure associated with poor clinical outcomes when greater than 1) that corresponded to a 27.3 percent reduction at 48 hours after intervention. They also cited a low major adverse event composite rate of 1.7 percent within 48 hours, device usage of only 37 minutes and median ICU length of stay of 1 day. According to the applicant, rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 hours were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively.</P>
                    <P>
                        The applicant cited a poster of an unpublished retrospective case review study by Hastings 
                        <SU>290</SU>
                        <FTREF/>
                         of 18 patients with DVT treated with INDIGO® followed by anticoagulation. Primary technical success (defined as restoration of blood flow with minimal residual thrombus (&lt;10%) without the need for a second session of treatment) was achieved in 15 patients. Three patients required adjunctive methods for successful clearance of thrombus, undergoing two sessions of treatment. Two patients had recurrence of DVT following single-session treatment, both of whom were asymptomatic at time of diagnosis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>290</SU>
                             Hastings, L.H., Perkowski, P.E. Single Session Percutaneous Mechanical Aspiration Thrombectomy for Symptomatic Proximal Deep Vein Thrombosis. Poster.
                        </P>
                    </FTNT>
                    <P>
                        The applicant cited the PRISM study,
                        <SU>291</SU>
                        <FTREF/>
                         a single-arm, multicenter, retrospective analysis of 79 patients with arterial occlusion from 2018, to provide evidence that use of INDIGO® with Lightning has a low major bleeding event rate, can result in revascularization without thrombolytics, and causes no clinically significant distal embolization. The applicant also stated that the interim results of the INDIAN study, a prospective trial using INDIGO® without Lightning to treat patients with ALI showed no device-related adverse events or major bleeding complications.
                        <SU>292</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>291</SU>
                             Saxon, R.R., Benenati, J.F., Teigen, C., Adams, G.K., Sewall, L.E., and Trialists, P. (2018). Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: Results of the multicenter prism trial. 
                            <E T="03">J Vasc Interv Radiol.</E>
                             29(1): p. 92-100
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>292</SU>
                             Donato, et al. Acute Lower Limb Malperfusion—(INDIAN) Registry: Protocol (as presented at VEITHsymposium 2019).
                        </P>
                    </FTNT>
                    <P>The applicant asserted that an unpublished laboratory bench test using water found that the 20.3 mL/sec average flow rate of catheter with Lightning generates 18-fold reduction in blood loss when compared to the use of the same catheter and Penumbra engine pump without the Lightning technology. The applicant asserted that a bench test showed that the Penumbra aspiration pump demonstrates continuous pressure, as evidenced by a sustained -29 inHg (inches of Mercury) through 60 seconds versus a 60-ml syringe which starts at -27 Hg and drops to 0 in Hg within 18 seconds.</P>
                    <P>The applicant also asserted that an abstract of a single-center retrospective case-control trial of 38 patients by Muck, P., et al. comparing two versions of INDIGO® catheters (12F and 8F) showed that median blood loss was 250mL in the larger Lightning 12F arm (n=9, larger catheter) and 375mL in the 8F arm without Lightning (n=27, smaller catheter). Technical success (defined as greater than 70 percent thrombus reduction) was achieved in 77 percent of patients in the Lightning 12F arm compared to 18.5 percent in the 8F arm without Lightning. The applicant also asserted that this study showed that none (0/9) of the patients in the INDIGO® with Lightning group required post-procedure transfusion, whereas 18.5 percent (5/27) of the INDIGO® without Lightning group required post-procedure transfusion.</P>
                    <P>We note that in its application, the applicant did not explicitly state what the comparator was for each of its claims in support of substantial clinical improvement; for example, whether INDIGO® is being compared to systemic thrombolysis, percutaneous catheter directed thrombolysis, or other aspiration thrombectomy catheters. Comparing INDIGO® to a medical treatment modality may not be appropriate since percutaneous interventions for PE and DVT have different clinical indications, risks, and benefits compared to medical or surgical interventions.</P>
                    <P>We also note that the applicant relies mostly on studies of INDIGO® without Lightning to substantiate its claims regarding INDIGO® with Lightning. Of all the studies provided by the applicant, only one small, unpublished study of DVT patients by Muck, P., et al. includes patients treated with INDIGO® with Lightning (which has the intelligent aspiration) versus earlier versions of the applicant's device. The applicant did not demonstrate superior outcomes using INDIGO® with Lightning compared to INDIGO® without Lightning.</P>
                    <P>
                        We note that outcomes for INDIGO® for the rates of pulmonary vascular injury at 48 hours, clinical deterioration, major bleeding and device-related deaths were stated by the applicant as low compared to systemic thrombolysis, but were not compared to outcomes for existing aspiration thrombectomy devices which may be a more appropriate comparator. We further note that in the poster study, all patients were maintained on anticoagulation following thrombectomy with INDIGO®, so it is difficult to assess the DVT 
                        <PRTPAGE P="25266"/>
                        recurrence rate (using INDIGO® alone) to support the claim that INDIGO® can be used with patients with high risk of bleeding.
                    </P>
                    <P>
                        We also note that suction generated through a vacuum may not be superior to other mechanisms of generating negative pressure used in other existing aspiration catheters. A study comparing suction forces and vacuum pressure of Penumbra pump to a 60-mL syringe and pumps manufactured by several other manufacturers showed that all catheters transmit similar vacuum pressure regardless of pump or 60-mL syringe.
                        <SU>293</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>293</SU>
                             Froehler, M.T. (2017). Comparison of vacuum pressures and forces generated by different catheters and pumps for aspiration thrombectomy in acute ischemic stroke. Interventional neurology, 6(3-4), 199-206.
                        </P>
                    </FTNT>
                    <P>Finally, we question whether there is enough evidence to support that “intelligent aspiration” associated with INDIGO with Lightning provides a substantial clinical improvement over existing aspiration catheters from INDIGO® and existing devices where the aspiration is controlled manually. No direct comparison of blood loss between INDIGO® with Lightning catheter and existing aspiration thrombectomy devices from other manufacturers was provided, specifically catheters that reduce blood loss by returning the aspirated blood back to the patient. The unpublished bench test included with the application may have demonstrated a reduction in average volume of water aspirated using the INDIGO® Catheter with Lightning fully functional compared to the INDIGO® catheter with Lightning deactivated (valve pin fixed to the open position). However, this study was not designed to compare blood loss during a thrombectomy procedure between aspiration controlled by a human versus by the Lightning “intelligent aspiration.”</P>
                    <P>We invite public comment on whether INDIGO® with Lightning meets the substantial clinical improvement criterion.</P>
                    <P>
                        We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for INDIGO® with Lightning or at the New Technology Town Hall meeting.
                    </P>
                    <HD SOURCE="HD3">j. Ischemia Care Respiratory and Stroke Test Kit or ISC-REST</HD>
                    <P>Ischemia Care submitted an application for new technology add-on payment for Ischemia Care Respiratory and Stroke Test Kit (ISC-REST) for FY 2022. Per the applicant, ISC-REST is a test kit composed of three tests to stratify the cause of ischemic strokes by differentiating those that originate in the heart, called cardioembolic (CE) strokes, and those that originate in the arteries, called large artery atherosclerotic (LA) strokes, once it has been determined that a patient has not suffered a hemorrhagic stroke. According to the applicant, ISC-REST is made up of three tests: (1) ISCDx, (2) the QIAstat-Dx Respiratory SARS-CoV-2 Panel, and (3) the QIAGEN Access Anti-SARS-CoV-2 Total Test. According to the applicant, the three test results provide information related to the cause of ischemic stroke and coronavirus disease 2019 (COVID-19) status to prevent a recurrent stroke. Per the applicant, the first of the three tests, ISCDx, is a blood test that uses RNA expression from whole blood to differentiate between CE and LA stroke, two types of ischemic stroke. According to the applicant, once blood is drawn, the RNA expression in the blood sample is analyzed and matched to the gene expression signatures and patterns associated with CE stroke and LA stroke. Per the applicant, the second test, the QIAstat-DX respiratory SARS-CoV-2 Panel, is a multiplexed nucleic acid real-time polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of nucleic acid from 22 respiratory pathogens, including the SARS-CoV-2 virus, in nasopharyngeal swabs. According to the applicant, the third test is the QIAGEN Access Anti-SARS-CoV-2 Total Test, a rapid, digital lateral flow serological test to detect antibodies to SARS-CoV-2 in human serum and plasma.</P>
                    <P>
                        According to the applicant, the ISC-REST kit is intended to be used when a patient presents at the hospital with an ischemic stroke, within 30 hours of symptom onset and with a National Institutes of Health Stroke Scale (NIHSS) score of ≥5. The NIHSS measures stroke-related neurologic deficit and has predictive validity for long-term stroke outcome.
                        <SU>294</SU>
                        <FTREF/>
                         Per the applicant, the ISC-REST kit is intended for use at the time of the standard evaluation, at the same time that normal blood samples are collected when a patient is admitted to the hospital for stroke. According to the applicant, to use the ISC-REST kit, blood is drawn into a PaxGene tube (for the ISCDx test), a nasal swab is obtained (for the QIAstat-Dx Respiratory SARS-CoV-2 Panel), and an additional blood sample is drawn (for the QIAGEN Access Anti-SARS-CoV-2 Total Test). Per the applicant, the hospital sends all three samples to a single laboratory, the Clinical Laboratory Improvement Amendments (CLIA) certified Ischemia Care laboratory, for processing and reporting. According to the applicant, three results are reported: (1) A result for whether the gene expression in the blood sample was consistent with CE stroke or LA stroke, (2) a result for respiratory screening that includes COVID-19, influenza, and other respiratory illnesses, and (3) a result for COVID-19 antibodies to determine whether the patient previously had COVID-19.
                    </P>
                    <FTNT>
                        <P>
                            <SU>294</SU>
                             Schlegel, Daniel et al., “Utility of the NIH Stroke Scale as a Predictor of Hospital Disposition,” 
                            <E T="03">Stroke,</E>
                             2003;34:134-137, 
                            <E T="03">https://doi.org/10.1161/01.STR.0000048217.44714.02</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, the number of cryptogenic ischemic strokes, or ischemic strokes where the cause is unknown, is concerning. The applicant states that there are 695,000 ischemic strokes each year in the United States, with 185,000 of these events being recurrent strokes. Per the applicant, for up to 40% of ischemic strokes, or roughly 250,000 ischemic strokes, the cause is cryptogenic.
                        <SU>295</SU>
                        <FTREF/>
                         The applicant states that when the cause of stroke is identified, secondary stroke prevention protocols may be adapted to prevent a bigger, more costly, and severe recurrent stroke. The applicant explains that cryptogenic stroke leads to high recurrence risk in cases of undetected atrial fibrillation. The applicant also explains that typically the diagnosis of the causes of stroke is complex, inconsistent across hospitals, expensive, and inconclusive. Further, the applicant claims that the cryptogenic rate is higher for stroke patients with COVID-19 than stroke patients without COVID-19, citing a retrospective study of patients hospitalized at a major New York health system between March and April 2020 that found that the cryptogenic rate was 65% for COVID-19 positive patients.
                        <SU>296</SU>
                        <FTREF/>
                         In that study, out of 3,556 patients that were hospitalized and diagnosed with COVID-19 during that time, 32 patients or under 1% of the sample size experienced an ischemic stroke. The study found that the standard stroke diagnostic workup did not establish the ischemic stroke etiology for a significant proportion of patients in the study with concurrent 
                        <PRTPAGE P="25267"/>
                        COVID-19 infection and ischemic stroke: cryptogenic stroke diagnosis was twice more prevalent in COVID-19-positive patients (65.6%), compared with both COVID-19-negative contemporary stroke patients (30.4%) and ischemic stroke patients hospitalized in the same hospital system during the same time period the year prior (25.0%).
                    </P>
                    <FTNT>
                        <P>
                            <SU>295</SU>
                             Saver, Jeffrey L., “Cryptogenic Stroke,” 
                            <E T="03">N Engl J Med,</E>
                             May 26, 2016, [374:2065-2074] DOI: 10.1056/NEJMcp1503946, available at: 
                            <E T="03">https://www.nejm.org/doi/10.1056/NEJMcp1503946</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>296</SU>
                             Shadi Yaghi, et al. SARS-CoV-2 and Stroke in a New York Healthcare System, 
                            <E T="03">Stroke.</E>
                             2020; 51:2002-2011. DOI: 10.1161/STROKEAHA.120.030335, available at: 
                            <E T="03">https://www.ahajournals.org/doi/10.1161/STROKEAHA.120.030791</E>
                            .
                        </P>
                    </FTNT>
                    <P>While the applicant states in the application that there is no standard of care pathway to determine the cause of stroke, a stroke patient presenting at the hospital is typically evaluated using a standard evaluation that includes imaging and hematologic testing to determine if the patient is a candidate for intervention. Diagnosing the cause of stroke, per the applicant, often requires expensive testing, risk to the patient, and invasive procedures, without a guarantee of a definitive diagnosis. The applicant explains that each suspected cause requires a focused workup to confirm the suspicion. Additionally, the applicant points out, a negative result in one pathway does not mean a positive result in another pathway. The applicant claims that the inability to accurately stratify patients by cause of stroke often results in either limiting use of advanced patient testing or performing too many tests. The applicant further claims that diagnosing the cause of stroke and preventing recurrent stroke using a standard evaluation is even more challenging for ischemic stroke patients with COVID-19 because these patients are presenting at younger ages and without traditional comorbidities, eliminating many of the traditional causes of stroke.</P>
                    <P>
                        While the applicant states that it is unclear to clinicians whether COVID-19 is a separate cause of stroke or aggravates comorbidities to cause a stroke, the applicant claims that the information that the ISC-REST kit would provide is important, as clinicians currently know very little about the vascular effects of COVID-19. The applicant states that the ISC-REST kit ties all of the clinical diagnosis pieces together: Respiratory viral and bacterial organism presence, COVID-19 antibody presence, and CE or LA stroke. Per the applicant, this combined testing is convenient for the clinician and also raises awareness about the COVID-stroke connection by providing real world evidence.
                        <E T="51">297 298</E>
                        <FTREF/>
                         Additionally, the applicant explains that traditional diagnosis of ischemic stroke cause is often complex, inconsistent, expensive, inconclusive and may require more invasive diagnosis procedures, such as implantable cardiac monitoring or transcranial doppler. Ultimately, according to the applicant, the traditional process to stratify the cause of stroke may require months or years of additional tests post event.
                    </P>
                    <FTNT>
                        <P>
                            <SU>297</SU>
                             Patients with Coronavirus Disease 2019 (COVID-19) vs Patients With Influenza, JAMA Neurol. 2020;77(11):1366-1372.
                        </P>
                        <P>
                            <SU>298</SU>
                             COVID-19 Is an Independent Risk Factor for Acute Ischemic Stroke, American Journal of Neuroradiology, August 2020, 41(8):1361-1364.
                        </P>
                    </FTNT>
                    <P>With respect to the newness criterion, each of the three tests in ISC-REST, as well as the ISC-REST test kit as a whole, have varying FDA authorization statuses and separate indications. The applicant stated in their application that they are seeking Emergency Use Authorization (EUA) from the FDA for the ISC-REST test kit. The applicant shared that the intended indication of ISC-REST is to provide three critical diagnostic tests in the same kit for convenience of the user during the COVID-19 public health emergency. For the ISCDx test, the applicant stated that the test had completed the requirements of the Clinical Laboratories Improvement Amendments (CLIA) analytical validations and is available as a Laboratory Developed Test. ISCDx's intended indication is to aid in the diagnosis of CE and LA stroke, when hemorrhagic stroke is ruled out, in conjunction with standard clinical evaluation and in the context of the patient's clinical history and other diagnostic test results. The test could also be used as part of the clinical evaluation and patient risk assessment. The QIAstat-Dx Respiratory SARS-CoV-2 Panel was granted an EUA on March 30, 2020 and is intended for patients suspected of COVID-19 by their healthcare provider for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae. The applicant states that results are for the identification of SARS-CoV-2 RNA, however, negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. According to the applicant, there is no EUA request pending approval for the QIAGEN Access Anti-SARS-CoV-2 Total Test.</P>
                    <P>The applicant stated that there are currently no ICD-10-PCS procedure codes that uniquely identify the use of ISC-REST. The applicant submitted a request for approval of a unique ICD-10-PCS procedure code to identify use of the technology beginning FY 2022. The applicant provided 81 ICD-10-PCS codes that they stated could be used to identify cases involving the use of ISC-REST in the interim. These 81 ICD-10-CM diagnosis codes are associated with cerebral infarctions, occlusions, and other neurological conditions consistent with ischemic stroke presentations.</P>
                    <P>As previously discussed, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>With regard to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, according to the applicant, there are no blood tests for stroke or its causes. The applicant also stated that there is no blood testing for the cause of stroke combined with COVID-19 screening.</P>
                    <P>With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG when compared to an existing technology, the applicant stated that the ISC-REST kit is not replacing an existing technology and reiterated that ISCDx is a blood test that stratifies ischemic stroke patients into CE and LA stroke causes The applicant stated that the technology would map to MS-DRGs 061,062, 063, 064, 065, 066, 067, 068 and that it is not requesting for ISC-REST to map to a new or different MS-DRG for FY 2022.</P>
                    <P>With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant stated that there are no existing technologies to stratify stroke populations by cause.</P>
                    <P>
                        We note the following concerns regarding whether the applicant meets the newness criterion. Under the regulations at 42 CFR 412.87(e)(2), CMS only considers, for add-on payments for a particular fiscal year, an application for which the new technology has received FDA marketing authorization by July 1 prior to the particular fiscal year. While the applicant stated that ISCDx, one of the three tests in ISC-REST test kit, has completed the requirements of the Clinical Laboratories Improvement 
                        <PRTPAGE P="25268"/>
                        Amendments, we note that this is not considered FDA marketing authorization as required in our regulations for the new technology add-on payment.
                        <SU>299</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>299</SU>
                             42 CFR 412.87(e)(2).
                        </P>
                    </FTNT>
                    <P>In the FY 2009 IPPS final rule (73 FR 48561 through 48563), we revised our regulations at § 412.87 to codify our longstanding practice of how CMS evaluates the eligibility criteria for new medical service or technology add-on payment applications. We stated that new technologies that have not received FDA approval do not meet the newness criterion. In addition, we stated we do not believe it is appropriate for CMS to determine whether a medical service or technology represents a substantial clinical improvement over existing technologies before the FDA makes a determination as to whether the medical service or technology is safe and effective. For these reasons, we first determine whether a new technology meets the newness criterion, and only if so, do we make a determination as to whether the technology meets the cost threshold and represents a substantial clinical improvement over existing medical services or technologies. We also finalized at 42 CFR 412.87(c) (subsequently redesignated as 412.87(e)) that all applicants for new technology add-on payments must have FDA approval or clearance by July 1 of the year prior to the beginning of the fiscal year for which the application is being considered.</P>
                    <P>In the FY 2021 IPPS/LTCH PPS final rule, to more precisely describe the various types of FDA approvals, clearances, licensures, and classifications that we consider under our new technology add-on payment policy, we finalized a technical clarification to § 412.87(e)(2) to indicate that new technologies must receive FDA marketing authorization (for example, pre-market approval (PMA); 510(k) clearance; the granting of a De Novo classification request; approval of a New Drug Application (NDA); or Biologics License Application (BLA) licensure) by July 1 of the year prior to the beginning of the fiscal year for which the application is being considered. As noted in the FY 2021 IPPS/LTCH PPS final rule, this technical clarification did not change our longstanding policy for evaluating whether a technology is eligible for new technology add-on payment for a given fiscal year, and we continue to consider FDA marketing authorization as representing that a product has received FDA approval or clearance for purposes of eligibility for the new technology add-on payment under § 412.87(e)(2) (85 FR 58742).</P>
                    <P>As previously summarized, the applicant is seeking an EUA from the FDA for the ISC-REST test kit. An EUA by the FDA allows a product to be used for emergency use, but under our longstanding policy, we believe it would not be considered an FDA marketing authorization for the purpose of new technology add-on payments, as a product that is available only through an EUA is not considered to have an FDA approval or clearance. Therefore, under the current regulations at 42 CFR 412.87(e)(2) and consistent with our longstanding policy of not considering eligibility for new technology add-on payments prior to a product receiving FDA approval or clearance, we believe a product available only through an EUA would not be eligible for new technology add-on payments.</P>
                    <P>We also refer the reader to our comment solicitation in section II.F.7 of the preamble of this proposed rule regarding how data reflecting the costs of a product with an EUA, which may become available upon authorization of the product for emergency use (but prior to FDA approval or clearance), should be considered for purposes of the 2-year to 3-year period of newness for new technology add-on payments for a product with or expected to receive an EUA, including whether the newness period should begin with the date of the EUA.</P>
                    <P>
                        Additionally, we are uncertain whether the mechanism of action of ISC-REST can be considered new. While the applicant claims that there is currently no other blood test available that identifies the cause of ischemic stroke through RNA biomarkers, we note that clinicians may order blood tests as part of the stroke consultation to gather information about stroke risk factors and other medical problems which may have caused the stroke.
                        <SU>300</SU>
                        <FTREF/>
                         In addition, we note that there are several types of RNA biomarker tests for stroke that have been developed and used in other settings, and we therefore note that this may not represent a new mechanism of action for ISC-REST. Similarly, we are not certain whether the QIAstat-Dx Respiratory SARS-CoV-2 Panel and QIAGEN Access Anti-SARS-CoV-2 Total Test components of ISC-REST have unique mechanisms of action, as they may be similar to other PCR nasal swabs and serology tests for COVID-19 that are currently in use during the COVID-19 public health emergency. We welcome public comment regarding whether ISC-REST has a unique mechanism of action even if some or all of its test components do not have unique mechanisms of action individually. Because ISC-REST delivers three separate test results through three separate tests, it is unclear whether the combination of the tests in one kit could be viewed as representing a unique mechanism of action over and above the mechanisms of action of the tests if they were to be performed separately.
                    </P>
                    <FTNT>
                        <P>
                            <SU>300</SU>
                             Mayo Clinic Staff, Stroke Diagnosis, Feb. 9, 2021, 
                            <E T="03">https://www.mayoclinic.org/diseases-conditions/stroke/diagnosis-treatment/drc-20350119</E>
                            .
                        </P>
                    </FTNT>
                    <P>With regard to whether the technology maps to the same or different MS-DRG as existing technologies, though the applicant did not state whether it believes the technology meets this criterion, we believe that under the proposed indication for ISCDx, ISC-REST would not be used until a patient had a confirmed ischemic stroke. Therefore, under the proposed indication, it seems that the technology would map to the same MS-DRGs as cases involving the standard of care for ischemic stroke and cerebral infarction. However, it appears that there may be scenarios where a patient has an occlusion or some other neurological condition that makes the patient present with stroke-like symptoms, without having had a stroke or infarction. We invite comments on whether, for this reason, cases involving the use of the technology may be assigned to the same or different MS-DRGs as cases not only involving the standard of care for ischemic stroke and cerebral infarction, but also nonspecific cerebrovascular accidents and pre-cerebral occlusions.</P>
                    <P>With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, we note the applicant's statement that there are no existing technologies to stratify stroke populations by cause does not address whether the technology meets this criterion. CMS requests comments on whether ISC-REST kit would be used as a diagnostic aid in the treatment of similar diseases and patient populations as the current standard-of-care ischemic stroke diagnosis evaluation.</P>
                    <P>We are inviting public comments on whether ISC-REST is substantially similar to other currently available therapies and/or technologies and whether this technology meets the newness criterion.</P>
                    <P>
                        With regard to the cost criterion, the applicant provided the following analysis. The applicant used claims data from one hospital system, made up of 
                        <PRTPAGE P="25269"/>
                        three hospitals with a total of 87 health care providers. The average percentage of patients across the three hospitals with Medicare or Medicare Advantage coverage was 69%, per the applicant. The applicant stated that raw data was provided from January 2020 through September 2020, then annualized for 2020. Per the applicant, the average standardized charges were calculated per MS-DRG by the hospital system that provided the data.
                    </P>
                    <P>As mentioned previously, the applicant stated that the technology would map to the following MS-DRGs: MS-DRG 061 (Ischemic Stroke, Precerebral Occlusion or Transient Ischemia with Thrombolytic Agent with MCC), 062 (Ischemic Stroke, Precerebral Occlusion or Transient Ischemia with Thrombolytic Agent with CC), 063 (Ischemic Stroke, Precerebral Occlusion or Transient Ischemia with Thrombolytic Agent without CC/MCC), 064 (Intracranial Hemorrhage Or Cerebral Infarction with MCC), 065 (Intracranial Hemorrhage or Cerebral Infarction with CC or TPA in 24 Hours), 066 (Intracranial Hemorrhage or Cerebral Infarction without CC/MCC), 067 (Nonspecific CVA And Precerebral Occlusion without Infarction with MCC), and 068 (Nonspecific CVA And Precerebral Occlusion Without Infarction Without MCC). The applicant's data included a total of 385 cases mapping to those MS-DRGs. The applicant did not submit claims data for two of the listed MS-DRGs, MS-DRG 063 and 067, because the data source that the applicant used did not have any cases under those MS-DRGs for the time period that the sample data was collected. The applicant imputed 11 claims for two other MS-DRGs, 061 and 068, because there were fewer than 11 claims submitted for these MS-DRGs.</P>
                    <P>The applicant stated that it compared the distribution of MS-DRGs in the hospital data to the distribution of MS-DRGs in the FY 2022 New Technology Add-On Payment thresholds, which includes the number of cases per MS-DRG. The applicant asserted that because the MS-DRG distributions were highly similar, the data sample obtained from the hospital system was representative of the distribution of MS-DRGs nationally.</P>
                    <P>The applicant did not remove charges for a prior technology because, as the applicant noted, ISC-REST is not replacing any other technology. The applicant then applied the one-year charge inflation factor of 1.06353 included in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 59039) to inflate the charges from FY 2020 to FY 2021. To add charges for the new technology, the applicant multiplied the cost of ISC-REST by the cost-to-charge ratio for acute care hospitals found in the FY 2020 IPPS/LTCH PPS final rule. The applicant explained that the urban and rural hospital cost-to-charge ratios were combined to yield a national average of 0.3095. However, we note that the applicant appears to have used the cost-to-charge ratios in Table 8A, which lists the statewide average operating cost-to-charge ratios for acute care hospitals.</P>
                    <P>The applicant calculated a final inflated average case-weighted standardized charge per case of $87,842 which exceeds the average case-weighted threshold amount, $57,110. The applicant contended that ISC-REST meets the cost criterion based on these analyses.</P>
                    <P>We have the following concerns regarding the cost criterion. It is not clear whether the applicant's use of private data from three hospitals is representative of the Medicare population. While the applicant states that the average Medicare and Medicare Advantage percentage of patients across the 3 hospitals was 69%, CMS is unsure whether the claims under the MS-DRGs the applicant provided are for Medicare patients, or private insurance patients in those hospitals. Similarly, because the applicant annualized data from the months of January to September 2020, it is not clear whether the portion of time selected by the applicant is representative of the entire year. Additionally, while the applicant points to the fact that the sample of claims data from the 3 hospitals had similar MS-DRG distributions as the FY 2022 New Technology Add-on Payment Thresholds, it is not clear whether this would indicate that the charging practices of the hospitals or their patient costs are similar to Medicare claims data nationally. It is also not clear whether the applicant's cost analysis is representative of the cost of the technology as the applicant did not use the applicable cost-to-charge ratio of 0.107 for laboratory services as provided in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58601). Finally, we note that it is not possible for CMS to verify the claims data submitted, as the applicant used hospital claims data that is not publicly available and did not identify the source. We are inviting public comments on whether ISC-REST meets the cost criterion.</P>
                    <P>With respect to the substantial clinical improvement criterion, the applicant asserted that ISC-REST represents a substantial clinical improvement over existing technologies for several reasons. First, the applicant asserts that ISC-REST has the ability to stratify ischemic stroke patients early in the diagnosis process to reduce the number of cryptogenic stroke diagnoses, which leads to appropriate medical management that can better reduce the risk of a recurrent stroke. Second, the applicant asserts that ISC-REST will lead to appropriate utilization of subsequent diagnostic testing, or decrease the necessary use of subsequent diagnostic testing, to determine stroke etiology, including: Implantable cardiac monitoring, hypercoagulation panels, magnetic resonance angiography, and other commonly used tests for ischemic stroke. Third, the applicant asserts that use of ISC-REST will lead to a reduction in at least one clinically significant adverse event, a recurrent stroke, including a reduction in mortality or a clinically significant complication. Fourth, the applicant further asserts that use of ISC-REST will result in a decreased use of, or more appropriate utilization of, therapeutic intervention, in cases where patients are medically managed for a comorbidity and a stroke occurs. Fifth, the applicant asserts that use of ISC-REST will result in a decreased number of future hospitalizations by reducing recurrent stroke risk and physician visits, as in some cases ISC-REST will result in a diagnosis pathway that will not require surgical or invasive procedures. Additionally, once ISC-REST identifies the cause of the stroke, the applicant asserts that the opportunity to manage a chronic population may include telemedicine approach, rather than in-person physician visits. Finally, the applicant asserts that ISC-REST will result in improved quality of life by helping avoid a recurrent stroke.</P>
                    <P>
                        The applicant submitted five information sources to address the substantial clinical improvement criterion, as well as supplementary information in the application itself and additional narrative responses. First, the applicant submitted a poster presentation by Jauch E.C., on the results and methodology of a Biomarkers of Acute Stroke Etiology (BASE) study to determine whether RNA expression can accurately differentiate LA stroke from CE stroke in the acute setting.
                        <SU>301</SU>
                        <FTREF/>
                         Similarly, the applicant submitted an unpublished manuscript detailing another BASE study on stroke biomarkers to determine 
                        <PRTPAGE P="25270"/>
                        if the etiology of acute ischemic stroke could be objectively determined by RNA expression using BASE blood samples.
                        <SU>302</SU>
                        <FTREF/>
                         Third, the applicant submitted a published study methodology paper by Jauch et al., on the methodology of an ongoing (at the time of publication) BASE study to identify serum markers defining the etiology of acute ischemic stroke.
                        <SU>303</SU>
                        <FTREF/>
                         The fourth information source, by Jickling et al., was a published article from 2010 on a study to design genetic probes for ischemic stroke. The fifth and final information source submitted was a 2016 journal article by Jeffrey L. Saver, with background information on etiologies of stroke.
                        <SU>304</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>301</SU>
                             Jauch, Edward C., on behalf of BASE clinical trial principal investigators, “RNA Expression for Diagnosis of Stroke Etiology Differentiating Large Artery and Cardioembolic Stroke: Analytical Validation of Testing From the BASE Clinical Trial,” 2020 AHA International Stroke Conference.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>302</SU>
                             Peacock, W.F. and Edward Jauch., “Cardioembolic vs Large Artery Atherosclerotic Stroke: Can we answer Hobson's question?”, pre-publication manuscript.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>303</SU>
                             Jauch, Edward C., et al. “Biomarkers of Acute Stroke Etiology (BASE) Study Methodology,” May 5, 2017.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>304</SU>
                             Saver, Jeffrey L., “Cryptogenic Stroke,” 
                            <E T="03">N Engl J Med,</E>
                             May 26, 2016.
                        </P>
                    </FTNT>
                    <P>
                        The first three information sources all describe the BASE trial (NCT02014896), a prospective, multicenter, observational, convenience, sample cohort study of patients presenting to the hospital within 24 hours of stroke onset, which looked to determine if the etiology of acute ischemic stroke can be objectively determined by RNA expression from patient blood samples.
                        <E T="51">305 306 307</E>
                        <FTREF/>
                         The primary objective of the BASE study was to confirm the diagnostic accuracy of the ISCDx test to identify stroke subtypes in patients with acute ischemic stroke. According to the BASE Study Methodology paper by Jauch et al., while enrollment for this multisite study was ongoing at the time of publication, it was expected to hit 1000 patients by March 2017.
                        <SU>308</SU>
                        <FTREF/>
                         The Base Study Methodology paper explains that blood samples were first collected from patients presenting to the hospital within 24 hours of stroke onset, and then again collected 24 hours and 48 hours later.
                        <SU>309</SU>
                        <FTREF/>
                         The tubes were kept at room temperature for up to 24 hours and then frozen −20 °C until shipped to the Ischemia Care CLIA laboratory where the ISCDx testing was performed. From these blood samples, RNA gene expression was utilized to identify stroke etiology marker candidates. Patients who met the inclusion criteria: (1) Had experienced a suspected acute ischemic stroke within 24(+/−6) hours of symptom onset; (2) had a normal baseline CT, without hemorrhage or alternate explanation for symptoms; (3) were older than 18 years old; and (4) gave informed consent. Control samples consisted of 100 non-stroke Emergency Department patients matched on clinical risk factors of age, race, gender, smoking history, diabetes, hypertension, atrial fibrillation, and hyperlipidemia. We note that there are changes from the previously stated study methodology in the two sources the applicant included with BASE study results.
                        <E T="51">310 311</E>
                        <FTREF/>
                         For example, while the study methodology as described in the Jauch et al. paper stated that the blood samples were kept at room temperature for up to 24 hours and then frozen,
                        <SU>312</SU>
                        <FTREF/>
                         in the poster presentation by Jauch, E.C., the samples were frozen within 72 hours of collection.
                        <SU>313</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>305</SU>
                             Jauch, Edward C., on behalf of BASE clinical trial principal investigators, “RNA Expression for Diagnosis of Stroke Etiology Differentiating Large Artery and Cardioembolic Stroke: Analytical Validation of Testing From the BASE Clinical Trial,” 2020 AHA International Stroke Conference.
                        </P>
                        <P>
                            <SU>306</SU>
                             Peacock, W.F. and Edward Jauch., “Cardioembolic vs Large Artery Atherosclerotic Stroke: Can we answer Hobson's question?”, pre- publication manuscript.
                        </P>
                        <P>
                            <SU>307</SU>
                             Jauch, Edward C., et al. “Biomarkers of Acute Stroke Etiology (BASE) Study Methodology,” May 5, 2017.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>308</SU>
                             Jauch, Edward C., et al. “Biomarkers of Acute Stroke Etiology (BASE) Study Methodology,” May 5, 2017.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>309</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>310</SU>
                             Peacock, W.F. and Edward Jauch., “Cardioembolic vs Large Artery Atherosclerotic Stroke: Can we answer Hobson's question?”, pre- publication manuscript.
                        </P>
                        <P>
                            <SU>311</SU>
                             Jauch, Edward C., on behalf of BASE clinical trial principal investigators, “RNA Expression for Diagnosis of Stroke Etiology Differentiating Large Artery and Cardioembolic Stroke: Analytical Validation of Testing From the BASE Clinical Trial,” 2020 AHA International Stroke Conference.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>312</SU>
                             Jauch, Edward C., et al. “Biomarkers of Acute Stroke Etiology (BASE) Study Methodology,” May 5, 2017.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>313</SU>
                             Jauch, Edward C., on behalf of BASE clinical trial principal investigators, “RNA Expression for Diagnosis of Stroke Etiology Differentiating Large Artery and Cardioembolic Stroke: Analytical Validation of Testing From the BASE Clinical Trial,” 2020 AHA International Stroke Conference.
                        </P>
                    </FTNT>
                    <P>
                        The applicant describes a set of study results, which are detailed in the unpublished manuscript by Peacock et al. and the poster presentation by Jauch, E.C.
                        <E T="51">314 315</E>
                        <FTREF/>
                         These analyses used adjudicated stroke diagnoses, classified as CE and LA, and determined by two board-certified neurologists blinded to each other's diagnosis and biomarker results. The 218 patients enrolled were randomly assigned to a derivation cohort (70%) or validation cohort (30%). Using the derivation set gene expression levels, a signature was created to distinguish between CE and LA ischemic stroke, with the derived model then applied to the validation cohort. 59% of the participants in the study were male with a median age of 70.7 years. The median time from symptom onset to blood collection was 1200 minutes (ranging from 448 to 1568 minutes). The applicant explains that, of the 218 patients enrolled with an NIHSS&gt;5, 149 were adjudicated as CE and 69 were adjudicated as LA. Additionally, sample analysis of the derivation cohort resulted in 9,513 unique gene-level probe-sets for signature inclusion, with the best set containing 45 genes. The diagnostic gene signature results in the early validation cohort distinguished CE stroke from LA stroke with a C-statistic of 0.78 (0.50-1.0, 95% CI), sensitivity of 0.90 and specificity of 0.70. The study concluded that RNA expression accurately identifies stroke etiology.
                    </P>
                    <FTNT>
                        <P>
                            <SU>314</SU>
                             Peacock, W.F. and Edward Jauch., “Cardioembolic vs Large Artery Atherosclerotic Stroke: Can we answer Hobson's question?”, pre- publication manuscript.
                        </P>
                        <P>
                            <SU>315</SU>
                             Jauch, Edward C., on behalf of BASE clinical trial principal investigators, “RNA Expression for Diagnosis of Stroke Etiology Differentiating Large Artery and Cardioembolic Stroke: Analytical Validation of Testing From the BASE Clinical Trial,” 2020 AHA International Stroke Conference.
                        </P>
                    </FTNT>
                    <P>The applicant also provided the following supplemental information to support that combining three tests in the ISC-REST kit improves patient outcomes over performing the lab tests separately. Though the applicant noted that there is no direct evidence currently available regarding the impact of using the ISC-REST kit, they explain that, in their experience, clinical supporters of the ISC-REST kit claim that they would order ISC-REST kit testing 100% of the time versus ordering three separate tests. The applicant claims that there is a convenience, cost effectiveness, and time savings associated with ISC-REST during a time when hospital resources are limited. Second, the applicant states that because the QIAstat-Dx Respiratory SARS-CoV-2 Panel tests for COVID-19 as well as 12 other common respiratory illnesses, in testing for several respiratory illnesses, ISC-REST may inform care decisions. Third, the applicant states that collecting the samples for each test together and testing them in the same laboratory will ensure high levels of quality control. The applicant also claims that using the ISC-REST test kit has investigative benefits, including the ability to help track and study how long the COVID-19 antibodies last in a chronic population based upon consistent measurement of the index events (stroke and COVID-19). Finally, the applicant states that the ISC-REST kit and adoption of guideline-directed appropriate care will result in prevention of recurrent strokes because it will impact clinician choice of therapeutics.</P>
                    <P>
                        After a review of the information provided by the applicant, we have the 
                        <PRTPAGE P="25271"/>
                        following concerns with regard to the substantial clinical improvement criterion.
                    </P>
                    <P>
                        We note that all of the BASE study results that the applicant submitted provide information on the ISCDx test on its own rather than the ISC-REST test kit, for which the applicant has submitted an application for new technology add-on payment consideration.
                        <E T="51">316 317</E>
                        <FTREF/>
                         As stated in the BASE Study methodology paper by Jauch, et al., the primary objective of the BASE study is to confirm the diagnostic accuracy of the ISCDx test to identify stroke subtypes in patients with acute ischemic stroke.
                        <SU>318</SU>
                        <FTREF/>
                         No data were provided with regard to the complete ISC-REST kit, the other components individually, or any combination. We are therefore unclear as to whether it is possible to draw conclusions about substantial clinical improvement for the ISC-REST kit using the limited data provided on the ISCDx test and without any data or studies on the ISC-REST kit. Specifically, the applicant did not submit data or studies on how treatment decisions are impacted after the ISC-REST kit is used or if there is any impact on patient outcomes as a result of using the technology. While the applicant has made claims regarding reducing downstream diagnostic tests and avoiding inappropriate medical intervention by using the ISC-REST kit, it did not provide any studies or data regarding these claims. The applicant also made claims as to how the individual parts of the test impact care decisions, but similarly did not provide data to demonstrate this. For example, the applicant claimed that, in testing for several respiratory illnesses, the QIAstat-Dx Respiratory SARS-CoV-2 Panel will inform care decisions, but did not submit any evidence that this is the case. We also note that, because the applicant has not submitted evidence to demonstrate the utility of the ISC-REST kit, it seems that the additional tests outside of the ISCDx test could result in clinical burden and additional cost without demonstrated benefits.
                    </P>
                    <FTNT>
                        <P>
                            <SU>316</SU>
                             Ibid.
                        </P>
                        <P>
                            <SU>317</SU>
                             Peacock, W.F. and Edward Jauch., “Cardioembolic vs Large Artery Atherosclerotic Stroke: Can we answer Hobson's question?”, pre- publication manuscript.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>318</SU>
                             Jauch, Edward C., et al. “Biomarkers of Acute Stroke Etiology (BASE) Study Methodology,” May 5, 2017.
                        </P>
                    </FTNT>
                    <P>
                        With regard to the studies submitted on ISCDx, we are unsure whether they demonstrate or examine the impacts of using the test on patient care and clinical outcomes. The applicant did not submit evidence to demonstrate that a recurrent stroke did not happen, that the use of more invasive investigational or further diagnostic tools was avoided, or that there was an increase in appropriate treatment and recurrent stroke prevention protocols after using the test. In the study methodology paper by Jauch et al., the applicant did not include full survey results because they were not available at the time the application was submitted. Additionally, we are unsure how to interpret the results from the small BASE study for ISCDx because there are variations between the study methodology as explained in the Jauch, E.C. et al. paper and the way the studies were actually conducted. For example, while the study methodology as described in the Jauch et al., paper stated that the blood samples were kept at room temperature for up to 24 hours and then frozen,
                        <SU>319</SU>
                        <FTREF/>
                         in the poster presentation by Jauch, E.C., the samples were frozen within 72 hours of collection.
                        <SU>320</SU>
                        <FTREF/>
                         We also have concerns regarding the testing accuracy of the ISCDx test. In the BASE study results that were submitted on the ISCDx test, the sensitivity was 0.90 and specificity was 0.70 for a sample size of 218 survey subjects.
                        <SU>321</SU>
                        <FTREF/>
                         Due to these figures, we question whether ISC-REST would alter the standard care ischemic stroke patients receive. Further, we note that the only trials submitted on the ISCDx test included patients whose cause of stroke was already determined. While the applicant claims that ISC-REST has the ability to stratify ischemic stroke patients early in the diagnosis process to reduce the number of cryptogenic stroke diagnoses and more appropriately manage stroke to reduce secondary recurrence, we question if there is sufficient evidence to evaluate this claim because the cause of stroke had already been determined in the study results the applicant submitted.
                    </P>
                    <FTNT>
                        <P>
                            <SU>319</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>320</SU>
                             Jauch, Edward C., on behalf of BASE clinical trial principal investigators, “RNA Expression for Diagnosis of Stroke Etiology Differentiating Large Artery and Cardioembolic Stroke: Analytical Validation of Testing From the BASE Clinical Trial,” 2020 AHA International Stroke Conference.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>321</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that there is no guideline standard of care pathway to determine cause of stroke, and uses this assertion as an underlying assumption for its claims in support of substantial clinical improvement. CMS notes that while there is room for clinicians to order certain additional tests over others depending on a patient's circumstances, there are algorithms developed by professional societies for the diagnosis and treatment of ischemic stroke.
                        <SU>322</SU>
                        <FTREF/>
                         These best practices are updated frequently to reflect current clinical research, and detail prehospital care, urgent and emergency evaluation and treatment, and in-hospital management, including early secondary prevention measures. CMS notes that by assuming that there is no guideline standard of care to determine the cause of stroke, the applicant has not presented information to compare the technology against a standard of care or other technology to allow for an assessment of whether the technology is a substantial clinical improvement over existing technologies to diagnose the cause of stroke.
                    </P>
                    <FTNT>
                        <P>
                            <SU>322</SU>
                             Power, William J. “Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association,” 
                            <E T="03">Stroke.</E>
                             2019 Dec; 50:e344 
                            <E T="03">https://doi.org/10.1161/STR.0000000000000211</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        We are also unsure whether the way the ISC-REST test kit is used will limit its ability to impact any care decisions and prevent hospital use. Specifically, we question if the extended 30-hour window for obtaining the patient samples, as well as the added element of shipping the ISC-REST kit to a single laboratory, is in line with stroke protocols, which focus on diagnosing a stroke as quickly as possible to maximize patient outcomes. There has been extensive research regarding the time-outcome relationship for stroke; because brain cells die rapidly after the event of the stroke, effective treatment must start as early as possible.
                        <SU>323</SU>
                        <FTREF/>
                         Since every minute matters in stroke treatment and secondary prevention, we believe that clinicians may order further diagnostic tests and begin a treatment plan before the ISC-REST kit results become available, which may limit the utility of the technology and its ability to impact care decisions. In other words, CMS questions whether ISC-REST would improve or alter the standard course of treatment for ischemic stroke due to the delay in receiving test results. We further note that sending the ISC-REST test kit to an external lab may cause a delay in COVID-19 test results as well. Therefore, we remain unclear as to the clinical benefit of combining these tests and are unsure how this potential for delay in results affects the technology's ability to impact care decisions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>323</SU>
                             Harpaz, Dorin., et al., “Point-of-Care-Testing in Acute Stroke Management: An Unmet Need Ripe for Technological Harvest,” 
                            <E T="03">Biosensors (Basel),</E>
                             2017 Sep; 7(3): 30. Published online 2017 Aug 3. DOI: 10.3390/bios7030030.
                        </P>
                    </FTNT>
                    <PRTPAGE P="25272"/>
                    <P>The applicant also submitted various narrative responses claiming that testing for COVID-19 at the same time as testing for the cause of the ischemic stroke constitutes substantial clinical improvement over existing technologies. Regarding the applicant's claims that the ISC-REST test kit is convenient for clinicians, CMS is unsure whether there is currently a need to order testing for COVID-19 along with the ISCDx test because, during the COVID-19 public health emergency, many hospitals automatically test for COVID-19 upon hospital admission to ensure proper treatment and containment. Further, CMS is unsure whether convenience for clinicians is evidence of substantial clinical improvement. With regard to the applicant's claim that, in its experience, clinical supporters of the ISC-REST kit claim that they would order ISC-REST kit testing 100% of the time versus ordering three separate tests, it is unclear whether clinical supporters of the ISC-REST kit are representative of all providers, including those participating in Medicare. Similarly, the applicant did not provide evidence to support its claim that ISC-REST will help gather data on any connection between COVID-19 and stroke, including a tracking mechanism for how long COVID-19 antibodies last, such as how ISC-REST would be better at gathering data on COVID-19 and stroke than other COVID-19 diagnostics.</P>
                    <P>
                        Regarding the applicant's claims that knowing the results of all three tests in the ISC-REST kit, including COVID-19 status, impacts clinicians' choice of therapeutics for secondary stroke prevention or other treatment decisions, we are not sure that this conclusion can be reached as the connection between COVID-19 and stroke has not been established. As evidence of the connection between COVID-19 and stroke, the applicant claims that the cryptogenic rate is higher for stroke patients with COVID-19 than stroke patients without COVID-19 and references a study of one hospital, where 32 patients hospitalized for COVID-19 or positive for COVID-19 experienced an ischemic stroke during a one-month period of time in the spring of 2020. Other studies have been conducted researching the possible link between COVID-19 and stroke, including one study with a larger sample size, analyzing over 27,000 participants across 54 health care facilities, that suggests that stroke in COVID-19 patients is infrequent, and is associated with typical stroke risk factors.
                        <SU>324</SU>
                        <FTREF/>
                         Another study, analyzing data from close to 25,000 discharges from a large New York-based health care system from January to April 2020, did not identify a positive association between ischemic stroke and COVID-19.
                        <SU>325</SU>
                        <FTREF/>
                         Based on the information that the applicant submitted, it is also unclear whether stroke treatment for an ischemic stroke patient, who is also COVID-19 positive, would be different than for an ischemic stroke patient who is COVID-19 negative. For example, it is unclear whether a stroke patient would not receive antiplatelet or anticoagulative treatment due to a COVID-19 diagnosis. Because the connection between stroke and COVID-19 is unclear and is still in the preliminary stages of research, we are unsure whether testing for the type of ischemic stroke as well as COVID-19 status is a substantial clinical improvement over existing technologies. As stated previously, the applicant did not submit studies or data on how using the ISC-REST kit has an impact on downstream treatment decisions or patient outcomes to determine whether knowing a patient's COVID-19 status and the type of ischemic stroke they experienced is a substantial clinical improvement over existing technologies. Furthermore, as there is research that casts doubt on the connection between COVID-19 and stroke,
                        <E T="51">326 327</E>
                        <FTREF/>
                         we question whether placing an emphasis on COVID-19 status and stroke may discourage a clinician from continuing to investigate the cause or treat an underlying predisposing condition for stroke, once the patient has recovered from COVID-19, and whether this could potentially lead to negative patient outcomes.
                    </P>
                    <FTNT>
                        <P>
                            <SU>324</SU>
                             Qureshi, et al. “Acute Ischemic Stroke and COVID-19: An Analysis of 27,676 Patients,” 
                            <E T="03">Stroke,</E>
                             4 Feb 2021, 
                            <E T="03">https://www.ahajournals.org/doi/abs/10.1161/STROKEAHA.120.031786</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>325</SU>
                             Bekelis, et al. Ischemic Stroke Occurs Less Frequently in Patients With COVID-19: A Multicenter Cross-Sectional Study, 
                            <E T="03">Stroke,</E>
                             51(12):3570-3476, 27 Oct 2020, 
                            <E T="03">https://pubmed.ncbi.nlm.nih.gov/33106109/#affiliation-1</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>326</SU>
                             Qureshi, et al. “Acute Ischemic Stroke and COVID-19: An Analysis of 27,676 Patients,” 
                            <E T="03">Stroke,</E>
                             4 Feb 2021, 
                            <E T="03">https://www.ahajournals.org/doi/abs/10.1161/STROKEAHA.120.031786</E>
                            . Qureshi, et al., 2021, Ibid.
                        </P>
                        <P>
                            <SU>327</SU>
                             Bekelis, et al. Ischemic Stroke Occurs Less Frequently in Patients With COVID-19: A Multicenter Cross-Sectional Study, 
                            <E T="03">Stroke,</E>
                             51(12):3570-3476, 27 Oct 2020, 
                            <E T="03">https://pubmed.ncbi.nlm.nih.gov/33106109/#affiliation-1</E>
                            . Bekelis, et al., 2020, Ibid.
                        </P>
                    </FTNT>
                    <P>We are inviting public comments on whether ISC-REST meets the substantial clinical improvement criterion.</P>
                    <P>
                        We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for ISC-REST.
                    </P>
                    <HD SOURCE="HD3">j. Lifileucel</HD>
                    <P>Iovance Biotherapeutics submitted an application for new technology add-on payments for lifileucel for FY 2022. According to the applicant, lifileucel is a proprietary, one-time autologous Tumor Infiltrating Lymphocytes (TIL) cell-based therapy being studied for effectiveness in solid tumors. TIL cell therapy with lifileucel involves the adoptive cell transfer (ACT) of autologous T-cells directly isolated from the tumor tissue and expanded ex vivo without any prior selection or genetic modification. Tumor antigen-specific T-cells are located within tumor lesions, where a dysfunctional state and low numbers prevent them from effectively eradicating the tumor. By isolating autologous TIL from the tumor microenvironment and expanding them, the lifileucel manufacturing process produces large numbers of reinvigorated T-cells. Following the infusion of lifileucel, the TIL migrate back into the tumor, including metastases, where they trigger specific tumor cell killing upon recognition of tumor antigens.</P>
                    <P>
                        According to the applicant, relapsed and refractory metastatic melanoma presents a high unmet medical need with low survival rates and limited durable treatment options.
                        <SU>328</SU>
                        <FTREF/>
                         Despite the advances in available treatments, responses in patients with metastatic melanoma are at times inadequate, with many patients either not responding (40% to 65%) 
                        <E T="51">329 330</E>
                        <FTREF/>
                         or displaying primary or acquired resistance (&gt;70%) and the disease progresses.
                        <E T="51">331 332 333 334 335</E>
                        <FTREF/>
                         The applicant 
                        <PRTPAGE P="25273"/>
                        stated there are currently no approved agents for the treatment of patients with metastatic melanoma who fail available standard-of-care therapies, which include immune checkpoint inhibitors (ICI) and BRAF/MEK inhibitors. According to the applicant, the only commonly used available therapy for these patients post progression is chemotherapy. The applicant stated that as demonstrated in the literature referenced previously, retreatment with chemotherapy 
                        <E T="51">336 337 338</E>
                        <FTREF/>
                         or experimental combined ICIs 
                        <SU>339</SU>
                        <FTREF/>
                         offers a poor Objective Response Rate (ORR) 
                        <SU>340</SU>
                        <FTREF/>
                         of 4%-10%,
                        <E T="51">341 342</E>
                        <FTREF/>
                         a median PFS of 2.7-3.7 months 
                        <E T="51">343 344 345</E>
                        <FTREF/>
                         and a median OS of ~7-8 months.
                        <E T="51">346 347</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>328</SU>
                             Sarnaik A, et al. Safety and efficacy of lifileucel (LN-144) tumor infiltrating lymphocyte therapy in metastatic melanoma patients after progression on multiple therapies—independent review committee data update. Poster presented at SITC 2019. Poster Number: P865 and abstract; Journal: J Immunotherapy Cancer 2020;8:A12.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>329</SU>
                             Mooradian MJ and Sullivan RJ. What to do when anti-PD-1 therapy fails in patients with melanoma. Oncology (Williston Park) 2019;33:141-8.
                        </P>
                        <P>
                            <SU>330</SU>
                             Gide TN, et al. Primary and acquired resistance to immune checkpoint inhibitors in metastatic melanoma. Clin Cancer Res 2018;24:1260-70.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>331</SU>
                             Luke JJ, et al. Targeted agents and immunotherapies: Optimizing outcomes in melanoma. Nature Reviews Clinical Oncology. Doi:10.1038/ncrclinonc.2017.43. Published online April 4, 2017.
                        </P>
                        <P>
                            <SU>332</SU>
                             Mooradian MJ and Sullivan RJ. What to do when anti-PD-1 therapy fails in patients with melanoma. Oncology (Williston Park) 2019;33:141-8.
                        </P>
                        <P>
                            <SU>333</SU>
                             Gide TN, et al. Primary and acquired resistance to immune checkpoint inhibitors in 
                            <PRTPAGE/>
                            metastatic melanoma. Clin Cancer Res 2018;24:1260-70.
                        </P>
                        <P>
                            <SU>334</SU>
                             Schachter J, et al. Pembrolizumab versus ipilimumab for advanced melanoma: Final overall survival results of a multicenter, randomized, open-label phase 3 study (KEYNOTE-006). Lancet 2017; 390:1853-62.
                        </P>
                        <P>
                            <SU>335</SU>
                             Ugurel S, et al. Survival of patients with advanced metastatic melanoma: The impact of novel therapies-update 2017. Eur J Cancer 2017; 83:247-257.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>336</SU>
                             Goldinger SM, et al. The utility of chemotherapy after immunotherapy failure in metastatic melanoma: A multicenter case series. J Clin Oncol 2018;36:e21588-e.
                        </P>
                        <P>
                            <SU>337</SU>
                             Larkin J, et al. Overall survival in patients with advanced melanoma who received nivolumab versus investigator's Choice chemotherapy in CheckMate 037: A randomized, controlled, open-label Phase III trial. J Clin Oncol 2018;36:383-90.
                        </P>
                        <P>
                            <SU>338</SU>
                             Ribas A, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): A randomised, controlled, phase 2 trial. Lancet Oncol. 2015; 16(8): 908-18.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>339</SU>
                             Kirchberger MC, et al. Combined low-dose ipilimumab and pembrolizumab after sequential ipilimumab and pembrolizumab failure in advanced melanoma. Eur J Cancer. 2016;65:182-184. doi:10.1016/j.ejca. 2016.07.003.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>340</SU>
                             As used by the applicant and the studies provided, Objective Response Rate (ORR) is the combination of Complete and Partial Responses.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>341</SU>
                             Larkin J, et al. Overall survival in patients with advanced melanoma who received nivolumab versus investigator's Choice chemotherapy in CheckMate 037: A randomized, controlled, open-label Phase III trial. J Clin Oncol 2018;36:383-90.
                        </P>
                        <P>
                            <SU>342</SU>
                             Ribas A, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): A randomised, controlled, phase 2 trial. Lancet Oncol. 2015; 16(8): 908-18.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>343</SU>
                             Goldinger SM, et al. The utility of chemotherapy after immunotherapy failure in metastatic melanoma: A multicenter case series. J Clin Oncol 2018;36:e21588-e.
                        </P>
                        <P>
                            <SU>344</SU>
                             Larkin J, et al. Overall survival in patients with advanced melanoma who received nivolumab versus investigator's Choice chemotherapy in CheckMate 037: A randomized, controlled, open-label Phase III trial. J Clin Oncol 2018;36:383-90.
                        </P>
                        <P>
                            <SU>345</SU>
                             Ribas A, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): A randomised, controlled, phase 2 trial. Lancet Oncol. 2015; 16(8): 908-18.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>346</SU>
                             Kirchberger MC, et al. Combined low-dose ipilimumab and pembrolizumab after sequential ipilimumab and pembrolizumab failure in advanced melanoma. Eur J Cancer. 2016;65:182-184. doi:10.1016/j.ejca. 2016.07.003.
                        </P>
                        <P>
                            <SU>347</SU>
                             Goldinger SM, et al. The utility of chemotherapy after immunotherapy failure in metastatic melanoma: A multicenter case series. J Clin Oncol 2018;36:e21588-e.
                        </P>
                    </FTNT>
                    <P>With respect to the newness criterion, the applicant stated that they are currently awaiting FDA approval of the Biologics License Application (BLA) for lifileucel as an autologous TIL immunotherapy indicated for the treatment of patients with unresectable or metastatic melanoma who have been previously treated with at least one systemic therapy, including a PD-1 blocking antibody and, if BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor. The applicant stated that currently, there are no ICD-10-PCS procedure codes to uniquely identify procedures involving lifileucel. We note that the applicant has submitted a request for approval for a unique ICD-10-PCS code for the administration of lifileucel beginning in FY 2022.</P>
                    <P>If a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>
                        With regard to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, the applicant asserted that lifileucel is not the same or similar to the mechanism of action of currently available products used in the treatment of advanced melanoma. According to the applicant, prior to 2011, the most common first-line treatment for patients with Stage III unresectable or Stage IV unresectable metastatic melanoma was single-agent therapy using dacarbazine (DTIC) or another alkylating agent, or combination chemotherapy using DTIC together with a platinum-based drug such as carboplatin and/or a microtubule inhibitor such as paclitaxel.
                        <E T="51">348 349 350</E>
                        <FTREF/>
                         IL-2 therapy has also been used as part of a biochemotherapy (BCT) antineoplastic regimen. The applicant asserted that since 2011, treatment options for advanced-stage melanoma have included kinase inhibitors such as BRAF and MEK inhibitors, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and programmed cell-death protein 1 (PD-1) blocking antibodies. According to the applicant, the currently available first and second line treatments for advanced melanoma include kinase inhibitors (BRAF and MEK inhibitors) and ICIs (anti-CTLA-4 antibody and anti-PD1 antibody).
                        <SU>351</SU>
                        <FTREF/>
                         The applicant asserts that there are no approved treatment options for patients with metastatic melanoma that have progressed after two lines of therapy.
                    </P>
                    <FTNT>
                        <P>
                            <SU>348</SU>
                             Gogas HD, et al. The role of taxanes in the treatment of metastatic melanoma. Melanoma Res. 2004;14(5): 415-420.
                        </P>
                        <P>
                            <SU>349</SU>
                             Yang AS and Chapman PB. The history and future of chemotherapy for melanoma. Hematol Oncol Clin North Am. 2009;23(3): 583-597.
                        </P>
                        <P>
                            <SU>350</SU>
                             Yushak M, et al. Advances in the systemic treatment of metastatic melanoma. Oncology (Williston Park). 2013; 27(5).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>351</SU>
                             Luke JJ, et al. Targeted agents and immunotherapies: Optimizing outcomes in melanoma. Nature Reviews Clinical Oncology. Doi:10.1038/ncrclinonc.2017.43. Published online April 4, 2017.
                        </P>
                    </FTNT>
                    <P>According to the applicant, TIL cell therapy with lifileucel uses a novel and distinct mechanism of action which delivers a highly customized, personalized, and targeted treatment for unresectable or metastatic melanoma. Lifileucel TIL cell therapy involves the ACT of autologous T-cells directly isolated from the patient's tumor tissue and expanded ex vivo. Following the infusion of lifileucel, the TIL migrates back into the patient's tumor deposits, including metastases, where they trigger specific tumor cell killing upon recognition of tumor antigens. According to the applicant, after approval, lifileucel will be the only personalized, cellular therapy indicated for the treatment of unresectable or metastatic melanoma.</P>
                    <P>
                        The applicant asserted TIL cell therapy with lifileucel is also highly differentiated from currently approved chimeric antigen receptor (CAR) T-cell therapies which treat liquid tumors: YESCARTA® (axicabtagene ciloleucel) and KYMRIAH® (tisagenlecleucel), both approved for the treatment of large B-cell lymphoma in adults, and recently approved TECARTUS
                        <E T="51">TM</E>
                         (brexucabtagene autoleucel) indicated for the treatment of relapsed/refractory mantle cell lymphoma (MCL). According to the applicant, CAR T-cell therapies mainly target only single/surface tumor antigens, versus TIL cell therapy which targets multiple tumor antigens. The applicant stated that there are no examples of successful utility of CAR T-cell therapy in solid tumors. The applicant further stated that the TIL mechanism of action does not rely on genetically engineered receptors, but maintains some physiologic control and therefore avoids hyperactivation that may be responsible for complications from CAR T-cell therapy such as cytokine release syndrome (CRS) or neurotoxicity.
                        <SU>352</SU>
                        <FTREF/>
                         Per the applicant, 
                        <PRTPAGE P="25274"/>
                        there have been no off-tissue effects found to date following treatment with TIL cell therapy, and TIL therefore offers a differentiated safety profile compared to CAR T-cell products or ICIs and confirms the mechanism of action differentiation discussed previously.
                    </P>
                    <FTNT>
                        <P>
                            <SU>352</SU>
                             Fardis M, et al. Current and future directions for tumor infiltrating lymphocyte therapy for the 
                            <PRTPAGE/>
                            treatment of solid tumors. Cell and Gene Therapy Insights, 2020; 6(6), 855-863.
                        </P>
                    </FTNT>
                    <P>With respect to the second criterion, whether a product is assigned to the same or different MS-DRG, the applicant stated that CMS has not yet determined the MS-DRG mapping for cellular therapies such as lifileucel. The applicant asserted that while TIL cell therapy is different from CAR T-cell therapy mechanistically, from tumor (solid vs. liquid) activity, and from a safety perspective, there are other similarities that support grouping the two technologies into a common MS-DRG for autologous T-cell immunotherapy. The applicant asserted that both CAR T-cell and TIL require collection of a patient's lymphocyte cells which are the core component of a complicated and lengthy manufacturing process to produce a patient-specific therapeutic dose. The applicant added that both are primarily administered in a hospital inpatient setting because of the risk of significant but treatable adverse events. Lastly, the applicant stated because of the complex process required to develop a personalized treatment and the total cost of caring for patients who have received TIL cell therapy that is similar to CAR T-cell therapy, these cases are expected to be comparably resource intensive.</P>
                    <P>With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant stated that with FDA approval, lifileucel will be the only FDA-approved cellular treatment for patients with unresectable or metastatic melanoma who have been previously treated with at least one systemic therapy.</P>
                    <P>Based on the information provided by the applicant, we have several questions with regard to the newness criterion. With respect to the first criterion for substantial similarity, we note that for FY 2019 (83 FR 41299), CMS approved two CD19 directed CAR T-cell therapies, YESCARTA® and KYMRIAH®, for new technology add-on payments. The applicant asserted that CAR T-cell therapies and TIL therapies can be differentiated by multiple criteria as listed previously. We are seeking public comment on whether the mechanism of action for lifileucel is different from existing therapies, in particular whether the distinguishing criteria identified by the applicant are sufficient to differentiate the mechanism of action of TIL from CAR T-cell therapies.</P>
                    <P>We are inviting public comments on whether lifileucel is substantially similar to other currently available therapies and/or technologies and whether this technology meets the newness criterion.</P>
                    <P>With regard to the cost criterion, the applicant provided the following analysis to demonstrate the technology meets the cost criterion. The applicant conducted multiple analyses to include a primary cohort, a cohort with a principle or admitting ICD-10 diagnosis of melanoma and metastasis and a cohort with any ICD-10 diagnosis of melanoma and metastasis. The ICD-10 codes and MS-DRGs identified by the applicant (for the primary cohort) are listed in the following tables.</P>
                    <GPH SPAN="3" DEEP="260">
                        <GID>EP10MY21.156</GID>
                    </GPH>
                    <P>To conduct the primary analysis, the applicant identified a cohort of patients that would be eligible for lifileucel that met the criteria of having any ICD-10 diagnosis of melanoma from the following table, and any ICD-10 diagnosis of metastasis from the following table, and any ICD-10 procedure code indicating administration of IL-2 or other chemotherapy via central or peripheral vein from the following table.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="80">
                        <PRTPAGE P="25275"/>
                        <GID>EP10MY21.157</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25276"/>
                        <GID>EP10MY21.158</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="660">
                        <PRTPAGE P="25277"/>
                        <GID>EP10MY21.159</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="73">
                        <PRTPAGE P="25278"/>
                        <GID>EP10MY21.160</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="186">
                        <GID>EP10MY21.161</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>The applicant used the FY 2019 MedPAR file dataset with the FY 2019 Final Rule with Correction Notice IPPS Impact File and the FY 2022 New Technology Thresholds to perform their cost analyses. Using the FY 2019 MedPAR file dataset, the applicant's search resulted in the identification of 20 MS-DRGs to which cases in the primary cohort mapped, as previously listed. The applicant provided two sensitivity cohorts: (1) A principal or admitting ICD-10 diagnosis of melanoma and metastasis; and (2) any ICD-10 diagnosis of melanoma and metastasis. The applicant stated that the analysis was limited to Medicare discharges from facilities paid under the IPPS by only including hospitals listed in the FY 2019 Final Rule IPPS Impact File. The previously discussed criteria resulted in 220 claims from 20 MS-DRGs in the primary cohort, 1,052 claims from 79 MS-DRGs in the sensitivity cohort 1, and 6,988 claims from 369 MS-DRGs in sensitivity cohort 2. The applicant imputed a case count of 11 for those MS-DRGs with fewer than 11 cases, which per the applicant resulted in a significantly higher case count than if it used the actual case counts. The applicant stated that imputing the cases did not change the results of the charge threshold analyses presented below, and the final inflated average case-weighted standardized charge per case exceeded the case-weighted threshold in all scenarios regardless of whether the actual case count or minimimum case count of 11 is used. For each cohort, the applicant provided multiple analyses, by first using the threshold from each MS-DRG included, second using the MS-DRG 018 threshold for all included MS-DRGs and the national pharmacy CCR (0.187) to calculate charges, and lastly using the MS-DRG 018 threshold for all included MS-DRGs and the applicant-calculated CAR T-cell CCR (0.314) to calculate charges. For example, in the first analysis, the applicant used a threshold amount of $62,724 for MS-DRG 838 but in second and third analyses the applicant used a threshold of $1,251,126 for MS-DRG 838 (the same threshold for MS-DRG 018). The applicant first calculated a case weighted threshold of $70,220, $72,889, and $67,947 for the primary, sensitivity one, and sensitivity two cohorts respectively based on a case-weighted average of the threshold amounts for the MS-DRGs to which the cases identified based on the claims data search mapped. The applicant calculated a case weighted threshold of $1,251,126 for all secondary calculations where the MS-DRG 018 threshold was applied for all MS-DRGs identified. We note, in section II.D. of this proposed rule, we are proposing to assign other immunotherapies MS-DRG 018 (for example Introduction of lifileucel immunotherapy into peripheral vein, percutaneous approach, new technology group 7), in addition to CAR T-cell therapies. Therefore, it seems the appropriate threshold for comparison is that of MS-DRG 018, with an average case-weighted threshold amount of $1,251,126.</P>
                    <P>For the analyses using the MS-DRG 018 thresholds, to calculate the average charge per case, the applicant used the cases identified based on the claims data search and mapped them to the MS-DRG 018 threshold. To determine the charges for lifileucel, the applicant converted cost to charges by dividing by the FY 2021 IPPS/LTCH PPS final rule national average pharmacy CCR of 0.187, and in secondary analyses, by a CAR T-cell CCR of 0.314 calculated by the applicant. To estimate the CAR T-cell CCR, the applicant obtained the MS-DRG 018 arithmetic mean charge in the AOR/BOR FY2021 Proposed Rule File released by CMS ($1,387,946). The applicant subtracted publicly reported non-drug charges for TECARTUS of $201,610 from the total arithmetic mean charge to estimate CAR T-cell charges (approximately $1,186,336). The applicant then divided a CAR T-cell wholesale acquisition cost of $373,000 (WAC for those CAR T-cell products approved as of FY 2019) by the estimated CAR T-cell charges, to estimate a CAR T-cell CCR of 0.314 (CCR = 373,000/1,186,336).</P>
                    <P>
                        The applicant stated no charges were removed for the prior technology because previous treatments will continue to be reflected in cases where 
                        <PRTPAGE P="25279"/>
                        lifileucel is administered. Next the applicant calculated the average standardized charge per case using the FY 2019 IPPS/LTCH PPS final rule Impact file. The 2-year inflation factor of 13.2% (1.13218) was obtained from the FY 2021 IPPS/LTCH PPS final rule and applied to the average standardized charge per case.
                    </P>
                    <P>The applicant calculated the final inflated average case-weighted standardized charge per case by adding the estimated charges for the technology to the inflated average standardized charge per case. The applicant determined a final inflated average case-weighted standardized charge per case of $2,188,043 and $1,355,334 from the primary cohort, pharmacy and CAR T-cell CCR analyses with CAR T-cell thresholds respectively, which both exceed the average case-weighted threshold amount of $1,251,126.</P>
                    <P>The applicant determined a final inflated average case-weighted standardized charge per case of $2,134,830 and $1,302,121 from the sensitivity cohort one using the pharmacy and CAR T-cell CCR analyses with CAR T-cell thresholds respectively, which both exceed the average case-weighted threshold amount of $1,251,126.</P>
                    <P>The applicant determined a final inflated average case-weighted standardized charge per case of $2,131,524 and $1,298,815 from the sensitivity cohort two using the pharmacy and CAR T-cell CCR analyses with CAR T-cell thresholds respectively, which both exceed the average case-weighted threshold amount of $1,251,126. Because the final inflated average case-weighted standardized charge per case for all the analyses exceeded the average case-weighted threshold amount, the applicant maintained that the technology meets the cost criterion.</P>
                    <P>Based on the information provided by the applicant, we have the following concerns regarding the cost analysis.</P>
                    <P>As noted in previous discussions, the submitted costs for CAR T-cell therapies vary widely due to differences in provider billing and charging practices for this therapy. Therefore, with regard to the use of this data for purposes of calculating a CAR T-cell CCR, we are uncertain how representative this data is for use in the applicant's cost analyses given this potential for variability.</P>
                    <P>The applicant also uses both ICD-10 diagnosis code categories and subcategories which are not valid diagnosis codes and therefore, not appropriate to include for purposes of the cost analysis. There is a potential that inappropriately including ICD-10 diagnosis code categories and subcategories may alter the number of cases identified for inclusion in the cost analysis. We are seeking public comment on whether this issue may affect the cost analysis.</P>
                    <P>We continue to be interested in public comments regarding the eligibility of CAR T-cell technologies for new technology add-on payments when assigned to MS-DRG 018. As we have noted in prior rulemaking with regard to the CAR T-cell therapies (83 FR 41172 and 85 FR 58603 through 58608), if a new MS-DRG were to be created, then consistent with section 1886(d)(5)(K)(ix) of the Act, there may no longer be a need for a new technology add-on payment under section 1886(d)(5)(K)(ii)(III) of the Act. We invite public comments on whether lifileucel meets the cost criterion.</P>
                    <P>With respect to the substantial clinical improvement criterion, the applicant asserted that lifileucel represents a substantial clinical improvement over existing technologies. In support of this assertion, the applicant provided data from two cohorts of the C-144-01 study, an ongoing phase 2, multicenter study (NCT02360579) consisting of four cohorts:</P>
                    <P>• Cohort 1 (n=30 generation 1 non-cryopreserved TIL product), not included for review as part of the applicant's new technology add-on payment application.</P>
                    <P>• Cohort 2 (n=60 generation 2 cryopreserved TIL product), included for review as part of the applicant's new technology add-on payment application.</P>
                    <P>• Cohort 3 (a sub-sample of n=10 from cohorts 1, 2, and 4), not included for review as part of the applicant's new technology add-on payment application.</P>
                    <P>• Cohort 4 (n=75 generation 2 cryopreserved TIL product), included for review as part of the applicant's new technology add-on payment application and also provided to the FDA as part of the applicant's BLA application.</P>
                    <P>The applicant stated that C-144-01 (NCT02360579) is a multi-cohort, Phase 2 clinical trial evaluating the safety and efficacy of lifileucel in patients that have been diagnosed with unresectable or metastatic Stage IIIc or IV melanoma. In addition to what the applicant previously described, the authors stated that in a sub-group analysis of 42 patients who were primary refractory to anti-PD-1, the ORR was 40.5% comparable to the overall cohort.</P>
                    <P>
                        According to the applicant, the primary objective of this study was to evaluate the efficacy of lifileucel in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the independent review committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
                        <SU>353</SU>
                        <FTREF/>
                         The applicant added that secondary objectives were to: (1) Evaluate the efficacy endpoints of duration of response (DOR), disease control rate (DCR), and progression free survival (PFS); (2) further evaluate the efficacy of lifileucel in patients with unresectable or metatstatic melanoma by assessing ORR, DOR, DCR, and PFS; (3) to evaluate overall survival (OS); and (4) to characterize the safety profile of lifileucel. For cohort 2, 60 patients were determined to allow estimation of the ORR using the maximum half width of the two-sided 95% confidence limit of less than 13.2% when ORR is expected to range from 20-50%. For cohort 4, approximately 75 patients were planned to be infused based on the null hypothesis of 10% ORR (based on historical control) which resulted in over 90% power to demonstrate superiority to this control. Patients included in this study were 18 years or older, had an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 upon entry, an estimated life expectancy of less than or equal to 3 months, and had unresectable or metastatic melanoma (stage IIIC or IV) treated with at least one prior systemic therapy including an anti-PD-1 antibody and a BRAF/MEK inhibitor. Patients were required to have a washout period of at least 28 days from prior anticancer therapy(ies) to the start of the planned nonmyeloablative lymphodeletion (NMA-LD) preconditioning regimen. The applicant explained that prior to the infusion of lifileucel, the patient receives NMA-LD with cyclophosphamide (60 mg/kg) intravenously daily for 2 days followed by fludarabine (25 mg/m
                        <SU>2</SU>
                        ) intravenously for 5 days to eliminate potentially suppressive immune cells which support the tumor and to maximize engraftment and potency of the lifileucel therapy through homeostatic proliferation.
                        <SU>354</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>353</SU>
                             Eisenhauer EA, et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). European Journal of Cancer. 45 (2009) 228-247.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>354</SU>
                             Rosenberg, SA and Restifo, N. Adoptive cell transfer as personalized immunotherapy for human cancer, Science. 2015;348 (6230):62-68.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that the patients in this study had a high tumor burden at baseline and had received a mean of 3.3 lines (range, 1-9) of prior therapies. Twenty-eight patients (42%) had liver and/or brain lesions at baseline. Each prior line of therapy was defined as any 
                        <PRTPAGE P="25280"/>
                        concomitant therapy given to the patient even if more than one target for each treatment was involved.
                        <SU>355</SU>
                        <FTREF/>
                         The applicant added that 77% of patients had progressed on prior anti-CTLA-4 blockade therapy, 99% had progressed on prior anti-PD-1/PD-L1 therapy, and 23% had received BRAF/MEK inhibitors. All patients had received PD on their prior therapy before study entry.
                    </P>
                    <FTNT>
                        <P>
                            <SU>355</SU>
                             Ghate S, et al. Patterns of treatment and BRAF testing with immune checkpoint inhibitors and targeted therapy in patients with metastatic melanoma presumed to be BRAF positive. Melanoma Res 2019;29:301-10.
                        </P>
                    </FTNT>
                    <P>
                        As justification for the null hypothesis of ORR less than or equal to 10%, the applicant stated that according to the NCCN guideline for metastatic melanoma, the only approved treatment is dacarbazine (DTIC) whereas other agents such as carboplatin, paclitaxel, docetaxel, nab-paclitaxel, and temozolomide are not approved by the FDA and are not appropriate as comparators. The applicant next presented the results from four studies which had at least one treatment arm receiving DTIC: (1) An abstract of a sample with metastatic melanoma previously treated with post-anti-PD-1 (no prior BRAF/MEK, metastatic melanoma) which resulted in a 10% ORR in the DTIC arm; 
                        <SU>356</SU>
                        <FTREF/>
                         (2) a sample with advanced melanoma previously treated with post-ipilimumab (+/− BRAF inhibitor) which resulted in a 10.6% ORR in the DTIC arm, (3) a sample of treatment-naïve patients with unresectable stage IIIc or IV melanoma which resulted in a 9.8% ORR in the DTIC arm,
                        <SU>357</SU>
                        <FTREF/>
                         and (4) a sample of chemo-naïve patients with metastatic melanoma of which 9% had received prior therapy for metastatic disease which resulted in an 11% ORR in the DTIC arm.
                        <SU>358</SU>
                        <FTREF/>
                         The applicant stated that the historical control ORR of 10% for advanced melanoma was used for two reasons. First, the results from the first study (post-anti-PD-1) 
                        <SU>359</SU>
                        <FTREF/>
                         most closely represent patients in the C-144-01 study because they received prior anti-PD-1 treatment while the other studies did not. Second, the applicant stated that response rates to chemotherapy, including DTIC, in recent phase 3 melanoma trials ranged from 4% to 10%.
                        <SU>360</SU>
                         
                        <SU>361</SU>
                        <FTREF/>
                         Also included in the application is a summary of results from six studies in patients treated with a DTIC monotherapy in advanced or metastatic melanoma prior to checkpoint inhibitor FDA approval which showed ORRs ranging from 5%-20%.
                    </P>
                    <FTNT>
                        <P>
                            <SU>356</SU>
                             Goldinger SM, et al. The utility of chemotherapy after immunotherapy failure in metastatic melanoma: A multicenter case series. J Clin Oncol 2018;36:e21588-e.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>357</SU>
                             Ribas A, et al. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol. 2013;31(5):616-622.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>358</SU>
                             Hersh EM, et al. A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapynaive patients with metastatic melanoma. Ann Oncol. 2015;26(11):2267-2274.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>359</SU>
                             Goldinger SM, et al. The utility of chemotherapy after immunotherapy failure in metastatic melanoma: A multicenter case series. J Clin Oncol 2018;36:e21588-e.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>360</SU>
                             NCCN Clinical Guidelines in Oncology (NCCN Guidelines. Cutaneous Melanoma. Versions 2018 and 2019. 
                            <E T="03">https://www.nccn.org/professionals/physician_gls/#site</E>
                            .
                        </P>
                        <P>
                            <SU>361</SU>
                             Ribas A, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): A randomised, controlled, phase 2 trial. Lancet Oncol. 2015; 16(8): 908-18.
                        </P>
                    </FTNT>
                    <P>
                        Next, the applicant discussed the efficacy results from the C-144-01 study. The applicant stated that regardless of location of tumor resected and BRAF mutational status, and across ages (20-79), patients responded to lifileucel therapy. Among patients in cohort 2 (n=66) there was an ORR of 36% (95% CI 25, 49) and a DCR of 80% (95% CI 69, 89). When considering best overall response, two patients (3%) achieved complete response (CR), 22 patients (33%) achieved partial response (PR), 29 patients (44%) achieved stable disease, 9 patients (14%) had progressive disease, and 4 patients (6%) were non-evaluable. The applicant highlighted that the ORR (36.5% for those less than 65 years and 35.7% for those 65 and older) and DCR (71.2% for those less than 65 years and 78.6% for those 65 and older) were consistent across age groups. The applicant contends that these results following the one-time, single infusion of lifileucel represent a substantial improvement over chemotherapy which offers poor ORR of 4%-10%.
                        <SU>362</SU>
                         
                        <SU>363</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>362</SU>
                             Larkin J, et al. Overall survival in patients with advanced melanoma who received nivolumab versus investigator's Choice chemotherapy in CheckMate 037: a randomized, controlled, open-label Phase III trial. J Clin Oncol 2018;36:383-90.
                        </P>
                        <P>
                            <SU>363</SU>
                             Ribas A, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): A randomised, controlled, phase 2 trial. Lancet Oncol. 2015; 16(8): 908-18.
                        </P>
                    </FTNT>
                    <P>
                        Next, the applicant asserted that, because the median duration of response (DOR) had not been reached at a median follow-up of 18.7 months, the treatment effect will be durable and provide long-term benefit to those treated with lifileucel. The applicant stated that at the median follow-up, 50% (n=12) of responders showed ongoing response to lifileucel. The applicant added that the median DOR for treatment with DTIC is 5 to 6 months 
                        <SU>364</SU>
                         
                        <SU>365</SU>
                        <FTREF/>
                         and that retreatment with an immune checkpoint inhibitor or chemotherapy has demonstrated a median overall survival of around 7-8 months.
                        <SU>366</SU>
                         
                        <SU>367</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>364</SU>
                             Gogas HJ, et al. Chemotherapy for metastatic melanoma: Time for a change? Cancer 2007;109:455-64.
                        </P>
                        <P>
                            <SU>365</SU>
                             Serrone L, et al. Dacarbazine-based chemotherapy for metastatic melanoma: Thirty-year experience overview. J Exp Clin Cancer Res 2000;19: 21-34.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>366</SU>
                             Kirchberger MC, et al. Combined low-dose ipilimumab and pembrolizumab after sequential ipilimumab and pembrolizumab failure in advanced melanoma. Eur J Cancer. 2016;65: 182-184. doi:10.1016/j.ejca. 2016.07.003.
                        </P>
                        <P>
                            <SU>367</SU>
                             Goldinger SM, et al. The utility of chemotherapy after immunotherapy failure in metastatic melanoma: A multicenter case series. J Clin Oncol 2018;36:e21588-e.
                        </P>
                    </FTNT>
                    <P>
                        Lastly, the applicant stated that the safety profile of lifileucel was consistent with the underlying advanced disease and the known toxicities associated with the single course of lymphodepleting preconditioning regimen and IL-2. The applicant stated that all patients experienced at least one treatment-emergent adverse event (TAEA) during the course of the study with the most common adverse event of any grade being hematologic along with chills, pyrexia, fatigue, tachycardia, and hypotension.
                        <SU>368</SU>
                        <FTREF/>
                         The applicant added that the most common grade 
                        <FR>3/4</FR>
                         TEAEs included thrombocytopenia (82%), anemia (56%), febrile neutropenia (55%), neutropenia (39%), hypophosphatemia (35%), leukopenia (35%), and lymphopenia (32%),
                        <SU>369</SU>
                        <FTREF/>
                         which were consistent with the lymphodepletion regimen and known profile of IL-2.
                        <SU>370</SU>
                         
                        <SU>371</SU>
                         
                        <SU>372</SU>
                        <FTREF/>
                         One patient died due to intra-abdominal hemorrhage reported as possibly related to TIL and one due to acute respiratory failure 
                        <PRTPAGE P="25281"/>
                        assessed as not related to TIL.
                        <SU>373</SU>
                        <FTREF/>
                         The applicant stated that there was no difference in the incidence of TEAEs (for example any grade, among grades 3 to 4, and among grade 5) in patients 65 or older as compared to those younger than 65. Furthermore, the applicant stated that AEs occurred and generally resolved within the first 14 days following TIL infusion and IL-2 administration, during which time patients typically remained in the inpatient setting.
                    </P>
                    <FTNT>
                        <P>
                            <SU>368</SU>
                             Sarnaik A, et al. Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advance melanoma progressed on multiple prior therapies. Oral presentation at ASCO2020. Abstract Number: 10006; Journal: J Clin Oncol 38:2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>369</SU>
                             Sarnaik A, et al. Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advance melanoma progressed on multiple prior therapies. Oral presentation at ASCO2020. Abstract Number: 10006; Journal: J Clin Oncol 38:2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>370</SU>
                             Rosenberg SA, et al. Durable complete responses in heavily pretreated patients with metastatic melanoma using Tcell transfer Immunotherapy. Clinical Cancer Research. 2011; 17(13):4550-4557. doi:10.1158/1078-0432.CCR-11-0116. 2,75,101
                        </P>
                        <P>
                            <SU>371</SU>
                             Goff SL, et al. Randomized, prospective evaluation comparing intensity of lymphodepletion before adoptive transfer of tumor-infiltrating lymphocytes for patients with metastatic melanoma. J Clin Oncol. 2016 Jul 10;34(20):2389-97. PubMed PMID: 27217459. Pubmed Central PMCID:PMC4981979.
                        </P>
                        <P>
                            <SU>372</SU>
                             Dudley ME, et al. Adoptive cell therapy for patients with metastatic melanoma: Evaluation of intensive myeloablative chemoradiation preparative regimens. J Clin Oncol. 2008; 26(32): 5233-5239.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>373</SU>
                             Sarnaik A, et al. Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advance melanoma progressed on multiple prior therapies. Oral presentation at ASCO2020. Abstract Number: 10006; Journal: J Clin Oncol 38:2020.
                        </P>
                    </FTNT>
                    <P>
                        In support of its claims regarding substantial clinical improvement, the applicant submitted four additional pieces of evidence.
                        <SU>374</SU>
                         
                        <SU>375</SU>
                         
                        <SU>376</SU>
                         
                        <SU>377</SU>
                        <FTREF/>
                         First is an article which describes the tumor-infiltrating lymphocytes (TIL) manufacturing process, the mechanism of action of these products, what the authors identify as clear advantages of TIL in the treatment of solid tumors, and lastly the results of C-144-01.
                        <SU>378</SU>
                        <FTREF/>
                         The authors stated that this onetime autologous treatment involves a product individually derived for each patient, is not selected for the recognition of shared antigens that would be expressed in normal tissues, and is specific to the tumor neoantigens, reducing the risk for autoimmune toxicity. The authors also stated that the TIL mechanism of action does not rely on engineered receptors but maintains some physiologic control and avoids hyperactivation, which therefore suggests that TIL offers a different safety profile compared to CAR T-cell products or ICIs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>374</SU>
                             Fardis M, et al. Current and future directions for tumor infiltrating lymphocyte therapy for the treatment of solid tumors. Cell and Gene Therapy Insights, 2020; 6(6), 855-863.
                        </P>
                        <P>
                            <SU>375</SU>
                             Sarnaik A, et al. Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advance melanoma progressed on multiple prior therapies. Oral presentation at ASCO2020. Abstract Number: 10006; Journal: J Clin Oncol 38:2020.
                        </P>
                        <P>
                            <SU>376</SU>
                             Sarnaik A, et al. Safety and efficacy of lifileucel (LN-144) tumor infiltrating lymphocyte therapy in metastatic melanoma patients after progression on multiple therapies—independent review committee data update. Poster presented at SITC 2019. Poster Number: P865 and abstract; Journal: J Immunotherapy Cancer 2020;8:A12. Sarnaik, 
                            <E T="03">et al.</E>
                             SITC 2019
                        </P>
                        <P>
                            <SU>377</SU>
                             Sarnaik A, et al. Lifileucel therapy leads to durable response in heavily pretreated, refractory, advanced melanoma. Poster presented at SMR 2019. Pending publication; online access: Advanced Melanoma, Practice Update, March 11, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>378</SU>
                             Fardis M, et al. Current and future directions for tumor infiltrating lymphocyte therapy for the treatment of solid tumors. Cell and Gene Therapy Insights, 2020; 6(6), 855-863.
                        </P>
                    </FTNT>
                    <P>
                        The second piece of evidence provided by the applicant is a presentation given at the 2020 ASCO annual meeting 
                        <SU>379</SU>
                        <FTREF/>
                         which, per the applicant, focused on the C-144-01 study design, overview, patient procedures, TIL manufacturing, and patient characteristics of cohort 2. The presentation asserts, as the applicant has previously, that there are currently no approved agents for patients with metastatic melanoma whose disease progressed after ICIs and BRAF/MEK inhibitors. The presentation repeats study design, patient characteristics of cohort 2, safety outcomes, and efficacy outcomes, as previously described by the applicant. The presentation states that the adverse event profile was consistent with the underlying advanced disease and the safety profile of the lymphodepletion and IL-2 regimens and adds that the median number of IL-2 doses administered was six. The author concluded that lifileucel had demonstrated potential efficacy and durability of response for patients with metastatic melanoma and that it represented a viable therapeutic option warranting further investigation (that is, pivotal Cohort 4).
                    </P>
                    <FTNT>
                        <P>
                            <SU>379</SU>
                             Sarnaik A, et al. Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advance melanoma progressed on multiple prior therapies. Oral presentation at ASCO2020. Abstract Number: 10006; Journal: J Clin Oncol 38:2020.
                        </P>
                    </FTNT>
                    <P>
                        The applicant next submitted an abstract from a poster presentation 
                        <SU>380</SU>
                        <FTREF/>
                         that discusses the TIL manufacturing process and the previously discussed study C-144-01. The presentation adds that tumors resected at local institutions were processed in central Good Manufacturing Practice (GMP) facilities for TIL production in a 22-day process. Final TIL infusion product was cryopreserved and shipped to sites. Patients received one week of cyclophosphamide/fludarabine preconditioning lymphodepletion, a single lifileucel infusion, followed by up to 6 doses of IL-2. The authors conclude by stating that response per IRC assessment and concordance between investigator read ORR and IRC will be reported.
                    </P>
                    <FTNT>
                        <P>
                            <SU>380</SU>
                             Sarnaik A, et al. Safety and efficacy of lifileucel (LN-144) tumor infiltrating lymphocyte therapy in metastatic melanoma patients after progression on multiple therapies—independent review committee data update. Poster presented at SITC 2019. Poster Number: P865 and abstract; Journal: J Immunotherapy Cancer 2020;8:A12.
                        </P>
                    </FTNT>
                    <P>
                        Lastly, the applicant submitted a peer-reviewed and published post summary presented at the Society for Melanoma Research 2019 annual meeting 
                        <SU>381</SU>
                        <FTREF/>
                         that discusses the results of the C-144-01 study as previously discussed by the applicant and other presentations. The author added that TIL therapy uses a patient's own immune cells to attack cancer. Tumor-infiltrating lymphocyte cells are extracted from a patient's own tumor tissue, expanded through a proprietary process, and infused back into the patient. After infusion, tumor-infiltrating lymphocytes reach tumor tissue, where they attack tumor cells. Lastly the author concluded that lifileucel treatment resulted in a 36.4% overall response rate with a median duration of response having not been reached after a median of one year in patients with heavily pretreated metastatic melanoma with high baseline disease burden who received prior anti-PD-1 and BRAF/MEK inhibitors.
                    </P>
                    <FTNT>
                        <P>
                            <SU>381</SU>
                             Sarnaik A, et al. Lifileucel therapy leads to durable response in heavily pretreated, refractory, advanced melanoma. Poster presented at SMR 2019. Pending publication; online access: Advanced Melanoma, Practice Update, March 11, 2020.
                        </P>
                    </FTNT>
                    <P>
                        After review of the information provided by the applicant, we have the following concerns concerning the substantial clinical improvement criterion. We note that results provided by the applicant are based on an ongoing phase two trial, C-144-01, and that these are potentially partial results from which we may not be able to draw end conclusions. We also note the potential for overestimating treatment effects when trials stop early or report interim results.
                        <SU>382</SU>
                         
                        <SU>383</SU>
                         
                        <SU>384</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>382</SU>
                             Pocock SJ. When (not) to stop a clinical trial for benefit. JAMA 2005; 294:2228e30.
                        </P>
                        <P>
                            <SU>383</SU>
                             Pocock SJ, Hughes MD. Practical problems in interim analyses, with particular regard to estimation. Control Clin Trials 1989; 10(4 Suppl): 209Se21S.
                        </P>
                        <P>
                            <SU>384</SU>
                             Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, et al. Randomized trials stopped early for benefit: A systematic review. JAMA 2005; 294:2203e9.
                        </P>
                    </FTNT>
                    <P>
                        We question the selection of ORR as the primary outcome, which combines the results of complete and partial responders. Specifically, we question if the results experienced by those who are complete responders may substantially differ from those who are partial responders. We also question the appropriateness of combining these two groups together. Further, we note that the applicant used a surrogate endpoint (ORR) rather than overall survival or other measure. We believe that this measure may not be the most appropriate measure with which to evaluate substantial clinical improvement in this patient population because it may not capture patients' clinical experience as fully as a measure of overall survival at some later time point. We are seeking public comment on whether the ORR is an appropriate measure of efficacy of this and other treatments when considering substantial clinical improvement.
                        <PRTPAGE P="25282"/>
                    </P>
                    <P>Lastly, we note that a historical control is used for all of the studies provided and that the analyses using this historical control do not account for baseline differences between the groups being compared. This makes it difficult to determine if the results seen are due to the treatment, random occurrences, or bias. Further, we note that the patient sample or samples used to construct the historical control may not be representative of the C-144-01 cohort. We are unable to verify the appropriateness of this historical control because the evidence describing the historical control takes the form of abstracts or was not provided.</P>
                    <P>We are inviting public comments on whether lifileucel meets the substantial clinical improvement criterion.</P>
                    <P>
                        We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for lifileucel.
                    </P>
                    <HD SOURCE="HD3">k. Narsoplimab</HD>
                    <P>The Omeros Corporation submitted an application for new technology add-on payments for narsoplimab for FY 2022. Narsoplimab is a fully human monoclonal antibody for the treatment of HSCT-TMA, also known as transplant-associated thrombotic microangiopathy (TA-TMA), for which the applicant has submitted a Biologics License Application (BLA). According to the applicant, narsoplimab inhibits mannan-binding lectin serine protease 2 (MASP-2), the effector enzyme of the lectin pathway of the complement system, and activation of the lectin pathway that prevents complement-mediated inflammation and exhibits anticoagulant effects while leaving intact the respective functions of the classical and alternative pathways of innate immunity. According to the applicant, there are currently no FDA-approved products indicated for the treatment of hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA).</P>
                    <P>
                        According to the applicant, HSCT-TMA is a lethal complication of hematopoietic stem cell transplantation (HSCT) that results in thrombosis in the small blood vessels, leading to organ failure.
                        <SU>385</SU>
                         
                        <SU>386</SU>
                         
                        <SU>387</SU>
                        <FTREF/>
                         According to the applicant, clinical guidelines for the treatment of HSCT-TMA are being developed by members of the American Society for Transplant and Cellular Therapy (ASTCT) and are expected to be published in 2021. The applicant stated that current management of HSCT-TMA includes modification or cessation of any immune-suppressive regimen, appropriate treatment of infections and/or graft-versus-host disease (GvHD) if present, aggressive control of hypertension, and other supportive therapy as deemed appropriate by the treating physician.
                        <SU>388</SU>
                        <FTREF/>
                         However, according to the applicant, the withdrawal of immunosuppressive therapies and ongoing monitoring for resolution of TMA symptoms has been determined to be ineffective.
                        <SU>389</SU>
                        <FTREF/>
                         The applicant stated that there are multiple off-label treatments for HSCT-TMA which have either not been reviewed by the FDA or have been reviewed and not deemed adequate for registration purposes; these unapproved treatments include therapeutic plasma exchange (TPE), eculizumab, defibrotide sodium, rituximab, and vincristine sulfate. The applicant asserted that available evidence for agents used off-label to treat HSCT-TMA is derived from observational studies and case series with mixed results, and none of the agents have been evaluated for efficacy or safety in a robust clinical trial in patients with HSCT-TMA.
                        <SU>390</SU>
                        <FTREF/>
                         In summary, the applicant stated with regard to these unapproved therapies that: (1) The use of TPE is based on the extrapolation of its effectiveness for thrombocytopenic purpura with poor outcomes leading the Blood and Marrow Transplant Clinical Trials Network Toxicity Committee in 2005 to recommend that TPE not be considered as a standard of care for HSCT-TMA; 
                        <SU>391</SU>
                        <FTREF/>
                         (2) eculizumab is a C5 inhibitor that blocks activation of the terminal cascade of complement 
                        <SU>392</SU>
                        <FTREF/>
                         of which the use is constrained by lack of efficacy and safety evaluations by the FDA 
                        <SU>393</SU>
                        <FTREF/>
                         and associated increased susceptibility to infections; 
                        <SU>394</SU>
                         
                        <SU>395</SU>
                        <FTREF/>
                         (3) defibrotide (Defitelio®), an oligonucleotide mixture with profibrinolytic properties whose mechanism of action has not been fully elucidated 
                        <SU>396</SU>
                        <FTREF/>
                         is not approved by the FDA for the treatment of HSCT-TMA nor considered a standard of care; (4) rituximab (Rituxan®), a monoclonal antibody that targets the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes,
                        <SU>397</SU>
                        <FTREF/>
                         is not approved by the FDA for the treatment of HSCT-TMA; and (5) Vincristine sulfate, a vinca alkaloid isolated as a 1:1 sulfate salt from the periwinkle plant is not approved by the FDA for the treatment of HSCT-TMA.
                        <SU>398</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>385</SU>
                             Gavriilaki, E et al. Transplant-associated thrombotic microangiopathy: Opening Pandora's box. Bone Marrow Transplantation (2017) 52, 1355-1360.
                        </P>
                        <P>
                            <SU>386</SU>
                             Jodele, S et al (2016). New approaches in the diagnosis, pathophysiology, and treatment of pediatric hematopoietic stem cell transplantation-associated thrombotic microangiopathy. Transfus Apher Sci. 2016 April; 54(2): 181-190.
                        </P>
                        <P>
                            <SU>387</SU>
                             Rosenthal, J Hematopoietic cell transplantation-associated thrombotic microangiopathy: A review of pathophysiology, diagnosis, and treatment. Journal of Blood Medicine 2016:7 181-186.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>388</SU>
                             Khosla J et al. Hematopoietic stem cell transplant-associated thrombotic microangiopathy: Current paradigm and novel therapies. Bone Marrow Transplant. 2018; 53(2):129-137.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>389</SU>
                             Li A et al. Transplant-associated thrombotic microangiopathy is a multifactorial disease unresponsive to immunosuppressant withdrawal. Biol Blood Marrow Transplant. 2019; 25(3):570-576.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>390</SU>
                             Li A et al. Transplant-associated thrombotic microangiopathy is a multifactorial disease unresponsive to immunosuppressant withdrawal. Biol Blood Marrow Transplant. 2019; 25(3):570-576.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>391</SU>
                             Schwatz, J et al. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice— Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Seventh Special Issue. Journal of Clinical Apheresis 31:149-338 (2016).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>392</SU>
                             FDA. (2019, june). 
                            <E T="03">Soliris Prescribing Information.</E>
                             Retrieved from Highlights of Prescribing Information: 
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125166s431lbl.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>393</SU>
                             Li A et al. Transplant-associated thrombotic microangiopathy is a multifactorial disease unresponsive to immunosuppressant withdrawal. Biol Blood Marrow Transplant. 2019;25(3):570-576.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>394</SU>
                             Bohl SR, Kuchenbauer F, von Harsdorf S, Kloevekorn N, Schonsteiner SS, Rouhi A, et al. Thrombotic Microangiopathy after Allogeneic Stem Cell Transplantation: A Comparison of Eculizumab Therapy and Conventional Therapy. Biol Blood Marrow Transplant. 2017; 23(12):2172-7.
                        </P>
                        <P>
                            <SU>395</SU>
                             Khosla J et al. Hematopoietic stem cell transplant-associated thrombotic microangiopathy: Current paradigm and novel therapies. Bone Marrow Transplant. 2018; 53(2):129-137.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>396</SU>
                             FDA. (2016, march). 
                            <E T="03">Defitelio Prescribing Information.</E>
                             Retrieved from Highlights of Prescribing Information: 
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208114lbl.pdf</E>
                             Defitelio PI. 3/2016.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>397</SU>
                             FDA. (2019, september). Rituxan 
                            <E T="03">Prescribing Information.</E>
                             Retrieved from Highlights of Prescribing Information: 
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5450lbl.pdf</E>
                             Rituxan PI. 9/2019.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>398</SU>
                             FDA. (2020, july). Vincristine 
                            <E T="03">Prescribing Information.</E>
                             Retrieved from Highlights of Prescribing Information: 
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202497s011lbl.pdf</E>
                             Vincristine PI. 7/2020.
                        </P>
                    </FTNT>
                    <P>
                        With respect to the newness criterion, the applicant stated in its application that it is in the process of completing a rolling submission of a Biologics License Application (BLA) to the FDA for narsoplimab for the treatment of HSCT-TMA. According to the applicant, narsoplimab has received Orphan Drug designation and Breakthrough Therapy Designation from FDA for the treatment of patients with HSCT-TMA who have persistent thrombotic microangiopathy despite modification of immunosuppressive therapy. The applicant submitted a request for approval for a unique ICD-10-CM code for HSCT-TMA and an 
                        <PRTPAGE P="25283"/>
                        ICD-10-PCS code for the administration of narsoplimab; there are currently no ICD-10-CM codes that describe HSCT-TMA or ICD-10-PCS codes that describe narsoplimab.
                    </P>
                    <P>If a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>
                        With regard to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, the applicant asserted that narsoplimab has a unique mechanism of action as it is the first therapeutic to target mannan-binding lectin serine protease 2 (MASP-2) and the first to inhibit the lectin pathway of the complement system. The applicant stated that MASP-2 inhibition specifically blocks the lectin pathway of complement but does not inhibit the classical and alternative pathways, leaving the complement system's effector function in adaptive immunity intact, which is important for fighting infection.
                        <SU>399</SU>
                         
                        <SU>400</SU>
                        <FTREF/>
                         According to the applicant, the mechanism of action of narsoplimab not only results in inhibition of lectin pathway-mediated activation of complement, but also blocks the MASP-2 mediated procoagulant activities in the coagulation cascade. The procoagulant effects of MASP-2, independent of its role in the complement system, include the conversion of prothrombin to thrombin as well as the activation of Factor XII to XIIa.
                        <SU>401</SU>
                         
                        <SU>402</SU>
                         
                        <SU>403</SU>
                        <FTREF/>
                         In addition, MASP-2 is activated by fibrin and activated platelets, further augmenting a procoagulant state.
                        <SU>404</SU>
                        <FTREF/>
                         The applicant asserted that by inhibiting these procoagulant activities of MASP-2, narsoplimab provides important anticoagulant benefits, without affecting bleeding parameters (that is, prothrombin time, activated partial thromboplastin time, international normalized ratio, or bleeding time). According to the applicant, narsoplimab is the only drug that addresses all the components of HSCT-TMA and is the only product that inhibits complement activation and has anticoagulant activity. Therefore, the applicant asserts that the mechanism of action of narsoplimab differs from that of the products occasionally used off label: eculizumab, defibrotide sodium, rituximab, and vincristine.
                    </P>
                    <FTNT>
                        <P>
                            <SU>399</SU>
                             Rambaldi, A et al. Improved survival following OMS721 treatment following hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCTTMA). European Hematology Society. Stockholm, June 15, 2018. Abstract PF724.
                        </P>
                        <P>
                            <SU>400</SU>
                             Elhadad, S et al 2020. MASP2 levels are elevated in thrombotic microangiopathies: association with microvascular endothelial cell injury and suppression by anti-MASP2 antibody narsoplimab. Clinical and Experimental Immunology, 0: 2-9.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>401</SU>
                             Demopulos, Gregory, A. Dudler, Thomas, Nilsson, Bo. Compositions and methods of inhibiting MASP-2 for the treatment of various thrombotic diseases and disorders. WO2019246367 (US20200140570A1). World International Property Organization. 26 December 2019.
                        </P>
                        <P>
                            <SU>402</SU>
                             Krarup, A et al. Simultaneous Activation of Complement and Coagulation by MBLAssociated Serine Protease 2. 2007. PLoS ONE 2(7): e623.
                        </P>
                        <P>
                            <SU>403</SU>
                             Gulla, KC et al. Activation of mannan-binding lectin-associated serine proteases leads to generation of a fibrin clot. Immunology, 2009. 129, 482-495.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>404</SU>
                             Kozarcanin, H et al. The lectin complement pathway serine proteases (MASPs) represent a possible crossroad between the coagulation and complement systems in thromboinflammation. Journal of Thrombosis and Haemostasis, 2016. 14: 531-545.
                        </P>
                    </FTNT>
                    <P>With respect to the second criterion, whether a product is assigned to the same or different MS-DRG, the applicant stated that patients who receive narsoplimab will be assigned to the same DRGs as patients who are diagnosed with HSCT-TMA/transplant-associated thrombotic microangiopathy (TA-TMA) regardless of the treatment.</P>
                    <P>
                        With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant stated that narsoplimab treats a different disease than existing technologies. According to the applicant, when treating HSCT-TMA, clinicians may rely on approaches that have limited efficacy 
                        <SU>405</SU>
                        <FTREF/>
                         such as to reduce or discontinue anti-GVHD therapies (for example, calcineurin inhibitors), initiate therapeutic plasma exchange (TPE), and/or administer anti-CD20 antibody therapies, terminal complement inhibitors and/or oligonucleotide therapies.
                        <SU>406</SU>
                         
                        <SU>407</SU>
                         
                        <SU>408</SU>
                        <FTREF/>
                         The applicant stated that narsoplimab will be the first technology specifically indicated to treat HSCT-TMA.
                    </P>
                    <FTNT>
                        <P>
                            <SU>405</SU>
                             Li A et al. Transplant-associated thrombotic microangiopathy is a multifactorial disease unresponsive to immunosuppressant withdrawal. Biol Blood Marrow Transplant. 2019; 25(3):570-576.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>406</SU>
                             Dhakal P et al. Is complement blockade an acceptable therapeutic strategy for hematopoietic cell transplant-associated thrombotic microangiopathy? Bone Marrow Transplant. 2017; 52(3):352-356.
                        </P>
                        <P>
                            <SU>407</SU>
                             Khosla J et al. Hematopoietic stem cell transplant-associated thrombotic microangiopathy: current paradigm and novel therapies. Bone Marrow Transplant. 2018; 53(2):129-137.
                        </P>
                        <P>
                            <SU>408</SU>
                             Li A et al. Transplant-associated thrombotic microangiopathy is a multifactorial disease unresponsive to immunosuppressant withdrawal. Biol Blood Marrow Transplant. 2019; 25(3):570-576.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, existing products that are currently used off-label to treat HSCT-TMA patients are indicated for the treatment of other distinct diseases. Eculizumab is indicated for: (1) The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; (2) the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy; (3) the treatment of anti-acetylcholine antibody-positive generalized myasthenia gravis; and (4) the treatment of anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).
                        <SU>409</SU>
                        <FTREF/>
                         Defibrotide sodium is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction following HSCT.
                        <SU>410</SU>
                        <FTREF/>
                         The applicant further asserted that HSCT-TMA is different from aHUS due to varying underlying causes (that is, Shiga toxin infection, genetic mutation),
                        <SU>411</SU>
                        <FTREF/>
                         its association with receipt of a stem cell transplant and associated endothelial cell injury,
                        <SU>412</SU>
                        <FTREF/>
                         and aHUS resulting from mutations and/or polymorphisms in complement genes rather than having received an HSCT.
                        <SU>413</SU>
                         
                        <SU>414</SU>
                        <FTREF/>
                         In regard to VOD, the applicant asserts that while this patient population is similar to HSCT-TMA patients with regard to both having received HSCT, VOD is a separate disease affecting only the liver whereas HSCT-TMA is a multi-factorial disease impacting many organ systems, such as the kidneys, the lungs, the CNS and the gastrointestinal tract.
                        <SU>415</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>409</SU>
                             FDA. (2019, june). 
                            <E T="03">Soliris Prescribing Information.</E>
                             Retrieved from Highlights of Prescribing Information: 
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125166s431lbl.pdf</E>
                             Soliris PI. 6/2019.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>410</SU>
                             FDA. (2016, march). 
                            <E T="03">Defitelio Prescribing Information.</E>
                             Retrieved from Highlights of Prescribing Information: 
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208114lbl.pdf</E>
                             Defitelio PI. 3/2016.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>411</SU>
                             Lee, H et al. Consensus regarding diagnosis and management of atypical hemolytic uremic syndrome. 2020. Korean J Intern Med 2020; 35:25-40.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>412</SU>
                             Rosenthal, J Hematopoietic cell transplantation-associated thrombotic microangiopathy: a review of pathophysiology, diagnosis, and treatment. Journal of Blood Medicine 2016:7 181-186.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>413</SU>
                             Rosenthal, J Hematopoietic cell transplantation-associated thrombotic microangiopathy: a review of pathophysiology, diagnosis, and treatment. Journal of Blood Medicine 2016:7 181-186.
                        </P>
                        <P>
                            <SU>414</SU>
                             Masias, C et al. None of the above: thrombotic microangiopathy beyond TTP and HUS. Blood. 2017; 129(21):2857-2863.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>415</SU>
                             Bonifazi, F et al. Diagnosis and Treatment of VOD/SOS After Allogeneic Hematopoietic Stem Cell Transplantation. Front Immunol. 2020; 11: 489.
                        </P>
                    </FTNT>
                    <P>
                        Furthermore, the applicant summarized key distinctions between HSCT-TMA and the diseases for which 
                        <PRTPAGE P="25284"/>
                        the other off-label therapeutics are indicated (eculizumab, defibrotide sodium, plasmapheresis with fresh frozen plasma and rituximab). According to the applicant, HSCT-TMA is associated with HSCT endothelial cell injury, has unique triggers such as immune dysregulation caused by infection, chemotherapy, and GVHD, and involves the initiation of the complement system including the lectin pathway. Atypical hemolytic uremic syndrome (aHUS), treated by eculizumab, is associated with unchecked abnormal activation of alternative complement system due to genetic mutations in complement factors or inhibitory autoantibodies to factor H and I and has an onset that is idiopathic or secondary to triggers such as infection, fever, pregnancy, malignant hypertension, transplant, and diarrheal illnesses. Veno-occlusive disease (VOD), treated by defibrotide sodium, is a complication observed after HSCT where sinusoidal endothelial cells and hepatocytes in zone 3 of the hepatic acinus are damaged by toxic metabolites generated during the conditioning regimen. Thrombocytopenic purpura (TTP), treated by plasmapheresis with fresh frozen plasma and rituximab, is characterized by an ADAMTS-13 deficiency that is not commonly seen in HSCT-TMA with decreased ADAMTS activity due to genetic alterations to the gene or presence of inhibitory autoantibodies.
                    </P>
                    <P>In summary, the applicant believes that narsoplimab is not substantially similar to other currently available therapies and/or technologies and meets the “newness” criterion. We note that the applicant asserts that there are no FDA-approved products indicated for the treatment of HSCT-TMA and we are inviting public comment on whether narsoplimab therefore has a unique mechanism of action. In addition, we note that although the cause or triggers of thrombotic microangiopathy may be different between HSCT and for example HUS or TTP, the resulting disease may be similar. We welcome public comments on whether HSCT-TMA is a similar disease to other forms of TMA.</P>
                    <P>We are inviting public comments on whether narsoplimab is substantially similar to other currently available therapies and/or technologies and whether this technology meets the newness criterion.</P>
                    <P>With regard to the cost criterion, the applicant provided the following analysis to demonstrate the technology meets the cost criterion. The applicant stated that due to what it described as a lack of sufficient coding in the HSCT-TMA space, the applicant provided multiple scenarios to show that narsoplimab meets the cost criterion. The applicant stated they are not requesting that narsoplimab map to a new or different MS-DRG.</P>
                    <P>The applicant used the full calendar year 2019 National Medicare 100% inpatient Limited Dataset to identify patients with a combined diagnosis of history of stem cell transplantation (SCT, ICD-10 code Z94.84) OR complications of stem cell transplant (ICD-10 code T86.5) AND thrombotic microangiopathy (TMA, ICD-10 code M31.1) OR hemolytic-uremic syndrome (HUS, ICD-10 code D59.3). Claims from PPS-exempt hospitals were excluded. In the base case analysis where all MS-DRGs were included, a total of 83 cases across 38 MS-DRGs were identified. The applicant imputed a case count of 11 for those MS-DRGs with fewer than 11 cases, which increased the number of claims from 83 to 396 because all MS-DRGs had fewer than 11 claims. The applicant then varied this initial analysis in two ways. First, sensitivity analyses one and two varied the reduction for the charges related to the prior technology to 25 percent and 50 percent of prior related therapy charges, respectively, which are possibly tied to decreased length of stay and/or decreased ICU utilization. Second, the applicant provided four scenarios which varied the price of narsoplimab from zero to three greater values.</P>
                    <P>The applicant first calculated a case weighted threshold of $96,810 for all scenarios based upon the dollar threshold for each MS-DRG grouping and the proportion of cases in each MS-DRG. The applicant then calculated the average charge per case. The applicant stated that because narsoplimab is an adjunctive therapy, no charges for a prior technology or a technology being replaced were removed. In the base case analysis, no charges related to the prior technology were removed because narsoplimab is not anticipated to offset standard of care costs. However, according to the applicant, because of a reduction in complications leading to mortality and other clinically significant complications, narsoplimab is anticipated to decrease the rate of hospitalization and length of stay. Therefore, two sensitivity analyses were included which removed 25 percent and 50 percent of prior related therapy charges which could potentially be related to a decrease in length of stay and/or decrease in ICU utilization in sensitivity analyses one and two, respectively. The applicant stated the 50% charge reduction analysis was performed as an extreme analysis to examine the unlikely possibility that narsoplimab offsets a considerable amount of costs associated with treating TMA. Because of the reduction in complications leading to mortality and other clinically significant complications, the applicant asserted that for many with long-term sequelae, narsoplimab is anticipated to decrease the rate of hospitalization and length of stay. Next the applicant calculated the average standardized charge per case using the FY 2021 IPPS/LTCH PPS final rule Impact file. The 2-year inflation factor of 13.2% (1.13218) was obtained from the FY 2021 IPPS/LTCH PPS final rule and applied to the average standardized charge per case.</P>
                    <P>To determine the charges for narsoplimab, the applicant converted cost to charges by dividing by the FY 2021 IPPS/LTCH PPS final rule national average drug CCR of 0.187. No charges related to the use of the technology were added by the applicant because utilization of narsoplimab is not anticipated to result in incremental costs. The applicant calculated the final inflated average case-weighted standardized charge per case by adding the charges for the technology to the inflated average standardized charge per case. In the base analysis where a technology related price of $0 was used, the applicant determined a final inflated average case-weighted standardized charge per case of $363,815, which exceeds the average case-weighted threshold amount of $96,810. In the same base analysis, the applicant determined a final inflated average case-weighted standardized charge per case of $272,861 in scenario one of the sensitivity analyses, which exceeds the average case-weighted threshold amount of $96,810. Lastly, in the same base analysis, the applicant determined a final inflated average case-weighted standardized charge per case of $181,908 in scenario two of the sensitivity analyses, which exceeds the average case-weighted threshold amount of $96,810. The applicant then provided a secondary cost analysis where the price of narsoplimab was the average of the three greater values used as the charges for the technology, and identified a final inflated average case-weighted standardized charge per case of $898,574, $807,621, and $716,667 in the base, 25 percent sensitivity, and 50 percent sensitivity analyses respectively.</P>
                    <P>
                        We note that in its application, the applicant only provided, in Excel format, the primary base analysis without sensitivity scenarios. We are therefore unable to verify all other analyses, to include the sensitivity 
                        <PRTPAGE P="25285"/>
                        analyses, discussed in this section and in the application. The applicant includes many MS-DRGs which are defined by other factors which may or may not be related to the intended indication for narsoplimab. For instance, the applicant identified MS-DRG 193 (Simple Pneumonia and Pleurisy with MCC) for inclusion in the cost analysis. Therefore, we are uncertain if the cases identified in the preceding cost analysis adequately identify potential cases eligible for narsoplimab. We are seeking public comment with regard to whether the MS-DRGs used in these cost analyses are appropriately representative of the cases that would be eligible for use of the technology. We invite public comments on whether narsoplimab meets the cost criterion.
                    </P>
                    <P>With respect to the substantial clinical improvement criterion, the applicant asserted that narsoplimab represents a substantial clinical improvement over existing technologies. According to the applicant, compared to the current recommendation of cessation of immunosuppressive therapies, narsoplimab demonstrates a substantial clinical improvement for the treatment of HSCT-TMA because it fulfills an unmet need for patients, demonstrated a statistically significant complete response rate in the pivotal clinical trial, provides a reduction in clinically significant adverse events, resulted in higher 100-day survival rates, decreases the rate of subsequent therapeutic interventions, and is anticipated to decrease the rate of hospitalizations and length of stay.</P>
                    <P>The applicant asserts that narsoplimab offers a treatment option for a patient population unresponsive to current available treatments. According to the applicant, the FDA awarded narsoplimab Breakthrough Therapy designation after reviewing literature for patients similar to those in the applicant's pivotal trial. The applicant states that if approved by the FDA, narsoplimab will be the only drug or biological approved for the treatment of HSCT-TMA.</P>
                    <P>
                        In support of the assertion that narsoplimab offers a treatment option for patients unresponsive to currently available treatments, the applicant provided an abstract of their pivotal trial, a single-arm trial of 28 adult HSCT-TMA patients.
                        <SU>416</SU>
                        <FTREF/>
                         The abstract states that patients who had not responded to immunosuppression modification and who had thrombocytopenia, evidence of microangiopathic hemolytic anemia, and increased creatinine were included in the study. The applicant adds that patients with mild disease were excluded from the study. Patients received narsoplimab intravenously once weekly for four or eight weeks with a 6-week follow up period. The primary endpoint was a response-based composite measure requiring improvement both in laboratory TMA markers (platelet count and Lactate Dehydrogenase (LDH)) and in clinical status (that is organ function). Secondary endpoints were surivival and changes in laboratory TMA markers. The applicant asserts that a complete response rate of 15% was identified in conjunction with the FDA as the threshold to demonstrate efficacy for narsoplimab. The applicant states that narsoplimab resulted in a 61% complete response rate (CRR) in patients with HSCT-TMA who received at least one dose of the drug; the per protocol analysis (that is, patients who received at least the per-protocol-specified 4 weeks of treatment) resulted in a 74% complete response rate. The applicant states that these complete response rates are higher than the expected response of 10% to 15% in the absence of narsoplimab.
                    </P>
                    <FTNT>
                        <P>
                            <SU>416</SU>
                             Rambaldi, A et al. Narsoplimab for the treatment of Adult Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy European Hematology Society. Abstract S262. 2020.
                        </P>
                    </FTNT>
                    <P>
                        In applying for Breakthrough Therapy designation, the applicant states that a literature review was conducted to identify studies in a patient population similar to that in the pivotal trial. Searching in PubMed using pre-identified search terms (transplant-associated thrombotic microangiopathy; thrombotic microangiopathy stem cell; and cancer-associated thrombotic microangiopathy), the applicant identified nine references that met inclusion criteria and excluded an unknown number of articles because the patient data was not included in the publication. Studies were included if they were published in the year 2000 or later and included: (1) Survival data for patients; (2) documentation that immunosuppression was modified; and (3) documentation of patient response to immunosuppression modification.
                        <SU>417</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>417</SU>
                             Rambaldi, A et al. Improved survival following OMS721 treatment following hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCTTMA). European Hematology Society. Stockholm, June 15, 2018. Abstract PF724.
                        </P>
                    </FTNT>
                    <P>Of the nine studies included, there was a mean sample size of 7.4 ranging from 1-17 totaling 67 participants. The applicant identified a median overall survival of 21 days (95% CI 15-29) which ranged from 7 to 43 days. The applicant compared these results to those of the pivotal trial, where 16 of 28 patients died with a median overall survival of 274 days (p &lt; 0.0001) compared via a log-rank test to that identified in the literature review. The applicant stated that a one-hundred-day survival post HSCT-TMA diagnosis was observed in 68% (n=28) of the full analysis set, 83% (n=23) in the patients treated per the protocol, and 94% (n=17) of complete responders.</P>
                    <P>The applicant asserted that in a high-risk study population, narsoplimab demonstrated substantial clinical improvement compared to current treatment approaches, meaningfully decreasing the rates of clinically significant complications, including mortality, and reducing the need for subsequent interventions; as a result, narsoplimab is anticipated to decrease the rate of hospitalization and length of stay. The applicant stated that the primary objectives in the pivotal study for narsoplimab were to evaluate safety, tolerability, and response-based efficacy requiring improvement in TMA laboratory markers of platelet count and LDH and improvement in clinical status on the basis of transfusions, renal, pulmonary, gastrointestinal, and neurological symptoms. The applicant stated that platelet count on average increased from baseline over time, LDH decreased from baseline, haptoglobin steadily increased from baseline, and hemoglobin increased over time with the use of narsoplimab. The applicant reported that overall 48% and 55% of patients had freedom from red blood cell and platelet transfusions, respectively. The applicant asserted that due to the decreased rate of complications, narsoplimab has the potential to lead to decreased hospital length of stay as well as decreased intensive care usage.</P>
                    <P>Lastly, the applicant asserted that narsoplimab is well tolerated with no treatment related complications. The applicant stated that the most common adverse events in the pivotal trial were nausea, vomiting, diarrhea, hypokalemia, neutropenia, and fever, which are comparable to those typically seen in the post-transplant population. Six deaths (21%) occurred, collectively, from sepsis, AML progression, and graft-versus host disease, which according to the applicant are causes of death common in patients with HSCT.</P>
                    <P>
                        In addition to the previously discussed pivotal trial abstract, the applicant submitted four additional citations (three case studies and one case series) in support of the substantial clinical improvement of narsoplimab. The first citation is described by the 
                        <PRTPAGE P="25286"/>
                        applicant as a case study of an 18-year-old patient with biopsy-proven HSCT-TMA of the gastrointestinal tract which required transfusions. The applicant states that the patient received narsoplimab which led to the resolution of TMA and all transfusions were discontinued. The applicant submitted an educational agenda in support of this citation which does not provide any additional information.
                        <SU>418</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>418</SU>
                             Rafael Duarte, Diagnosis and treatment options for transplant-associated microangiopathy. European Society for Blood and Marrow Transplantation (EBMT). Abstract 2019.
                        </P>
                    </FTNT>
                    <P>
                        The second citation concerns the results of a case study of a 14 year-old patient who did not tolerate eculizumab for the treatment of HSCT-TMA and was treated successfully with OMS721 (
                        <E T="03">i.e.,</E>
                         narsoplimab). The applicant submitted the abstract which states that after receiving allogeneic HSCT, the patient began to show progressive deterioration.
                        <SU>419</SU>
                        <FTREF/>
                         The patient was treated twice with eculizumab at months seven and eleven both resulting in pulmonary edema. The patient next received narsoplimab after which he began to improve and did not experience any adverse events.
                    </P>
                    <FTNT>
                        <P>
                            <SU>419</SU>
                             Zecca, et al. Resolution of acute kidney injury secondary to HSCT-TMA by the anti-MASP-2 monoclonal antibody OMS721 in pediatric HSCT recipient. European Society for Blood and Marrow Transplantation (EBMT). Abstract 2017.
                        </P>
                    </FTNT>
                    <P>
                        The third citation is a presentation given at the European Society for Blood and Marrow Transplantation in 2017 
                        <SU>420</SU>
                        <FTREF/>
                         which discusses a 46-year-old patient with T-acute lymphoblastic leukemia who received HSCT. The applicant states this case study is about a patient with HSCT-TMA and late-onset acute GI GVHD who was treated with narsoplimab which resulted in the resolution of melena and hemolysis, increased platelets, and neurologic improvements over 354 days.
                    </P>
                    <FTNT>
                        <P>
                            <SU>420</SU>
                             Caprioli, et al. Effective treatment of GVHD-associated transplant-associated microangiopathy Transplant Complications Working Party. Crash course on diagnosis and treatment of non-infectious complications after HCT. 19-20 October 2017 in Granada, Spain in conjunction with the European Society for Blood and Marrow Transplantation (EBMT). Abstract 2017.
                        </P>
                    </FTNT>
                    <P>
                        Lastly, the applicant submitted a presentation which discusses the results of a case series.
                        <SU>421</SU>
                        <FTREF/>
                         The applicant states that laboratory marker and clinical improvement were seen following narsoplimab treatment in severely ill, complex patients with HSCT-TMA. The case series included results from 2 patients (age 19 and age 48), both of whom underwent HSCT, the latter of which was HIV positive. The 19-year-old patient received 18 doses of narsoplimab showing favorable response with resolution of gastrointestinal bleeding and microangiopathic hemolytic anemia. The 48-year-old patient received eight doses of narsoplimab, but despite partial improvement remained on transfusions and dialysis until sudden death on day 31.
                    </P>
                    <FTNT>
                        <P>
                            <SU>421</SU>
                             Duarte, et al. Treatment of severe hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) with the MASP-2 inhibitor narsoplimab (OMS721). European Society for Blood and Marrow Transplantation (EBMT). Abstract 2020.
                        </P>
                    </FTNT>
                    <P>After review of the provided information and citations we have concerns with regard to the substantial clinical improvement criterion. Firstly, the sample from which the applicant draws conclusions is small (sample size of pivotal trial 28, plus five case studies). Furthermore, we are unable to verify the methods, results, and conclusions of these studies as the applicant only provided evidence in the form of abstracts and presentations. For example, one citation provided by the applicant in the form of a non-peer-reviewed conference poster details interim results from what appear to be the pivotal trial.</P>
                    <P>
                        With regard to methodological concerns, first, we note the potential for overestimating treatment effects when trials stop early or report interim results.
                        <SU>422</SU>
                         
                        <SU>423</SU>
                         
                        <SU>424</SU>
                        <FTREF/>
                         Second, the authors pool data from an historical cohort of patients drawn from published literature to calculate survival rates in patients with HSCT-TMA and then retrospectively compare these rates to the survival in their treated cohort. We are unable to evaluate the appropriateness of this historical comparison cohort based on the evidence provided in the form of two citations, an abstract 
                        <SU>425</SU>
                        <FTREF/>
                         and a poster.
                        <SU>426</SU>
                        <FTREF/>
                         This analysis may not adequately account for baseline differences between the patients treated with narsoplimab and the patients across the articles from which a historical control was developed. In addition, we note that we may lack the ability to evaluate whether this literature review to obtain the historical control effectively identified the historical control, as the applicant only provided general details on how the search was performed.
                    </P>
                    <FTNT>
                        <P>
                            <SU>422</SU>
                             Pocock SJ. When (not) to stop a clinical trial for benefit. JAMA 2005; 294:2228e30.
                        </P>
                        <P>
                            <SU>423</SU>
                             Pocock SJ, Hughes MD. Practical problems in interim analyses, with particular regard to estimation. Control Clin Trials 1989; 10(4 Suppl): 209Se21S.
                        </P>
                        <P>
                            <SU>424</SU>
                             Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH,Briel M, et al. Randomized trials stopped early for benefit: a systematic review. JAMA 2005; 294:2203e9.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>425</SU>
                             Rambaldi, A et al. Improved survival following OMS721 treatment following hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCTTMA). European Hematology Society. Stockholm, June 15, 2018. Abstract PF724.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>426</SU>
                             Rambaldi, A et al. Improved survival following oms721 treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (hct-tma). European Hematology Association (poster). Stockholm, June 15, 2018. Abstract PF724.
                        </P>
                    </FTNT>
                    <P>We further note that the study design described in the pivotal trial, upon which the applicant bases its claims for substantial clinical improvement, was not appropriately designed to test for comparisons with another treatment such as an historical control. Furthermore, the methods utilized in the pivotal trial do not lend themselves to making statistical inferences based on the provided protocol (for example, no power assessment performed, no assessment for multiple comparisons, no pre-identified alpha).</P>
                    <P>We are inviting public comments on whether narsoplimab meets the substantial clinical improvement criterion.</P>
                    <P>
                        We received one written comment in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                        . The commenter stated that they are enthusiastic about the results of the single arm open-label trial OMS721-TMA-001 evaluating narsoplimab for the treatment of HSCT-TMA. The commenter added that narsoplimab offers a treatment option for these high-risk patients that appears to markedly increase complete response rates with a substantial reduction in clinically significant complications including mortality. The commenter stated that the approval of the application for new technology add-on payments will help ensure appropriate patients will get the benefit of narsoplimab for treatment of HSCT-TMA.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the commenter's input and will take this comment into consideration when deciding whether to approve new technology add-on payments for narsoplimab for FY 2022.
                    </P>
                    <HD SOURCE="HD3">
                        l. NexoBrid
                        <E T="51">TM</E>
                    </HD>
                    <P>
                        Vericel Corporation submitted an application for NexoBrid
                        <E T="51">TM</E>
                         for new technology add-on payments for FY 2022. According to the applicant, NexoBrid
                        <E T="51">TM</E>
                         is a novel, non-surgical option for eschar removal (debridement). Eschar is the dead tissue and dried secretions from a skin wound following a burn, and removal is essential for wound healing. According to the applicant, NexoBrid
                        <E T="51">TM</E>
                         is a mixture of proteolytic enzymes (enriched in bromelain) and has been developed for patients with deep partial thickness (DPT) and/or full thickness 
                        <PRTPAGE P="25287"/>
                        (FT) thermal burns. According to the applicant, NexoBrid
                        <E T="51">TM</E>
                         has not yet received approval from FDA. The applicant further noted that NexoBrid
                        <E T="51">TM</E>
                         was approved by the European Medicines Agency (EMA) in 2012 and is currently commercially available in many countries.
                    </P>
                    <P>
                        The applicant stated that timely, rapid debridement of eschar in burn patients is necessary for assessing the burn injury, initiating the wound healing process, and preventing further complications, such as local infection, sepsis and extension of the burn injury.
                        <E T="51">427 428 429</E>
                        <FTREF/>
                         The applicant stated that NexoBrid
                        <E T="51">TM</E>
                         has been identified by the Biomedical Advanced Research and Development Authority (BARDA) as a critical medical countermeasure to address the public health emergency need for a debridement product for the treatment of burns in adults, especially for mass casualty events, where surgical capacity is limited, and rapid assessment of burn severity and intervention are imperative.
                        <SU>430</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>427</SU>
                             Edmondson, S. J., Jumabhoy, I. A., &amp; Murray, A. (2018). Time to start putting down the knife: A systematic review of burns excision tools of randomised and non-randomised trials. 
                            <E T="03">Burns, 44</E>
                            (7), 1721-1737.
                        </P>
                        <P>
                            <SU>428</SU>
                             Gibran, N. S., et al. (2013). Summary of the 2012 ABA burn quality consensus conference. 
                            <E T="03">Journal of Burn Care &amp; Research, 34</E>
                            (4), 361-385.
                        </P>
                        <P>
                            <SU>429</SU>
                             Xiao-Wu, et al. (2002). Effects of delayed wound excision and grafting in severely burned children. 
                            <E T="03">Archives of surgery, 137</E>
                            (9), 1049-1054.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>430</SU>
                             BARDA Initiates the Procurement of NexoBrid for Emergency Response. 
                            <E T="03">http://ir.mediwound.com/newsreleases/news-release-details/barda-initiates-procurement-nexobrid-emergency-response.</E>
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that the current standard of care for burn debridement includes surgical and non-surgical approaches. The applicant stated that the surgical approach relies primarily on surgical tangential excision through use of sharp instruments such as scalpels and dermatomes.
                        <E T="51">431 432</E>
                        <FTREF/>
                         The applicant stated that surgical procedures include minor excision, avulsion, hydrosurgery (for example, VERSAJET
                        <E T="51">TM</E>
                        ), scraping, brushing, dermabrasion, and excisions.
                        <SU>433</SU>
                        <FTREF/>
                         The applicant stated that non-surgical standard of care treatments include enzymatic debridement such as clostridial collagenase ointment (example, SANTYL®), antimicrobial agents such as silver sulfadiazine (example, SILVADENE®), or various hydrogels.
                        <E T="51">434 435 436 437 438 439</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>431</SU>
                             Edmondson, S. J., et al. (2018). Time to start putting down the knife: A systematic review of burns excision tools of randomised and non-randomised trials. 
                            <E T="03">Burns, 44</E>
                            (7), 1721-1737.
                        </P>
                        <P>
                            <SU>432</SU>
                             Hindocha, S., et al. (2013). Burn eschar debridement: a review. 
                            <E T="03">J. Wound. Technol.</E>
                             July, 12-14.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>433</SU>
                             Legemate, C. M., et al. “Application of hydrosurgery for burn wound debridement: an 8-year cohort analysis.” 
                            <E T="03">Burns</E>
                             45.1 (2019): 88-96.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>434</SU>
                             Loo, Y. L., Goh, B. K., &amp; Jeffery, S. (2018). An overview of the use of bromelain-based enzymatic debridement (NexoBrid®) in deep partial and full thickness burns: appraising the evidence. 
                            <E T="03">Journal of Burn Care &amp; Research, 39</E>
                            (6), 932-938.
                        </P>
                        <P>
                            <SU>435</SU>
                             Pham, C. H., et al. (2019). The role of collagenase ointment in acute burns: a systematic review and meta-analysis. 
                            <E T="03">Journal of wound care, 28</E>
                            (Sup2), S9-S15.
                        </P>
                        <P>
                            <SU>436</SU>
                             Cancio, L. C., Barillo, D. J., Kearns, R. D., Holmes IV, J. H., Conlon, K. M., Matherly, A. F., . . . &amp; Palmieri, T. (2017). Guidelines for burn care under austere conditions: surgical and nonsurgical wound management. 
                            <E T="03">Journal of Burn Care &amp; Research, 38</E>
                            (4), 203-214.
                        </P>
                        <P>
                            <SU>437</SU>
                             Hansbrough, J. F., et al (1995). Wound healing in partial-thickness burn wounds treated with collagenase ointment versus silver sulfadiazine cream. 
                            <E T="03">The Journal of burn care &amp; rehabilitation, 16</E>
                            (suppl_3_pt_1), 241-247.,
                        </P>
                        <P>
                            <SU>438</SU>
                             Klasen, H. J. (2000). A historical review of the use of silver in the treatment of burns. II. Renewed interest for silver. 
                            <E T="03">Burns, 26</E>
                            (2), 131-138.,
                        </P>
                        <P>
                            <SU>439</SU>
                             Soroff, H. S., &amp; Sasvary, D. H. (1994). Collagenase ointment and polymyxin B sulfate/bacitracin spray versus silver sulfadiazine cream in partial-thickness burns: A pilot study. 
                            <E T="03">The Journal of burn care &amp; rehabilitation, 15</E>
                            (1), 13-17.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, NexoBrid
                        <E T="51">TM</E>
                         is a botanical and biologic product for topical use and is comprised of two components: The NexoBrid
                        <E T="51">TM</E>
                         powder that contains the active pharmaceutical ingredient (API) and a Gel Vehicle. The NexoBrid
                        <E T="51">TM</E>
                         API is a concentrate of proteolytic enzymes enriched in bromelain extracted from pineapple stems. The applicant stated that the mechanism of action of NexoBrid
                        <E T="51">TM</E>
                         is mediated by the proteolytic activity of its enzymes and is associated with selective debridement of eschar and denatured collagen while sparing healthy tissue.
                    </P>
                    <P>
                        The applicant stated that according to the American Hospital Association (AHA) Coding Clinic, “Non-excisional debridement is coded with root operation `extraction' ”.
                        <SU>440</SU>
                        <FTREF/>
                         The applicant added that NexoBrid
                        <E T="51">TM</E>
                         could be identified with ICD-10-PCS code series 0HD Extraction of Skin or 0JD Extraction of subcutaneous tissue and fascia. The applicant stated that it has not requested that its technology map to a new or different MS-DRG.
                    </P>
                    <FTNT>
                        <P>
                            <SU>440</SU>
                             American Hospital Association (AHA) Coding Clinic, Volume 2, number 1, 2015, pg 23
                        </P>
                    </FTNT>
                    <P>
                        With respect to the newness criterion, the applicant stated they have not yet received FDA approval. The applicant submitted a Biologic License Application (BLA) for NexoBrid
                        <E T="51">TM</E>
                         for FDA approval on June 30, 2020 on the basis of two pivotal Phase 3 clinical trials. In September 2020, the FDA accepted the application and communicated a PDUFA date of June 29, 2021.
                    </P>
                    <P>
                        The applicant indicated that the ICD-10-PCS code series for non-excisional debridement, 0HD (Extraction of Skin) or 0JD (Extraction of subcutaneous tissue and fascia) could be used to identify NexoBrid
                        <E T="51">TM</E>
                         use. The applicant indicated that NexoBrid
                        <E T="51">TM</E>
                         is not separately identified with a unique ICD-10-PCS code. The applicant submitted a request for an ICD-10-PCS code to uniquely identify the use of NexoBrid
                        <E T="51">TM</E>
                         beginning in FY 2022.
                    </P>
                    <P>As discussed previously, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would, therefore, not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>
                        With respect to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, the applicant stated that NexoBrid
                        <E T="51">TM</E>
                         is unique due to the bromelain active ingredient, which is extracted from pineapple stems. The applicant claimed that a search of the FDA website for the key words “bromelain” and “pineapple” did not yield any approved applications under section 505(b)(1) of the Federal Food, Drug, and Cosmetic (FD&amp;C Act) or section 351(a) of the Public Health Service (PHS) Act.
                    </P>
                    <P>
                        With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant did not address the question directly, but stated that no existing technology used now or previously is similar to NexoBrid
                        <E T="51">TM</E>
                         that would be captured under burn MS-DRGs as identified in the following table.
                    </P>
                    <GPH SPAN="3" DEEP="55">
                        <GID>EP10MY21.162</GID>
                    </GPH>
                    <PRTPAGE P="25288"/>
                    <P>
                        With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease, and the same or similar patient population when compared to an existing technology, the applicant stated that NexoBrid
                        <E T="51">TM</E>
                         does treat the same patient population as existing approaches to eschar removal. The applicant further stated that the ability to use NexoBrid
                        <E T="51">TM</E>
                         at the bedside offers an effective option for rapid eschar removal that avoids the operating room, and that the ability to use NexoBrid
                        <E T="51">TM</E>
                         in delicate areas offers particular value in burn treatment.
                    </P>
                    <P>
                        We have the following concerns regarding whether the technology meets the substantial similarity criteria and whether it should be considered new. While the applicant discussed the differences between NexoBrid
                        <E T="51">TM</E>
                         and products made by other manufacturers, we note the applicant does not provide enough information regarding the composition of the proteolytic enzymes used within the NexoBrid
                        <E T="51">TM</E>
                         active pharmaceutical ingredient, its mechanism of action, and how the ingredient(s) differs from other enzymatic debridement products on the market. Specifically, it is not clear whether the proteolytic enzyme is a type of collagenase similar to existing collagenase based enzymatic debridement products, since the applicant claimed that NexoBrid
                        <E T="51">TM</E>
                         debrides denatured collagen in the wound. In addition, the applicant states that NexoBrid
                        <E T="51">TM</E>
                         uses a new ingredient but does not explain how this represents a new mechanism of action. We also note that, while the applicant did not state so directly, we believe that patients treated using NexoBrid
                        <E T="51">TM</E>
                         would be assigned to the same MS-DRGs as those patients who were treated with competitive products or services used for burns. We further note that the applicant did not suggest that NexoBrid
                        <E T="51">TM</E>
                         was used to treat a different population from existing treatments.
                    </P>
                    <P>
                        We are inviting public comments on whether NexoBrid
                        <E T="51">TM</E>
                         is substantially similar to other currently available therapies and/or technologies, and whether NexoBrid
                        <E T="51">TM</E>
                         meets the newness criterion.
                    </P>
                    <P>With regard to the cost criterion, the applicant provided two scenarios: Scenario 1: without grafting, which excluded cases with an ICD-10-PCS code for replacement of skin, and Scenario 2: with grafting, which required at least one ICD-10-PCS code for replacement of skin. Under the first scenario, the applicant searched the FY 2019 MedPAR dataset for cases reporting ICD-10-CM diagnosis codes for second- or third-degree burns as a primary diagnosis, and an ICD-10-PCS code(s) for excision or extraction of skin or subcutaneous tissue and fascia; these criteria resulted in the identification of 347 cases mapping to three unique MS-DRGs. Under the second scenario, the applicant again searched the FY 2019 MedPAR dataset for the same ICD-10 codes but with an additional ICD-10-PCS code for replacement of skin. Under the second scenario, the applicant identified 1,283 cases mapping to five unique MS-DRGs. In the following tables the applicant lists the MS-DRGs to which cases are assigned in each scenario:</P>
                    <GPH SPAN="3" DEEP="61">
                        <GID>EP10MY21.163</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="101">
                        <GID>EP10MY21.164</GID>
                    </GPH>
                    <P>
                        With respect to the MS-DRGs identified based on the claims search and included in the cost analysis, particularly MS-DRG 003, the applicant confirmed that this MS-DRG was appropriately representative of potential NexoBrid
                        <E T="51">TM</E>
                         patients.
                    </P>
                    <P>
                        The applicant used the FY 2019 MedPAR LDS file with the FY 2022 New Technology thresholds to calculate the case-weighted thresholds, and the FY 2019 FR IPPS/LTCH PPS standardizing file to standardize charges. The applicant then removed 100 percent of the operating room charges and 24.5 percent of the blood charges from the identified cases to conservatively estimate the charges that potentially may be avoided through the use of NexoBrid
                        <E T="51">TM</E>
                        . After standardizing the charges, the applicant applied what it indicated was the 2-year inflation factor used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier threshold charges of 13.1 percent. We note that the inflation factor was 13.2 percent (1.13218) for FY 2021 (85 FR 59039), which would have resulted in higher inflated charges. To calculate the charges for the technology, the applicant divided the cost of the technology by the national average CCR for the Drugs cost center of 0.187 from the FY 2021 IPPS/LTCH PPS final rule.
                    </P>
                    <P>
                        Under scenario one, the applicant calculated a final inflated case-weighted average standardized charge per case of $95,828, which exceeded the average case-weighted threshold amount of $55,536. Under scenario two, the final inflated average case-weighted standardized charge per case of $334,405 exceeded the average case-weighted threshold amount of $168,985. The applicant stated that because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount for both scenarios, the technology meets the cost criterion.
                        <PRTPAGE P="25289"/>
                    </P>
                    <P>
                        According to the applicant, NexoBrid
                        <E T="51">TM</E>
                         is indicated for the treatment of thermal burns. The cost analysis performed by the applicant includes MS-DRG 003 (ECMO or Tracheostomy w MV &gt;96 Hours or Principal Diagnosis Except Face, Mouth and Neck w Major O.R. Procedures), which per the applicant is appropriately representative of potential NexoBrid
                        <E T="51">TM</E>
                         patients. However, MS-DRG 003 does not appear to be representative of the target patient population for NexoBrid
                        <E T="51">TM</E>
                        . We are seeking public comment on whether the use of this MS-DRG and others for the cost analysis appropriately reflects the potential cases treated by the technology.
                    </P>
                    <P>We are inviting public comment on whether NexoBrid® meets the cost criterion.</P>
                    <P>
                        With respect to the substantial clinical improvement criterion, the applicant asserted that NexoBrid
                        <E T="51">TM</E>
                         can be used in a patient population that is unresponsive to, or ineligible for currently available treatments because NexoBrid
                        <E T="51">TM</E>
                         can be used at the bedside and is therefore an effective eschar removal option for patients for whom surgery or general anesthesia may be contraindicated. The applicant asserted that NexoBrid
                        <E T="51">TM</E>
                         allows for the diagnosis of a medical condition in a manner different from existing technology because it allows for depth-of-burn diagnoses of indeterminant depth and/or mixed depth wounds. The applicant also asserted that NexoBrid
                        <E T="51">TM</E>
                         represents a substantial clinical improvement due to significantly improved clinical outcomes in the following ways: (1) Reduction in clinically significant adverse events by reducing the surgical burden associated with surgical excision, reducing donor site morbidity due to reduced autografting, reducing blood loss due to adoption of a non-surgical approach, and reduced usage of surgical escharotomies; (2) decreased rate in a subsequent diagnostic or therapeutic intervention by reducing the need for surgical excision and reducing the need for autografts; (3) improved quality of life due to reduced scarring associated with reduction in autografting; and (4) NexoBrid
                        <E T="51">TM</E>
                         is aligned with key benefits to elderly burn patients who may be too unwell for surgical excision.
                    </P>
                    <P>
                        The applicant asserted that because NexoBrid
                        <E T="51">TM</E>
                         can be used at the bedside, it provides a unique non-surgical option for rapid, consistent eschar removal in patients for whom surgery or general anesthesia may be contraindicated. The applicant claimed that currently available non-surgical eschar removal procedures are generally considered inefficient, can result in a lengthy sloughing period, and have the potential for development of granulation tissue and increased infection and scarring.
                        <E T="51">441 442 443</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>441</SU>
                             Hansbrough, J. F., et al. (1995). Wound healing in partial-thickness burn wounds treated with collagenase ointment versus silver sulfadiazine cream. 
                            <E T="03">The Journal of burn care &amp; rehabilitation, 16</E>
                            (suppl_3_pt_1), 241-247.
                        </P>
                        <P>
                            <SU>442</SU>
                             Klasen, H. J. (2000). A historical review of the use of silver in the treatment of burns. II. Renewed interest for silver. 
                            <E T="03">Burns, 26</E>
                            (2), 131-138.
                        </P>
                        <P>
                            <SU>443</SU>
                             Soroff, H. S., &amp; Sasvary, D. H. (1994). Collagenase ointment and polymyxin B sulfate/bacitracin spray versus silver sulfadiazine cream in partial-thickness burns: a pilot study. 
                            <E T="03">The Journal of burn care &amp; rehabilitation, 15</E>
                            (1), 13-17.
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted two pivotal Phase 3 clinical trials to primarily support its claims of substantial clinical improvement. The DETECT study (NCT02148705) is a multi-center, multi-national, assessor blinded, randomized, 3:3:1 controlled, three-arm study from which data is not yet publicly available. Per the applicant, this study aimed to demonstrate superiority of NexoBrid
                        <E T="51">TM</E>
                         treatment over Gel Vehicle (placebo) control and standard of care treatment, in hospitalized adult subjects with DPT and/or FT thermal burn of 3-30% total body surface area (TBSA) and total burn wounds of no more than 30% TBSA. A total of 175 subjects were randomized in to the DETECT study with 169 subjects being treated with NexoBrid, SOC consisting of surgical and/or nonsurgical treatment as per the investigators' discretion, or placebo.
                        <SU>444</SU>
                        <FTREF/>
                         NCT00324311 is an earlier multi-center, open-label, randomized, controlled clinical trial including 156 patients aged 4-55 years with deep partial and full thickness burns covering 5-30% TBSA. Patients were randomly assigned to burn debridement with NexoBrid
                        <E T="51">TM</E>
                         or standard of care, which included surgical excisional or non-surgical debridement.
                        <SU>445</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>444</SU>
                             NexoBrid Draft Labeling Text
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>445</SU>
                             Rosenberg, L., et al, A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT. Burns 2014, Vol 40(3): 466-474.
                        </P>
                    </FTNT>
                    <P>
                        The applicant asserted that in patients with indeterminant partial-thickness and/or mixed depth burns, NexoBrid
                        <E T="51">TM</E>
                         debridement allows for a more accurate assessment of burn depth. The applicant stated, “each additional non-autografted NexoBrid
                        <E T="51">TM</E>
                        -treated patient (relative to standard of care eschar removal) has an indeterminate superficial partial thickness wound that would otherwise have been incorrectly diagnosed as a deep partial thickness wound.” The applicant suggested that deep partial thickness wounds require autografting. The applicant noted that the Phase 3 clinical trial NCT00324311 of patients with DPT and FT thickness had burns ranging from 5-30%TBSA.
                        <SU>446</SU>
                        <FTREF/>
                         The applicant claimed that it can be estimated that approximately 16.2% of NexoBrid
                        <E T="51">TM</E>
                         treated wounds (34.1% autograft rate in standard of care group minus 17.9% autograft rate in the NexoBrid
                        <E T="51">TM</E>
                         treated group) would have been autografted had other standard of care methods for burn debridement been used.
                    </P>
                    <FTNT>
                        <P>
                            <SU>446</SU>
                             Ibid. Rosenberg, L., et al, A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT. Burns 2014, Vol 40(3): 466-474.
                        </P>
                    </FTNT>
                    <P>
                        The applicant asserted that the use of NexoBrid
                        <E T="51">TM</E>
                         as a non-surgical option for treatment reduces potential adverse events that may be associated with surgery or general anesthesia such as blood loss. The applicant noted that in the DETECT trial, median blood loss during eschar removal was significantly higher in the standard of care arm compared with NexoBrid
                        <E T="51">TM</E>
                        . It also noted that the NCT00324311 trial demonstrated smaller reductions in hemoglobin and hematocrit values before and after treatment in the NexoBrid
                        <E T="51">TM</E>
                         arm compared to the standard of care arm.
                    </P>
                    <P>
                        The applicant asserted that the use of NexoBrid
                        <E T="51">TM</E>
                         may reduce instances of surgical escharotomies which may be needed when a circumferential eschar produces a tourniquet effect that compromises circulation or movement.
                        <E T="51">447 448 449</E>
                        <FTREF/>
                         According to the applicant, this requires an emergency escharotomy involving incising through areas of burnt skin to release the eschar and its constrictive effects, restore distal circulation, and allow adequate ventilation. The applicant claimed that reducing the need for an escharotomy also reduces the need for subsequent surgical reconstruction of the escharotomy wound, and potential complications, including uncontrolled bleeding, incomplete release, damage to deep structures, functional deficits, and scarring.
                    </P>
                    <FTNT>
                        <P>
                            <SU>447</SU>
                             Kreiger et al, Efficacy of enzymatic debridement of deeply burned hands. Burns 2012, Vol 38: 108-112.
                        </P>
                        <P>
                            <SU>448</SU>
                             Giudice et al, Cost Analysis of a Novel Enzymatic Debriding Agent for Management of Burn Wounds. Biomed Res Int 2017, Vol 2017.
                        </P>
                        <P>
                            <SU>449</SU>
                             Palao et al, Use of a selective enzymatic debridement agent (NexoBrid®) for wound management: Learning curve. World J of Dermatology 2017, Vol 6(2): 32-41.
                        </P>
                    </FTNT>
                    <P>
                        To support the claim that NexoBrid
                        <E T="51">TM</E>
                         reduces the time to eschar removal, the applicant asserted that NexoBrid
                        <E T="51">TM</E>
                         has been shown in the two phase 3 multi-center, randomized-controlled trials to have a lower average time of eschar removal compared to the standard of 
                        <PRTPAGE P="25290"/>
                        care, with the DETECT study demonstrating 1.0 day eschar removal versus 3.8 days and NCT00324311 demonstrating 2.2 days versus 8.7 days (p&lt;0.0001) for treated and control groups respectively.
                        <SU>450</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>450</SU>
                             Rosenberg, L., et al, A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT. Burns 2014, Vol 40(3): 466-474.
                        </P>
                    </FTNT>
                    <P>
                        The applicant also included a systematic review and meta-analysis of clostridial collagenase ointment (CCO) studies by Pham, C. H., et al. to support its claim of decreased eschar removal time as compared to existing non-surgical therapies.
                        <SU>451</SU>
                        <FTREF/>
                         Per the study, the reported average time to clean wound bed (complete eschar removal) for CCO ranged from 6 days to 9.3 days with daily dressing changes among the prospective studies included in the systematic review. We note that the literature review was limited to the efficacy and use of CCO in burn patients and did not discuss other standard of care therapies.
                    </P>
                    <FTNT>
                        <P>
                            <SU>451</SU>
                             [Insert cite]
                        </P>
                    </FTNT>
                    <P>
                        The applicant asserted that the use of NexoBrid
                        <E T="51">TM</E>
                         can lead to decreased need for surgical excision. The applicant stated that in a pooled analysis of both Phase 3 clinical trials, NexoBrid
                        <E T="51">TM</E>
                         exhibited lower incidence of surgical excision to complete eschar removal (26.9% vs 70.6%), lower mean percent wound area surgically excised (11.5% vs 55.1%), and a higher rate of complete eschar removal without rescue surgical excision (90.5% vs 70.1%) compared to standard of care. The applicant cited these results as proof of the tissue-sparing effects compared with standard of care. The applicant further stated that the NCT00324311 study 
                        <SU>452</SU>
                        <FTREF/>
                         showed that among patients with wounds comprised entirely of deep partial thickness (DPT) burns in this study, the incidence of excision or dermabrasion after debridement was statistically significantly lower with NexoBrid
                        <E T="51">TM</E>
                         compared with standard of care (15.1% vs 65.5%, p&lt;0.0001), and that the mean percent wound area excised was also statistically significantly lower with NexoBrid
                        <E T="51">TM</E>
                        , 14.6% versus 44.5% in standard of care group (p &lt;0.0001). The applicant stated that in the DETECT study, the incidence of complete eschar removal in the NexoBrid
                        <E T="51">TM</E>
                         group was 93.35% (70 of 75 patients) versus 100% in the standard of care group (which included both surgical and non-surgical debridement) versus 4.0% in the gel vehicle placebo group. The applicant stated that the incidence of excision to complete eschar removal was statistically significantly lower with NexoBrid
                        <E T="51">TM</E>
                        , 4.0% versus 72% for the standard of care group (p&lt;0.0001).
                    </P>
                    <FTNT>
                        <P>
                            <SU>452</SU>
                             Rosenberg, L., et al, A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT. Burns 2014, Vol 40(3): 466-474.
                        </P>
                    </FTNT>
                    <P>
                        The applicant asserted that the shorter time to complete eschar removal for patients treated with NexoBrid
                        <E T="51">TM</E>
                         has been shown to be associated with effective prevention of the subsequent need for autografting. The applicant stated that in the first published Phase 3 pivotal clinical trial NCT00324311,
                        <SU>453</SU>
                        <FTREF/>
                         the autograft rate was 17.9% in the NexoBrid
                        <E T="51">TM</E>
                         treated arm vs. 34.1% in the standard of care treated group (p=0.009), and the percentage of wound autografted was lower in the NexoBrid
                        <E T="51">TM</E>
                         group, 8.4% vs. 21.5% in the standard of care group (p=0.0054). The applicant further stated that among patients with at least one wound that was entirely a DPT burn, significantly fewer wound autografts were performed in the NexoBrid
                        <E T="51">TM</E>
                         group, 17.9% (19/106 wounds) versus 34% (30/88 wounds) in the standard of care group (p=0.0099), and the percent treated wound area autografted was also significantly lower in the NexoBrid
                        <E T="51">TM</E>
                         group, 8.4% versus 21.5% in the standard of care group (p=0.0054).
                    </P>
                    <FTNT>
                        <P>
                            <SU>453</SU>
                             Rosenberg, L., et al, A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT. Burns 2014, Vol 40(3): 466-474.
                        </P>
                    </FTNT>
                    <P>
                        The applicant also stated that a prospective single-arm study of NexoBrid
                        <E T="51">TM</E>
                         showed that 25 patients with partial thickness burns who were treated with NexoBrid
                        <E T="51">TM</E>
                         experienced a reduction in the need for autografting compared to patients treated with standard of care.
                        <SU>454</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>454</SU>
                             Palao, R., et al. (2017). Use of a selective enzymatic debridement agent (NexoBrid®) for wound management: Learning curve. World Journal of Dermatology, 6(2), 32-41.
                        </P>
                    </FTNT>
                    <P>
                        The applicant also cited studies comparing NexoBrid
                        <E T="51">TM</E>
                         to surgical debridement in hand and facial burns. The applicant stated that a single center controlled study of 40 hand burns demonstrated a reduced need for autografting with NexoBrid
                        <E T="51">TM</E>
                        , with 15% of patients receiving NexoBrid
                        <E T="51">TM</E>
                         compared to 95% of patients treated with the standard of care (excisional surgical debridement) requiring autografting (p=0.034).
                        <SU>455</SU>
                        <FTREF/>
                         The single center controlled study of 26 face burns demonstrated a reduced need for autografting with NexoBrid®, with 15% of patients receiving NexoBrid
                        <E T="51">TM</E>
                         compared to 77% of patients treated with the standard of care requiring autografting (p=−0.002).
                        <SU>456</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>455</SU>
                             Schulz, A., et al. (2017). Enzymatic versus traditional surgical debridement of severely burned hands: a comparison of selectivity, efficacy, healing time, and three-month scar quality. 
                            <E T="03">Journal of Burn Care &amp; Research, 38</E>
                            (4), e745-e755.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>456</SU>
                             Schulz, A., et al. (2017). Enzymatic debridement of deeply burned faces: healing and early scarring based on tissue preservation compared to traditional surgical debridement. 
                            <E T="03">Burns, 43</E>
                            (6), 1233-1243.
                        </P>
                    </FTNT>
                    <P>
                        The applicant asserted that because the use of NexoBrid
                        <E T="51">TM</E>
                         reduces areas that require autografting, this results in decreased donor site morbidity, which is particularly useful for patients with limited donor site area (example, high total body surface area burns), or risk factors for delayed wound healing (example, advanced age).
                        <E T="51">457 458</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>457</SU>
                             Holmes Iv, J. H., et al. (2018). A comparative study of the ReCell® device and autologous split-thickness meshed skin graft in the treatment of acute burn injuries. 
                            <E T="03">Journal of Burn Care &amp; Research, 39</E>
                            (5), 694-702.
                        </P>
                        <P>
                            <SU>458</SU>
                             Gould, L., et al. (2015). Chronic wound repair and healing in older adults: current status and future research. 
                            <E T="03">Wound Repair and Regeneration, 23</E>
                            (1), 1-13.
                        </P>
                    </FTNT>
                    <P>
                        Per the applicant, by selectively debriding only non-viable tissue, NexoBrid
                        <E T="51">TM</E>
                         reduces the area of burn that requires autografting compared to surgical excision and other non-surgical approaches of eschar debridement. Per the applicant, NexoBrid
                        <E T="51">TM</E>
                        's selective debridement of non-viable tissue is especially useful in delicate areas such as face,
                        <SU>459</SU>
                        <FTREF/>
                         hands,
                        <E T="51">460 461</E>
                        <FTREF/>
                         feet, and genitals which are difficult areas to excise eschar surgically.
                        <E T="51">462 463</E>
                        <FTREF/>
                         The applicant also claimed that the use of NexoBrid
                        <E T="51">TM</E>
                         results in decreased scarring from the reduced need for autografting.
                    </P>
                    <FTNT>
                        <P>
                            <SU>459</SU>
                             Schulz, A., et al. (2017). Enzymatic debridement of deeply burned faces: healing and early scarring based on tissue preservation compared to traditional surgical debridement. 
                            <E T="03">Burns, 43</E>
                            (6), 1233-1243.
                        </P>
                        <P>
                            <SU>459</SU>
                             Rosenberg et al, A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT. Burns 2014, Vol 40(3): 466-474.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>460</SU>
                             Schulz, A., et al. (2017). Enzymatic versus traditional surgical debridement of severely burned hands: a comparison of selectivity, efficacy, healing time, and three-month scar quality. 
                            <E T="03">Journal of Burn Care &amp; Research, 38</E>
                            (4), e745-e755.
                        </P>
                        <P>
                            <SU>461</SU>
                             Krieger, Y., et al. (2012). Efficacy of enzymatic debridement of deeply burned hands. 
                            <E T="03">Burns, 38</E>
                            (1), 108-112.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>462</SU>
                             Cordts, T., et al. (2016). Enzymatic debridement for the treatment of severely burned upper extremities-early single center experiences. 
                            <E T="03">BMC dermatology, 16</E>
                            (1), 1-7.
                        </P>
                        <P>
                            <SU>463</SU>
                             Hirche, C., et al. (2020). Eschar removal by bromelain based enzymatic debridement (NexoBrid®) in burns: European consensus guidelines update. 
                            <E T="03">Burns.</E>
                        </P>
                    </FTNT>
                    <P>
                        The applicant asserted that the two single-center controlled trials discussed in this section, one of patients with hand burns
                        <SU>464</SU>
                        <FTREF/>
                         and one of patients with 
                        <PRTPAGE P="25291"/>
                        facial burns,
                        <SU>465</SU>
                        <FTREF/>
                         demonstrated that cosmesis of the healed wound using NexoBrid
                        <E T="51">TM</E>
                         was comparable if not better than traditional surgical debridement (standard of care arm). In addition, per the applicant, a single arm prospective study of 36 patients showed that only 11.1% of patients treated with NexoBrid
                        <E T="51">TM</E>
                         developed hypertrophic scars.
                        <SU>466</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>464</SU>
                             Schultz et al, Enzymatic Versus Traditional Surgical Debridement of Severely Burned Hands: A Comparison of Selectivity, Efficacy, Healing Time, and Three-Month Scar Quality. J Burn Care and Research 2016, Vol 38(4): 745-755.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>465</SU>
                             Schultz et al, Enzymatic debridement of deeply burned faces: Healing and early scarring based on tissue preservation compared to traditional surgical debridement. Burns 2017b, Vol 43(2017): 1233-1243.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>466</SU>
                             Corrales-Benitez et al, Reduced need for grafting and low incidence of hypertrophic scarring in burns after enzymatic debridement. J. Plastic Surgery Latin America 2016, Vol 42(4).
                        </P>
                    </FTNT>
                    <P>
                        In further support of their statements suggesting that the use of NexoBrid
                        <E T="51">TM</E>
                         results in reduced time to complete debridement, reduced need for surgery, and reduced need for autografting, the applicant submitted a literature review that identified studies published between 2012 and 2017 involving the use of NexoBrid
                        <E T="51">TM</E>
                         in deep partial and full thickness burns.
                        <SU>467</SU>
                        <FTREF/>
                         In this article, studies were evaluated for proposed benefits of NexoBrid
                        <E T="51">TM</E>
                         and categorized under supporting evidence, contradicting evidence, and anecdotal opinions. Seven prospective studies met the inclusion criteria including four randomized controlled trials. Six proposed benefits associated with the use of NexoBrid
                        <E T="51">TM</E>
                         were extracted from the studies including reduced time to complete debridement, need for surgery, area of burns excised, need for autograft, time to wound closure, and improved scar quality. The authors of the literature review stated that most of the proposed benefits had strong supporting evidence from controlled trials as well as some anecdotal data. The authors further stated that for the proposed benefits of scar quality improvement and reduced time to wound healing, three sources and one anecdotal study provided refuting evidence. Incidence of pain was also evaluated and was mainly anecdotal, lacking formal objective assessment or cohort study.
                        <SU>468</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>467</SU>
                             Loo, Y. L., Goh, B. K., &amp; Jeffery, S. (2018). An overview of the use of bromelain-based enzymatic debridement (NexoBrid®) in deep partial and full thickness burns: appraising the evidence. 
                            <E T="03">Journal of Burn Care &amp; Research,</E>
                             39(6), 932-938.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>468</SU>
                             Loo, Y. L., Goh, B. K., &amp; Jeffery, S. (2018). An overview of the use of bromelain-based enzymatic debridement (NexoBrid®) in deep partial and full thickness burns: appraising the evidence. 
                            <E T="03">Journal of Burn Care &amp; Research, 39</E>
                            (6), 932-938.
                        </P>
                    </FTNT>
                    <P>
                        Regarding the substantial clinical improvement criterion, we have the following concerns. We note that the applicant's claims of superiority of NexoBrid
                        <E T="51">TM</E>
                         to standard of care debridement methods are non-specific because the studies cited were not designed to compare NexoBrid
                        <E T="51">TM</E>
                         to a specific non-surgical method or an enzymatic debridement product. In addition, we are unclear whether comparing NexoBrid
                        <E T="51">TM</E>
                         to a surgical treatment modality is the most appropriate comparator since mechanical means of debridement have different clinical indications, risks, and benefits compared to enzymatic debridement. We note that studies also did not demonstrate that NexoBrid
                        <E T="51">TM</E>
                         selectively debrides eschar and does not injure viable skin. In addition, it may be difficult to generalize across studies of NexoBrid
                        <E T="51">TM</E>
                         because the wound care and timing of the debridement and subsequent autografting varies across different burn centers and studies. We note that we are unable to verify the results of the DETECT study as it does not appear that this data has been published or provided by the applicant. Finally, we note that a review of seven studies of NexoBrid
                        <E T="51">TM</E>
                         
                        <SU>469</SU>
                        <FTREF/>
                         observed that when compared to the standard of care, there were variable reports of the cosmetic outcome of NexoBrid
                        <E T="51">TM</E>
                        , prolonged wound closure, longer lengths of stay, and significant pain associated with NexoBrid
                        <E T="51">TM</E>
                         eschar debridement.
                    </P>
                    <FTNT>
                        <P>
                            <SU>469</SU>
                             Loo, Y.L., et al, An Overview of the Use of Bromelain-Based Enzymatic Debridement (NexoBrid®) in Deep Partial and Full Thickness Burns: Appraising the Evidence. J Burn Care and Research 2018, Vol 39(6): 932-938.
                        </P>
                    </FTNT>
                    <P>
                        We invite public comment on whether NexoBrid
                        <E T="51">TM</E>
                         meets the substantial clinical improvement criterion.
                    </P>
                    <P>
                        We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for the NexoBrid
                        <E T="51">TM</E>
                        .
                    </P>
                    <HD SOURCE="HD3">m. Olumiant® (baricitinib)</HD>
                    <P>
                        Eli Lilly and Company submitted an application for new technology add-on payments for Olumiant® (baricitinib) for FY 2022. Olumiant® is a Janus kinase (JAK) 1 and 2 inhibitor used in combination with remdesivir as a treatment option for coronavirus disease 2019 (COVID-19), a respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Olumiant® has not yet received marketing approval from FDA to treat COVID-19, but has received an emergency use authorization (EUA) by the FDA. Olumiant® has been previously approved by FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis, who have had inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
                        <SU>470</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>470</SU>
                             Olumiant (baricitinib) [package insert]. US Food and Drug Administration. Available at 
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207924s002lbl.pdf</E>
                            . Revised July 8, 2020. Accessed October 8, 2020.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that patients diagnosed with COVID-19 are at an elevated risk for excess morbidity and mortality due to the underlying SARS-CoV-2 infection and subsequent cytokine activation. The applicant stated that the cause of respiratory failure in COVID-19 is a hyperinflammatory state characterized by upregulation of multiple cytokines and that Olumiant® may be a viable treatment in patients with COVID-19 requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) because of its anti-inflammatory activity and ability to reverse dysregulated inflammatory markers in patients with COVID-19.
                        <SU>471</SU>
                        <FTREF/>
                         The applicant noted treatment with baricitinib 4 mg resulted in reduced plasma levels of the cytokine IL-6 in hospitalized patients with COVID-19, a finding that was replicated after being observed in patients with rheumatoid arthritis.
                        <E T="51">472 473 474</E>
                        <FTREF/>
                         The applicant also claimed that Olumiant® potentially has anti-viral activity in inhibiting SARS-CoV-2 from entering and infecting lung cells due to its affinity for adaptor-associated kinase-1 (AAK1).
                        <SU>475</SU>
                        <FTREF/>
                         The applicant noted that there are ongoing 
                        <PRTPAGE P="25292"/>
                        studies to evaluate the impact of the antiviral host activity of Olumiant®.
                    </P>
                    <FTNT>
                        <P>
                            <SU>471</SU>
                             McInnes IB, Byers NL, Higgs RE, et al. Comparison of baricitinib, upadacitinib, and tofacitinib mediated regulation of cytokine signaling in human leukocyte subpopulations. Arthritis Res Ther. 2019;21(1):183. 
                            <E T="03">https://doi.org/10.1186/s13075-019-1964-1</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>472</SU>
                             Bronte V, Ugel S, Tinazzi E, et al. Baricitinib restrains the immune dysregulation in severe COVID-19 patients [published online August 18, 2020]. J Clin Invest. 
                            <E T="03">https://doi.org/10.1172/JCI141772</E>
                            .
                        </P>
                        <P>
                            <SU>473</SU>
                             Sims JT, Krishnan V, Chang CY, et al. Characterization of the cytokine storm reflects hyperinflammatory endothelial dysfunction in COVID-19 [published online September 10, 2020]. J Allergy Clin Immunol. 
                            <E T="03">https://doi.org/10.1016/j.jaci.2020.08.031</E>
                            .
                        </P>
                        <P>
                            <SU>474</SU>
                             Stebbing J, Krishnan V, de Bono S, et al; Sacco Baricitinib Study Group. Mechanism of baricitinib supports artificial intelligence-predicted testing in COVID-19 patients. EMBO Mol Med. 2020;12(8):e12697. 
                            <E T="03">https://doi.org/10.15252/emmm.202012697.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>475</SU>
                             Richardson P, Griffin I, Tucker C, Smith D, Oechsle O, Phelan A, Rawling M, Savory E, Stebbing J. Baricitinib as potential treatment for 2019-nCoV acute respiratory disease. Lancet. 2020 Feb 15; 395(10223):e30-e31. doi: 10.1016/S0140-6736(20)30304-4. Epub 2020 Feb 4. Erratum in: Lancet. 2020 Jun 20; 395(10241):1906. PMID: 32032529; PMCID: PMC7137985.
                        </P>
                    </FTNT>
                    <P>With respect to the newness criterion, Olumiant® received Emergency Use Authorization (EUA) from FDA on November 19, 2020 for the emergency use of Olumiant®, indicated for use in combination with remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in certain hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The applicant stated that it intends to submit a supplemental new drug application (sNDA) for Olumiant®.</P>
                    <P>In the FY 2009 IPPS final rule (73 FR 48561 through 48563), we revised our regulations at § 412.87 to codify our longstanding practice of how CMS evaluates the eligibility criteria for new medical service or technology add-on payment applications. We stated that new technologies that have not received FDA approval do not meet the newness criterion. In addition, we stated we do not believe it is appropriate for CMS to determine whether a medical service or technology represents a substantial clinical improvement over existing technologies before the FDA makes a determination as to whether the medical service or technology is safe and effective. For these reasons, we first determine whether a new technology meets the newness criterion, and only if so, do we make a determination as to whether the technology meets the cost threshold and represents a substantial clinical improvement over existing medical services or technologies. We also finalized at 42 CFR 412.87(c) (subsequently redesignated as 412.87(e)) that all applicants for new technology add-on payments must have FDA approval or clearance by July 1 of the year prior to the beginning of the fiscal year for which the application is being considered.</P>
                    <P>In the FY 2021 IPPS/LTCH PPS final rule, to more precisely describe the various types of FDA approvals, clearances, licensures, and classifications that we consider under our new technology add-on payment policy, we finalized a technical clarification to § 412.87(e)(2) to indicate that new technologies must receive FDA marketing authorization (for example, pre-market approval (PMA); 510(k) clearance; the granting of a De Novo classification request; approval of a New Drug Application (NDA); or Biologics License Application (BLA) licensure) by July 1 of the year prior to the beginning of the fiscal year for which the application is being considered. As noted in the FY 2021 IPPS/LTCH PPS final rule, this technical clarification did not change our longstanding policy for evaluating whether a technology is eligible for new technology add-on payment for a given fiscal year, and we continue to consider FDA marketing authorization as representing that a product has received FDA approval or clearance for purposes of eligibility for the new technology add-on payment under § 412.87(e)(2) (85 FR 58742).</P>
                    <P>An EUA by the FDA allows a product to be used for emergency use, but under our longstanding policy, we believe it would not be considered an FDA marketing authorization for the purpose of new technology add-on payments, as a product that is available only through an EUA is not considered to have FDA approval or clearance. Therefore, under the current regulations at 42 CFR 412.87(e)(2) and consistent with our longstanding policy of not considering eligibility for new technology add-on payments prior to a product receiving FDA approval or clearance, we believe a product available only through an EUA would not be eligible for new technology add-on payments.</P>
                    <P>We also refer the reader to our comment solicitation in section II.F.7 of the preamble of this proposed rule regarding how data reflecting the costs of a product with an EUA, which may become available upon authorization of the product for emergency use (but prior to FDA approval or clearance), should be considered for purposes of the 2-year to 3-year period of newness for new technology add-on payments for a product with or expected to receive an EUA, including whether the newness period should begin with the date of the EUA. With respect to Olumiant®, we are specifically requesting comment on whether the newness period for this technology would begin on November 19, 2020, the date of its EUA, when the product became available on the market.</P>
                    <P>
                        In response to the COVID-19 public health emergency (PHE), we established the New COVID-19 Treatments Add-on Payment (NCTAP) under the IPPS for COVID-19 cases that meet certain criteria (85 FR 71155). We believe that as drugs and biological products become available and are authorized for emergency use or approved by FDA for the treatment of COVID-19 in the inpatient setting, it is appropriate to increase the current IPPS payment amounts to mitigate any potential financial disincentives for hospitals to provide new COVID-19 treatments during the PHE. Therefore, effective for discharges occurring on or after November 2, 2020 and until the end of the PHE for COVID-19, we established the NCTAP to pay hospitals the lesser of (1) 65 percent of the operating outlier threshold for the claim or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment, including the adjustment to the relative weight under section 3710 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, for certain cases that include the use of a drug or biological product currently authorized for emergency use or approved for treating COVID-19.
                        <SU>476</SU>
                        <FTREF/>
                         Qualifying inpatient cases involving the use of Olumiant®, in combination with VEKLURY®, are currently eligible for NCTAP beginning November 19, 2020, the date Olumiant® received EUA, through the end of the PHE.
                    </P>
                    <FTNT>
                        <P>
                            <SU>476</SU>
                             Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, 85 FR 71142, 71155 (November 6, 2020). 
                            <E T="03">https://www.govinfo.gov/content/pkg/FR-2020-11-06/pdf/2020-24332.pdf</E>
                            .; For more information on NCTAP, refer to CMS' provider toolkit at 
                            <E T="03">https://www.cms.gov/medicare/covid-19/new-covid-19-treatments-add-payment-nctap</E>
                            .
                        </P>
                    </FTNT>
                    <P>We anticipate that there might be inpatient cases of COVID-19, beyond the end of the PHE, for which payment based on the assigned MS-DRG may not adequately reflect the additional cost of new COVID-19 treatments. In order to continue to mitigate potential financial disincentives for hospitals to provide new treatments, and to minimize any potential payment disruption immediately following the end of the PHE, we believe that the NCTAP should remain available for cases involving eligible treatments, including Olumiant®, in combination with VEKLURY®, for the remainder of the fiscal year in which the PHE ends (for example, until September 30, 2022). We refer the reader to our proposal in section II.F.8. of the preamble of this proposed rule to extend the NCTAP through the end of the fiscal year in which the PHE ends for certain products and discontinue the NCTAP for products approved for new technology add-on payments in FY 2022.</P>
                    <P>
                        The applicant indicated that Olumiant® could be reported using the ICD-10-PCS codes 3E0DXGC (Introduction of other therapeutic substance into mouth and pharynx, external approach) or 3E0G7GC (Introduction of other therapeutic substance into upper GI, via natural or artificial opening) but stated that these codes do not uniquely identify the administration of Olumiant®. We note that ICD-10-PCS codes XW0DXF5 (Introduction of other new technology therapeutic substance into mouth and pharynx, external approach, new technology group 5) and 3E0H7GC (Introduction of other therapeutic 
                        <PRTPAGE P="25293"/>
                        substance into lower G.I. via natural or artificial opening) could also be used to report use of Olumiant®. We note that as of January 1, 2021, Olumiant® is uniquely identified by ICD-10-PCS codes XW0DXM6 (Introduction of baricitinib into mouth and pharynx, external approach, new technology group 6), XW0G7M6 (Introduction of baricitinib into upper GI, via natural or artificial opening, new technology group 6), and XW0H7M6 (Introduction of baricitinib into lower GI, via natural or artificial opening, new technology group 6).
                    </P>
                    <P>As discussed previously, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>With respect to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, according to the applicant, Olumiant® does not use the same or a similar mechanism of action when compared to an existing technology to achieve a therapeutic outcome, as there are no JAK inhibitor therapies that have received an EUA or an approval from FDA to treat COVID-19.</P>
                    <P>
                        The applicant notes that currently there is one therapy approved by FDA to treat COVID-19 in hospital inpatients, remdesivir, and one therapy, besides Olumiant®, that has received EUA for the treatment of COVID-19, convalescent plasma.
                        <SU>477</SU>
                        <FTREF/>
                         The applicant claims that the mechanism of action for both of these treatments differs from Olumiant®, which works as a JAK inhibitor.
                    </P>
                    <FTNT>
                        <P>
                            <SU>477</SU>
                             The Federal Drug and Food Administration. Emergency Use Authorizations: Drug and Biological Products. 2020. 
                            <E T="03">https://www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatory-and-policy-framework/emergency-useauthorization#coviddrugs</E>
                            .
                        </P>
                    </FTNT>
                    <P>With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant stated that there are no JAK inhibitor therapies that have received an EUA or an approval from FDA for the treatment of patients with COVID-19 and that Olumiant® could therefore not be assigned to the same MS-DRG as existing technologies.</P>
                    <P>With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, according to the applicant, Olumiant® represents a potential new treatment option for adult and pediatric patients 2 years or older with suspected or laboratory-confirmed COVID-19 requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The applicant also stated that COVID-19 is an entirely distinct disease from those caused by other coronaviruses including severe acute respiratory syndrome (SARS) and the Middle East respiratory syndrome coronavirus (MERS-CoV).</P>
                    <P>In summary, the applicant asserted that Olumiant® is not substantially similar to other available therapies because, as a JAK inhibitor, it has a unique mechanism of action; there are no other products assigned to the same MS-DRG; and it treats a different patient population and disease—COVID-19. However, although there may not be any other JAK inhibitors for the treatment of COVID-19 assigned to the same MS-DRG as Olumiant®, we note that Olumiant® may map to the same MS-DRG as other existing COVID-19 treatments. We also note that Olumiant® involves the treatment of the same patient population and disease as other treatments for COVID-19, as Olumiant® is given to the same patients as remdesivir due to the EUA indication.</P>
                    <P>As discussed in section II.F.7 of the preamble, we are requesting comment regarding how data reflecting the costs of a product with an EUA, which may become available upon authorization of the product for emergency use (but prior to FDA approval or clearance), should be considered for purposes of the 2-year to 3-year period of newness for new technology add-on payments for a product with or expected to receive an EUA, including whether the newness period should begin with the date of the EUA. We are also specifically requesting comment on whether the newness period for Olumiant® would begin on November 19, 2020, the date of its EUA, when the product became available on the market.</P>
                    <P>As previously discussed, under the regulations at 42 CFR 412.87(e)(2) and consistent with our longstanding policy of not considering eligibility for new technology add-on payments prior to a product receiving FDA approval or clearance, we believe a product available only through an EUA would not be eligible for new technology add-on payments.</P>
                    <P>We are inviting public comment on whether Olumiant® meets the newness criterion.</P>
                    <P>With respect to the cost criterion, the applicant performed four analyses. Two of these analyses were based on proxy COVID-19 cases using ICD-10-CM B97.29 with additional coding to identify manifestation. The applicant stated that these cases were then differentiated into proxy COVID-19 cases with supplemental oxygen and all proxy COVID-19 cases. The applicant stated that they also conducted two supplemental analyses to confirm that actual COVID-19 cases using Olumiant® would meet the cost threshold using linked 837 and 835 inpatient Electronic Data Interchange (EDI) transaction sets that were processed during February through June of 2020. The applicant then identified COVID-19 cases with supplemental oxygen and all COVID-19 cases.</P>
                    <P>For the first analysis, the applicant searched the FY 2019 MedPAR LDS claims data file for potential cases representing patients who may be eligible for treatment using Olumiant®. The applicant identified proxy COVID-19 cases with supplemental oxygen by using ICD-10-CM diagnosis code B97.29 with one of the following ICD-10-CM codes: J12.89, J20.8, J40, J22, J98.8, and J80. The applicant excluded ICD-10-CM codes B34.2 and Z03.818. The applicant stated that this coding methodology was based on CDC guidance for coding COVID-19 cases prior to April 1, 2020. The applicant then limited the group to those cases that had ICD-10-PCS codes for supplemental oxygen. The ICD-10-PCS codes included ventilation (5A1935Z, 5A1945Z, 5A1955Z, 5A09357, 5A09358, 5A09359, 5A0935B, 5A0935Z, 5A09457, 5A09458, 5A09459, 5A0945B, 5A0945Z, 5A09557, 5A09558, 5A09559, 5A0955B, and 5A0955Z), extracorporeal membrane oxygenation (5A15223, 5A1522F, 5A1522G, 5A1522H, 5A15A2F, 5A15A2G, and 5A15A2H), and ICD-10-CM code Z99.81. This resulted in 473 cases mapping to the 11 MS-DRGs listed below.</P>
                    <GPH SPAN="3" DEEP="142">
                        <PRTPAGE P="25294"/>
                        <GID>EP10MY21.165</GID>
                    </GPH>
                    <P>For the second analysis, the applicant identified all proxy COVID-19 cases using the same ICD-10-CM codes that were previously described; however, the applicant did not include or exclude any cases based on the ICD-10-PCS codes listed in claims. This resulted in 1,726 cases mapping to the following 25 MS-DRGs.</P>
                    <GPH SPAN="3" DEEP="120">
                        <GID>EP10MY21.166</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="174">
                        <GID>EP10MY21.167</GID>
                    </GPH>
                    <P>For the third analysis, the applicant used Inovalon provider-sourced pre- and post-adjudicated claims data to identify CY 2020 claims for COVID-19 cases that may be eligible for treatment involving Olumiant®. Specifically, the applicant used linked 837 and 835 inpatient Electronic Data Interchange (EDI) transaction sets that were processed between February and June of 2020. For discharges prior to April 1, 2020, the applicant identified cases using ICD-10-CM diagnosis code B97.29 with one of the following ICD-10-CM codes: J12.89, J20.8, J40, J22, J98.8, and J80. The applicant excluded ICD-10-CM codes B34.2 and Z03.818. For cases discharged on or after April 1, 2020, the applicant identified cases using ICD-10-CM code U07.1 and excluded codes B34.2 and Z03.818. The applicant then limited the group to those cases that had ICD-10-PCS codes for supplemental oxygen. The ICD-10-PCS codes included ventilation (5A1935Z, 5A1945Z, 5A1955Z, 5A09357, 5A09358, 5A09359, 5A0935B, 5A0935Z, 5A09457, 5A09458, 5A09459, 5A0945B, 5A0945Z, 5A09557, 5A09558, 5A09559, 5A0955B, and 5A0955Z) and extracorporeal membrane oxygenation (5A15223, 5A1522F, 5A1522G, 5A1522H, 5A15A2F, 5A15A2G, and 5A15A2H), and ICD-10-CM code Z99.81 Dependence on supplemental oxygen. This resulted in 966 cases, which were mapped to the following 7 MS-DRGs:</P>
                    <GPH SPAN="3" DEEP="96">
                        <PRTPAGE P="25295"/>
                        <GID>EP10MY21.168</GID>
                    </GPH>
                    <P>For the fourth analysis, the applicant identified all COVID-19 cases using the same ICD-10-CM diagnosis codes as previously described. For discharges prior to April 1, 2020, the applicant identified cases using ICD-10-CM diagnosis code B97.29 with one of the following ICD-10-CM codes: J12.89, J20.8, J40, J22, J98.8, and J80. The applicant excluded ICD-10-CM codes B34.2 and Z03.818. For cases discharged on or after April 1, 2020, the applicant identified cases using ICD-10-CM code U07.1 and excluded codes B34.2 and Z03.818. The applicant did not include or exclude any cases based on the ICD-10-PCS codes listed in claims. Based on this analysis, the applicant found 3,826 cases, which map to 21 MS-DRGs listed below.</P>
                    <GPH SPAN="3" DEEP="250">
                        <GID>EP10MY21.169</GID>
                    </GPH>
                    <P>
                        For each analysis, the applicant then removed 12.5 percent of the length of stay charges from the relevant cases to estimate the reduction in charges due to decrease in number of hospitalization days that may be avoided through use of baricitinib. The applicant determined this percentage based on findings from the ACTT-2 trial,
                        <SU>478</SU>
                        <FTREF/>
                         sponsored by the National Institute of Allergy and Infection Diseases (NIAID), which found an improved median time to recovery from 8 to 7 days (that is, a 12.5 percent improvement).
                    </P>
                    <FTNT>
                        <P>
                            <SU>478</SU>
                             Kalil, A.C., Patterson, T.F., Mehta, A.K., et al. Baricitinib plus remdesivir for adults with Covid-19. (2020). 
                            <E T="03">New England Journal of Medicine.</E>
                             DOI: 10.1056/NEJMoa2031994
                        </P>
                    </FTNT>
                    <P>For the first two analyses, the applicant then standardized the charges and applied a 2-year inflation factor of 1.131096 that the applicant stated was used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier threshold charges. We note that the 2-year inflation factor used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier threshold charges is 1.13218, which would have increased the inflated charges figure. For analysis three and four, the applicant standardized the charges and applied a one-year inflation factor of 6.4 percent, the one-year inflation factor published in the FY 2021 IPPS/LTCH PPS final rule.</P>
                    <P>For each analysis, the applicant then calculated and added the charges for Olumiant® by taking the estimated per patient cost of the drug, and converting it to a charge by dividing the costs by the national average CCR (cost-to-charge ratio) of 0.187 for drugs from the FY 2021 IPPS/LTCH PPS final rule (85 FR 58601).</P>
                    <P>In the first analysis, which included proxy COVID-19 with supplemental oxygen cases, the applicant computed a final inflated average case-weighted standardized charge per case of $88,728, which exceeded the average case-weighted threshold amount of $69,276.</P>
                    <P>In the second analysis, which included all proxy COVID-19 cases, the applicant computed a final inflated average case-weighted standardized charge per case of $68,562, which exceeded the average case-weighted threshold amount of $56,643.</P>
                    <P>
                        In the third analysis, which included COVID-19 with supplemental oxygen cases, the applicant computed a final inflated average case-weighted 
                        <PRTPAGE P="25296"/>
                        standardized charge per case of $198,114, which exceeded the average case-weighted threshold amount of $123,238.
                    </P>
                    <P>In the fourth analysis, which included all COVID-19 cases, the applicant computed a final inflated average case-weighted standardized charge per case of $99,870, which exceeded the average case-weighted threshold amount of $75,891.</P>
                    <P>Because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount under both analyses described previously, the applicant asserted that the technology meets the cost criterion.</P>
                    <P>We invite public comments on whether Olumiant® meets the cost criterion.</P>
                    <P>
                        With respect to the substantial clinical improvement criterion, the applicant asserted that Olumiant® in combination with remdesivir represents a substantial clinical improvement over existing technologies because it improves time to recovery, improves the odds of improvement in clinical status at Day 15 after enrollment, and reduces mortality in the treatment of COVID-19 compared to remdesivir alone.
                        <SU>479</SU>
                        <FTREF/>
                         The applicant also stated that the combination of Olumiant® and remdesivir has a favorable risk/benefit profile in comparison to remdesivir alone. The applicant also claimed that Olumiant® improves respiratory function in patients treated with corticosteroids for SARS-CoV-2 pneumonia when compared with corticosteroids alone.
                    </P>
                    <FTNT>
                        <P>
                            <SU>479</SU>
                             Kalil, A.C., Patterson, T.F., Mehta, A.K., et al. Baricitinib plus remdesivir for adults with Covid-19. (2020). 
                            <E T="03">New England Journal of Medicine.</E>
                             DOI: 10.1056/NEJMoa2031994.
                        </P>
                    </FTNT>
                    <P>
                        In support of these claims, the applicant submitted the results of the Adaptive COVID-19 Treatment Trial (ACTT-2) 
                        <SU>480</SU>
                        <FTREF/>
                         which was a randomized, double-blind, placebo-controlled clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The ACTT-2 trial included 1,033 hospitalized patients with COVID-19 and assessed whether the combination of Olumiant® plus remdesivir was superior to remdesivir + placebo. There were 515 patients randomized to the treatment group and 518 to the control group. Of those in the treatment group, 507 (98.4 percent) received treatment as assigned. Of those in the control group, 509 (98.3 percent) received treatment as assigned. A total of 498 patients in the treatment group and 495 in the control group completed the trial through day 29, recovered, or died. The mean age of the patients was 55.4 years, and 63.1 percent were male. An ordinal scale was used in the study that identified the patient's baseline disease severity at enrollment and ranged from 1 (not hospitalized, no limitations on activities) to 8 (death). This scale is displayed in the table below. The intention-to-treat population included 706 patients with moderate disease (ordinal score of 4 [hospitalized, not requiring supplemental oxygen—requiring ongoing medical care] or 5 [hospitalized, requiring supplemental oxygen]) and 327 with severe disease (ordinal score of 6 [hospitalized, on non-invasive ventilation or high flow oxygen devices] or 7 [hospitalized, on mechanical ventilation or ECMO]). Patients received remdesivir intravenously as a 200-mg loading dose on day 1, followed by a 100-mg maintenance dose administered daily on days 2 through 10 or until hospital discharge or death. Baricitinib was administered as a 4-mg daily dose (either orally [two 2-mg tablets] or through a nasogastric tube) for 14 days or until hospital discharge.
                    </P>
                    <FTNT>
                        <P>
                            <SU>480</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="129">
                        <GID>EP10MY21.170</GID>
                    </GPH>
                    <P>In support of its claim that Olumiant® in combination with remdesivir improves time to recovery from COVID-19 compared to remdesivir alone, the applicant cited the primary outcome of the ACTT-2 study, which showed that the median time to recovery for the Olumiant® plus remdesivir (treatment) group was 7 days and the median time to recovery for remdesivir plus placebo (control) group was 8 days (rate ratio for recovery, 1.16 (1.01-1.32); p=0.03). Recovery was defined as the participant being well enough for hospital discharge, meaning the participant either no longer required supplemental oxygen or ongoing medical care in the hospital, or was no longer hospitalized at Day 29.</P>
                    <P>The applicant also stated that the median time to recovery among patients receiving noninvasive ventilation or high-flow oxygen (baseline ordinal score of 6) was 10 days for the treatment group and 18 days in the control group (rate ratio for recovery, 1.51; 95 percent CI, 1.10-2.08). The applicant stated that the median time to recovery was one day shorter among patients receiving supplemental oxygen (baseline ordinal score of 5) in the Olumiant® and remdesivir group (5 days vs. 6 days) rate ratio 1.17; CI, 0.98-1.39). The applicant noted that for those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal score of 7), the rate ratio for recovery was 1.08 (95 percent CI, 0.59 to 1.97).</P>
                    <P>
                        The applicant asserted that the secondary outcome of the ACTT-2 study supports its claim of improved odds of improvement in clinical status at Day 15 based on the eight-category ordinal scale. The applicant summarized the results of the study which showed that the odds of improvement in clinical status at Day 15 were greater in the Olumiant® group compared to the placebo group (odds ratio 1.3; 95 percent CI, 1.0-1.6). The applicant also stated that the odds of 
                        <PRTPAGE P="25297"/>
                        improvement in clinical status at Day 15 were greater for patients receiving noninvasive ventilation or high-flow oxygen (baseline ordinal score of 6) in the Olumiant® group versus the control group (odds ratio 2.2; 95 percent CI, 1.4-3.6).
                    </P>
                    <P>The applicant asserted that the study conducted by Kalil et al. (2020) supports its claim of reduced mortality in the Olumiant® and remdesivir group compared to the control group because the Kaplan-Meier estimates of mortality at day 28 after randomization were 5.1 percent (95 percent CI, 3.5-7.6) in the combination (Olumiant® and remdesivir) group and 7.8 percent (95 percent CI, 5.7 to 10.6) in the control group (hazard ratio for death, 0.65; 95 percent CI, 0.39 to 1.09). The applicant also stated that the greatest numerical differences in mortality between patients in the combination group and those in the control group were observed among those with a baseline ordinal score of 5 (1.9 percent vs. 4.7 percent; hazard ratio, 0.40; 95 percent CI, 0.14 to 1.14) or 6 (7.5 percent vs. 12.9 percent; hazard ratio, 0.55; 95 percent CI, 0.22 to 1.38). The applicant also cited the Kaplan-Meier estimates of mortality at 14 days after randomization, which were 1.6 percent in the combination group and 3.0 percent in the control group (hazard ratio, 0.54; 95 percent CI, 0.23 to 1.28).</P>
                    <P>The applicant also asserted that the incidence of new use of oxygen was lower in patients treated with Olumiant® in combination with remdesivir compared to remdesivir alone (22.9 percent vs. 40.3 percent respectively; difference, −17.4 percentage points; 95 percent CI, −31.6 to −2.1) and that the incidence of new use of mechanical ventilation or ECMO was lower in the combination group (10.0 percent vs. 15.2 percent; difference, −5.2 percentage points; 95 percent CI, −9.5 to −0.9) based on Kalil et al. (2020). The applicant also stated that there were fewer median days of receipt of mechanical ventilation or ECMO among the 128 patients for which these interventions were started after enrollment or who died with no observed new use in the Olumiant® in combination with remdesivir group compared to the remdesivir group (16 median days in the combination group and 27 median days in the control group (difference, −11.0; 95 percent CI, −18.3 to −3.7)). The applicant also stated that the incidence of progression to death or noninvasive or invasive ventilation was lower in the combination group than in the control group (22.5 percent vs. 28.4 percent; rate ratio, 0.77; 95 percent CI, 0.60 to 0.98) and that the incidence of progression to death or invasive ventilation was also lower (12.2 percent vs. 17.2 percent; rate ratio, 0.69; 95 percent CI, 0.50 to 0.95).</P>
                    <P>The applicant asserted that the study conducted by Kalil et al. (2020) supports its claim that the combination of Olumiant® in combination with remdesivir has a favorable benefit/risk profile compared to remdesivir alone. The applicant states that serious adverse events occurred in 81 patients (16.0 percent) in the combination group (six of these were thought to be related to the trial product) and in 107 patients (21.0 percent) in the control group (five of these were thought to be related to the trial product) and the between-group difference was −5.0 percentage points (95 percent CI, −9.8 to −0.3; P = 0.03). The applicant also states that Grade 3 or 4 adverse events occurred in 207 patients (40.7 percent) in the combination group and 238 (46.8 percent) in the control group.</P>
                    <P>
                        The applicant also cited an observational study 
                        <SU>481</SU>
                        <FTREF/>
                         to support the claim that there was greater improvement in pulmonary function in patients receiving lopinavir/ritonavir and hydroxychloroquine with Olumiant® and corticosteroids when compared to patients receiving lopinavir/ritonavir and hydroxychloroquine with corticosteroids alone. In this study, the primary end point was the change in oxygen saturation as measured by pulse oximetry (SpO2)/FiO2 from hospitalization to discharge. The applicant stated that there was a greater improvement in SpO2/FiO2 from hospitalization to discharge observed in the Olumiant® in combination with corticosteriods versus the corticosteroids alone group (mean differences adjusted for IPSW, 49; 95 percent CI: 22, 77; p&lt;0.001).
                    </P>
                    <FTNT>
                        <P>
                            <SU>481</SU>
                             Rodriguez, J.L., Sanchez-Niveas, G., Arevalo-Serrano, J., et al. (2020). Baricitinib improves respiratory function in patients treated with corticosteroids for SARS-CoV-2 pneumonia: An observational study. 
                            <E T="03">Rheumatology.</E>
                             00:1-9.
                        </P>
                    </FTNT>
                    <P>
                        In our assessment of the applicant's claims in support of substantial clinical improvement, we have the following concerns. With regard to the ACTT-2 trial, we note that there were no statistically significant differences in time to recovery or odds of improvement in clinical status at Day 15 between the Olumiant®+remdesivir group compared to the remdesivir+placebo group for patients with a baseline ordinal score of 4, 5, or 7. We further note that although the applicant asserted that Olumiant®+remdesivir reduces mortality compared to remdesivir alone, the difference between the treatment and control groups was not statistically significant. We also note that the ACTT-2 study protocol prohibited the use of systemic corticosteroids for the treatment of COVID-19 but allowed systemic steroids for standard indications such as asthma exacerbation, acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD), laryngeal edema, adrenal insufficiency and shock 
                        <SU>482</SU>
                        <FTREF/>
                         and we are therefore unsure if the use of corticosteroids among the patient population may be a confounding factor. With regard to the Rodriguez-Garcia (2020) study, we note that this study did not involve the treatment of patients with Olumiant® in combination with remdesivir, which is the authorized use per its EUA, and the use of multiple treatments in this trial may make the effect of Olumiant® on greater improvement in pulmonary function unclear. Finally, we note that the current clinical guidelines from the Infectious Diseases Society of America (IDSA) recommend the use of Olumiant® with remdesivir rather than remdesivir alone among hospitalized patients with severe COVID-19 who cannot receive corticosteroids because of a contraindication.
                        <SU>483</SU>
                        <FTREF/>
                         In addition, guidelines from the National Institutes of Health (NIH) state that there are insufficient data to recommend for or against the use of Olumiant® in combination with remdesivir, where corticosteroids can be used instead, and there is insufficient data to recommend for or against the use of Olumiant®, in combination with corticosteroids.
                        <SU>484</SU>
                        <FTREF/>
                         We are therefore interested in data regarding the use of Olumiant® in combination with remdesivir over corticosteroids.
                    </P>
                    <FTNT>
                        <P>
                            <SU>482</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>483</SU>
                             Infectious Diseases Society of America. (2021, March 18). Recommendations 15-16: Baricitinib with remdesivir vs. remdesivir alone for hospitilized patients who cannot recieve corticosteriods due to contraindication. 
                            <E T="03">IDSA Guidelines on the Treatment and Management of Patients with COVID-19.</E>
                             Retrieved from 
                            <E T="03">https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/</E>
                            . * Severe patients defined as defined as patients with SpO
                            <E T="52">2</E>
                             ≤94% on room air, including patients on supplemental oxygen, oxygen through a high-flow device, or non-invasive ventilation.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>484</SU>
                             National Institutes of Health. (2021, February 11). Kinase Inhibitors: Baricitinib and Other Janus Kinase Inhibitors, and Bruton's Tyrosine Kinase Inhibitors., 
                            <E T="03">COVID-19 Treatment Guidelines.</E>
                             Retrieved from 
                            <E T="03">https://www.covid19treatmentguidelines.nih.gov/immunomodulators/kinase-inhibitors/.</E>
                        </P>
                    </FTNT>
                    <P>We welcome public comment on whether Olumiant® meets the substantial clinical improvement criterion.</P>
                    <P>
                        In this section, we summarize and respond to written public comments 
                        <PRTPAGE P="25298"/>
                        received in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for Olumiant®.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The applicant responded to questions elicited by its presentation at the New Technology Town Hall Meeting held in December 2020.
                    </P>
                    <P>The applicant was asked to elaborate on the efficacy of Olumiant® and remdesivir as monotherapies versus in combination and how to think about appropriate use. The applicant stated that the evidence generated in randomized controlled clinical trials designed to evaluate remdesivir, Olumiant®, and the combination of Olumiant® and remdesivir has come primarily from the Adaptive Covid-19 Treatment Trial (ACTT) trials sponsored by NIAID. The applicant also stated that ACTT-1 was the first trial of the ACTT program and showed that remdesivir, when compared to placebo, is an effective treatment for hospitalized adult patients with coronavirus disease 2019 (Covid-19) pneumonia who were receiving standard of care as background treatment. The applicant stated that to address unmet medical needs still identified after the completion of ACTT-1 (namely morbidity and mortality due to Covid-19), ACTT-2 was designed to evaluate the combination of Olumiant® and remdesivir versus remdesivir in hospitalized adult patients with Covid-19 pneumonia who were receiving standard of care as background treatment. The applicant stated that the study did not evaluate Olumiant® alone; therefore, they do not have results generated by a RCT on the efficacy and safety profile of Olumiant® alone for the treatment of Covid-19 patients. The applicant stated that the ACTT-2 trial results show that the combination of Olumiant® was superior to remdesivir and placebo in reducing recovery time and accelerating improvement in clinical status among hospitalized patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation.</P>
                    <P>
                        The applicant was asked what the mechanism of action is for baricinitib's antiviral activity. The applicant stated that patients diagnosed with COVID-19 are at an elevated risk for excess morbidity and mortality due to the underlying severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and subsequent cytokine activation. Management of COVID-19 is supportive; and respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of mortality. The cause of respiratory failure in COVID-19 is a hyperinflammatory state characterized by upregulation of multiple cytokines. The applicant stated that in Wuhan, China, COVID-19-infected patients admitted to the ICU exhibited increased plasma concentrations of IL-2, IL-7, IL-10, GM-CSF, IP-10, MCP-1, MIP1-α, and TNF-α, compared with the non-ICU patients. Elevated IL-6 and hyperferritinemia were predictors of death in these patients with COVID-19.
                        <E T="51">485 486 487</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>485</SU>
                             Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020; 395(10223):497-506. 
                            <E T="03">https://doi.org/10.1016/S0140-6736(20)30183-5</E>
                            .
                        </P>
                        <P>
                            <SU>486</SU>
                             Ruan Q, Yang K, Wang W, et al. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020; 46(5):846-848. 
                            <E T="03">https://doi.org/10.1007/s00134-020-05991-x.</E>
                        </P>
                        <P>
                            <SU>487</SU>
                             Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: A retrospective cohort study. Lancet. 2020;395(10229):1054-1062. 
                            <E T="03">https://doi.org/10.1016/S0140-6736(20)30566-3</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that Olumiant® may be a viable treatment in patients with COVID-19 requiring supplemental oxygen, invasive mechanical ventilation, or ECMO because of its anti-inflammatory activity and ability to reverse dysregulated inflammatory markers in patients with COVID-19.
                        <E T="51">488 489</E>
                        <FTREF/>
                         Relevant to COVID-19 and the potential role played by IL-6, the applicant stated that it is notable that treatment with Olumiant® 4 mg resulted in reduced plasma levels of IL-6 in hospitalized patients with COVID-19, a finding that was replicated after being observed in patients with RA.
                        <E T="51">490 491 492</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>488</SU>
                             McInnes IB, Byers NL, Higgs RE, et al. Comparison of baricitinib, upadacitinib, and tofacitinib mediated regulation of cytokine signaling in human leukocyte subpopulations. Arthritis Res Ther. 2019; 21(1):183. 
                            <E T="03">https://doi.org/10.1186/s13075-019-1964-1.</E>
                        </P>
                        <P>
                            <SU>489</SU>
                             Sims JT, Krishnan V, Chang CY, et al. Characterization of the cytokine storm reflects hyperinflammatory endothelial dysfunction in COVID-19 [published online September 10, 2020]. J Allergy Clin Immunol. 
                            <E T="03">https://doi.org/10.1016/j.jaci.2020.08.031.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>490</SU>
                             Bronte V, Ugel S, Tinazzi E, et al. Baricitinib restrains the immune dysregulation in severe COVID-19 patients [published online August 18, 2020]. J Clin Invest. 
                            <E T="03">https://doi.org/10.1172/JCI141772.</E>
                        </P>
                        <P>
                            <SU>491</SU>
                             Sims JT, Krishnan V, Chang CY, et al. Characterization of the cytokine storm reflects hyperinflammatory endothelial dysfunction in COVID-19 [published online September 10, 2020]. J Allergy Clin Immunol. 
                            <E T="03">https://doi.org/10.1016/j.jaci.2020.08.031.</E>
                        </P>
                        <P>
                            <SU>492</SU>
                             Stebbing J, Krishnan V, de Bono S, et al; Sacco Baricitinib Study Group. Mechanism of baricitinib supports artificial intelligence-predicted testing in COVID-19 patients. EMBO Mol Med. 2020; 12(8):e12697. 
                            <E T="03">https://doi.org/10.15252/emmm.202012697</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that the biochemical inhibitory effects of Olumiant® on human numb-associated kinase (NAK) members, responsible for SARS-CoV-2 viral propagation, measuring nanomolar affinities for AAK1, BIKE, and GAK were recently confirmed.
                        <SU>493</SU>
                        <FTREF/>
                         In addition, the applicant noted that some plasma markers that were dysregulated in moderate to severe hospitalized patients with COVID-19, that represent myeloid dysregulation, endothelial and cardiovascular inflammation, along with reduced antigen presenting plasmacytoid dendritic cells, were normalized over time with Olumiant® treatment.
                        <SU>494</SU>
                        <FTREF/>
                         The applicant stated that the impact of this antiviral host activity in patients with COVID-19 is being evaluated through collection of nasopharyngeal swabs, serum and whole blood for RNA, epigenetic analysis, and cellular phenotyping in the ongoing randomized Study KHAA.
                    </P>
                    <FTNT>
                        <P>
                            <SU>493</SU>
                             Stebbing J, Krishnan V, de Bono S, et al; Sacco Baricitinib Study Group. Mechanism of baricitinib supports artificial intelligence-predicted testing in COVID-19 patients. EMBO Mol Med. 2020; 12(8):e12697. 
                            <E T="03">https://doi.org/10.15252/emmm.202012697</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>494</SU>
                             Sims JT, Krishnan V, Chang CY, et al. Characterization of the cytokine storm reflects hyperinflammatory endothelial dysfunction in COVID-19 [published online September 10, 2020]. J Allergy Clin Immunol. 
                            <E T="03">https://doi.org/10.1016/j.jaci.2020.08.031.</E>
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that previous studies of corticosteroids in other viral pneumonias, especially SARS and Middle East respiratory syndrome (MERS), found an association with delayed viral clearance, and reinforced concerns that corticosteroids may impair host response to SARS-CoV-2.
                        <E T="51">495 496</E>
                        <FTREF/>
                         In contrast, treatment with Olumiant® from 2 distinct clinical case series indicate that the adaptive immune response responsible to generate IgG antibodies against SARS-CoV-2-specific spike proteins remains intact after treatment with Olumiant®.
                        <E T="51">497 498</E>
                        <FTREF/>
                         The applicant stated that the effects of corticosteroid treatment on adaptive immunity are 
                        <PRTPAGE P="25299"/>
                        believed to occur through the non-canonical signaling pathways. The applicant asserted that the immunomodulatory pathway targeted by Olumiant®, JAK1/JAK2 signaling, opposed to NFKB (nuclear factor kappa-B cells) signaling targeted by corticosteroids, may offer an explanation to these effects.
                    </P>
                    <FTNT>
                        <P>
                            <SU>495</SU>
                             Lee N, Allen Chan KC, Hui DS, et al. Effects of early corticosteroid treatment on plasma SARS associated coronavirus RNA concentrations in adult patients. J Clin Virol. 2004; 31(4):304-309. 
                            <E T="03">https://doi.org/10.1016/j.jcv.2004.07.006.</E>
                        </P>
                        <P>
                            <SU>496</SU>
                             Arabi YM, Mandourah Y, Al-Hameed F, et al; Saudi Critical Care Trial Group. Corticosteroid therapy for critically ill patients with Middle East Respiratory Syndrome. Am J Respir Crit Care Med. 2018; 197(6):757-767. 
                            <E T="03">https://doi.org/10.1164/rccm.201706-1172OC.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>497</SU>
                             Bronte V, Ugel S, Tinazzi E, et al. Baricitinib restrains the immune dysregulation in severe COVID-19 patients [published online August 18, 2020]. J Clin Invest. 
                            <E T="03">https://doi.org/10.1172/JCI141772</E>
                            .
                        </P>
                        <P>
                            <SU>498</SU>
                             Stebbing J, Krishnan V, de Bono S, et al; Sacco Baricitinib Study Group. Mechanism of baricitinib supports artificial intelligence-predicted testing in COVID-19 patients. EMBO Mol Med. 2020; 12(8):e12697. 
                            <E T="03">https://doi.org/10.15252/emmm.202012697</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        The applicant also noted differences between Olumiant® and dexamethasone. The applicant stated that drugs acting on glucocorticoid receptors, such as dexamethasone, have a broad pathway approach to reduce inflammation that is known to be associated with profound immunosuppression, secondary hospital-acquired infections, gastrointestinal bleeding, hyperglycemia, and post-hospital neuromuscular weakness. JAK inhibitors, such as Olumiant®, act on several critical pathways to reduce inflammation while minimizing biological redundancy and have favorable PK properties and less immunosuppression.
                        <SU>499</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>499</SU>
                             Stebbing J, Krishnan V, de Bono S, et al; Sacco Baricitinib Study Group. Mechanism of baricitinib supports artificial intelligence-predicted testing in COVID-19 patients. EMBO Mol Med. 2020; 12(8):e12697. 
                            <E T="03">https://doi.org/10.15252/emmm.202012697.</E>
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that the anti-inflammatory effects of Olumiant® have also been demonstrated by the reduction of serum levels of IFN-γ, IP-10, GM-CSF, and MCP-1 in pediatric patients with steroid-dependent chronic inflammation, resulting in control of disease activity and the ability to wean or taper steroids.
                        <SU>500</SU>
                        <FTREF/>
                         The applicant went on to state that, furthermore, dose‐dependent decreases in IFN biomarkers confirmed an in vivo effect of Olumiant® on type‐1 IFN signaling in pediatric patients suffering from CANDLE and SAVI.
                        <SU>501</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>500</SU>
                             Sanchez GAM, Reinhardt A, Ramsey S, et al. JAK1/2 inhibition with baricitinib in the treatment of autoinflammatory interferonopathies. J Clin Invest. 2018; 128(7):3041-3052. 
                            <E T="03">https://doi.org/10.1172/JCI98814.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>501</SU>
                             Kim H, Brooks KM, Tang CC, et al. Pharmacokinetics, pharmacodynamics, and proposed dosing of the oral JAK1 and JAK2 inhibitor baricitinib in pediatric and young adult CANDLE and SAVI patients. Clin Pharmacol Ther. 2018; 104(2):364-373. 
                            <E T="03">https://doi.org/10.1002/cpt.936.</E>
                        </P>
                    </FTNT>
                    <P>The applicant was asked if the adverse events were higher or unchanged among at risk subgroup populations over 65 years with comorbidities such as diabetes or chronic lung or renal disease in patients with COVID-19 and treated with Olumiant®. The applicant responded that there were 71 and 78 patients in the remdesivir+placebo groups and Olumiant®+remdesivir groups, respectively, who were over 65 years of age and had diabetes, chronic lung disease or renal disease in ACTT-2. The applicant stated that treatment emergent adverse events were reported in 62.0 percent of remdesivir+placebo and 57.7 percent of Olumiant®+remdesivir patients. Serious adverse events were reported in 33.8 percent of remdesivir+placebo and 28.2 percent of Olumiant®+remdesivir patients. The applicant stated that these findings are consistent with that in the overall population; fewer events in the Olumiant®+remdesivir group compared to remdesivir and placebo group.</P>
                    <P>Lastly, the applicant was asked to explain the difference in median time to recovery between patients who did not receive oxygen, which was 5 days in the Olumiant® and remdesivir group, and 4 days in the remdesivir and placebo group. For patients that did receive supplemental O2 and other respiratory interventions, the median time to recovery was shorter in those patients who received Olumiant® and remdesivir compared to the remdesivir and placebo group. The applicant replied that across all outcome measures, a more pronounced treatment effect was observed in patients with more severe disease at baseline. These data did not show additional benefit of adding Olumiant® to remdesivir for patients in the milder disease status. The applicant also stated that the ACTT-2 trial was not designed or powered to evaluate efficacy in each subgroup of patients per baseline ordinal scale. The applicant stated that these data led the applicant to request Emergency Use Authorization for Olumiant® and FDA authorized the use of Olumiant® in combination with remdesivir, for treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).</P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the applicant's comment. We will take the responses into consideration when deciding whether to approve new technology add-on payments for Olumiant®.
                    </P>
                    <HD SOURCE="HD3">n. Pure-Vu® System</HD>
                    <P>Motus GI holdings, Inc. submitted an application for new technology add-on payments for the Pure-Vu® System for FY 2022. The Pure-Vu® System is an FDA cleared system designed to connect to currently marketed colonoscopes to provide high intensity, intra-procedural cleansing of the colon during a colonoscopy. According to the applicant, the Pure-Vu® System is indicated for use in patients requiring therapeutic or diagnostic colonoscopies where the bowel has not been adequately prepared. The applicant asserted that the Pure-Vu® System would be used in situations such as a lower gastrointestinal bleed (LGIB), as LGIB does not allow for adequate bowel preparation.</P>
                    <P>The applicant asserted that the Pure-Vu® System device helps to avoid aborted and delayed colonoscopy procedures due to poor visualization of the colon mucosa by creating a unique High Intensity, Pulsed Vortex Irrigation Jet that consists of a mixture of air and water to break-up fecal matter, blood clots, and other debris, and scrub the walls of the colon while simultaneously removing the debris through two suction channels. The applicant stated that the suction channels have a sensor to detect the formation of a clog in the channels, triggering the system to automatically purge and then revert to suction mode once the channel is clear. According to the applicant, this combination of the agitation of the fluid in the colon via the pulsed vortex irrigation and simultaneous removal of the debris allows the physician to visualize the colon and achieve a successful colonoscopy or other advanced procedure through the colonoscope even if the patient is not properly prepped and has debris either blocking the ability to navigate the colon or covering the colon wall obscuring the mucosa and any pathology that may be present. The applicant asserted that the constant volume suction pumps do not cause the colon to collapse, which allows the physician to continue to navigate the colon while cleansing and avoids the need to constantly insufflate the colon, which may be required with other colonoscopy irrigation systems.</P>
                    <P>The applicant stated that the Pure-Vu® System is comprised of a workstation that controls the function of the system, a disposable oversleeve that is mounted on a colonoscope and inserted into the patient, and a disposable connector with tubing (umbilical tubing with main connector) that provides the interface between the workstation, the oversleeve, and off the shelf waste containers.</P>
                    <P>
                        The applicant explained that the workstation has two main functions: Cleansing via irrigation and evacuation, and acting as the user interface of the system. The applicant explained that the irrigation into the colon is achieved by an electrical pump that supplies pressurized gas (air) and a peristaltic 
                        <PRTPAGE P="25300"/>
                        pump that supplies the liquid (water or saline). According to the applicant, the pressurized gas and liquid flow through the “main connector” and are mixed upon entry into the umbilical tubing that connects to the oversleeve. The applicant explained that the gas pressure and flow are controlled via regulators and the flow is adjusted up or down depending on the cleansing mode selected. The applicant stated that a foot pedal connected to the user interface activates the main functions of the system so that the user's hands are free to perform the colonoscope procedure in a standard fashion.
                    </P>
                    <P>The applicant stated that the evacuation mode (also referred to as suction) removes fecal matter and fluids out of the colon. The applicant noted that the evacuation function is active during cleansing so that fluid is inserted and removed from the colon simultaneously. The applicant explained that the evacuation pumps are designed in a manner that prevents the colon from collapsing when suctioning, which facilitates the ability to simultaneously irrigate and evacuate the colon. According to the applicant, during evacuation, the system continuously monitors the pressure in the evacuation channels of the oversleeve and if the pressure drops below pre-set limits the pumps will automatically reverse the flow. The applicant explained that the clog sensor triggers the system to automatically purge the material out of the channel and back into the colon where it can be further emulsified by the Pulsed Vortex Irrigation Jet, and then automatically reverts back into evacuation mode once the channel is cleared. The applicant stated that the evacuation (suction) that drains fecal matter and fluids out of the colon is generated by peristaltic pumps that can rotate in both directions, either to evacuate fluids and fecal matter from the colon through the evacuation tubes and into a waste container, or while in the reverse direction, to purge the evacuation tubes. The applicant claimed the suction created by this type of pump creates a constant volume draw of material from the colon and therefore prevents the colon from collapsing rapidly. According to the applicant, purging of evacuation tubes may be activated in two ways: The purging cycle is automatically activated when low pressure is noted by the evacuation-line sensor (it is also activated for the first 0.5 seconds when evacuation is activated to make sure the line is clear from the start); or a manual purge may be activated by the user by pushing the “manual purge” button on the foot pedal. The applicant claimed the pressure-sensing channel is kept patent by using an air perfusion mechanism where an electrical pump is used to perfuse air through the main connector and into the oversleeve, while the sensor located in the workstation calculates the pressure via sensing of the channel.</P>
                    <P>The applicant explained the Pure-Vu® System is loaded over a colonoscope and that the colonoscope with the Pure-Vu® Oversleeve is advanced through the colon in the same manner as a standard colonoscopy. The applicant stated that the body of the oversleeve consists of inner and outer sleeves with tubes intended for providing fluid path for the cleansing irrigation (2X), the evacuation of fluids (2X), the evacuation sensor (1X) and that the flexible head is at the distal end of the oversleeve and is designed to align with the colonoscope's distal end in a consistent orientation. The applicant explained that the distal cleansing and evacuation head contains the irrigation ports, evacuation openings, and a sensing port. According to the applicant, the system gives the physician the control to cleanse the colon as needed based on visual feedback from the colonoscope to make sure they have an unobstructed view of the colon mucosa to detect and treat any pathology. The applicant noted that since the Pure-Vu® System does not interfere with the working channel of the colonoscope, the physician is able to perform all diagnostic or therapeutic interventions in a standard fashion with an unobstructed field of view.</P>
                    <P>
                        According to the applicant, multiple studies have shown that inadequate bowel visualization leads to missed pathology, delayed diagnosis, extended hospital stay, and in some cases, additional therapy being administered, especially in the acute LGIB population, which is the most common indication for inpatients that require colonoscopy.
                        <E T="51">502 503</E>
                        <FTREF/>
                         Unknown abdominal pain, infection, and foreign body removal were also cited by the applicant as being common indications for an inpatient colonoscopy.
                    </P>
                    <FTNT>
                        <P>
                            <SU>502</SU>
                             Garber A, Sarvepalli S, Burke CA, Bhatt A, Ibrahim M, McMichael J, et al. Modifiable Factors Associated with Quality of Bowel Preparation Among Hospitalized Patients Undergoing Colonoscopy. J Hosp Med. 2019; 14(5):278-83.
                        </P>
                        <P>
                            <SU>503</SU>
                             Yadlapati R, Johnston ER, Gregory DL, Ciolino JD, Cooper A, Keswani RN. Predictors of Inadequate Inpatient Colonoscopy Preparation and Its Association with Hospital Length of Stay and Costs. Dig Dis Sci. 2015; 60(11):3482-90.
                        </P>
                    </FTNT>
                    <P>
                        The applicant explained that when a patient with LGIB is admitted to the hospital, they are stabilized and then started on bowel preparation for the colonoscopy procedure. The applicant claimed that the patient typically is placed on a liquid-only diet while consuming 4-6 liters of polyethylene glycol (PEG) based solution until the rectal effluent is clear. If the rectal effluent is not clear, additional bowel preparation is prescribed. The applicant stated that for severe LGIB cases, a patient is prescribed to consume a rapid purge of 1 liter every 30-45 minutes with a total volume of 4-14 liters, which could lead to purgative intolerance or vomiting. The applicant claimed that even in situations where bowel preparation has been completed, and clear rectal effluent while on a clear liquid diet has been confirmed, there are no guarantees that a patient's bowel is clean for a successful colonoscopy. The applicant submitted data from a study by the Cleveland Clinic showing 51 percent of 8,819 patients observed over a 4-year period were inadequately prepared for colonoscopies, leading to one extra day in the hospital compared to patients that were adequately prepared.
                        <SU>504</SU>
                        <FTREF/>
                         The applicant cited another study, by Northwestern University, demonstrating an association between inadequate bowel preparation and increased length of stay (LOS) in hospitals, with inadequately prepared patients staying two more days than adequately prepared patients on average.
                        <SU>505</SU>
                        <FTREF/>
                         The applicant claimed additional time spent in hospitals increases the patient's exposure to risks of hospital-acquired infections. The applicant claimed this risk is especially impactful to patients who are admitted for LGIB, which is seen at a higher prevalence in the elderly population.
                        <E T="51">506 507</E>
                        <FTREF/>
                         The applicant stated in the elderly population, continuous bowel preparation also poses increased risk due to their higher comorbidities and potential for electrolyte imbalances such as hyperphosphatemia, hypocalcemia, and hypokalemia.
                        <SU>508</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>504</SU>
                             Garber A, Sarvepalli S, Burke CA, Bhatt A, Ibrahim M, McMichael J, et al. Modifiable Factors Associated with Quality of Bowel Preparation Among Hospitalized Patients Undergoing Colonoscopy. J Hosp Med. 2019; 14(5):278-83.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>505</SU>
                             Yadlapati R, Johnston ER, Gregory DL, Ciolino JD, Cooper A, Keswani RN. Predictors of Inadequate Inpatient Colonoscopy Preparation and Its Association with Hospital Length of Stay and Costs. Dig Dis Sci. 2015; 60(11):3482-90.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>506</SU>
                             Parra-Blanco A, Ruiz A, Alvarez-Lobos M, Amoros A, Gana JC, Ibanez P, et al. Achieving the best bowel preparation for colonoscopy. World J Gastroenterol. 2014; 20(47):17709-26.
                        </P>
                        <P>
                            <SU>507</SU>
                             Hauck K, Zhao X. How dangerous is a day in hospital? A model of adverse events and length of stay for medical inpatients. Med Care. 2011; 49(12):1068-75.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>508</SU>
                             Parra-Blanco A, Ruiz A, Alvarez-Lobos M, Amoros A, Gana JC, Ibanez P, et al. Achieving the best bowel preparation for colonoscopy. World J Gastroenterol. 2014; 20(47):17709-26.
                        </P>
                    </FTNT>
                    <PRTPAGE P="25301"/>
                    <P>
                        The applicant cited a practical guide authored by Kim B., et al., to assert that poor visualization of the colon mucosa has a direct effect on the ability to detect the presence of a GI bleed or the aftermath stigmata and administer treatment successfully.
                        <SU>509</SU>
                        <FTREF/>
                         The applicant used the Boston Bowel Preparation Scale (BBPS), developed by Lai E. et al,
                        <SU>510</SU>
                        <FTREF/>
                         as a reliable method to measure bowel preparation. The applicant stated that the scale is a range (0-9) of dirtiest to cleanest for the whole colon and 0 to 3 for each of the 3 segments of the colon; the right colon (including the cecum and ascending colon), the transverse colon (including the hepatic and splenic flexures), and the left colon (including the descending colon, sigmoid colon, and rectum). Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is nine and the minimum BBPS score for an unprepared colon is zero. The points are assigned as follows: Zero = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; one = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid; two = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; three = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
                    </P>
                    <FTNT>
                        <P>
                            <SU>509</SU>
                             Kim BS, Li BT, Engel A, et al. Diagnosis of gastrointestinal bleeding: A practical guide for clinicians. World J Gastrointest Pathophysiol. 2014; 5(4):467-478.doi:10.4291/wjgp.v5.i4.467.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>510</SU>
                             Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston Bowel Preparation Scale: A valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy. 2009; 69(3):620-625.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that evidence-based guidelines and clinical reviews in high impact biomedical journals recommend colonoscopy as the preferred initial modality for the diagnosis and treatment of acute lower gastrointestinal bleeding.
                        <E T="51">511 512</E>
                        <FTREF/>
                         The applicant stated that colonoscopy has been less frequently utilized than might otherwise be indicated because it suffers from the significant disadvantage of requiring the need for a large volume bowel preparation.
                        <SU>513</SU>
                        <FTREF/>
                         The applicant states that even with a bowel preparation, poor visualization often occurs because of a poorly prepared colon. Based on these assertions, the applicant inferred that colonoscopy for acute lower gastrointestinal bleeding would be much more utilized and lead to more diagnoses and interventions with intraprocedural bowel preparation, which puts the control of the visualization (cleanliness) of the colon mucosa in the hands of the endoscopist. The applicant further stated it is important to appreciate that alternatives to colonoscopy, including angiography and vascular embolization treatments to create hemostasis, have risks of ischemic vascular injury, retroperitoneal bleeding and acute renal injury.
                        <SU>514</SU>
                        <FTREF/>
                         The applicant stated that aside from the colonoscopy, other modalities such as tagged red blood cell scans, computed tomography (CT) angiograms, and mesenteric angiographies all require an active source of bleed in order to achieve a successful diagnostic yield. The applicant claimed that even when diagnosis is achieved using these modalities, a colonoscopy may still be ordered to treat the source of the bleed via epinephrine injections and clipping and thermal therapies, to prevent potential surgical interventions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>511</SU>
                             Strate LL, Gralnek IM. ACG Clinical Guideline: Management of Patients With Acute Lower Gastrointestinal Bleeding. Am J Gastroenterol. 2016 Apr;111(4):459-74. doi: 10.1038/ajg.2016.41. Epub 2016 Mar 1. Erratum in: Am J Gastroenterol. 2016 May;111(5):755. PMID: 26925883; PMCID: PMC5099081.
                        </P>
                        <P>
                            <SU>512</SU>
                             Gralnek IM, Neeman Z, Strate LL. Acute Lower Gastrointestinal Bleeding. N Engl J Med. 2017 Mar 16;376(11):1054-1063. doi: 10.1056/NEJMcp1603455. PMID: 28296600.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>513</SU>
                             Carney BW, Khatri G, Shenoy-Bhangle AS. The role of imaging in gastrointestinal bleed. Cardiovasc Diagn Ther. 2019 Aug;9(Suppl 1):S88-S96. doi: 10.21037/cdt.2018.12.07. PMID: 31559156; PMCID: PMC6732104.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>514</SU>
                             Ibid. Carney BW, Khatri G, Shenoy-Bhangle AS. The role of imaging in gastrointestinal bleed. Cardiovasc Diagn Ther. 2019 Aug;9(Suppl 1):S88-S96. doi: 10.21037/cdt.2018.12.07. PMID: 31559156; PMCID: PMC6732104.
                        </P>
                    </FTNT>
                    <P>With respect to the newness criterion, the Pure-Vu® System first received FDA 510(k) clearance on September 22, 2016 under 510(k) number K60015. Per the applicant, this initial device was very cumbersome to set up and required direct support from the company and therefore was not viable for a small company with limited resources to market the device. The applicant noted that the initial device could have been sold starting on January 27, 2017 when the first device came off the manufacturing line. Per the applicant, the device was allocated for clinical evaluations but 10 institutions throughout the country purchased the device outside of a clinical study, primarily to allow physicians to try the product prior to committing to a clinical trial. The applicant further noted that minor modifications were made to the Pure-Vu System in additional 510(k) clearances dated December 12, 2017 and June 21, 2018. The current marketed Pure-Vu System was then granted 510(k) clearance on June 6, 2019 under 510(k) number K191220. Per the applicant, this clearance changed the entire set-up of the device, redesigned the user interface, and reduced the size, among other changes. According to the applicant, this updated version was commercially available as of September 19, 2019.</P>
                    <P>Currently, there are no ICD-10-PCS procedure codes to uniquely identify procedures involving the Pure-Vu® System. We note that the applicant has submitted a request for approval for a unique ICD-10-PCS code for the use of the Pure-Vu® System beginning FY 2022.</P>
                    <P>If a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and therefore would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>With respect to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, the applicant asserted that the Pure-Vu® System has a different mechanism of action than existing technologies due to its ability to break up and remove a high volume of debris from the colon and dislodge adherent films from the colon wall in a safe manner that cannot be achieved with irrigation done through the working channel of a colonoscope. The applicant also asserted that due to the controlled simultaneous removal of the debris and fluid by the evacuation pumps in the system, the Pure-Vu® System eliminates the likelihood of creating a fluid load in the colon, which cannot be achieved with any other device on the market. The applicant further asserted a differing mechanism of action via the ability to sense and automatically clear a blockage versus manual suction through the working channel of a colonoscope, which can clog quickly if there is any appreciable debris. Lastly, the applicant explained that the Pure-Vu® System is an oversleeve device that allows use of the working channel of the colonoscope to be open and allows therapy to be administered in tandem with cleansing, unlike existing technologies on the market.</P>
                    <P>
                        The applicant noted that the ClearPath system, a colonoscopy system by the company Easy Glide, received FDA clearance, but according to the applicant, was never fully brought to the US market. ClearPath was listed as the predicate device for the initial version of the Pure-Vu System® approved on September 22, 2016 (FDA 510(K) number K160015), in which both 
                        <PRTPAGE P="25302"/>
                        devices are described as able to irrigate and suction at any time during the procedure without any tools needing to be removed from the colonoscope working channel.
                        <SU>515</SU>
                        <FTREF/>
                         The applicant claimed that this system did not have the High Intensity Pulsed Vortex Irrigation Jet and controlled suction capabilities with the sensing and auto purge technology that is critical to get the desired clinical outcome.
                    </P>
                    <FTNT>
                        <P>
                            <SU>515</SU>
                             FDA. 2016, September. Pure Vu System 510(k) premarket notification. Deparment of Health and Human Services. Accessed at 
                            <E T="03">https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160015.pdf.</E>
                        </P>
                    </FTNT>
                    <P>With respect to the second criterion, whether a product is assigned to the same or a different MS-DRG, the applicant stated that the Pure-Vu System is assigned to the same MS-DRGs as existing technologies. The applicant lists 21 MS-DRGs as being applicable, with MS-DRG 378 (gastrointestinal hemorrhage with complication or comorbidity (CC)) accounting for 37.1 percent of cases, and MS-DRG 377 (gastrointestinal hemorrhage with major complication or comorbidity (MCC)) accounting for 18.9 percent of total cases.</P>
                    <P>With respect to the third criterion, whether the new use of technology involves the treatment of the same or similar type of disease and the same or similar patient population when compared to an existing technology, the applicant stated that the Pure-Vu System® does involve treatment of the same or similar type of disease and patient population as existing technology.</P>
                    <P>After reviewing the information submitted by the applicant, we are unclear whether the Pure-Vu® System's mechanism of action is similar to that of the version of the product that received initial 510(k) clearance that was approved on September 22, 2016 or other versions of the system. In addition, with regard to the previous versions of Pure-Vu, we are unsure if the limited availability noted by the applicant would allow the technology to be considered commercially available. We are also unclear what the applicant means regarding the ClearPath system being not fully brought to the U.S. market. If the ClearPath system and/or earlier versions of the Pure-Vu System were considered to be available on the U.S. market, then we are concerned that the current version of Pure-Vu® would no longer be considered new, as we believe it may be substantially similar to ClearPath and/or earlier versions of the Pure-Vu® System because they also allow for irrigation and suction of the colon without utilizing the working channel. If the current version of Pure-Vu is substantially similar to ClearPath and/or previous versions, then it appears that the current Pure-Vu system may no longer be within the newness period. We further note that though the applicant states the Pure-Vu® System features a high intensity pulsed vortex irrigation jet and controlled suction capabilities with sensing and auto purge technology, the Pure-Vu® System irrigates the colon using water and gas like other existing irrigation methods. We are therefore uncertain as to whether these features of the Pure-Vu® System result in a new mechanism of action. We invite public comment on whether the Pure-Vu® System has a new mechanism of action compared to these predicate devices.</P>
                    <P>We are inviting public comments on whether the Pure-Vu® System is substantially similar to existing technologies and whether it meets the newness criterion.</P>
                    <P>
                        With regard to the cost criterion, the applicant searched the FY 2019 MedPAR claims data file with the FY 2019 Final Rule with Correction Notice IPPS Impact File to identify potential cases representing patients who may be eligible for treatment using the Pure-Vu® System. The applicant identified claims that reported an ICD-10-CM diagnosis code of ICD-10-CM Z12.11 (Encounter for screening for malignant neoplasm of colon), K92.2 (Gastrointestinal hemorrhage, unspecified), D50.0 (Iron deficiency anemia secondary to blood loss (chronic)), and C18._ 
                        <E T="51">516</E>
                        <FTREF/>
                         (malignant neoplasm of colon). The ICD-10-PCS procedure codes listed in the following table were used to identify claims involving colonoscopy procedures.
                    </P>
                    <FTNT>
                        <P>
                            <SU>516</SU>
                             Fourth character is required to describe specific location of neoplasm.
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="85">
                        <GID>EP10MY21.171</GID>
                    </GPH>
                    <P>The claim search conducted by the applicant resulted in 163,236 claims mapping to 633 MS-DRGs. The applicant stated that MS-DRGs 377 (G.I. Hemorrhage W MCC), 378 (G.I. Hemorrhage W CC), and 379 (G.I. Hemorrhage W/O CC/MCC) were the most common MS-DRGs to which cases reporting the listed ICD-10-PCS codes were assigned. The applicant stated that the large number of DRGs to which these cases were assigned suggests that patients were admitted to the hospital for a wide variety of reasons, but during the course of their hospital stay the patients received a colonoscopy. According to the applicant, since GI bleeding is among the most common reasons for a patient needing an urgent colonoscopy, MS-DRGs 377-379 would be expected to be the most common MS-DRGs to which cases involving the Pure-Vu technology would be assigned. Lastly, the applicant did not have any data available to suggest any specific reasons why potential patients who would be eligible for the Pure-Vu technology would map to specific MS-DRGs identified based on the claims search, such as MS-DRG 291 (Heart Failure and Stroke).</P>
                    <P>The applicant determined an average unstandardized case weighted charge per case of $63,265.</P>
                    <P>
                        The applicant did not remove charges for prior technology. The applicant stated that no prior technology is being replaced. The applicant then standardized the charges using the FY 2019 Final Rule with Correction Notice Impact File. Next, the applicant applied the 2-year inflation factor used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier threshold charges (1.13218). To calculate the charges for the new technology, the applicant used the national average CCR for the 
                        <PRTPAGE P="25303"/>
                        Supplies and Equipment cost center of 0.297 from the FY 2021 Final IPPS rule. The applicant calculated a final inflated average case-weighted standardized charge per case of $93,914, which exceeded the average case-weighted threshold amount of $63,265 by $30,649. The applicant stated that because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount, the therapy meets the cost criterion.
                    </P>
                    <P>After reviewing the information submitted by the applicant as part of its FY 2022 new technology add-on payment application for the Pure-Vu® System, we note that the MS-DRGs used in the cost analysis were not limited to those describing conditions likely to require a colonoscopy. For example, the applicant included cases assigned to MS-DRG 291 (Heart Failure and Shock with MCC). When included in the cost analysis, the assumption made is that all 1,948 cases for heart failure also had a colonoscopy performed where the technology could have potentially been utilized. We question whether all cases identified by the applicant appropriately represent potential cases eligible for the Pure-Vu® System. We invite public comment on whether the Pure-Vu® System meets the cost criterion.</P>
                    <P>With respect to the substantial clinical improvement criterion, the applicant asserted that the Pure-Vu® System offers the ability to achieve rapid beneficial resolution of the disease process treatment by achieving rapid and full visualization of the colon, which will improve diagnostic yield and the effectiveness of treatment of diseases of the bowel. The applicant claimed that due to the Pure-Vu® System's ability to cleanse the colon during the colonoscopy procedure in conjunction with a standard bowel preparation, or with an enema (to allow entry into the rectum) and without any purgative based preparation, the technology allows for earlier intervention. The applicant stated that in the case of an LGIB, this will reduce bleeding by achieving more rapid hemostasis and reduce the overall length of stay in the hospital for a portion of this population. The applicant also asserted the technology reduces the subsequent diagnostic and, in some instances, therapeutic interventions by minimizing aborted and early repeat procedures due to poor visualization caused by inadequate preparation. The applicant stated that the system can provide cleansing and removal of fecal matter, blood and other debris while maintaining the visibility of the colonoscope's camera and availability of the working channel to apply critical therapies.</P>
                    <P>
                        In support of its claims, the applicant submitted a self-sponsored, U.S.-based, multicenter, prospective, single arm study in the inpatient setting, analyzing 94 patients, 65 of which (68 percent) had a GI bleed.
                        <SU>517</SU>
                        <FTREF/>
                         Of the 94 patients (41 percent females/59 percent males), the mean age was 62 years. According to the applicant, the study's primary endpoint was the rate of improved bowel cleansing level from baseline to after use of the Pure-Vu® System per colon segment using the Boston Bowel Preparation Scale (BBPS). The BBPS score was recorded for each colorectal segment (left colon, transverse colon, and right colon segments) both prior to (baseline) and after colon cleansing with the Pure-Vu® System. An adequate cleansing level was 
                        <E T="03">a priori</E>
                         defined as a BBPS ≥2 in all evaluated colon segments. The study found that in 79 of the 94 patients (84 percent), the physician was able to successfully diagnose or rule out a GI bleed in the colon per the patients' colonoscopy indication using only the Pure-Vu® System. The analysis showed statistically significant visualization improvement in each colon segment after Pure-Vu® use with a mean BBPS score in the descending colon, sigmoid, and rectum of 1.74 pre-Pure-Vu® use and 2.89 post-Pure-Vu® use (
                        <E T="03">P</E>
                        &lt;0.001); in the transverse colon of 1.74 pre-Pure-Vu® use and 2.91 post Pure-Vu® use (
                        <E T="03">P</E>
                        &lt;0.001); and the ascending colon and cecum of 1.50 pre-Pure-Vu® use and 2.86 post Pure-Vu® use (
                        <E T="03">P</E>
                        &lt;0.001). The study found only 2 percent of cases where the diagnosis could not be achieved due to inadequate preparation. Overall, the 84 (89.4 percent) patients that received the Pure-Vu® System within the study improved BBPS scores from 38 percent (95 percent CI 28, 49) to 96 percent (95 percent CI 90, 99) in segments evaluated. The study noted one procedure related perforation which required surgical repair, and the patient was discharged 48 hours post operatively and recovered fully.
                    </P>
                    <FTNT>
                        <P>
                            <SU>517</SU>
                             Helmut Neumann ML, Tim Zimmermann, Gabriel Lang, Jason B. Samarasena, Seth A. Gross, Bhaumik Brahmbhatt, Haleh Pazwash, Vladimir Kushnir. Evaluation of bowel cleansing efficacy in hospitalized patient population using the pure-vu system. Gastrointestinal Endoscopy. 2019;89(6).
                        </P>
                    </FTNT>
                    <P>
                        The applicant also provided three outpatient clinical studies to demonstrate the Pure-Vu® System's capability to convert patients to adequate preparation where preparation was previously inadequate, and the visualization was poor based on the BBPS. In the first study, Perez J., et al. conducted an outpatient prospective pilot study using the Pure-Vu® System.
                        <SU>518</SU>
                        <FTREF/>
                         The study observed 50 patients with poorly prepared colons undergoing colonoscopy at two outpatient clinical sites in Spain and Israel, respectively. The applicant claimed study patients underwent a reduced bowel preparation consisting of the following: No dried fruits, seeds, or nuts starting 2 days before the colonoscopy, a clear liquid diet starting 18 to 24 hours before colonoscopy, and a split dose of 20mg oral bisacodyl. The study found the number of patients with an adequate cleansing level (BBPS≥2 in each colon segment) increased significantly from 31 percent (15/49) prior to use of the Pure-Vu System (baseline) to 98 percent (48/49) after use of the Pure-Vu® System (
                        <E T="03">P</E>
                        &lt;0.001), with no serious adverse events reported.
                    </P>
                    <FTNT>
                        <P>
                            <SU>518</SU>
                             Perez Jimenez J, Diego Bermudez L, Gralnek IM, Martin Herrera L, Libes M. An Intraprocedural Endoscopic Cleansing Device for Achieving Adequate Colon Preparation in Poorly Prepped Patients. J Clin Gastroenterol. 2019;53(7):530-4.
                        </P>
                    </FTNT>
                    <P>
                        In the second study provided by the applicant, van Keulen, et al. also conducted a single-arm, prospective study on 47 patients with a median age of 61 years in the outpatient setting in the Netherlands using the Pure-Vu® System.
                        <SU>519</SU>
                        <FTREF/>
                         Within the study, cecal intubation was achieved in 46/47 patients. This multicenter feasibility study found that the Pure-Vu® System significantly improved the proportion of patients with adequate bowel cleansing from 19.1 percent prior to the use of the Pure-Vu® System to 97.9 percent after its use (
                        <E T="03">P</E>
                        &lt;0.001) and median BBPS score (from 3.0 [IQR 0.0-5.0] to 9.0 [IQR 8.0-9.0]).
                    </P>
                    <FTNT>
                        <P>
                            <SU>519</SU>
                             Van Keulen KE, Neumann H, Schattenberg JM, Van Esch AAJ, Kievit W, Spaander MCW, Siersema PD. A novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: A feasibility study. Endoscopy. 2019 Jan;51(1):85-92. doi: 10.1055/a-0632-1927. Epub 2018 Jul 11.
                        </P>
                    </FTNT>
                    <P>
                        In the third study provided by the applicant that directly evaluated the Pure-Vu® System in a clinical setting, Bertiger G., et al. performed a United States-based single center, prospective, outpatient study investigating regimes of reduced outpatient bowel preparations, which included low doses of over-the-counter laxatives, and eliminating the typical 24 hour clear liquid diet restriction, which was replaced by a low residue diet the day before the procedure. In this study, 46 of a possible 49 patients received a colonoscopy, 8 of which took the over-the-counter laxative (“MiraLAX arm”), 21 patients ingested two doses of 7.5 oz Magnesium Citrate (MgC) each taken with 19.5 oz of clear liquid (“Mag Citrate 15 oz arm”), and 18 patients 
                        <PRTPAGE P="25304"/>
                        ingested 2 doses of 5 oz MgC taken with 16 oz of clear liquid (“Mag Citrate 10 oz arm”). Of the 46 subjects, 59 percent were males and there was a mean age of 61±9.48 years. The study found that each of the 3 study arms revealed significant differences in BBPS score between the baseline preparation and post-cleansing via Pure-Vu. All the preparation regimens resulted in inadequately prepped colons. Comparing the mean BBPS rating for both pre- and post- Pure-Vu® use, the MiraLAX arm was inferior (
                        <E T="03">P</E>
                         &lt;0.05) to both Mag Citrate arms. For the MiraLAX arm, the mean BBPS Score improved from 1.50 to 8.63. For the Mag Citrate 15 oz arm, the mean BBPS score improved from 3.62 to 8.95. For the Mag Citrate 10 oz arm, the mean BBPS Score improved from 4.76 to 9.0.
                    </P>
                    <P>In addition to the retrospective studies provided, the applicant also submitted three case studies to highlight the various clinical presentations of LGIB with the use of the Pure-Vu® System. In the first case, the applicant presented a 71-year-old woman with multiple episodes of bloody bowel movements and low hemoglobin levels for 2 days after a screening colonoscopy where 8 polyps were removed. The applicant stated that the patient underwent a successful colonoscopy using Pure-Vu without standard inpatient bowel preparation within 5 hours, and in addition to expediting the colonoscopy, four significant post-polypectomy ulcers were found and clipped by allowing the physician to cleanse the area and place the clips simultaneously. The applicant claimed that since the Pure-Vu® System does not impact the use of the endoscope's working channel, the physician was able to cleanse the area as needed during the intervention to allow precise placement of the clips applied to achieve hemostasis and the patient was discharged that same day.</P>
                    <P>The applicant submitted another case example where a 52-year-old male was admitted from the emergency department to the ICU due to significant GI bleeding, hemorrhagic shock, and acute kidney injury (AKI) six days after a colonoscopy where nine polyps were removed, including two polyps greater than 2 cm. The applicant stated that angiographic control of the bleeding was not considered due to AKI with rising creatinine, and bedside colonoscopy was immediately performed with the Pure-Vu® System without any bowel prep. Per the applicant, the physician was able to visualize the entire colon to confirm all sources of bleeding and place two clips to obtain hemostasis, and the patient was downgraded out of the ICU that day and discharged from the hospital the following day.</P>
                    <P>In the third case study submitted by the applicant, a 64-year-old male was admitted to the ICU with one day of bright red blood per rectum (BRBPR) along with a complex set of disorders including but not limited to alcohol use disorder, heart failure with reduced ejection fraction of 30 percent, and multidrug resistant tuberculosis. The Pure-Vu® System was used to attempt to definitively identify the bleeding source in the ICU. The applicant stated that although no active sites of bleeding were seen, red blood was found in the entire colon, and the patient was transferred out of the ICU 2 days later and discharged 3 days after transfer to the floor. The applicant claimed that while the patient's bleeding had stopped by the time the colon was examined, the ability to directly visualize the entire colon using the Pure-Vu® System helped avoid a third CT angiography during this hospitalization and helped the physicians to confirm that prior coil embolization had not resulted in focal colonic ischemia. The applicant asserted that this case showed that the Pure-Vu® System can be used with minimal preparation, enabling rapid investigation of LGIB in a very complex patient. The applicant concluded that these case studies demonstrate that a change in patient management occurs when the option of the Pure-Vu® System is available, especially when there is an urgent or severe GI bleed, where circumstances where other procedures (such as CT angiography) are insufficient and the option to perform the colonoscopy sooner is preferred.</P>
                    <P>After reviewing the information submitted by the applicant as part of its FY 2022 new technology add-on payment application for the Pure-Vu® System, we have the following concerns. While the studies provided in support of the Pure-Vu® System measure improvement of bowel preparation using the BBPS, the applicant did not provide data indicating that the improved BBPS directly leads to improved clinical outcomes (for example, reduction of blood loss in LGIB or reduction of missed polyps) based on use of the Pure-Vu® System. Additionally, we note that the applicant has not provided any studies comparing the efficacy of the Pure-Vu® System to other existing methods or products for irrigation in support of its claims that the product is superior at removing debris from the colon while simultaneously preventing the colon from collapsing, allowing use of the working channel, or improving outcomes. Furthermore, we note that many of the provided studies were based on small sample sizes, which may affect the quality and reliability of the data provided in support of the technology. In addition, we note that the methodology described in the provided studies often involved time to adequately prepare the colon and included outpatient planned procedures, which may not reflect the emergent situations that the applicant states the Pure-Vu® System is intended to address in the inpatient setting. We also note that the Helmut, et al. study noted one procedure related perforation which required surgical repair and we invite public comments regarding the concern of procedure related perforation.</P>
                    <P>We are inviting public comments on whether the Pure-Vu® System meets the substantial clinical improvement criterion.</P>
                    <P>
                        We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for the Pure-Vu® System.
                    </P>
                    <HD SOURCE="HD3">o. Rapid ASPECTS</HD>
                    <P>iSchemaView (which is in the process of a name change to RapidAI) submitted an application for new technology add-on payments for Rapid ASPECTS for FY 2022. According to the applicant, Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using computed tomography (CT) image data. The applicant asserted that the software automatically registers images and segments and analyzes ASPECTS Regions of Interest (ROIs). According to the applicant, Rapid ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The applicant stated that the imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT Score.</P>
                    <P>The applicant stated Rapid ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known Middle Cerebral Artery (MCA) or Internal Carotid Artery (ICA) occlusion, for evaluation of extent of disease. The applicant stated that extent of disease refers to the number of ASPECTS regions affected, which is reflected in the total score.</P>
                    <P>
                        According to the applicant, the Rapid ASPECTS device provides information that may be useful in the 
                        <PRTPAGE P="25305"/>
                        characterization of early ischemic brain tissue injury during image interpretation (within 6 hours). The applicant stated Rapid ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROIs and numerical scoring. The applicant stated that Rapid ASPECTS is not intended for primary interpretation of CT images; it is used to assist physician evaluation. The applicant asserted Rapid ASPECTS has been validated in patients with known MCA or ICA occlusion prior to ASPECT scoring.
                    </P>
                    <P>According to the applicant, when patients with a suspected stroke arrive at an emergency department, they are rapidly triaged to the CT scanner for a non-contrast CT (NCCT) and CT angiography (CTA). The applicant stated that CTA directly images large vessel occlusions and the NCCT can exclude brain hemorrhage and identify early signs of brain infarction. The applicant asserted that automated large vessel occlusion (LVO) detection software is now used at many sites to quickly identify LVOs on CTA and provide physicians with early notification that an LVO has been identified. The applicant stated that following identification of an LVO, the next imaging evaluation required is for a physician, typically a radiologist or neuroradiologist, to determine the ASPECT score by taking a close look at the NCCT for evidence of early infarct signs. The applicant stated that patients with an ASPECT score between 6 and 10 who meet clinical criteria for thrombectomy should receive thrombectomy as soon as possible, if treatment can occur within 6 hours of symptoms onset. The applicant asserted that for patients who present beyond 6 hours, a CT perfusion or MRI scan are required to identify which patients are eligible for thrombectomy.</P>
                    <P>
                        The applicant stated approximately 800,000 primary (first-time) or secondary (recurrent) strokes occur each year in the U.S., with the majority being primary strokes (roughly 600,000). Of these strokes, approximately 87% are ischemic infarctions, 10% are primary hemorrhages, and 3% are subarachnoid hemorrhage.
                        <SU>520</SU>
                        <FTREF/>
                         According to the applicant, the incidence of stroke rapidly increases with age, doubling for each decade after age 55. The applicant asserted that among adults ages 35 to 44, the incidence of stroke is 30 to 120 in 100,000 per year, and for those ages 65 to 74, the incidence is 670 to 970 in 100,000 per year. Therefore, according to the applicant, the primary burden of stroke affects the Medicare-age population. The applicant stated the most disabling strokes are those due to large vessel occlusions (LVOs), and treatment of these strokes has the largest therapeutic benefits.
                        <SU>521</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>520</SU>
                             Ovbiagele B, et al. Stroke Epidemiology: Advancing Our Understanding of Disease Mechanism and Therapy 
                            <E T="03">Neurotherapeutics.</E>
                             (2011) 8:319-329.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>521</SU>
                             Ovbiagele B, et al. Stroke Epidemiology: Advancing Our Understanding of Disease Mechanism and Therapy 
                            <E T="03">Neurotherapeutics.</E>
                             (2011) 8:319-329.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that Rapid ASPECTS received FDA 510(k) clearance as a CADx software device on June 26, 2020 and provided a date of first installation of September 1, 2020. The applicant described Rapid ASPECTS as a machine learning-based automated software for assessment of ASPECTS. The applicant asserted that Rapid ASPECTS remains the only cleared ASPECTS software and the only stroke imaging software to receive a CADx clearance by the FDA. The legally marketed predicate device that Rapid ASPECTS is substantially equivalent to, per FDA, is QuantX,
                        <SU>522</SU>
                        <FTREF/>
                         which was granted De Novo authorization on July 19, 2017. QuantX is a CADx software device used to assist radiologists in the assessment and characterization of breast abnormalities using magnetic resonance (MR) image data and is indicated for evaluation of patients presenting for high-risk screening, diagnostic imaging workup, or evaluation of extent of known disease.
                        <SU>523</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>522</SU>
                             Rapid ASPECTS 510(k) clearance letter from FDA: 
                            <E T="03">https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200760.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>523</SU>
                             QuantX De Novo decision summary from FDA: 
                            <E T="03">https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170022.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <P>We note the applicant submitted a request for approval of a unique ICD-10-PCS procedure code to identify use of the technology beginning FY 2022. According to the applicant, this new ICD-10-PCS code would be reported in addition to the non-contrast CT using the appropriate code as listed in current coding systems.</P>
                    <P>As discussed previously, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>With regard to the first criterion, whether a product uses the same or a similar mechanism of action to achieve a therapeutic outcome, the applicant asserted Rapid ASPECTS uses a new mechanism of action (machine learning) to assess CT scans and synthesize a single ASPECT score when compared to existing options which are limited to clinical assessment by a human reader. According to the applicant, this software remains the only FDA-cleared ASPECTS software and the only stroke imaging software to receive a CADx clearance by the FDA. The applicant asserted Rapid ASPECTS is fully automated and produces a score for each of the 10 ASPECTS regions, as well as a total score in approximately 2 minutes.</P>
                    <P>With regard to the second criterion, whether the technology is assigned to the same or a different MS-DRG, the applicant stated that cases involving Rapid ASPECTS would be assigned to the same MS-DRGs as cases involving patients confirmed with an eligible LVO by a positive CTA. According to the applicant, in these cases, the traditional clinical pathway requires a physician to determine the ASPECT score through an imaging evaluation. The applicant noted that Rapid ASPECTS may result in patients being assigned to a different MS-DRG depending on whether or not a mechanical thrombectomy is performed as a result of the Rapid ASPECTS results.</P>
                    <P>With regard to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant asserted Rapid ASPECTS addresses the current stroke population.</P>
                    <P>In summary, the applicant believes that Rapid ASPECTS is not substantially similar to other currently available therapies because Rapid ASPECTS uses a new mechanism of action (machine learning) to assess CT scans and synthesize a single ASPECT score. We are unclear as to whether machine learning to assess CT scans and synthesize a single ASPECT score would represent a unique mechanism of action, or how the mechanism of action by which Rapid ASPECTS assesses stroke imaging is distinct from other automated stroke imaging analysis tools, or the traditional hospital workflow.</P>
                    <P>
                        We continue to be interested in public comments regarding issues related to determining newness for technologies that use AI, an algorithm or software, as discussed in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58628). Specifically, we are interested in public comment on how these technologies, including devices classified as radiological computer aided triage and notification software and radiological computer-assisted diagnostic software, may be considered for the purpose of identifying a unique mechanism of 
                        <PRTPAGE P="25306"/>
                        action; how updates to AI, an algorithm or software would affect an already approved technology or a competing technology; whether software changes for an already approved technology could be considered a new mechanism of action, and whether an improved algorithm by competing technologies would represent a unique mechanism of action if the outcome is the same as an already approved AI new technology.
                    </P>
                    <P>We invite public comments on whether Rapid ASPECTS is substantially similar to existing technologies, including specifically with respect to the mechanism of action, and whether it meets the newness criterion.</P>
                    <P>With respect to the cost criterion, the applicant provided three analyses: (1) A baseline analysis containing all cases reporting one of the targeted ICD-10-CM codes below as the principal diagnosis code for cerebral infarction that map to one of the applicant's targeted MS-DRGs; (2) an analysis limited to MS-DRGs with a case volume over 100; and (3) an analysis limited to MS-DRGs 023, 062, 064, 065, and 066, which per the applicant would reflect 80 percent of all stays. For the baseline analysis, the applicant first extracted all inpatient stays from the CY 2018 Limited Data Set Standard Analytic File (LDS SAF) that contained a principal ICD-10-CM diagnosis code for cerebral infarction. The applicant used the following ICD-10-CM diagnosis codes.</P>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="25307"/>
                        <GID>EP10MY21.172</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="210">
                        <PRTPAGE P="25308"/>
                        <GID>EP10MY21.173</GID>
                    </GPH>
                    <P>The applicant then removed cases for hospitals that are not paid under the IPPS. The applicant also removed inpatient stays and their assigned MS-DRGs from its analysis where the assigned MS-DRG met any of the following conditions: (1) The MS-DRG is for a part of the body not related to the head; (2) the MS-DRG is a psychiatric MS-DRG, alcohol-related MS-DRG, or a catchall MS-DRG; (3) the MS-DRG has a very small number of cases; or (4) the MS-DRG is unlikely to involve an LVO. The applicant identified 66,990 cases mapping to 27 MS-DRGs, as listed in the following table, in descending order by volume:</P>
                    <GPH SPAN="3" DEEP="305">
                        <GID>EP10MY21.174</GID>
                    </GPH>
                    <P>
                        The applicant then standardized the charges and applied the 2-year charge inflation factor of 13.2 percent used to adjust the outlier threshold determination (85 FR 59039). The applicant did not remove charges for prior technology, as the applicant believes Rapid ASPECTS does not eliminate or replace any prior technology or services. The applicant also noted that it did not remove charges related to the prior technology, as the applicant believes Rapid ASPECTS does not reduce costs during the inpatient stay.
                        <PRTPAGE P="25309"/>
                    </P>
                    <P>The applicant then added charges for the technology. The applicant stated that it estimated the cost per case of Rapid ASPECTS using historical utilization data gathered from its Rapid CTA module. The applicant anticipates Rapid ASPECTS will be used in the same hospital sites as Rapid CTA, which also provides the applicant with a baseline number of Medicare and non-Medicare patients who were identified with a suspected LVO. The applicant estimated that approximately 20.5 percent of all patients who received a RAPID CTA scan qualified as inpatients eligible for a Rapid ASPECTS scan. The applicant divided the total number of qualified Medicare and non-Medicare inpatients by the total number of subscriber hospitals to arrive at an average number of inpatients eligible to be scanned with Rapid ASPECTS per subscriber hospital per year. The applicant then took the estimated average sales price per annual contract of Rapid ASPECTS per hospital and divided it across the estimated annual number of Rapid ASPECTS inpatients per site to estimate the average cost per case per subscriber hospital. Finally, the applicant divided the average cost per case by the national average CCR for radiology of 0.136 (85 FR 58601).</P>
                    <P>The applicant calculated a case-weighted threshold amount of $76,398 and a final inflated average case-weighted standardized charge per case of $90,097. Based on this analysis, the applicant asserted that Rapid ASPECTS meets the cost criterion because the final inflated average case-weighted standardized charge per case exceeds the case-weighted threshold amount. The applicant submitted two additional scenarios to demonstrate that the technology meets the cost criterion using the same methodology described but with limits on the cases. The first scenario limited the analysis to MS-DRGs with at least 100 cases. This resulted in a case-weighted threshold of $76,457 and a final inflated average case weighted standardized charge per case of $90,172. The second scenario limited the analysis to MS-DRGs 023, 062, 064, 065, and 066, which per the applicant reflect 80 percent of all stays. This second alternative method resulted in a case-weighted threshold of $67,890 and a final inflated average case-weighted standardized charge per case of $77,614. Across all three analyses, the applicant maintained that the technology meets the cost criterion because the final inflated average case-weighted standardized charge per case exceeds the average case-weighted threshold amount.</P>
                    <P>We note the following concerns regarding the cost analysis for Rapid ASPECTS. The applicant stated it removed from its analysis those cases and their assigned MS-DRG where the assigned MS-DRG was for a body part that is not the head; however the list of MS-DRGs the applicant presented included MS-DRGs 37 (Extracranial Procedures w/MCC) and 38 (Extracranial Procedures w/CC), which by definition describe procedures outside of the head. We would like to understand why these MS-DRGs and their assigned cases were included in the baseline analysis. We would also like to understand the time period of the claims the applicant selected from the CY 2018 SAF, as this could have implications for the inflation factor used to update charges if the applicant selected claims from FY 2018 as opposed to FY 2019.</P>
                    <P>The applicant appears to have used a single list price of Rapid ASPECTS per hospital with a cost per patient that can vary based on the volume of cases. We note that the cost per patient varies based on the utilization of the technology by the hospitals. The cost per patient could be skewed by the small number of hospitals utilizing the technology and their low case volumes. It is possible, if hospitals with large patient populations adopt Rapid ASPECTS, the cost per patient would be significantly lower.</P>
                    <P>In the FY 2021 IPPS/LTCH PPS final rule (85 FR 58630), we stated our understanding that there are unique circumstances to determining a cost per case for a technology that utilizes a subscription for its cost. We stated our intent to continue to consider the issues relating to the calculation of the cost per unit of technologies sold on a subscription basis as we gain more experience in this area. We continue to welcome comments from the public as to the appropriate method to determine a cost per case for such technologies, including comments on whether the cost per case should be estimated based on subscriber hospital data as described previously, and if so, whether the cost analysis should be updated based on the most recent subscriber data for each year for which the technology may be eligible for the new technology add-on payment.</P>
                    <P>We invite public comment on whether Rapid ASPECTS meets the cost criterion.</P>
                    <P>With respect to the substantial clinical improvement criterion, the applicant asserted Rapid ASPECTS represents a substantial clinical improvement over existing technologies because it improves diagnostic decisions by improving accuracy of ASPECT scoring. The applicant also asserted it improves diagnostic decisions by reducing inter-rater variability of ASPECT scoring. The applicant also asserted it represents a substantial clinical improvement by improving treatment decisions and by improving time to treatment.</P>
                    <P>
                        According to the applicant, the first stroke treatment, tissue plasminogen activator (tPA), was first approved in the United States for intravenous administration to patients with acute stroke in 1996, and a study demonstrating successful catheter-directed intra-arterial infusion of a thrombolytic agent for this indication was first published in 1999.
                        <SU>524</SU>
                        <FTREF/>
                         The applicant asserted that the first positive randomized controlled studies using modern mechanical thrombectomy devices for LVO stroke were published in 2015 and support combined treatment with tPA and catheter-based thrombectomy as the most effective treatment approach for patients who can be treated within six hours of symptom onset.
                        <SU>525</SU>
                        <FTREF/>
                         According to the applicant, following the publication of these trials, the American Heart Association (AHA) and American Stroke Association (ASA) released new guidelines in 2016, 2018 and 2019 that all specified the following Level 1A recommendation:
                    </P>
                    <FTNT>
                        <P>
                            <SU>524</SU>
                             Furlan A, Higashida R, et al. Intra‐arterial prourokinase for acute ischemic stroke: the PROACT II study: a randomized controlled trial: Prolyse in Acute Cerebral Thromboembolism. 
                            <E T="03">JAMA.</E>
                             1999;282:2003-2011.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>525</SU>
                             Goyal M, Menon BK, et al for the HERMES collaborators. Endovascular thrombectomy after large‐vessel ischaemic stroke: a meta‐analysis of individual patient data from five randomised trials. 
                            <E T="03">Lancet</E>
                             2016; 387: 1723-31.
                        </P>
                    </FTNT>
                    <P>Patients should receive mechanical thrombectomy with a stent retriever if they meet all the following criteria:</P>
                    <P>• Pre-stroke modified Rankin Score (mRS) score of 0 to 1.</P>
                    <P>• Causative occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA) segment 1 (M1).</P>
                    <P>• Age ≥18 years.</P>
                    <P>• NIH Stroke Scale (NIHSS) score of ≥6.</P>
                    <P>• Alberta stroke program early CT score (ASPECTS) of ≥6.</P>
                    <P>
                        • Treatment can be initiated (groin puncture) within 6 hours of symptom onset.
                        <SU>526</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>526</SU>
                             Powers WJ, Rabinstein A, Ackerson T, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. 
                            <E T="03">Stroke.</E>
                             2019;50:e344-e418.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, the above-recommended guidelines from the 
                        <PRTPAGE P="25310"/>
                        AHA/ASA have been widely accepted and outline the key requirements that are still used today to select early window (less than 6 hours) candidates for thrombectomy. The applicant asserted the imaging requirements (the second and the fifth criterion) require that patients be screened for an LVO with CTA and then once an LVO in the ICA or MCA is discovered, the ASPECTS score must be assessed to verify that it is 6 or higher. According to the applicant, the ASPECTS score is an assessment of the CT scan in a stroke patient to determine if there is evidence of irreversible injury in ten different brain regions. The applicant stated that patients who have more than five regions that are already irreversibly injured are not candidates for thrombectomy.
                    </P>
                    <P>
                        According to the applicant, it is well validated in the stroke literature that faster treatment leads to better outcomes. The applicant stated that compared with the best medical therapy alone, in the first five positive LVO endovascular thrombectomy trials that were published in the 
                        <E T="03">New England Journal of Medicine</E>
                         and subsequently summarized in a pooled analysis by the HERMES group, thrombectomy was associated with improved outcomes when procedure start (arterial puncture) could be performed within the first 7.3 hours after symptom onset among patients meeting the brain imaging entry criteria for inclusion in these randomized trials.
                        <SU>527</SU>
                        <FTREF/>
                         The applicant asserted that within this period, functional outcomes were better the sooner after symptom onset that endovascular reperfusion was achieved, emphasizing the importance of programs to enhance patient awareness, out-of-hospital care, and in-hospital management to shorten symptom onset-to-treatment times. The applicant asserted that the magnitude of the association between time to treatment and outcome is clinically meaningful. According to the applicant, in patients with acute ischemic stroke due to LVO, among every 1000 patients achieving substantial endovascular reperfusion, for every 15-minutes faster emergency department door-to-reperfusion time, an estimated 39 patients would have a less-disabled outcome at 3 months, including 25 more who would achieve functional independence (mRS 0-2).
                        <SU>528</SU>
                        <FTREF/>
                         The applicant stated that in addition to faster time from emergency department door to reperfusion, faster time from brain imaging to reperfusion was associated with better 3-month functional outcomes.
                        <SU>529</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>527</SU>
                             Goyal M, Menon BK, et al for the HERMES collaborators. Endovascular thrombectomy after large‐vessel ischaemic stroke: a meta‐analysis of individual patient data from five randomised trials. 
                            <E T="03">Lancet</E>
                             2016; 387: 1723-31.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>528</SU>
                             Goyal M, Menon BK, et al for the HERMES collaborators. Endovascular thrombectomy after large‐vessel ischaemic stroke: a meta‐analysis of individual patient data from five randomised trials. 
                            <E T="03">Lancet</E>
                             2016; 387: 1723-31.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>529</SU>
                             Ibid. Goyal M, Menon BK, et al for the HERMES collaborators. Endovascular thrombectomy after large‐vessel ischaemic stroke: a meta‐analysis of individual patient data from five randomised trials. 
                            <E T="03">Lancet</E>
                             2016; 387: 1723-31.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, the interpretation of early infarct signs in CT first became clinically important following the FDA approval of tPA for stroke treatment in 1996 because it was shown that the response to tPA could be predicted based on the degree of early brain injury that could be visualized on the CT scan. The applicant asserted it was clear that intravenous tPA could be harmful in patients with advanced early infarct signs because they had a high risk of intracranial hemorrhage. The applicant stated, however, only rough qualitative estimates of the degree of early infarct signs were performed. The applicant asserted stroke clinicians generally felt safe to give tPA if the early infarct signs were confined to less than one-third of the middle cerebral artery territory.
                        <SU>530</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>530</SU>
                             von Kummer R, Allen KL, Holle R, et al. Acute stroke: usefulness of early CT findings before thrombolytic therapy. 
                            <E T="03">Radiology</E>
                             1997; 205:327-33.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, beginning in the 2000s, a more detailed and quantitative analysis of early infarct signs was proposed: The Alberta Stroke Program Early CT score (ASPECTS).
                        <SU>531</SU>
                        <FTREF/>
                         The applicant stated this score requires the evaluation of 10 pre-defined MCA vascular territories. The applicant asserted these individual regions are assessed for focal hypoattenuation of the cortex and in the basal ganglia, reduction of gray and white matter differentiation, and the loss of the insular ribbon sign. According to the applicant, ASPECTS is calculated by subtracting 1 point for each involved region; scores less than 6 typically signify patients with an irreversible large hemispheric infarction.
                        <SU>532</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>531</SU>
                             Barber PA, Demchuk AM, et al. Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy. ASPECTS Study Group. Alberta Stroke Programme Early CT Score. 
                            <E T="03">Lancet.</E>
                             2000 May 13;355(9216):1670-4.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>532</SU>
                             Albers GW, MD, Wald MJ, Mlynash M, et al. Automated Calculation of Alberta Stroke Program Early CT Score Validation in Patients With Large Hemispheric Infarct. 
                            <E T="03">Stroke.</E>
                             2019;50:3277-3279.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, the ASPECTS evaluation became clinically essential in 2015 after mechanical thrombectomy was found to be effective for treatment of patients with a large vessel occlusion within the 6-hour time frame.
                        <E T="51">533 534</E>
                        <FTREF/>
                         The applicant stated that some of the large randomized controlled trials that ultimately led to the establishment of thrombectomy as a standard procedure required an ASPECTS greater than or equal to 6 for inclusion. According to the applicant, the MR CLEAN trial, which enrolled patients with lower ASPECT scores than the other four trials, reported the smallest overall treatment effect and in particular, patients with an ASPECT score less than 5 did not show benefit with an adjusted odds ratio close to 1.0.
                        <SU>535</SU>
                        <FTREF/>
                         The applicant asserted that for these reasons, an ASPECTS evaluation is required in most national and international thrombectomy guidelines. The applicant stated most guidelines, including the AHA/ASA guidelines discussed above, require an ASPECT score greater than or equal to six 6 for a patient to qualify for thrombectomy in the early treatment window.
                        <SU>536</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>533</SU>
                             Goyal M, Menon BK, et al for the HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: A meta‐analysis of individual patient data from five randomised trials. 
                            <E T="03">Lancet</E>
                             2016; 387: 1723-31.
                        </P>
                        <P>
                            <SU>534</SU>
                             Powers WJ, Rabinstein A, Ackerson T, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. 
                            <E T="03">Stroke.</E>
                             2019;50:e344-e418.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>535</SU>
                             Berkhemer OA, Fransen PS, et al; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. 
                            <E T="03">N Engl J Med.</E>
                             2015;372:11-20.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>536</SU>
                             Powers WJ, Rabinstein A, Ackerson T, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. 
                            <E T="03">Stroke.</E>
                             2019;50:e344-e418.
                        </P>
                    </FTNT>
                    <P>
                        The applicant asserted ASPECT score determination is challenging because early infarct signs are often very subtle and challenging to interpret correctly. According to the applicant, there is often disagreement between experts on the exact score and sometimes these disagreements preclude a definite answer regarding if the patient qualifies for thrombectomy or not. The applicant asserted these interpretation challenges are manifested by limited
                        <FTREF/>
                         inter-rater 
                        <PRTPAGE P="25311"/>
                        agreement, even among experts.
                        <E T="51">537 538 539</E>
                         The applicant cited the DEFUSE 2 study in which two expert readers graded ischemic change on NCCT using the ASPECT score. The applicant asserted that full-scale agreement (measured by the intraclass correlation coefficient) for CT-ASPECTS was only moderate at 0.579.
                        <SU>540</SU>
                        <FTREF/>
                         According to the applicant, these inter-rater differences can have important clinical implications, as discussed further. The applicant asserted that many physicians who evaluate acute stroke patients are not confident that they can accurately determine an ASPECT score, and oftentimes there are significant delays before a radiologist reads the scan.
                    </P>
                    <P>
                        The applicant stated current AHA/ASA guidelines recommend a CT scan be performed within 25 minutes of Emergency Department arrival and the radiologist interpretation of the scan occur within 45 minutes of arrival.
                        <SU>541</SU>
                        <FTREF/>
                         According to the applicant, based on these guidelines, radiologists have about 20 minutes to read the scan, however, many hospitals, especially community and primary stroke centers, do not meet these guidelines. The applicant asserted Medicare data indicate that only 72% of patients meet these guidelines. The applicant stated that automated software, such as Rapid ICH, Rapid LVO and Rapid ASPECTS can assess CT and CTA findings (both to rule out hemorrhage, confirm an LVO and to assess early signs of infarction with ASPECTS) within minutes.
                    </P>
                    <FTNT>
                        <P>
                            <SU>537</SU>
                             Albers GW, MD, Wald MJ, Mlynash M, et al. Automated Calculation of Alberta Stroke Program Early CT Score Validation in Patients With Large Hemispheric Infarct. 
                            <E T="03">Stroke.</E>
                             2019;50:3277-3279.
                        </P>
                        <P>
                            <SU>538</SU>
                             Kobkitsuksakul C, Tritanon O, Suraratdecha V. Interobserver agreement between senior radiology resident, neuroradiology fellow, and experienced neuroradiologist in the rating of Alberta Stroke Program Early Computed Tomography Score (ASPECTS). 
                            <E T="03">Diagn Interv Radiol.</E>
                             2018.
                        </P>
                        <P>
                            <SU>539</SU>
                             McTaggart RA, Jovin TG, Lansberg MG, et al. Alberta stroke program early computed 
                            <PRTPAGE/>
                            tomographic scoring performance in a series of patients undergoing computed tomography and MRI: Reader agreement, modality agreement, and outcome prediction. 
                            <E T="03">Stroke.</E>
                             2015 Feb;46(2):407‐12.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>540</SU>
                             McTaggart RA, Jovin TG, Lansberg MG, et al. Alberta stroke program early computed tomographic scoring performance in a series of patients undergoing computed tomography and MRI: Reader agreement, modality agreement, and outcome prediction. 
                            <E T="03">Stroke</E>
                             2015 Feb;46(2):407‐12.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>541</SU>
                             AHA/ASA. Target: Stroke Campaign Manual, published 2010. 
                            <E T="03">http://www.strokeassociation.org/idc/groups/heart-public/@wcm/@hcm/@gwtg/documents/downloadable/ucm_308277.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, the limited inter-rater agreement for traditional ASPECT scoring can lead to triaging ineligible patients to thrombectomy or failing to treat eligible patients. The applicant cited a study in which four experienced readers rated ASPECT scores in patients who presented with LVO and severe strokes. The applicant stated the inter-rater agreement between these raters was poor with an interclass correlation of 0.32.
                        <SU>542</SU>
                        <FTREF/>
                         According to the applicant, the range of agreement for individual raters with the gold standard assessment of the score (obtained with a concurrent MRI) for identifying patients with a score less than six 6 ranged from 35% to 94%. The applicant asserted this study demonstrates there can be substantial disagreement between physicians regarding if a patient is eligible for thrombectomy based on their assessment of the ASPECT score, which can lead to eligible patients not receiving this highly effective therapy, as well as the performance of unnecessary procedures.
                    </P>
                    <FTNT>
                        <P>
                            <SU>542</SU>
                             Albers GW, MD, Wald MJ, Mlynash M, et al. Automated Calculation of Alberta Stroke Program Early CT Score Validation in Patients with Large Hemispheric Infarct. 
                            <E T="03">Stroke.</E>
                             2019;50:3277-3279.
                        </P>
                    </FTNT>
                    <P>
                        The applicant asserted that particularly the Medicare population might be at risk and impacted by these limitations as the majority of LVOs occur in the Medicare population. The applicant stated that the average age of patients in the HERMES pooled analysis of thrombectomy studies was 68 years.
                        <SU>543</SU>
                        <FTREF/>
                         Therefore, according to the applicant, inaccuracy of traditional ASPECT scoring translates into a substantial percentage of Medicare patients having erroneous triage decisions made regarding their eligibility for thrombectomy, which it asserted can result in unnecessary procedures and increased Medicare costs, as well as increased disability in eligible patients who are not treated because of inaccurate ASPECT scoring.
                    </P>
                    <FTNT>
                        <P>
                            <SU>543</SU>
                             Goyal M, Menon BK, et al for the HERMES collaborators. Endovascular thrombectomy after large‐vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. 
                            <E T="03">Lancet</E>
                             2016; 387: 1723-31.
                        </P>
                    </FTNT>
                    <P>
                        As stated previously, the applicant asserted Rapid ASPECTS represents a substantial clinical improvement over existing technologies because it improves diagnostic decisions by improving accuracy of ASPECT scoring. The applicant presented three retrospective cohort studies (two peer-reviewed and one under review) to support the claim that diagnostic decisions made by clinicians would have been improved with use of Rapid ASPECTS. According to the applicant, two of the studies showed that the automated Rapid ASPECTS score is significantly more accurate than the scores obtained by experienced clinicians.
                        <E T="51">544 545</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>544</SU>
                             Maegerlein C, Fischer J, Mönch S, MD et al. Automated Calculation of the Alberta Stroke Program Early CT Score: Feasibility and Reliability. 
                            <E T="03">Radiology</E>
                             2019; 291:141-148.
                        </P>
                        <P>
                            <SU>545</SU>
                             Albers GW, MD, Wald MJ, Mlynash M, et al. Automated Calculation of Alberta Stroke Program Early CT Score Validation in Patients With Large Hemispheric Infarct. 
                            <E T="03">Stroke.</E>
                             2019;50:3277-3279.
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted a retrospective cohort study which compared ASPECT scoring of CT images from patients with MCA occlusion (n=100) between Rapid ASPECTS software and two expert neuroradiologist reads. According to the applicant, Rapid ASPECTS showed a substantial agreement (k=0.78) when imaging took place more than 1 hour after symptom onset, which increased to high agreement (k=0.92) for imaging occurring after 4 hours. The applicant asserted that the neuroradiologist raters did not achieve comparable results to the software until the time interval of greater than 4 hours (k=0.83 and k=0.76). In this study, experts developed the reference consensus score and then, after 6 weeks, the same two neuroradiologists again determined ASPECTS by using only the baseline CT. The experts had moderate agreement with the consensus score (k=0.57 and k=0.57) while Rapid ASPECTS had better agreement (k=0.9). There was minimal agreement across experts and software in the timeframe of less than 1 hour between symptom onset and imaging, but better software agreement when the time was between 1 and 4 hours. There was agreement across experts for imaging occurring after 4 hours. According to the applicant, this study showed that in acute stroke of the MCA, Rapid ASPECTS had better agreement than that of human readers with a predefined consensus score.
                        <SU>546</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>546</SU>
                             Maegerlein C, Fischer J, Mönch S, MD et al. Automated Calculation of the Alberta Stroke Program Early CT Score: Feasibility and Reliability. 
                            <E T="03">Radiology</E>
                             2019; 291:141-148.
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted another retrospective cohort study to compare Rapid ASPECTS, as well as the mean score from four experienced readers, with a diffusion-weighted magnetic resonance imaging (DW-MRI) ASPECTS obtained following the baseline CT in patients (n=65) with large hemispheric infarcts.
                        <SU>547</SU>
                        <FTREF/>
                         DW-MRI is sensitive in the detection of small and early infarcts. Small infarcts might not appear on CT scans for days. The AHA/ASA guidelines state that DW-MRI can be useful for selecting candidates for mechanical thrombectomy between 6 and 24 hours after the patient was last known well (that is, the time at which the patient was known to be without signs and symptoms of the current stroke).
                        <SU>548</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>547</SU>
                             Albers GW, MD, Wald MJ, Mlynash M, et al. Automated Calculation of Alberta Stroke Program Early CT Score Validation in Patients With Large Hemispheric Infarct. 
                            <E T="03">Stroke.</E>
                             2019;50:3277-3279.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>548</SU>
                             Powers WJ, Rabinstein A, Ackerson T, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. 
                            <E T="03">Stroke.</E>
                             2019;50:e344-e418.
                        </P>
                    </FTNT>
                    <PRTPAGE P="25312"/>
                    <P>
                        According to the applicant, Rapid ASPECTS' automated score had a higher level of agreement with the mean of the DW-MRI ASPECTS, both for the full scale and for the dichotomized scale of either &lt;6 or ≥6 which is the difference for treatment/no treatment (difference in intraclass correlation coefficient, p&lt;0.001). The applicant stated that the mean DW-MRI ASPECT score was &lt;6 in 63/65 (97%) of the cases; of these, RAPID ASPECTS agreed with the DW-MRI score in 46/63 (73%) of the cases (95% confidence interval [CI] 60-83%) vs. 35/63 56% of the cases (95% CI 44-69%) for the median score of the two experienced readers (p=0.027). The range of agreement for individual clinician CT ASPECTS with the median DW-MRI score for identifying patients with a score &lt;6 was 35% to 94%. According to the applicant, this study demonstrated the accuracy for determining which patients have an ASPECTS &lt;6 (which would exclude them from thrombectomy) was significantly higher with the software.
                        <SU>549</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>549</SU>
                             Albers GW, MD, Wald MJ, Mlynash M, et al. Automated Calculation of Alberta Stroke Program Early CT Score Validation in Patients With Large Hemispheric Infarct. 
                            <E T="03">Stroke.</E>
                             2019;50:3277-3279.
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted an additional retrospective cohort study under review for publication which compared physicians' (two expert neuroradiologists and six typical readers) ability to read ASPECTS in patients with an LVO (n=50; 10 regions in each patients' scan for a total of 500 individual regions) within 6 hours of symptom onset when assisted by Rapid ASPECTS, compared with their unassisted score. The applicant stated that the average ASPECT score of three additional experienced neuroradiologists who were provided access to a follow-up MRI was used as the reference standard. The applicant asserted that when typical readers read the scan in conjunction with the Rapid ASPECTS software, their agreement with the expert reads improved from 72% to 78% (p&lt;0.0001, test of proportions). According to the applicant, Rapid ASPECTS alone achieved correlations for total ASPECT scores that were similar to the three experienced neuroradiologist readers who had access to a follow-up MRI scan to help enhance the quality of their reads. The applicant asserted the results from this study showed that the aid of Rapid ASPECTS can significantly improve typical readers' scores and that the automated scores generated by Rapid ASPECTS are interchangeable with the scores generated by expert neuroradiologists.
                        <SU>550</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>550</SU>
                             Delio PR, Wong ML, Tsai JP, et al. Assistance from Automated ASPECTS Software Improves Reader Performance (under review 2020).
                        </P>
                    </FTNT>
                    <P>
                        As stated previously, the applicant asserted Rapid ASPECTS represents a substantial clinical improvement over existing technologies because it improves diagnostic decisions by reducing inter-rater variability of ASPECT scoring. To support this claim the applicant submitted the study performed by iSchemaView and analyzed by an independent statistician that led to the FDA clearance of Rapid ASPECTS. According to the applicant, acute CT scans in patients with LVO (n=50) were read by eight readers both with and without Rapid ASPECTS. The applicant asserted that the standard deviation of ASPECT scores ranged from 0.35 to 4.5 without assistance as compared to 0.46 to 4.7 with assistance. The applicant stated that the median standard deviation dropped from 2.2 to 1.4 when assistance was used to read the scans. According to the applicant, a t-test to evaluate the hypothesis of equal standard deviations supported a significant difference in standard deviations (p=0.0002), and non-parametric tests arrived at the same conclusion (p&lt;0.0001 for a Wilcoxon Rank Sum Test).
                        <SU>551</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>551</SU>
                             Copeland K. Variability of ASPECT Scores Internal Analysis iSchemaView of data submitted to U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health, 2020a.
                        </P>
                    </FTNT>
                    <P>As stated previously, the applicant asserted Rapid ASPECTS represents a substantial clinical improvement by improving treatment decisions and by improving time to treatment. The applicant asserted that in the study performed by iSchemaView of the acute CT scans in patients with LVO (n=50) which were read by eight readers both with and without Rapid ASPECTS, a Receiver Operating Characteristic (ROC) analysis demonstrated significant improvement in typical readers' ability to identify patients who have a score of 6 to 10 if they read the scan in conjunction with the automated score. According to the applicant, the area under the curve (AUC) improved from 0.78 without Rapid ASPECTS to 0.85 with Rapid ASPECTS (p=0.0049).</P>
                    <P>
                        The applicant asserted that of the 400 treatment assessments (50 scans * 8 readers) in this study, 7% were changed from an incorrect assessment to a correct assessment when the scan was read in conjunction with the automated score compared with traditional scoring, a statistically significant difference.
                        <SU>552</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>552</SU>
                             Copeland K. Treat/No Treat Analysis, Internal Analysis iSchemaView of data submitted to U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health, 2020.
                        </P>
                    </FTNT>
                    <P>
                        The applicant cited three retrospective studies that, according to the applicant, have shown treatment decisions made by experienced clinicians would have been improved with the use of Rapid ASPECTS.
                        <E T="51">553 554 555</E>
                        <FTREF/>
                         As stated previously, the applicant asserted that one study showed that agreement regarding whether a patient had a treatment-eligible score based on a concurrent MRI scan interpreted by two experts was significantly higher for the Rapid ASPECTS score than for experienced clinicians.
                        <SU>556</SU>
                        <FTREF/>
                         According to the applicant, Rapid ASPECTS has also been shown to improve the reads of a typical CT scan reader to become as accurate as a neuroradiologist read.
                        <SU>557</SU>
                        <FTREF/>
                         The applicant asserted that since radiologists are not immediately available at the time when many LVO patients present, and obtaining a read from a neuroradiologist often takes even longer, the time to determine an ASPECT score will be substantially improved with the software, leading to faster treatment times which have been shown to reduce disability. According to the applicant, Rapid ASPECTS provides an opportunity to impact the current selection and allocation pathway for stroke care.
                    </P>
                    <FTNT>
                        <P>
                            <SU>553</SU>
                             Albers GW, MD, Wald MJ, Mlynash M, et al. Automated Calculation of Alberta Stroke Program Early CT Score Validation in Patients With Large Hemispheric Infarct. 
                            <E T="03">Stroke.</E>
                             2019;50:3277-3279.
                        </P>
                        <P>
                            <SU>554</SU>
                             Delio PR, Wong ML, Tsai JP, et al. Assistance from Automated ASPECTS Software Improves Reader Performance (under review 2020).
                        </P>
                        <P>
                            <SU>555</SU>
                             Maegerlein C, Fischer J, Mönch S, MD et al. Automated Calculation of the Alberta Stroke Program Early CT Score: Feasibility and Reliability. 
                            <E T="03">Radiology</E>
                             2019; 291:141-148.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>556</SU>
                             Albers GW, MD, Wald MJ, Mlynash M, et al. Automated Calculation of Alberta Stroke Program Early CT Score Validation in Patients With Large Hemispheric Infarct. 
                            <E T="03">Stroke.</E>
                             2019;50:3277-3279.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>557</SU>
                             Delio PR, Wong ML, Tsai JP, et al. Assistance from Automated ASPECTS Software Improves Reader Performance (under review 2020).
                        </P>
                    </FTNT>
                    <P>After reviewing the information submitted by the applicant, we have the following questions regarding whether Rapid ASPECTS meets the substantial clinical improvement criterion.</P>
                    <P>
                        In the studies provided by the applicant, the reference ASPECT score to which Rapid ASPECTS was compared was generally derived from a mean value of the ASPECT scores rated from a small sample of expert radiologists. We note that the radiologists used to identify the reference to which Rapid ASPECTS was compared may not be representative of radiologists in the United States. We are also unclear whether a mean ASPECT score, identified from radiologists whom 
                        <PRTPAGE P="25313"/>
                        the applicant describes as having low levels of agreement, is representative of a meaningful value as it does not represent the score of any particular radiologist. We further question whether individuals participating in these studies may have altered their behavior in a substantive way by interacting with computer-generated ratings, which would complicate study findings.
                    </P>
                    <P>We further note that the correlation between the ASPECT scoring of expert and Rapid ASPECTS is the primary outcome in many of the articles provided. Though this information may be important and informative, it is not clear that a high correlation between expert and Rapid ASPECTS scoring is necessarily indicative of substantial clinical improvement. Furthermore, whether these providers agree with the technology does not determine whether they are correct, and it could be the case that both AI and radiologists agree on an incorrect score.</P>
                    <P>We note that the applicant stated that inter-rater disagreement with ASPECT scores leads to erroneous triage and treatment of Medicare patients. It is unclear how the applicant determined that disagreement between scores translates into inappropriate treatment, or necessarily shows that the scoring class (&lt;6 vs ≥6) was inaccurate. The applicant also asserted that many physicians who evaluate acute stroke patients are not confident that they can accurately determine an ASPECT score, but it did not provide evidence to support this claim. Additionally, we observe that the studies provided did not demonstrate improvements in clinical outcomes such as disability, mortality, or length of stay; rather, improved outcomes were inferred by relying on the assumption that faster treatment results in better outcomes. Without measuring the impact of the technology on treatment outcomes, we are uncertain whether Rapid ASPECTS represents a substantial clinical improvement.</P>
                    <P>Lastly, we note that the applicant submitted the AHA/ASA guidelines and a review of stroke literature as support for clinical improvement. It is unclear how the guidelines support a finding of substantial clinical improvement for Rapid ASPECTS because the guidelines are for the current standard of care. Additionally, the applicant did not provide evidence to support its assertion that hospitals are not meeting the AHA/ASA guideline that radiologists read the CT scan of acute ischemic stroke patients within 20 minutes. The stroke literature review identified the inter-rater differences among ASPECT scoring, but did not demonstrate that inter-rater disagreements have led to triaging ineligible patients to thrombectomy or failing to treat eligible patients in clinical practice. It is unclear how the literature on inter-rater reliability for ASPECT scoring would demonstrate a substantial clinical improvement in how Rapid ASPECTS supports improved triaging of stroke care. The applicant's stroke literature review also identified that faster treatment leads to better outcomes. While this supports the urgency of stroke care, we are unsure how it demonstrates a substantial clinical improvement in how Rapid ASPECTS supports the urgency of stroke care.</P>
                    <P>We are inviting public comments on whether Rapid ASPECTS meets the substantial clinical improvement criterion.</P>
                    <P>
                        In this section, we summarize and respond to written public comments received in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for Rapid ASPECTS.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters, some of whom participated in one of the retrospective studies assessing Rapid ASPECTS, asserted that Rapid ASPECTS offers a substantial clinical improvement over the current standard of care for evaluation and treatment of patients diagnosed with LVO. They cited the studies summarized in this section and their clinical experience with Rapid ASPECTS and stated that Rapid ASPECTS improves treatment decisions by improving the accuracy of the assessment of candidates eligible for thrombectomy as well as reducing the time to appropriate treatment, which leads to better outcomes.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We thank the commenters for their input and will take this information into consideration when deciding whether to approve new technology add-on payments for Rapid ASPECTS.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         The applicant responded to the questions received at the New Technology Town Hall Meeting held in December 2020.
                    </P>
                    <P>First, the applicant was asked if an ROC analysis had been performed with Rapid ASPECTS. The applicant stated that an ROC analysis had been performed for one of the retrospective studies assessing Rapid ASPECTS (Delio et al., 2020, under review). According to the applicant, using the scores for the 500 ASPECT regions for all 8 readers shows the AUC improved from 0.78 without RAPID to 0.85 with RAPID-assisted reads. The applicant stated the reference standard was the read from three experienced neuroradiologists who were provided access to a follow-up MRI scan to help enhance the accurary of the reference standard. The applicant asserted that the difference of 0.06 between the AUCs is statistically significant (p=0.0049).</P>
                    <P>
                        Second, the applicant was asked if clinical benefits of RAPID Aspects were directly observed in prospective studies using the Rapid ASPECTS software. The applicant cited a recent retrospective study reporting a series of 176 patients from one hospital in Alexandria, Egypt diagnosed with Acute Ischemic Stroke (AIS) and subsequently treated with tPA between January 2018 and December 2019. Results were reported on 122 of these patients; 36 had their NCCT images analyzed by Rapid ASPECTS and 86 had their NCCT images analyzed by a remote neuroradiologist who received the image by the text messaging platform WhatsApp. The applicant asserted that Rapid ASPECTS had excellent agreement (k=0.80) with the neuroradiologist's read. The door-to-needle time for the 86 WhatsApp-read patients was 52.3 ±16 minutes and for the 36 Rapid ASPECTS patients was 36.8 ±11 minutes (p=0.001), representing a 14-minute reduction in the door-to-treatment time in Rapid ASPECTS group compared with the WhatsApp standard care group. According to the applicant, there was also a significantly increased likelihood of functional independence and fewer hemorrhagic complications in patients treated with reperfusion therapy in the Rapid ASPECTS group (p&lt;0.001). The applicant also asserted that the use of Rapid ASPECTS was shown to be cost-effective in this study.
                        <SU>558</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>558</SU>
                             Mansour, Ossama Yassin, et al. “Deciding Thrombolysis in AIS Based on Automated versus on WhatsApp Interpreted ASPECTS, a Reliability and Cost-Effectiveness Analysis in Developing System of Care.” 
                            <E T="03">Frontiers in Neurology</E>
                             11 (2020): 333.
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the applicant's responses to questions asked at the New Technology Town Hall Meeting. Regarding generalizability, we note that the study results from a small, non-randomized sample generated from a single hospital in Alexandria, Egypt, may limit the ability to assert findings are generalizable across the variety of health care settings in the United States. We question whether the fact that the radiologists in this study received the images via WhatsApp is generalizable to the standard of care in the United States. We also note the study did not attempt to control for other variables such as the mix of patients in each group or time of day or other changes 
                        <PRTPAGE P="25314"/>
                        in hospital practices over time. Additionally, since only patients with confirmed acute ischemic stroke were included in the study results, no information was given about the imaging and interpretation of other patients imaged. We note that the retrospective study had two neuroradiologists interpret the NCCT images at a later time and compare their ASPECT score to the Rapid ASPECTS-generated score reading the same scans. The study reported that in only one patient, the Rapid ASPECTS software underestimated the extent of early ischemic changes by providing an automated ASPECTS &gt;6, while the score was &lt;6 by agreement read (which would indicate that tPA treatment was not appropriate). We note that the clinical outcome of that patient was not reported.
                    </P>
                    <P>We appreciate the information provided by the applicant and will take these comments into consideration when deciding whether to approve new technology add-on payments for Rapid ASPECTS.</P>
                    <HD SOURCE="HD3">
                        p. Steripath® Micro
                        <E T="51">TM</E>
                         Blood Collection System
                    </HD>
                    <P>
                        Magnolia Medical Technologies, Inc. submitted an application for new technology add-on payments for the Steripath® Micro
                        <E T="51">TM</E>
                         Blood Collection System, which is also referred to as the Steripath® Micro
                        <E T="51">TM</E>
                         Initial Specimen Diversion Device (ISDD®), for FY 2022. The applicant described the Steripath® Micro
                        <E T="51">TM</E>
                         ISDD® (“Steripath Micro”) as a proprietary and patent-protected single-use, disposable device, which is indicated for use in the collection of blood cultures by nurses, phlebotomists, and technicians in emergency departments and inpatient units in acute care hospitals to reduce blood culture contamination and false positive diagnostic test results for sepsis. According to the applicant, Steripath® Micro
                        <E T="51">TM</E>
                         ISDD®, along with the Steripath and Steripath® Gen2, are part of a product portfolio utilizing their Steripath® ISSD® technology.
                    </P>
                    <P>
                        The applicant explained that the Steripath® Micro
                        <E T="51">TM</E>
                         ISDD® uses a syringe-driven (or blood culture bottle-driven) architecture that uses negative pressure to flip a proprietary internal bladder, which, in turn, creates gentle negative pressure to divert and sequester the initial 0.6 to 0.9 mL of blood, the portion known to most likely contain contaminants. According to the applicant, once diversion is complete, the user presses a side button to isolate the diverted blood. The applicant further explained that once the blood is isolated, a second independent blood flow pathway is opened to collect the blood specimen into the syringe (or blood culture bottle) for blood culture testing.
                    </P>
                    <P>
                        The applicant stated that the design and development of the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® was inspired by patients who present with symptoms concerning for sepsis and who are hypotensive (low blood pressure) and hypovolemic (low blood volume), have difficult intravenous access (DIVA), or are small in stature with lower blood volume. According to the applicant, clinicians typically utilize a syringe technique to collect blood from this patient population to enable management of negative pressure (attempting to avoid vein collapse) while improving the opportunity to collect a sufficient volume of blood to culture, which the applicant stated is a critical determinant of blood culture sensitivity (that is, avoiding false negative results). The applicant claimed that this patient population is generally ineligible for existing ISDD® technologies due to risk of vein collapse. According to the applicant, the negative pressure created by Steripath® Micro
                        <SU>TM</SU>
                         ISDD®'s bladder-driven mechanism is designed to achieve initial specimen diversion while avoiding collapsing of the veins (losing venous access) of this patient population. The applicant stated that the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® is available with a preassembled sterile integrated syringe for syringe-driven diversion and blood culture sample collection, and components of the system may be used for infusion following sample collection after disconnection of the ISDD®.
                    </P>
                    <P>According to the applicant, blood culture is the gold standard diagnostic test for bloodstream infections, including septicemia. The applicant explained that blood cultures are drawn from patients displaying symptoms of a potential bloodstream infection with results guiding therapeutic decisions and influencing outcomes for patients for their duration in acute care. The applicant stated that the standard of care is to collect two separate blood cultures, each consisting of two blood culture bottles containing aerobic or anaerobic medium. The applicant further noted that the major automated microbial blood culture detection systems (BACTEC and BacT/ALERT) recommend 8-10 mL of blood in each of the aerobic and anaerobic bottles—up to 40 mL total distributed across all four bottles.</P>
                    <P>
                        The applicant stated that despite the critical role blood culture plays in providing diagnoses, an estimated 20 percent to over 50 percent of all positive blood culture results for sepsis are suspected to be false positive due to blood culture contamination, as explained in greater detail below.
                        <SU>559</SU>
                        <FTREF/>
                         The applicant stated that blood culture contamination creates clinical confusion which leads to a risk of inappropriate antibiotic therapy,
                        <E T="51">560 561 562 563</E>
                        <FTREF/>
                         extended length of stay of an average of 2.0 to 2.4 days,
                        <E T="51">564 565</E>
                        <FTREF/>
                          
                        <E T="03">Clostridium difficile</E>
                         (CDI) infection,
                        <E T="51">566 567</E>
                        <FTREF/>
                         multidrug resistance organism (MDRO) infections, Acute Kidney Injury (AKI),
                        <SU>568</SU>
                        <FTREF/>
                         hospital-acquired infection (HAI) or hospital-acquired condition (HAC),
                        <SU>569</SU>
                        <FTREF/>
                         false-positive Central Line-Associated Blood Stream Infection (CLABSI) treatment, false positives reported to National Healthcare Safety Network (NHSN)/CMS (thus biasing the data), and additional lab and/or other diagnostic testing.
                        <SU>570</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>559</SU>
                             Snyder S, et al. Effectiveness of practices to reduce blood culture contamination: A Laboratory Medicine Best Practices systematic review and meta-analysis. 
                            <E T="03">Clinical Biochemistry.</E>
                             2012; 45(0):999-1011.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>560</SU>
                             Rupp M, et al. Reduction in Blood Culture Contamination Through Use of Initial Specimen Diversion Device. 
                            <E T="03">Clinical Infectious Diseases.</E>
                             2017; 65(2):201-205.
                        </P>
                        <P>
                            <SU>561</SU>
                             Bell M, et al. Effectiveness of a novel specimen collection system in reducing blood culture contamination rates. Journal of Emergency Nursing 44.6 (2018): 570-575.
                        </P>
                        <P>
                            <SU>562</SU>
                             Doern G, et al. A Comprehensive Update on the Problem of Blood Culture Contamination and a Discussion of Methods for Addressing the Problem. Clinical Microbiology Reviews. 2020; 33:e00009-19.
                        </P>
                        <P>
                            <SU>563</SU>
                             Chang D, et al. Impact of blood culture diversion device on molecular pathogen identification on vancomycin use. Poster presented at: Society for Healthcare Epidemiology of America (2017).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>564</SU>
                             Skoglund E et al. Estimated Clinical and Economic Impact through Use of a Novel Blood Collection Device To Reduce Blood Culture Contamination in the Emergency Department: A Cost-Benefit Analysis. 2019; 57:e01015-18.
                        </P>
                        <P>
                            <SU>565</SU>
                             Geisler B, et al. Model to evaluate the impact of hospital-based interventions targeting false-positive blood cultures oneconomic and clinical outcomes. 
                            <E T="03">Journal of Hospital Infection.</E>
                             2019; 102:438-444.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>566</SU>
                             Ibid. Geisler B, et al. Model to evaluate the impact of hospital-based interventions targeting false-positive blood cultures oneconomic and clinical outcomes. 
                            <E T="03">Journal of Hospital Infection.</E>
                             2019; 102:438-444.
                        </P>
                        <P>
                            <SU>567</SU>
                             Doern G, et al. A Comprehensive Update on the Problem of Blood Culture Contamination and a Discussion of Methods for Addressing the Problem. Clinical Microbiology Reviews. 2020; 33:e00009-19.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>568</SU>
                             Khalili H, et al. “Antibiotics induced acute kidney injury: Incidence, risk factors, onset time and outcome.” Acta Medica Iranica (2013): 51(12): 871-878.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>569</SU>
                             Doern G, et al. A Comprehensive Update on the Problem of Blood Culture Contamination and a Discussion of Methods for Addressing the Problem. 
                            <E T="03">Clinical Microbiology Reviews.</E>
                             2020; 33:e00009-19.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>570</SU>
                             Ibid. Doern G, et al. A Comprehensive Update on the Problem of Blood Culture Contamination and a Discussion of Methods for Addressing the 
                            <PRTPAGE/>
                            Problem. 
                            <E T="03">Clinical Microbiology Reviews.</E>
                             2020; 33:e00009-19.
                        </P>
                    </FTNT>
                    <PRTPAGE P="25315"/>
                    <P>
                        The applicant explained that the detection of bacteremia is of particular concern for Medicare beneficiaries, given that the mean age for United States patients afflicted with sepsis in 2014 was 66.5, with sepsis present in 35 percent of all United States hospitalizations that resulted in death.
                        <SU>571</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>571</SU>
                             Rhee C, et al. Incidence and Trends of Sepsis in US Hospitals Using Clinical vs Claims Data, 2009-2014. 
                            <E T="03">JAMA.</E>
                             2017; 318:1241-1249.
                        </P>
                    </FTNT>
                    <P>
                        With regard to the newness criterion, the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® is a Class II medical device that received 510(k) clearance from the FDA on October 8, 2020. The 510(k) clearance was based on substantial equivalence to an earlier version of the device, Steripath® Gen2, which received 510(k) clearance on February 28, 2020. According to the applicant, the Steripath® ISDD® product portfolio, including the Steripath® Micro
                        <SU>TM</SU>
                         ISDD®, is the only FDA 510(k)-cleared family of devices indicated to reduce blood culture contamination.
                        <SU>572</SU>
                        <FTREF/>
                         According to the applicant, a supplemental Special 510(k) submission and clearance is anticipated for an additional configuration of the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® device that incorporates a butterfly safety venipuncture needle.
                    </P>
                    <FTNT>
                        <P>
                            <SU>572</SU>
                             Bell, Mary, et al. Effectiveness of a novel specimen collection system in reducing blood culture contamination rates. 
                            <E T="03">Journal of Emergency Nursing</E>
                             44.6 (2018): 570-575.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, there are currently no ICD-10-PCS procedure codes to distinctly identify the use of the Steripath® Micro
                        <SU>TM</SU>
                         ISDD®. The applicant submitted a request for a new ICD-10-PCS procedure code for implementation on October 1, 2021.
                    </P>
                    <P>As discussed above, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>
                        According to the applicant, diversion techniques use the same basic principle to reduce blood culture contamination by sequestering blood most likely to contain dislodged skin fragments and/or flora. With regard to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, the applicant discussed current/alternative treatments to avoid blood contamination, but states that manual diversion, passive diversion, and the Steripath® Gen2 device are not comparable alternatives to Steripath® Micro
                        <SU>TM</SU>
                        .
                    </P>
                    <P>
                        According to the applicant, manual diversion, which involves the phlebotomist or other medical professional first collecting blood into a waste tube and then manually switching to a sample collection tube, is not a replacement for Steripath® Micro
                        <SU>TM</SU>
                         ISDD® because manual diversion inherently entails additional opportunities for human error through touch contamination and process variation, without the ability to manage and ensure healthcare worker compliance. The applicant further explained that manual diversion techniques introduce, at a minimum, one additional surface (waste tube top), which must either be sterilized (or carefully handled if pre-packaged sterile) to avoid cross contamination through the inoculation needle. The applicant noted that if the inoculation needle is contaminated in this manner, both blood culture bottles can become contaminated, which can be interpreted (inaccurately) as a true positive through laboratory testing. The applicant explained that Steripath® Micro
                        <SU>TM</SU>
                         ISDD® is a closed system to prevent opportunities for touch contamination beyond conventional methods of blood culture sample acquisition. The applicant further explained that since Steripath® Micro
                        <SU>TM</SU>
                         ISDD® is a pre-assembled and packaged sterile kit that does not require manual connections, it avoids touch-point contamination and prevents the need for additional time, focus, and manual diversion procedural compliance from the operator.
                    </P>
                    <P>
                        The applicant stated that the Kurin product, a competitor diversion device that uses passive diversion (or relying on the patients blood pressure), is not a comparable alternative to Steripath® Micro
                        <SU>TM</SU>
                         ISDD® as it is not FDA-cleared to reduce blood-culture contamination. The applicant claimed that passive diversion, because of its limitations, is integrated into the Kurin product to redirect 0.15 mL of blood. The applicant stated that passive devices are susceptible to bypassing diversion when the culture bottle is inoculated before diversion is complete, and that this limitation is not present within the Steripath® Micro
                        <E T="51">TM</E>
                         ISDD® architecture. The applicant asserted that the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® uses a novel syringe-driven (or blood culture bottle-driven) negative pressure to flip an internal bladder which, in turn, creates gentle negative pressure to divert and sequester the initial 0.6 to 0.9 mL of blood.
                    </P>
                    <P>
                        The applicant further stated that the Steripath® Gen2 ISDD® is not a comparable product to Steripath® Micro
                        <SU>TM</SU>
                         ISDD®, as it uses greater negative pressure to divert an initial 1.5-2.0 mL of blood for the adult patient population. According to the applicant, the Steripath® Micro
                        <E T="51">TM</E>
                         ISDD® platform leverages ISDD® technology but is smaller, easier-to-use, and employs a novel proprietary diversion bladder technology to address patients who are hypotensive and hypovolemic, have difficult intravenous access, or are small in stature with lower blood volume.
                    </P>
                    <P>
                        Specifically, the applicant explained that the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® uses syringe-driven (or blood culture bottle-driven) negative pressure to flip an internal bladder which in turn creates gentle negative pressure to effectively and consistently divert and sequester the initial 0.6 to 0.9 mL of blood, the portion known to most likely contain contaminants, with this patient population. The applicant asserts this differentiates the Steripath® Micro
                        <SU>TM</SU>
                         from the Steripath® Gen2. The applicant further explained that once diversion is complete, the user presses a button to isolate the diverted blood and, automatically, a second independent blood flow pathway opens to collect the blood specimen into the syringe (or blood culture bottle) for culture.
                    </P>
                    <P>
                        With respect to the second criterion, whether the technology is assigned to the same or a different MS-DRG, the applicant did not indicate whether the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® would be assigned to the same MS-DRGs as cases representing patients who receive diagnostic information from competing technologies or traditional blood collection methods.
                    </P>
                    <P>
                        With respect to the third criterion, whether the new use of the technology involves the treatment of the same or similar type of disease and the same or similar patient population, the applicant stated that the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® was fundamentally designed to address a specific and broader patient population than any other technology that is currently available and FDA 510(k) cleared to prevent blood culture contamination. The applicant explained that in a certain subset of `hard-stick' (low blood volume, hypovolemic and hypotensive) patients, blood culture using passive diversion or the Steripath® Gen2 ISDD® is not possible. According to the applicant, Steripath® Micro
                        <E T="51">TM</E>
                         is the first ISDD designed specifically to address the unmet needs of the low blood volume, hypovolemic and hypotensive, `hard-stick' patient populations (many requiring integrated sterile syringe collection) that is FDA 510(k) cleared indicated to reduce blood culture contamination.
                    </P>
                    <P>
                        We have the following concerns regarding whether the technology meets 
                        <PRTPAGE P="25316"/>
                        the substantial similarity criteria and whether it should be considered new. Although we understand that the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® version may divert less blood volume and utilize less negative pressure than the Steripath® Gen2 ISDD®, we note that both devices utilize negative pressure and, according to the applicant, leveraged Magnolia Medical Technologies' foundational ISDD® technology, and it is unclear whether this represents a new mechanism of action. We further note that the applicant also appears to consider the devices as similar, as they exclusively rely on studies conducted using the Steripath® Gen2 ISDD® to demonstrate substantial clinical improvement. We therefore believe that the newness date for Steripath® Micro
                        <SU>TM</SU>
                         ISDD® would begin on February 28, 2020, the date on which the predicate device received 510(k) clearance.
                    </P>
                    <P>
                        We also note that the applicant claimed that the Steripath® ISDD® product portfolio, including the Steripath® Micro
                        <E T="51">TM</E>
                         ISDD®, is the only FDA 510(k)-cleared family of devices indicated to reduce blood culture contamination and we are inviting public comment on whether there are other FDA-cleared products designed to reduce blood culture contamination.
                    </P>
                    <P>
                        We are inviting public comments on whether the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® is substantially similar to other technologies and whether the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® meets the newness criterion.
                    </P>
                    <P>
                        With regard to the cost criterion, the applicant searched the FY 2019 MedPAR FR claims data file with the FY 2019 Final Rule IPPS Impact File to identify potential cases representing patients who may be eligible for treatment using Steripath® Micro
                        <SU>TM</SU>
                         ISDD®.
                    </P>
                    <P>
                        The applicant used 37 Infection ICD-10-CM Diagnosis Codes and 15 Sepsis ICD-10-CM Diagnosis codes to identify patients who could potentially benefit from the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® during an inpatient stay. These ICD-10-CM codes are provided in the following table:
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="440">
                        <GID>EP10MY21.175</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="182">
                        <PRTPAGE P="25317"/>
                        <GID>EP10MY21.176</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="66">
                        <GID>EP10MY21.177</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        In its analysis, the applicant identified a primary cohort to assess whether this therapy met the cost criterion. The applicant stated that clinical literature suggests the DIVA population represents anywhere from 17 percent to 59 percent of all patients that present as symptomatic for sepsis and require blood cultures.
                        <E T="51">573 574 575</E>
                        <FTREF/>
                         The applicant added that the literature did not provide any additional information on the distribution of the DIVA population within the larger infection/sepsis population. To account for this, the applicant randomly selected 33% of claims that included one of the ICD-10 codes listed above in one of the first two diagnosis code positions on the claim to include in the cost analysis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>573</SU>
                             Sou, V., et al. A clinical pathway for the management of difficult venous access. BMC Nursing 16, 64 (2017).
                        </P>
                        <P>
                            <SU>574</SU>
                             Armenteros-Yeguas V., et al. Prevalence of difficult venous access and associated risk factors in highly complex hospitalized patients. J Clin Nurs. 2017;26(23-24):4267-4275.
                        </P>
                        <P>
                            <SU>575</SU>
                             Van Loon, FH, et al. Development of the A-DIVA Scale: A Clinical Predictive Scale to Identify Difficult Intravenous Access in Adult Patients Based on Clinical Observations. Medicine. 2016 Apr;95(16)e3428.
                        </P>
                    </FTNT>
                    <P>
                        The applicant removed MS-DRGs describing kidney and urinary tract infections and renal failure because these cases are not likely to benefit from use of the Steripath® Micro
                        <SU>TM</SU>
                         ISDD®. The applicant stated that these diagnoses rely on technologies not relevant to Steripath® Micro
                        <SU>TM</SU>
                         ISDD®, such as urine cultures and blood cultures specific to urea and creatinine. Lastly the applicant excluded cases in MS-DRGs that accounted for less than 1% of the total cases in the identified sample.
                    </P>
                    <P>The claim search conducted by the applicant resulted in 295,790 claims mapping to six MS-DRGs: 871 (Septicemia or severe sepsis w/o mv &gt;96 hours w mcc), 872 (Septicemia or severe sepsis w/o mv &gt;96 hours w/o mcc), 853 (Infectious &amp; parasitic diseases w o.r. procedure w mcc), 870 (Septicemia or severe sepsis w mv &gt;96 hours or peripheral extracorporeal membrane oxygenation (ecmo)), 854 (Infectious &amp; parasitic diseases w o.r. procedure w cc), and 177 (Respiratory infections &amp; inflammations w mcc). The applicant determined an average unstandardized case weighted charge per case of $69,973.</P>
                    <P>
                        The applicant stated that studies show blood culture contamination (BCC) increases length of stay (LOS) and leads to unnecessary antimicrobial therapy and/or hospital-acquired conditions. The applicant stated that a retrospective analysis involving hospitalized patients with septicemia-compatible symptoms found that avoiding BCC would decrease costs by $6,463, including $4,818 in savings for inpatient care. 53 percent of savings were attributed to reduced LOS and 26 percent to reduced antibiotic use.
                        <SU>576</SU>
                        <FTREF/>
                         The applicant stated that to account for these savings, they removed $2,500 by inflating costs to charges using the national average cost-to-charge ratio (CCR) for routine days and $2,300 by inflating costs to charges using the pharmacy national average CCR. Because the previous study cited did not describe where non-LOS related inpatient savings arose, the applicant assumed that the savings arose from reduced drug use and therefore the pharmacy national average CCR was used.
                    </P>
                    <FTNT>
                        <P>
                            <SU>576</SU>
                             Geisler, BP, 
                            <E T="03">et al.</E>
                             Model to evaluate the impact of hospital-based interventions targeting false-positive blood cultures on economical and clinical outcomes. J Hosp Infect. 2019 Aug;102(4):438-444.
                        </P>
                    </FTNT>
                    <P>
                        Because, according to the applicant, savings accrue in around 3% of cases where the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® is used, the applicant applied three percent of the savings described above to every case in the sample population. The applicant stated that removing the $4,800 in cost savings from 3 percent of the cases is mathematically the same as removing 3 percent of the cost savings from all cases. The applicant then standardized the charges using the FY 2019 Final Rule Impact File. Next, the applicant applied the 2-year inflation factor used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier threshold charges (1.13218). To calculate the charges for the technology, the applicant used the national average CCR for the Supplies and Equipment cost center of 0.297 from the FY 2021 Final IPPS rule. The applicant calculated a final inflated average case-
                        <PRTPAGE P="25318"/>
                        weighted standardized charge per case of $76,796, which exceeded the average case-weighted threshold amount of $69,973 by $6,824. The applicant stated that because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount, the therapy meets the cost criterion.
                    </P>
                    <P>
                        Based on the information provided by the applicant, we note the following concerns with regard to the cost criterion. In its analysis, the applicant stated it randomly selected 33% of claims that included one of the ICD-10 codes listed above in one of the first two diagnosis code positions on the claim to include in the cost analysis. Implicit in this decision to randomly select a subsample is the belief that Steripath® Micro
                        <SU>TM</SU>
                         ISDD® cases are randomly distributed across all cases identified. If performed properly, the intent of random sampling from a population is to identify a smaller group of cases which remains representative or similar to the greater population. An added effect of proper random sampling is that the sample often has less variance than the population from which it was drawn. We are therefore concerned that random sampling may be inappropriate in this situation if the potential cases are not similarly randomly distributed.
                    </P>
                    <P>
                        Furthermore, if it is true that a subset of cases would be more representive of cases eligible for use of the Steripath® Micro 
                        <SU>TM</SU>
                         ISDD®, it may be more likely that those cases will be distributed based on certain characteristics, not randomly distributed. We are seeking public comment on whether the random sample used by the applicant would appropriately identify the cases eligible for the use of Steripath.
                    </P>
                    <P>
                        In its cost analysis, the applicant stated that, in order to account for savings from the use of Steripath® Micro
                        <SU>TM</SU>
                         ISDD®, it removed $2,500 by inflating costs to charges using the national average cost-to-charge ratio (CCR) for routine days and $2,300 by inflating costs to charges using the pharmacy national average CCR. From a methodological standpoint, we are not certain that the data from which savings were calculated are generalizable to the broader Medicare population's experience if Steripath® Micro
                        <E T="51">TM</E>
                         Blood Collection System is used. Specifically, we are not certain that the patient population and the resulting conclusions from the aforementioned study 
                        <SU>577</SU>
                         adequately generalize to the Medicare population.
                    </P>
                    <P>
                        Lastly, the applicant stated that because savings accrue in around three percent of cases where the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® is used, the applicant applied three percent of the savings described previously to every case in its sample population. We are unclear whether the three percent of cases which experienced savings in the one study provided by the applicant is adequately representative of the Medicare population. We are not certain that three percent of a sample experiencing some level of savings is the same as all cases experiencing three percent savings. Therefore, we are not certain that it is appropriate to apply three percent of savings across all cases in the applicant's cost analysis. As with the reduction in charges discussed previously, while the applicant's approach provides a more conservative estimate for purposes of the cost criterion, we question whether it accurately reflects the experiences of providers and Medicare beneficiaries.
                    </P>
                    <P>
                        We invite public comment on whether Steripath® Micro
                        <SU>TM</SU>
                         ISDD® meets the cost criterion. With respect to the substantial clinical improvement criterion, the applicant asserted that the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® represents a substantial clinical improvement over existing technologies. The applicant stated that data from studies show that Steripath Micro
                        <SU>TM</SU>
                         ISDD® offers the ability to reduce blood collection contamination with skin flora and asserted that it improves clinical outcomes relative to services or technologies previously available as demonstrated by reducing clinically significant adverse events (that is, a decrease in inappropriate antibiotic use and a decrease in inappropriate hospitalizations).
                    </P>
                    <P>
                        The applicant submitted with its application 17 Steripath® ISDD® technology-specific studies, including 5 peer-reviewed studies published in scientific journals, that it stated support the contamination rate reduction with Steripath® Gen2 ISDD ® of 73.6 percent to 100 percent, with resulting sustained contamination rates of 0.97 percent to 0.0 percent, which the applicant stated is below the 3.0 percent gold standard benchmark rate for blood culture contamination.
                        <SU>578</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>578</SU>
                             Zimmerman, F. et al. “Reducing blood culture contamination using an initial specimen diversion device.”
                            <E T="03">American Journal of Infection Control</E>
                             47.7 (2019): 822-826.
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted a retrospective controlled study by Bell M, et al.
                        <SU>579</SU>
                        <FTREF/>
                         that showed that investigators seeking to lower the blood culture contamination rate at four different Lee Health (a healthcare system in Florida) emergency departments found that Steripath® Gen2 ISDD® implementation reduced their blood culture contamination rate by 83.0 percent when compared to conventional methods of sample acquisition, (that is without diversion). The Lee Health emergency departments compared contamination rates obtained using Steripath® Gen2 ISDD® device as the standard of care from May 2016 through November 2016 to conventional methods which were collected from October 2015 through November 2016. The applicant stated that these findings support their claim that Steripath® ISDD® reduces the risk of blood culture contamination.
                    </P>
                    <FTNT>
                        <P>
                            <SU>579</SU>
                             Bell M, et al. Effectiveness of a novel specimen collection system in reducing blood culture contamination rates. Journal of Emergency Nursing 44.6 (2018): 570-575.
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted the Bauman, K, poster,
                        <SU>580</SU>
                        <FTREF/>
                         where investigators seeking to lower the blood culture contamination rate at the Inova Fairfax Medical Center found that Steripath® Gen2 implementation reduced their blood culture contamination rate by 81.5% when compared to conventional methods of sample acquisition. The trial use of Steripath® Gen2 lasted for one year, and results were compared to conventional methods for the year preceding the trial. According to the applicant, findings support the claim that Steripath® reduces the risk of blood culture contamination, while historical patient data from this hospital supported the claim that the lower contamination rate Steripath® enables will translate into a reduced patient length of stay of one day per avoided false positive event.
                    </P>
                    <FTNT>
                        <P>
                            <SU>580</SU>
                             Bauman, K. “Don't Stick Me Again! Reducing Blood Culture Contamination” Poster presented at: Emergency Nursing Annual Conference.
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted the Blakeney J, et al.
                        <SU>581</SU>
                        <FTREF/>
                         poster, a prospective controlled study comparing the use of Steripath® ISDD® to standard collection methods and the effect on blood culture contamination rates. Over a 16-week period, participants' blood was collected using both the Steripath® and conventional methods, with each being recorded. Per the applicant, outcomes showed that Steripath® ISDD® implementation reduced Beebe Healthcare's blood culture contamination rate by 74.6 percent when compared to conventional methods of sample acquisition. The applicant stated that the findings support the claim that Steripath® ISDD® reduces the risk of blood culture contamination.
                    </P>
                    <FTNT>
                        <P>
                            <SU>581</SU>
                             Blakeney J, et al. “Reduction of Blood Culture Contamination Using Initial Specimen Diversion Device”Poster presented at: American Society for Microbiology Annual Meeting (2018).
                        </P>
                    </FTNT>
                    <PRTPAGE P="25319"/>
                    <P>
                        The applicant submitted the Church K, et al.
                        <SU>582</SU>
                        <FTREF/>
                         prospective controlled study, which showed that investigators at the Medical University of South Carolina emergency department found that Steripath® Gen2 ISDD® implementation reduced their blood culture contamination rate by 73.6 percent when compared to conventional methods of sample acquisition. In this 20-month study, nurses were given autonomy to decide if a patient would be best served by the Steripath® Gen2 device or conventional methods, with choices being recorded. The uptake rate of the Steripath® Gen2 device was 66%, with exclusions being uncooperative patients and difficult to stick patients.
                    </P>
                    <FTNT>
                        <P>
                            <SU>582</SU>
                             Church K, et al. “Novel Blood Culture Collection Device Reduces False-Positive Blood Cultures, Saves Costs, and Increases Accuracy of Bloodstream Infection Diagnosis” Poster presented at: IHI National Forum (2017).
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted the Gauld L, et al.
                        <SU>583</SU>
                        <FTREF/>
                         study, an eight month long prospective controlled study which showed that investigators seeking to lower the blood culture contamination rate at the Medical University of South Carolina emergency department found that Steripath® Gen2 ISDD® implementation reduced their blood culture contamination rate by 86.3 percent when compared to conventional methods of sample acquisition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>583</SU>
                             Gauld L, et al. “Reducing the laboratory cost of false-positive blood cultures in the adult emergency department.” Poster presented at: IHI National Forum on Quality Improvement in Healthcare (2016).
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted a poster, Lanteri C, et al.,
                        <SU>584</SU>
                        <FTREF/>
                         with preliminary data and a paper, Huss, J, et al.,
                        <SU>585</SU>
                        <FTREF/>
                         that includes all of the poster data with additional data gathered. This prospective controlled study at Brooke Army Medical Center showed that Steripath® Gen2 ISDD® implementation reduced blood culture contamination rate by 91.7 percent from September 2015 through January 2016, and 89.7 percent from September 2015 through March 2016 when compared to conventional methods of sample acquisition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>584</SU>
                             Lanteri C, et al. “Reduction of Blood Culture Contaminations in the Emergency Department.” Poster presented at: Department of Defense Healthcare Quality and Safety Awards (2016).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>585</SU>
                             Huss, Jody L, et al. “Reducing Blood Culture Contamination with the Steripath® Blood Collection Kit.” Uniformed Services University, 2016
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted the Rupp M, et al.
                        <SU>586</SU>
                        <FTREF/>
                         paper, which is a 12-month, single center, prospective, controlled, open label trial. Investigators at the University of Nebraska Medical Center emergency department seeking to gauge the efficacy of the Steripath® Gen2 ISDD® without confounding variables conducted a matched-set controlled study and found that Steripath® implementation reduced their blood culture contamination rate by 87.6 percent when compared to conventional methods of sample acquisition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>586</SU>
                             Rupp M, et al. “Reduction in blood culture contamination through use of initial specimen diversion device.” Clinical Infectious Diseases 65.2 (2017): 201-205.
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted the Stonecypher K, et al.
                        <SU>587</SU>
                        <FTREF/>
                         8 week pilot study, which showed that investigators at the Michael E. DeBakey VA Medical Center emergency department found that Steripath® Gen2 ISDD® implementation reduced their blood culture contamination rate by 83.1 percent when compared to conventional methods of sample acquisition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>587</SU>
                             Stonecypher K, et al. “ER Pilot Leads to Hospital-wide Implementation of Blood Culture Device” Poster presented at: Emergency Nurses Association Annual Conference (2018)
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted the Tompkins L, et al.
                        <SU>588</SU>
                        <FTREF/>
                         abstract, which showed that investigators seeking to lower the blood culture contamination rate at Stanford Health Care found that Steripath® Gen2 ISDD® implementation reduced their blood culture contamination rate by 100 percent over a 4-month period when compared to conventional methods of sample acquisition. According to the applicant, full results are anticipated but not presently published.
                    </P>
                    <FTNT>
                        <P>
                            <SU>588</SU>
                             Tompkins L, et al. “Eliminating Blood Culture Contamination with an Initial-Specimen Diversion Device” Abstract presented at: IDWeek (2020).
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted the Tongma C, et al.
                        <SU>589</SU>
                        <FTREF/>
                         prospective controlled study, which showed that investigators seeking to lower the blood culture contamination rate at Rush University Medical Center emergency department found that Steripath® Gen2 ISDD® implementation reduced their blood culture contamination rate by 87.0 percent when compared to conventional methods of sample acquisition. The 6-month study was split into an initial 3 months of usual care and a subsequent 3 months using the Steripath® Gen2 ISDD®.
                    </P>
                    <FTNT>
                        <P>
                            <SU>589</SU>
                             Tongma C, et al. “Significant Reduction of Blood Culture Contamination in the Emergency Department (ED) Using the Steripath® Blood Diversion Device.” Poster presented: Infectious Diseases Society of America IDWeek Conference, Fall (2017).
                        </P>
                    </FTNT>
                    <P>The applicant provided the following studies to support secondary claims of substantial clinical improvement:</P>
                    <P>
                        The applicant submitted the Buchta C, et al.
                        <SU>590</SU>
                        <FTREF/>
                         animal (pig) model study, in which investigators hypothesized that despite proper skin antiseptic use, contamination may occur because flora from deeper regions (such as pores) are not effectively eliminated. The applicant stated that results confirmed the hypothesis that cannula may cause tissue fragments to be punched in the process of blood sample acquisition, supporting the mechanism by which Steripath® Gen2 ISDD® primarily addresses blood culture contamination (that is, diversion).
                    </P>
                    <FTNT>
                        <P>
                            <SU>590</SU>
                             Buchta C, et al. Skin plugs in phlebotomy puncture for blood donation. 
                            <E T="03">Wiener klinische Wochenschrift</E>
                             117.4 (2005): 141-144.
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted the Rhee C, et al.
                        <SU>591</SU>
                        <FTREF/>
                         retrospective cohort study, which featured adult patients admitted to 409 academic, community, and Federal hospitals from 2009-2014. Investigators sought to estimate national sepsis incidence and trends, concluding that sepsis was present in 6 percent of adult hospitalizations and 35 percent of hospitalizations resulting in death. According to the applicant, this helps put into context the role of Steripath® ISDD® in improving the efficacy of the primary tool used to guide therapy for bloodstream infections: blood culture.
                    </P>
                    <FTNT>
                        <P>
                            <SU>591</SU>
                             Rhee C, et al. Incidence and trends of sepsis in US hospitals using clinical vs claims data, 2009-2014. 
                            <E T="03">JAMA</E>
                             318.13 (2017): 1241-1249.
                        </P>
                    </FTNT>
                    <P>
                        The applicant submitted the Zimmerman F, et al.
                        <SU>592</SU>
                        <FTREF/>
                         paper (a randomized clinical trial) and the Binkhamis K and Forward K 
                        <SU>593</SU>
                        <FTREF/>
                         paper (a prospective controlled study), which demonstrated that manual diversion reduced blood culture contamination rate by 60.0 percent and 28.2 percent, respectively, when compared to conventional methods of sample acquisition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>592</SU>
                             Zimmerman F, et al. Modification of blood test draw order to reduce blood culture contamination: a randomized clinical trial. 
                            <E T="03">Clinical Infectious Diseases</E>
                             71.5 (2020): 1215-1220.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>593</SU>
                             Binkhamis K and Forward K. Effect of the initial specimen diversion technique on blood culture contamination rates. 
                            <E T="03">Journal of Clinical Microbiology</E>
                             52.3 (2014): 980-981.
                        </P>
                    </FTNT>
                    <P>
                        The applicant also submitted the Patton R and Schmitt T 
                        <SU>594</SU>
                        <FTREF/>
                         prospective controlled study, which showed that investigators seeking to trial manual diversion of 1 mL to lower the blood culture contamination rate at the Northwest Hospital and Medical Center Emergency Department found that manual diversion reduced their blood culture contamination rate by 43.8 percent when compared to conventional methods of sample acquisition. The applicant further stated that the findings additionally support the volume of diversion utilized by Steripath® Micro
                        <SU>TM</SU>
                         ISDD®.
                    </P>
                    <FTNT>
                        <P>
                            <SU>594</SU>
                             Patton R and Schmitt T. Innovation for reducing blood culture contamination: initial specimen diversion technique. 
                            <E T="03">Journal of Clinical Microbiology</E>
                             48.12 (2010): 4501-4503.
                        </P>
                    </FTNT>
                    <PRTPAGE P="25320"/>
                    <P>
                        The applicant also submitted the Syed S, et al.
                        <SU>595</SU>
                        <FTREF/>
                         preintervention and postintervention study, which showed that investigators at the AMITA Health Saint Francis Hospital Emergency Department found that manual diversion reduced their blood culture contamination rate by 30.9 percent when compared to conventional methods of sample acquisition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>595</SU>
                             Syed S, et al. Diversion Principle Reduces Skin Flora Contamination Rates in a Community Hospital. 
                            <E T="03">Archives of Pathology &amp; Laboratory Medicine</E>
                             144.2 (2020): 215-220.
                        </P>
                    </FTNT>
                    <P>
                        According to the applicant, the findings from these four studies support the claim that manual diversion reduces the risk of blood culture contamination relative to conventional methods of sample acquisition. We note that these studies discussed manual diversion and not Steripath® Micro
                        <SU>TM</SU>
                         or other diversion devices.
                    </P>
                    <P>
                        The applicant submitted the Alahmadi Y, et al.
                        <SU>596</SU>
                        <FTREF/>
                         study, which is a retrospective case-control study that showed that false positive blood cultures were associated with an average 5.4 day increase in patient length of stay and average increases of more than $7,500 in total charges to a healthcare system. The applicant also submitted the Bates D, et al.,
                        <SU>597</SU>
                        <FTREF/>
                         which is a prospective controlled study that showed false positive blood cultures were associated with an average of a 4.5 day increase in patient length of stay and average increases of more than $4,000 in total charges to a healthcare system. According to the applicant, investigators also noted that contaminants were independently correlated with a 39 percent increase in antibiotic charges.
                    </P>
                    <FTNT>
                        <P>
                            <SU>596</SU>
                             Alahmadi Y, et al. Clinical and economic impact of contaminated blood cultures within the hospital setting. 
                            <E T="03">Journal of Hospital Infection</E>
                             77.3 (2011): 233-236.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>597</SU>
                             Bates D, et al. Contaminant blood cultures and resource utilization: the true consequences of false-positive results. 
                            <E T="03">JAMA</E>
                             265.3 (1991): 365-369.
                        </P>
                    </FTNT>
                    <P>
                        The applicant provided a study to support its claim that the Steripath® ISDD® reduces the average length of stay for patients requiring blood culture, thereby lowering their risk of hospital-acquired infections (HAI) and conditions (HAC). The applicant explained that the Skoglund E, et al.
                        <SU>598</SU>
                        <FTREF/>
                         decision tree health care economic model paper showed that investigators found that overall, each false positive blood culture was on average associated with 2 day increases in patient length of stay and an average increase of more than $4,500 in total charges to a healthcare system. According to the applicant, Steripath® ISDD® implementation may reduce costs associated with contamination and reduce the average patient length of stay.
                    </P>
                    <FTNT>
                        <P>
                            <SU>598</SU>
                             Skoglund E, et al. Estimated clinical and economic impact through use of a novel blood collection device to reduce blood culture contamination in the emergency department: a cost-benefit analysis.
                        </P>
                        <P>
                            <E T="03">Journal of Clinical Microbiology</E>
                             57.1 (2019).
                        </P>
                    </FTNT>
                    <P>
                        The applicant provided four studies to support its claim that Steripath® ISDD® reduces the inappropriate administration of vancomycin and other antibiotics to drive antibiotic stewardship. The applicant submitted the Chang D, et al.
                        <SU>599</SU>
                        <FTREF/>
                         poster, a retrospective, nonrandomized study that recorded the San Antonio Military Medical Center Emergency Department's days of therapy (DOT) of vancomycin for 18 months as a baseline. Then, the hospital implemented a new blood culture test, and recorded the DOT of vancomycin for 7 months. Subsequently, the hospital implemented the Steripath® Gen2 device and recorded the DOT of vancomycin for an additional 14 months to complete the 39-month trial. Investigators found that Steripath® Gen2 ISDD® implementation reduced vancomycin days of therapy by 14.4 days per 1,000 patient days when compared to conventional methods of sample acquisition. According to the applicant, findings from the study, as reported by the study authors, support the claim that Steripath® ISDD® reduces the unnecessary administration of antibiotics by reducing the rate of false positive blood cultures.
                    </P>
                    <FTNT>
                        <P>
                            <SU>599</SU>
                             Chang D, et al. “Impact of blood culture diversion device on molecular pathogen identification on vancomycin use.” Poster presented at: Society for Healthcare Epidemiology of America (2017).
                        </P>
                    </FTNT>
                    <P>
                        The applicant also submitted the Souvenir D, et al.
                        <SU>600</SU>
                        <FTREF/>
                         cohort study of 3,276 cultures of blood from 1,433 patients in which investigators found that physicians treated almost half of all patients receiving a false positive blood culture result with antibiotics, with vancomycin misuse occurring in 34 percent of patients. The applicant also submitted the Heijden Y, et al.
                        <SU>601</SU>
                        <FTREF/>
                         study in which investigators found that physicians treated 27% of patients receiving a false positive blood culture result with antibiotics unnecessarily, with the median antibiotic regimen being 7 days in length. The applicant also submitted the Bates study,
                        <SU>602</SU>
                        <FTREF/>
                         as discussed previously, which showed contaminants were independently correlated with a 39 percent increase in antibiotic charges.
                    </P>
                    <P>According to the applicant, as Steripath® ISDD® is designed to reduce the incidence of blood culture contamination, Steripath® ISDD® implementation may reduce unnecessary antibiotic administration while supporting antimicrobial stewardship.</P>
                    <FTNT>
                        <P>
                            <SU>600</SU>
                             Souvenir D, et al. Blood cultures positive for coagulase-negative staphylococci: antisepsis, pseudobacteremia, and therapy of patients. 
                            <E T="03">Journal of Clinical Microbiology</E>
                             36.7 (1998): 1923-1926.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>601</SU>
                             Heijden, Yuri F., et al. “Clinical impact of blood cultures contaminated with coagulase-negative staphylococci at an academic medical center.” Infection Control and Hospital Epidemiology 32.6 (2011): 623.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>602</SU>
                             Bates D, et al. Contaminant blood cultures and resource utilization: the true consequences of false-positive results. 
                            <E T="03">JAMA</E>
                             265.3 (1991): 365-369
                        </P>
                    </FTNT>
                    <P>
                        We have the following concerns regarding the substantial clinical improvement criterion. We note that much of the evidence submitted by the applicant to support that Steripath® Micro
                        <SU>TM</SU>
                         represents a substantial clinical improvement over existing technologies speaks to the overall clinical value of reducing blood contamination, or the benefit of manual diversion over no diversion, but does not directly link the Steripath® Micro
                        <SU>TM</SU>
                         to improved clinical endpoints. We note that the applicant stated that all of the studies provided that address the specific technology used to reduce blood contamination through diversion of the initial sample during blood collection utilized the Steripath® Gen2 ISDD®, not the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® and we therefore question whether we have sufficient information to assess the clinical impact of Steripath® Micro
                        <E T="51">TM</E>
                        . Furthermore, the applicant did not present any clinical data to compare Steripath® Micro
                        <SU>TM</SU>
                         ISDD® to the Steripath® Gen2 ISDD®. We also note that comparative studies between Steripath® Micro
                        <SU>TM</SU>
                         and either manual diversion or competitor devices were not provided, and we question whether the standard of care used in the studies (that is, no diversion) is an appropriate comparator against which to test this technology. Additionally, we note that the applicant did not provide any clinical data demonstrating that the Steripath® Micro
                        <SU>TM</SU>
                         directly reduced length of stay, 
                        <E T="03">C. difficile</E>
                         infections, or other secondary results of antibiotic overuse. We are interested in any clinical data that directly links the Steripath® Micro
                        <SU>TM</SU>
                         to these outcomes.
                    </P>
                    <P>
                        Finally, we note that the claim of gentle negative pressure in support of the applicant's assertion that the technology would provide a treatment option for a new patient population was not addressed by any of the studies submitted. In addition, no data was supplied that quantified appropriate levels of negative pressure for either the 
                        <PRTPAGE P="25321"/>
                        typical or DIVA populations. Furthermore, no data was provided which compared the asserted appropriate level of negative pressure to levels of negative pressure created by the Steripath® Micro
                        <SU>TM</SU>
                         and Steripath® Gen2 devices. We are interested in any evidence of clinical improvement using the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® in the specific population identified by the applicant, the difficult intravenous access population.
                    </P>
                    <P>
                        We are inviting public comments on whether the Steripath® Micro
                        <SU>TM</SU>
                         ISDD® meets the substantial clinical improvement criterion.
                    </P>
                    <P>
                        We did not receive any written comments in response to the New Technology Town Hall meeting notice published in the 
                        <E T="04">Federal Register</E>
                         regarding the substantial clinical improvement criterion for Steripath® Micro
                        <SU>TM</SU>
                         ISDD®.
                    </P>
                    <HD SOURCE="HD3">
                        q. StrataGraft
                        <SU>TM</SU>
                         Skin Tissue
                    </HD>
                    <P>
                        Stratatech Corporation, a Mallinckrodt company, submitted an application for new technology add-on payments for the StrataGraft
                        <SU>TM</SU>
                         skin tissue (“StrataGraft”) for topical application for FY 2022. The applicant describes StrataGraft
                        <SU>TM</SU>
                         skin tissue as a viable, bioengineered, regenerative skin construct (BRSC) consisting of an epidermal layer of viable, fully stratified, allogeneic human NIKS® 
                        <SU>603</SU>
                        <FTREF/>
                         keratinocytes growing on a dermal layer composed of viable human dermal fibroblasts embedded in a collagen-rich matrix. The applicant noted that StrataGraft
                        <SU>TM</SU>
                         is intended for the treatment of adult patients with severe thermal burns that contain intact dermal elements and require surgical intervention (hereinafter referred to as severe thermal burns [STB]). The applicant stated that StrataGraft
                        <SU>TM</SU>
                         skin tissue is produced in a rectangular format of approximately 100 cm
                        <SU>2</SU>
                        , approximately 8 cm by 12.5 cm.
                    </P>
                    <FTNT>
                        <P>
                            <SU>603</SU>
                             Registered trademark of Stratatech Corporation, Madison, WI
                        </P>
                    </FTNT>
                    <P>
                        The applicant explained that the StrataGraft
                        <SU>TM</SU>
                         skin tissue promotes durable wound closure and regenerative healing for adult patients with STB. The applicant stated that in addition to providing immediate wound coverage and epidermal barrier function, the viable and metabolically active keratinocytes and fibroblasts in StrataGraft
                        <SU>TM</SU>
                         skin tissue provide sustained expression and secretion of growth factors, cytokines, and wound healing factors, which are anticipated to promote regenerative healing. The applicant stated that the StrataGraft
                        <SU>TM</SU>
                         skin tissue does not engraft; rather, it promotes regenerative healing and is replaced by the patient's own cells, eliminating the need for autografting to attain definitive closure of treated wounds.
                    </P>
                    <P>
                        The applicant explained that a thermal burn is the most common type of burn injury and accounts for approximately 86 percent of burn cases.
                        <SU>604</SU>
                        <FTREF/>
                         The applicant noted that burns are classified according to the depth of tissue injury as superficial (first-degree burns), partial-thickness (superficial and deep partial-thickness; second-degree burns), full-thickness (FT, third-degree burns), and fourth-degree burns (burns that have injured deeper structures such as muscle, fascia, and bone).
                        <E T="51">605 606</E>
                        <FTREF/>
                         The applicant also noted the percentage of total body surface area (TBSA) determines burn severity and directly correlates with mortality.
                        <SU>607</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>604</SU>
                             Schaefer TJ, Tannan SC. Thermal Burns. [Updated 2020 Jun 7]. In: StatPearls [internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. 
                            <E T="03">https://www.ncbi.nlm.nih.gov/books/NBK430773//</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>605</SU>
                             Kagan RJ, Peck MD, Ahrenholz DH, et al. Surgical management of the burn wound and use of skin substitutes: an expert panel white paper. J Burn Care Res. 2013;34(2):e60-e79.
                        </P>
                        <P>
                            <SU>606</SU>
                             Rice PL, Orgill DP. Assessment and classification of burn injury. UpToDate. 
                            <E T="03">https://www.uptodate.com/contents/assessment-and-classification-of-burn-injury</E>
                            . Literature review current through September 2020. Accessed September 25, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>607</SU>
                             Girard D, Laverdet B, Buhé V, et al. Biotechnological Management of Skin Burn Injuries: Challenges and Perspectives in Wound Healing and Sensory Recovery. Tissue Eng Part B Rev. 2017;23(1):59-82.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that in the U.S., approximately 500,000 burn injuries receive emergency medical treatment each year, leading to 40,000 burn injury hospitalizations with 30,000 at hospital burn centers.
                        <E T="51">608 609</E>
                        <FTREF/>
                         The applicant noted that children and the elderly represent especially vulnerable populations at increased risk for death due to the skin loss and its complications.
                        <SU>610</SU>
                        <FTREF/>
                         The applicant explained that in 2013, the rate of burn-related hospital stays was highest for infants aged younger than 1 year (29.6 per 100,000 population) and older adults (20.7 per 100,000 population for adults aged 65-84 and 26.3 per 100,000 population for adults aged 85 and older).
                        <SU>611</SU>
                        <FTREF/>
                         The applicant also stated that unintentional fire or burn injuries was the 8th leading cause of death in those 65 years or older.
                        <SU>612</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>608</SU>
                             Burn Injury Fact Sheet. American Burn Association. 
                            <E T="03">https://ameriburn.org/wp-content/uploads/2017/12/nbawfactsheet_121417-1.pdf</E>
                            . Published February 2018. Accessed July 1, 2020
                        </P>
                        <P>
                            <SU>609</SU>
                             HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville, MD. 
                            <E T="03">https://hcupnet.ahrq.gov/</E>
                            . Accessed June 5, 2019.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>610</SU>
                             Burn Injury Fact Sheet. American Burn Association. 
                            <E T="03">https://ameriburn.org/wp-content/uploads/2017/12/nbawfactsheet_121417-1.pdf</E>
                            . Published February 2018. Accessed July 1, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>611</SU>
                             McDermott KW, Weiss AJ, Elixhauser A. Burn-Related Hospital Inpatient Stays and Emergency Department Visits, 2013: Statistical Brief #217. 2016 Dec. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb. 
                            <E T="03">https://www.ncbi.nlm.nih.gov/books/NBK409513/</E>
                            . Accessed September 30, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>612</SU>
                             Burn Injury Fact Sheet. American Burn Association. 
                            <E T="03">https://ameriburn.org/wp-content/uploads/2017/12/nbawfactsheet_121417-1.pdf</E>
                            . Published February 2018. Accessed July 1, 2020
                        </P>
                    </FTNT>
                    <P>
                        The applicant explained that today, 96.7 percent of burn patients treated in burn centers will survive. The applicant noted that many of those survivors will sustain serious scarring and life-long physical disabilities.
                        <SU>613</SU>
                        <FTREF/>
                         The applicant stated that burn injuries pose a significant burden to patients; they can have a considerably negative effect on the patient's health-related quality of life (HRQoL), which was estimated to be reduced by 30 percent at the time of injury and by 9 percent in the long term.
                        <SU>614</SU>
                        <FTREF/>
                         The applicant explained that although most functional domains affected by burn injuries recover over time, HRQoL scores pertaining to physical and emotional role participation, anxiety, depression, pain, work, and heat sensitivity remained low at 12 months after the injury.
                        <SU>615</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>613</SU>
                             Burn Injury Fact Sheet. American Burn Association. 
                            <E T="03">https://ameriburn.org/wp-content/uploads/2017/12/nbawfactsheet_121417-1.pdf</E>
                            . Published February 2018. Accessed July 1, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>614</SU>
                             Miller T, Bhattacharya S, Zamula W, et al. Quality-of-life loss of people admitted to burn centers, United States. Qual Life Res. 2013;22(9):2293-2305.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>615</SU>
                             Spronk I, Legemate C, Oen I, van Loey N, Polinder S, van Baar M. Health related quality of life in adults after burn injuries: A systematic review. PLoS One. 2018;13(5):e0197507. Published 2018 May 24.
                        </P>
                    </FTNT>
                    <P>
                        The applicant explained that the standard of care for STB injuries is early excision and skin grafting. 
                        <E T="51">616 617 618</E>
                        <FTREF/>
                         The applicant noted that common surgical interventions for burn injury include: escharotomy, debridement, excision, and skin grafting.
                        <SU>619</SU>
                        <FTREF/>
                         The applicant explained that these burns have been treated with autografts, allografts, and xenografts in the past. The applicant stated that autologous grafts (autografts) are used most frequently because of the 
                        <PRTPAGE P="25322"/>
                        problems of infection and rejection when using allografts or xenografts.
                        <SU>620</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>616</SU>
                             Bittner EA, Shank E, Woodson L, Martyn JA. Acute and perioperative care of the burn-injured patient. Anesthesiology. 2015;122(2):448-464.
                        </P>
                        <P>
                            <SU>617</SU>
                             Girard D, Laverdet B, Buhé V, et al. Biotechnological Management of Skin Burn Injuries: Challenges and Perspectives in Wound Healing and Sensory Recovery. Tissue Eng Part B Rev. 2017;23(1):59-82.
                        </P>
                        <P>
                            <SU>618</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>619</SU>
                             Kagan RJ, Peck MD, Ahrenholz DH, et al. Surgical management of the burn wound and use of skin substitutes: an expert panel white paper. J Burn Care Res. 2013;34(2):e60-e79.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>620</SU>
                             Shevchenko RV, James SL, James SE. A review of tissue-engineered skin bioconstructs available for skin reconstruction. J R Soc Interface. 2010;7(43):229-258.
                        </P>
                    </FTNT>
                    <P>
                        The applicant explained that autografting involves surgical harvesting of healthy tissue from the patient (donor site) and transplantation of this skin to an injured site on the same patient.
                        <SU>621</SU>
                        <FTREF/>
                         The applicant noted that autografts can be harvested as split thickness or full thickness. According to the applicant, split-thickness skin grafts (STSGs), also called partial-thickness grafts, transfer a portion of the donor site skin, including the epidermis and some of the underlying dermis. The applicant also explained that this allows the donor site to heal from the epidermal elements left behind. The applicant also stated that full-thickness skin grafts (FTSGs) harvest the entire layer of skin as the graft; no dermal or epidermal elements remain at the donor site, which must be closed by local advancement of the adjoining skin or by a secondary local flap. The applicant stated that the process of revascularization takes longer for an FTSG than for an STSG because of the increased thickness of the tissue.
                        <SU>622</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>621</SU>
                             Girard D, Laverdet B, Buhé V, et al. Biotechnological Management of Skin Burn Injuries: Challenges and Perspectives in Wound Healing and Sensory Recovery. Tissue Eng Part B Rev. 2017;23(1):59-82.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>622</SU>
                             Leon-Villapalos J. Skin autografting. UpToDate. 
                            <E T="03">https://www.uptodate.com/contents/skin-autografting</E>
                            . Literature review current through September 2020. Accessed October 1, 2020.
                        </P>
                    </FTNT>
                    <P>
                        The applicant explained that early excision and skin grafting reduce the chance of wound infections and systemic sepsis, and have become the standard of care.
                        <E T="51">623 624 625</E>
                        <FTREF/>
                         The applicant noted that without autografting, an STB that contains some dermal elements usually requires greater than 3 weeks to heal, thereby increasing the risk for infection and other complications that may lead to the development of significant scarring and contracture.
                        <E T="51">626 627 628</E>
                        <FTREF/>
                         The applicant stated that while STBs require surgical debridement and grafting, superficial first-degree burns do not; 
                        <SU>629</SU>
                        <FTREF/>
                         however, in the acute phase of the burn injury, the clinical presentation of the severely injured burn patient usually involves a range of burn depths from a superficial burn to a FT burn.
                        <SU>630</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>623</SU>
                             Bittner EA, Shank E, Woodson L, Martyn JA. Acute and perioperative care of the burn-injured patient. Anesthesiology. 2015;122(2):448-464.
                        </P>
                        <P>
                            <SU>624</SU>
                             Girard D, Laverdet B, Buhé V, et al. Biotechnological Management of Skin Burn Injuries: Challenges and Perspectives in Wound Healing and Sensory Recovery. Tissue Eng Part B Rev. 2017;23(1):59-82
                        </P>
                        <P>
                            <SU>625</SU>
                             Id.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>626</SU>
                             Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983;23(10):895-898.
                        </P>
                        <P>
                            <SU>627</SU>
                             Kagan RJ, Peck MD, Ahrenholz DH, et al. Surgical management of the burn wound and use of skin substitutes: an expert panel white paper. J Burn Care Res. 2013; 34(2):e60-79.
                        </P>
                        <P>
                            <SU>628</SU>
                             Shupp JW, Nasabzadeh TJ, Rosenthal DS, Jordan MH, Fidler P, Jeng JC. A review of the local pathophysiologic bases of burn wound progression. J. Burn Care Res. 2010; 31(6):849-873.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>629</SU>
                             Bittner EA, Shank E, Woodson L, Martyn JA. Acute and perioperative care of the burn-injured patient. Anesthesiology. 2015;122(2):448-464.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>630</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        The applicant explained that although autografting is effective in closing wounds and has been a standard treatment for decades, it has limitations. The applicant stated that donor sites are often associated with several complications, including excessive pain, pruritus, infection, dyschromia, hypertrophic scarring, delayed healing, and the potential for conversion to a FT wound.
                        <SU>631</SU>
                        <FTREF/>
                         The applicant also noted that donor-site pain is typically more painful than that in the treatment (burned) site and may become chronic.
                        <E T="51">632 633</E>
                        <FTREF/>
                         In patients with burns of 50-60 percent TBSA, autograft is limited by donor-site availability.
                        <SU>634</SU>
                        <FTREF/>
                         The applicant explained that donor sites may be re-harvested if they heal in time without infection; however, this practice can lead to prolonged hospitalization and decreased quality of the skin from re-harvested sites. The applicant stated that after patients undergo skin grafting, in the long term, both the grafted wound site and the donor site require continuous physical and rehabilitative therapy to maintain the range of movement, minimize scar and contracture development, and maximize functional ability.
                        <SU>635</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>631</SU>
                             4 Osborne SN, Schmidt MA, Harper JR. An Automated and Minimally Invasive Tool for Generating Autologous Viable Epidermal Micrografts. Adv Skin Wound Care. 2016;29(2):57-64.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>632</SU>
                             Birchall MA, Varma S, Milward TM. The Moriarty sign: an appraisal. Br J Plast Surg. 1991;44(2):149-150.
                        </P>
                        <P>
                            <SU>633</SU>
                             Sinha S, Schreiner AJ, Biernaskie J, et al. Treating pain on skin graft donor sites. J. Trauma Acute Care Surg. 2017;83(5)954-964.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>634</SU>
                             Girard D, Laverdet B, Buhé V, et al. Biotechnological Management of Skin Burn Injuries: Challenges and Perspectives in Wound Healing and Sensory Recovery. Tissue Eng Part B Rev. 2017;23(1):59-82.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>635</SU>
                             Procter F. Rehabilitation of the burn patient. Indian J Plast Surg. 2010;43(Suppl):S101-S113.
                        </P>
                    </FTNT>
                    <P>
                        The applicant noted that autografting is especially undesirable in vulnerable patient populations, such as the elderly. The applicant stated that the healing of donor sites may be delayed or even lacking in elderly patients or patients whose wound-healing capabilities are compromised.
                        <SU>636</SU>
                        <FTREF/>
                         The applicant explained that because patients in these populations have thinner dermis and epidermis than non-elderly adults,
                        <E T="51">637 638</E>
                        <FTREF/>
                         there is a higher likelihood that the donor sites will go deep into the dermis during harvest or transform into FT wounds with their anatomical characteristics. The applicant stated that these patients are disproportionately affected and are at increased risk for death due to the skin loss and its complications.
                        <SU>639</SU>
                        <FTREF/>
                         The applicant also noted that the American College of Surgeons (ACS) developed guidelines to educate surgeons and other medical professionals about the significance of older adult burns and evidence-based prevention activities.
                        <SU>640</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>636</SU>
                             Bradow BP, Hallock GG, Wilcock SP. Immediate Regrafting of the Split Thickness Skin Graft Donor Site Assists Healing. Plast Reconstr Surg Glob Open. 2017;5(5):e1339. Published 2017 May 23.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>637</SU>
                             King A, Balaji S, Keswani SG. Biology and function of fetal and pediatric skin. Facial Plast Surg Clin North Am. 2013;21(1):1-6.
                        </P>
                        <P>
                            <SU>638</SU>
                             Wainwright DJ, Bury SB. Acellular dermal matrix in the management of the burn patient. Aesthet Surg J. 2011;31(7 Suppl):13S-23S.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>639</SU>
                             Greenhalgh DG. Management of the skin and soft tissue in the geriatric surgical patient. Surg Clin North Am. 2015;95(1):103-114
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>640</SU>
                             Statement on Older Adult Burn Prevention. American College of Surgeons (ACS). 
                            <E T="03">https://www.facs.org/aboutacs/statements/81-older-adult-burn</E>
                            . Published January 1, 2018. Accessed September 26, 2020.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that burn injuries result in substantial economic burden for healthcare systems and society. The applicant noted the average total hospital charges for a surviving patient with burns was estimated to be $98,062 and a patient who did not survive burns was estimated at $309,546.
                        <SU>641</SU>
                        <FTREF/>
                         For patients undergoing inpatient autografting, the applicant asserted that significant healthcare costs were observed during the first year, including per patient mean all-cause healthcare costs which ranged from $155,272 to $184,805.
                        <SU>642</SU>
                        <FTREF/>
                         The applicant explained that the primary cost driver in the first year was the cost incurred from the initial inpatient episode with autografting, accounting for 85 percent of the total costs.
                        <SU>643</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>641</SU>
                             American Burn Association. National Burn Repository 2019 update. 2019.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>642</SU>
                             Yu TC, Zhang X, Smiell J, Zhou H, Tan R, Boing E, Tan H. Healthcare resource utilization, treatment patterns, and cost of care among patients with thermal burns and inpatient autografting in two large privately insured populations in the United States. Burns. 2020;46(4):825-835.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>643</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that there is currently no skin replacement product approved or available that leads to durable wound closure while 
                        <PRTPAGE P="25323"/>
                        eliminating the need for harvesting an autograft.
                        <E T="51">644 645</E>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>644</SU>
                             Kagan RJ, Peck MD, Ahrenholz DH, et al. Surgical management of the burn wound and use of skin substitutes: an expert panel white paper. J Burn Care Res. 2013;34(2):e60-e79.
                        </P>
                        <P>
                            <SU>645</SU>
                             Carter JE, Holmes JH. The Surgical Management of Burn Wounds. 2016.
                        </P>
                    </FTNT>
                    <P>
                        The applicant explained that skin substitutes are a heterogeneous group of biologic, synthetic, or biosynthetic materials that can provide temporary or permanent coverage of open skin wounds. The applicant stated that the aim of skin substitutes is to replicate the properties of the normal skin,
                        <SU>646</SU>
                        <FTREF/>
                         and to provide the protective barrier function until definitive closure of the skin.
                        <SU>647</SU>
                        <FTREF/>
                         The applicant noted that synthetic skin substitutes need to be removed or undergo biodegradation or resorption so the skin can heal and regenerate.
                        <SU>648</SU>
                        <FTREF/>
                         The applicant also stated that biological skin substitutes have an architecture that resembles native skin and may allow the construction of a more natural new dermis.
                        <SU>649</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>646</SU>
                             Shahrokhi S. Skin substitutes. UpToDate. 
                            <E T="03">https://www.uptodate.com/contents/skin-substitutes</E>
                            . Literature review current through August 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>647</SU>
                             MacNeil S. Progress and opportunities for tissue-engineered skin. Nature 2007;445(7130)874-880.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>648</SU>
                             Halim A, Khoo T, Shah JY. Biologic and synthetic skin substitutes: An overview. Indian J. Plast. Surg. 2010;43(3)23
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>649</SU>
                             Ibid. Halim A, Khoo T, Shah JY. Biologic and synthetic skin substitutes: An overview. Indian J. Plast. Surg. 2010;43(3)23.
                        </P>
                    </FTNT>
                    <P>
                        The applicant explained that skin substitutes are an important adjunct in the management of acute or chronic wounds and can be used to cover defects following burns or other injuries, or for reconstruction, such as for release of extensive severe post-burn contractures.
                        <E T="51">650 651</E>
                        <FTREF/>
                         The applicant also stated that Kumar's 3-category system, as shown in the table that follows, is currently the most frequently used classification system in the field. However, the applicant notes that there is no universally accepted classification system that allows for simple categorization of all the products that are commercially available.
                        <SU>652</SU>
                        <FTREF/>
                         The applicant stated that several biologic and biosynthetic materials are currently used as skin substitutes to temporarily cover wounds. The applicant provided the following table which, according to the applicant, classifies skin substitutes according to Kumar (2008) and summarizes the applicant's assertions regarding existing skin substitute products.
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>650</SU>
                             Shahrokhi S. Skin substitutes. UpToDate. 
                            <E T="03">https://www.uptodate.com/contents/skin-substitutes</E>
                            . Literature review current through August 2020.
                        </P>
                        <P>
                            <SU>651</SU>
                             Leon-Villapalos J. Skin autografting. UpToDate. 
                            <E T="03">https://www.uptodate.com/contents/skin-autografting</E>
                            . Literature review current through September 2020. Accessed October 1, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>652</SU>
                             Shahrokhi S. Skin substitutes. UpToDate. 
                            <E T="03">https://www.uptodate.com/contents/skin-substitutes</E>
                            . Literature review current through August 2020. Accessed September 25, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>653</SU>
                             Kumar P. Classification of skin substitutes. Burns. 2008;34(1):148-149.
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="325">
                        <GID>EP10MY21.178</GID>
                    </GPH>
                    <P>
                        The applicant stated that StrataGraft
                        <SU>TM</SU>
                         skin tissue is a novel BRSC which possesses many of the physical and biological properties of an ideal skin substitute, including both epidermis and dermis with a barrier function comparable to that of intact human skin.
                        <SU>654</SU>
                        <FTREF/>
                         The applicant asserted that upon FDA approval, StrataGraft
                        <SU>TM</SU>
                         skin tissue will be the only skin substitute for treatment of STB classified by the FDA as a biologic (as 
                        <PRTPAGE P="25324"/>
                        opposed to other available treatments that are medical devices) that promotes durable wound closure and regenerative healing, thereby reducing or eliminating the need of autologous skin harvesting. According to the applicant, on June 5, 2020, Mallinckrodt finalized the rolling submission of a Biologics License Application (BLA) to the FDA seeking approval to market StrataGraft
                        <E T="51">TM</E>
                         skin tissue for the treatment of adult patients with STB. Currently, there are no ICD-10-PCS procedure codes to uniquely identify procedures involving Stratagraft
                        <E T="51">TM</E>
                        . We note that the applicant submitted a request for approval for a unique ICD-10-PCS code for the use of Stratagraft
                        <E T="51">TM</E>
                         beginning FY 2022.
                    </P>
                    <FTNT>
                        <P>
                            <SU>654</SU>
                             Schurr MJ, Foster KN, Centanni JM, et al. Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009;66(3):866-874.
                        </P>
                    </FTNT>
                    <P>
                        The applicant explained that StrataGraft
                        <SU>TM</SU>
                         skin tissue is a viable BRSC that may be applied universally to patients, that is, it is not a patient-specific product. The applicant stated that the active cellular components of StrataGraft
                        <SU>TM</SU>
                         skin tissue are the viable and metabolically active allogeneic human NIKS® keratinocytes and normal human dermal fibroblasts (NHDF).
                    </P>
                    <P>
                        The applicant noted that StrataGraft
                        <SU>TM</SU>
                         skin tissue comprises an epidermal layer and a dermal layer. The applicant explained that the epidermal layer of StrataGraft
                        <SU>TM</SU>
                         skin tissue is composed of differentiated, multilayered, viable epidermal keratinocytes that are adherent through normal hemidesmosomes to a dermal equivalent.
                        <SU>655</SU>
                        <FTREF/>
                         The applicant stated that human epidermal keratinocytes used are NIKS® keratinocytes, a continuous and consistent source of well-characterized, non-tumorigenic, long-lived keratinocyte precursors that are derived from a single neonatal human foreskin donor. The applicant asserted that NIKS® keratinocytes have normal steady state of messenger ribonucleic acid (mRNA) and protein expression levels for autocrine regulators and growth factors such as transforming growth factor (TGF)-α, TGF-β1, epidermal growth factor, and c-myc, providing further evidence of the normal function of these cells.
                        <SU>656</SU>
                        <FTREF/>
                         The applicant also explained that NIKS® keratinocytes produce normal adhesion proteins (example, integrins and cadherins) that permit tight adherence to each other and the dermal equivalent.
                        <SU>657</SU>
                        <FTREF/>
                         The applicant stated that cell-cell and cell-substratum adhesions confer excellent handling characteristics to StrataGraft
                        <SU>TM</SU>
                         skin tissue, enabling it to be meshed and secured in place as is routinely done with STSGs. The applicant noted that the dermal layer of StrataGraft
                        <SU>TM</SU>
                         skin tissue contains NHDF derived from a single healthy tissue donor.
                    </P>
                    <FTNT>
                        <P>
                            <SU>655</SU>
                             Schurr MJ, Foster KN, Centanni JM, et al. Phase I/II clinical evaluation of StrataGraft skin tissue: a consistent, pathogen-free human skin substitute. J Trauma. 2009;66(3):866‐874.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>656</SU>
                             Allen-Hoffmann BL, Schlosser SJ, Ivarie CA, Sattler CA, Meisner LF, O'Connor SL. Normal growth and differentiation in a spontaneously immortalized near-diploid human keratinocyte cell line, NIKS. J Invest Dermatol. 2000;114(3):444-455
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>657</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        The applicant explained that viable cells within StrataGraft
                        <SU>TM</SU>
                         skin tissue express and secrete a wide variety of peptides, growth factors, and cytokines that are known to promote healing, thereby reducing or eliminating the need for autograft in the management of thermal burns.
                        <SU>658</SU>
                        <FTREF/>
                         The applicant also stated that no currently available technology (competitor) for the treatment of STB is characterized by the autologous (endogenous) tissue regeneration of the burned skin.
                    </P>
                    <FTNT>
                        <P>
                            <SU>658</SU>
                             Harvestine J, Pradhan-Bhatt S, Steiglitz BM, Maher RJ, Comer AR, Gratz KR, Allen-Hoffmann BL. StrataGraft® Skin Tissue, a Bioengineered Regenerative Skin Construct for Severe Acute Wounds. Poster presented at: 2020 Biomedical Engineering Society (BMES) Virtual Annual Meeting, October 14-17, 2020.
                        </P>
                    </FTNT>
                    <P>
                        The applicant stated that the StrataGraft
                        <SU>TM</SU>
                         skin tissue is manufactured through organotypic culture under aseptic conditions in compliance with current Good Manufacturing Practices. The applicant explained that in organotypic culture, NIKS® keratinocytes undergo tissue-appropriate differentiation and stratification to produce a skin tissue that exhibits many of the structural and biological properties of intact human skin. The applicant noted that the epidermal layer of StrataGraft
                        <SU>TM</SU>
                         skin tissue exhibits typical production and organization of cell-type specific proteins (example, keratin, filaggrin, involucrin, and transglutaminase), development of a normal cornified envelope, and production of lipid-filled granules that are necessary for the generation and maintenance of robust epidermal barrier function similar to that found in vivo.
                        <SU>659</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>659</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>As discussed previously, if a technology meets all three of the substantial similarity criteria, it would be considered substantially similar to an existing technology and would not be considered “new” for purposes of new technology add-on payments.</P>
                    <P>
                        With regard to the first criterion, whether a product uses the same or similar mechanism of action to achieve a therapeutic outcome, according to the applicant, the mechanism of action of StrataGraft
                        <SU>TM</SU>
                         skin tissue in severe thermal burns is not the same or similar to an existing technology. The applicant states that StrataGraft
                        <SU>TM</SU>
                         skin tissue will be the first and only FDA-approved biologic for the treatment of STB that reduces or eliminates the need of autograft and for which the mechanism of action is a sustained expression and secretion of growth factors, cytokines, and wound healing factors, which are anticipated to promote regenerative healing and durable wound closure.
                        <E T="51">660 661</E>
                        <FTREF/>
                         The applicant explains that this unique mechanism of action is the reason StrataGraft
                        <SU>TM</SU>
                         skin tissue reduces or eliminates the need for harvest of donor site tissue.
                    </P>
                    <FTNT>
                        <P>
                            <SU>660</SU>
                             Proposed prescribing information. for Stratagraft
                            <SU>TM</SU>
                             skin tissue;. Submitted to FDA, April 2020.
                        </P>
                        <P>
                            <SU>661</SU>
                             Harvestine J, Pradhan-Bhatt S, Steiglitz BM, Maher RJ, Comer AR, Gratz KR, Allen-Hoffmann BL. StrataGraft® Skin Tissue, a Bioengineered Regenerative Skin Construct for Severe Acute Wounds. Poster presented at: 2020 Biomedical Engineering Society (BMES) Virtual Annual Meeting, October 14-17, 2020.
                        </P>
                    </FTNT>
                    <P>
                        With respect to the second criterion, whether a product would be assigned to the same MS-DRGs as existing technologies, the applicant indicated that the StrataGraft
                        <SU>TM</SU>
                         skin tissue would be assigned to the same MS-DRGs as cases representing patients who receive standard of care (autograft) or existing technologies used to treat STB. The applicant stated that the MS-DRGs in question do not differentiate between patients with burns of differential severity degree, in different body sites, due to thermal injury or corrosion, or with different percent TBSA involved.
                        <SU>662</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>662</SU>
                             MDC 22 Burns. Non-Extensive Burns. In: ICD-10-CM/PCS MS-DRG v37.2 Definitions Manual. Centers for Medicare &amp; Medicaid Services. 
                            <E T="03">https://www.cms.gov/icd10m/version372-fullcode-cms/fullcode_cms/P0353.html</E>
                            . Accessed October 1, 2020.
                        </P>
                    </FTNT>
                    <P>
                        With
                        <FTREF/>
                         respect to the third criterion, whether a product would be used to treat the same or similar type of disease and patient population, the applicant asserted that StrataGraft
                        <SU>TM</SU>
                         will treat the same or similar type of disease but not the same or similar patient population when compared to existing technologies. The applicant claimed that StrataGraft
                        <SU>TM</SU>
                         skin tissue will treat a burn patient population for whom the current standard of care and/or other available technologies may not be clinically feasible solutions to achieve durable wound closure. The applicant explains that in patients with burns of 50-60 percent of the TBSA, donor-site availability is limited.
                        <SU>663</SU>
                         The applicant also stated that autografting is especially 
                        <PRTPAGE P="25325"/>
                        undesirable in vulnerable patient populations, such as the elderly; healing of donor sites may be delayed or even lacking in elderly patients or patients whose wound-healing capabilities are compromised.
                        <SU>664</SU>
                        <FTREF/>
                         The applicant explained that these patients are disproportionately affected and are at increased risk for death due to the skin loss and its complications.
                        <SU>665</SU>
                        <FTREF/>
                         The applicant also states that the label for StrataGraft
                        <SU>TM</SU>
                         skin tissue will not be reserved for a patient population diagnosed with STB for whom standard-of-care treatment is not feasible or clinically desirable. The applicant asserts that this does not imply that StrataGraft
                        <SU>TM</SU>
                         skin tissue will not offer a treatment option to a new patient population.
                    </P>
                    <FTNT>
                        <P>
                            <SU>663</SU>
                             Girard D, Laverdet B, Buhé V, et al. Biotechnological Management of Skin Burn Injuries: Challenges and Perspectives in Wound Healing and Sensory Recovery. Tissue Eng Part B Rev. 2017;23(1):59-82.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>664</SU>
                             Bradow BP, Hallock GG, Wilcock SP. Immediate Regrafting of the Split Thickness Skin Graft Donor Site Assists Healing. Plast Reconstr Surg Glob Open. 2017;5(5):e1339. Published 2017 May 23.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>665</SU>
                             Greenhalgh DG. Management of the skin and soft tissue in the geriatric surgical patient. Surg Clin North Am. 2015;95(1):103-114.
                        </P>
                    </FTNT>
                    <P>
                        With respect to the first criterion, we note that there may be other biologic dressings that use some combination of keratinocytes, collagen, glycosaminoglycans (GAGs), cytokines, chemokines, and/or other growth factors in either a single, double, or triple layer configuration. While StrataGraft
                        <SU>TM</SU>
                         may have a unique combination of these features, we are interested in further information on whether there are any dressings with a regenerative mechanism of action that may be approved for burns.
                    </P>
                    <P>
                        With respect to the third criterion, StrataGraft
                        <SU>TM</SU>
                         may treat the same or similar patient population as the standard of care or existing technologies to treat STB. While we agree that in patients with burns of 50-60 percent of the TBSA, donor-site availability is more limited, we observe that neither of the two pivotal studies included patients with burns of 50 percent or greater of the TBSA.
                        <SU>666</SU>
                        <FTREF/>
                         We are unclear whether this suggests Stratagraft
                        <E T="51">TM</E>
                         is intended for treatment of patients with burns of less than 50 percent TBSA. We also question whether vulnerable patients, such as the elderly, are a new population as they are currently treated using standard of care or other technologies.
                    </P>
                    <FTNT>
                        <P>
                            <SU>666</SU>
                             Girard D, Laverdet B, Buhé V, et al. Biotechnological Management of Skin Burn Injuries: Challenges and Perspectives in Wound Healing and Sensory Recovery. Tissue Eng Part B Rev. 2017;23(1):59-82.
                        </P>
                    </FTNT>
                    <P>
                        We are inviting public comments on whether Stratagraft
                        <E T="51">TM</E>
                         is substantially similar to other technologies and whether Stratagraft
                        <E T="51">TM</E>
                         meets the newness criterion.
                    </P>
                    <P>
                        With regard to the cost criterion, the applicant stated that Stratagraft
                        <E T="51">TM</E>
                         skin tissue is seeking FDA approval for the proposed indication of treatment of adult patients with STBs that contain intact dermal elements and require surgical intervention. In order to identify the range of MS-DRGs that eligible patients may map to, the applicant conducted a claims search for cases that include ICD-10-CM codes for thermal burns of second, third degree, or those classified according to TSBA to identify cases eligible for use of Stratagraft
                        <E T="51">TM</E>
                         skin tissue utilization. The applicant identified cases reporting ICD-10-CM codes for diagnoses of second-degree thermal burns, any location (T20.2XXX to T25.2XXX); third-degree thermal burns, any location (T20.3XXX to T25.3XXX); and thermal burns classified according to extent of body surface involved (T31.XX).
                    </P>
                    <P>The applicant used the FY 2019 MedPAR Hospital LDS with the FY 2022 thresholds, and the FY 2019 IPPS/LTCH Final Rule Impact File and Standardizing File. The appliant's claim search in the aggregate identified 58,624 cases mapping to 21 MS-DRGs as listed in the following table. Of the total 21 MS-DRGs, only six had case volume greater than or equal to one percent across all cohorts and cumulatively represent 97.54 percent of cases. In cases where MS-DRGs had fewer than 11 discharges, the applicant imputed a minimum value of 11 cases for each MS-DRG.</P>
                    <GPH SPAN="3" DEEP="464">
                        <PRTPAGE P="25326"/>
                        <GID>EP10MY21.179</GID>
                    </GPH>
                    <P>To demonstrate that the technology meets the cost criterion, the applicant first identified four separate patient cohorts: Cohort (1) Patients with thermal burns of second or third degree in any body area, or thermal burns classified according to TBSA, who received autograft for reasons only related to thermal burns (n=14,774, MS-DRGs=21); Cohort (2) Patients with thermal burns of second or third degree in any body area, or thermal burns classified according to TBSA, who received autograft for reasons only related to thermal burns, and who underwent excisional debridement in the inpatient setting (n= 13,640, MS-DRGs=20); Cohort (3) Patients with thermal burns of second or third degree in any body area, or thermal burns classified according to TBSA, who received autograft for thermal burns, with or without other conditions (n=15,744, MS-DRGs=21); and Cohort (4) Patients with thermal burns of second or third degree in any body area, or thermal burns classified according to TBSA, who received autograft for thermal burns, with or without other conditions, and who underwent excisional debridement in the inpatient setting (n= 14,466, MS-DRGs=20). The applicant then identified eight analyses for the cost criterion: (1) Calculations for Cohort one (all MS-DRGs); (2) Calculations for cohort two (all MS-DRGs); (3) Calculations for Cohort three (all MS-DRGs); (4) Calculations for cohort four (all MS-DRGs); (5) Calculations for Cohort one (top 4 MS-DRGs by case volume); (6) Calculations for Cohort two (top 4 MS-DRGs by case volume); (7) Calculations for Cohort three (top 4 MS-DRGs by case volume); and (8) Calculations for Cohort 4 (top 4 MS-DRGs by case volume).</P>
                    <P>The applicant determined an average unstandardized case weighted charge per case of $173,650 for analysis one, $168,282 for analysis two, $178,530 for analysis three, $172,277 for analysis four, $158,851 for analysis five, $155,700 for analysis six, $162,377 for analysis seven, and $158,452 for analysis eight.</P>
                    <P>
                        The applicant stated that charges for and related to the prior technologies were not removed from the cost analysis.
                        <PRTPAGE P="25327"/>
                    </P>
                    <P>
                        After calculating the average standardized charge per case for all scenarios, the applicant calculated the standardized charge per case for each MS-DRG. Next, the applicant applied the 2-year inflation factor used in the FY 2021 IPPS/LTCH PPS final rule to calculate outlier threshold charges of 13.2 percent (1.13218). The applicant stated that the price for Stratagraft
                        <E T="51">TM</E>
                         skin tissue has not yet been established and therefore it did not add charges for the technology. Lastly, the applicant calculated the final average inflated standardized charge per case and the inflated case weighted standardized charge per case for each scenario.
                    </P>
                    <P>The applicant stated that, for analysis one, the final inflated average case-weighted standardized charge per case of $304,347 exceeded the average case-weighted threshold amount of $173,650 by $130,697. For analysis two, the final inflated average case-weighted standardized charge per case of $279,373 exceeded the average case-weighted threshold amount of $168,282 by $111,091. For analysis three, the final inflated average case-weighted standardized charge per case of $332,006 exceeded the average case-weighted threshold amount of $178,530 by $153,477. For analysis four, the final inflated average case-weighted standardized charge per case of $299,228 exceeded the average case-weighted threshold amount of $172,277 by $126,951. For analysis five, the final inflated average case-weighted standardized charge per case of $241,186 exceeded the average case-weighted threshold amount of $158,851 by $82,336. For analysis six, the final inflated average case-weighted standardized charge per case of $229,661 exceeded the average case-weighted threshold amount of $155,700 by $73,961. For analysis seven, the final inflated average case-weighted standardized charge per case of $257,800 exceeded the average case-weighted threshold amount of $162,377 by $95,423. For analysis eight, the final inflated average case-weighted standardized charge per case of $244,042 exceeded the average case-weighted threshold amount of $158,452 by $85,590.</P>
                    <P>
                        The applicant stated that because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount, Stratagraft
                        <E T="51">TM</E>
                         meets the cost criterion.
                    </P>
                    <P>
                        We invite public comment on whether Stratagraft
                        <E T="51">TM</E>
                         meets the cost criterion.
                    </P>
                    <P>
                        With respect to the substantial clinical improvement criterion, the applicant asserted that StrataGraft
                        <SU>TM</SU>
                         skin tissue is a substantial clinical improvement over existing technology for the treatment of adult patients with severe thermal burns with intact dermal elements because it achieves a significant rate of durable wound closure for patients with severe burns while minimizing or eliminating the complications associated with autograft harvest.
                    </P>
                    <P>
                        According to the applicant, the totality of the circumstances otherwise demonstrates that StrataGraft
                        <SU>TM</SU>
                         skin tissue, relative to technologies previously available, substantially improves the treatment of STB patients including Medicare beneficiaries. The applicant stated that because the benefits associated with its use are not accompanied by an increased incidence of adverse events as compared to autograft, StrataGraft
                        <SU>TM</SU>
                         skin tissue is a substantial clinical improvement.
                    </P>
                    <P>
                        The applicant explained that by significantly reducing or eliminating the harvest of donor sites, patients who receive StrataGraft
                        <SU>TM</SU>
                         skin tissue are spared short- and long-term sequelae and complications and, to a lesser extent, infection or conversion to a full-thickness wound of the donor sites.
                        <SU>667</SU>
                        <FTREF/>
                         The applicant stated that by significantly reducing or eliminating the need for autograft,
                        <SU>668</SU>
                        <FTREF/>
                         StrataGraft
                        <SU>TM</SU>
                         skin tissue is especially relevant for the elderly population where autograft is undesirable; these patients are disproportionately affected and are at increased risk for death due to the skin loss and its complications.
                        <SU>669</SU>
                        <FTREF/>
                         The applicant explained that aging and environmental factors can influence the severity of burns in vulnerable skin.
                        <E T="51">670 671</E>
                        <FTREF/>
                         The applicant stated that geriatric skin also exhibits slower wound healing and is at increased risk of excessive scarring.
                        <E T="51">672 673 674 675 676</E>
                        <FTREF/>
                         According to the applicant, age-related changes in wound healing capacity can include delayed infiltration of immune cells, decreased secretion of growth factors, and altered collagen remodeling.
                        <SU>677</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>667</SU>
                             Greenhalgh DG. Management of the skin and soft tissue in the geriatric surgical patient. Surg Clin North Am. 2015;95(1):103-114.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>668</SU>
                             Holmes JH, Shupp JW, Smith DJ, et al. T5: Preliminary analysis of a phase 3 open-label, controlled, randomized trial evaluating the efficacy and safety of a bioengineered regenerative skin construct in patients with deep partialthickness thermal burns. J. Burn Care Res. 2020;41(Supplement_1)S3-S4.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>669</SU>
                             Greenhalgh DG. Management of the skin and soft tissue in the geriatric surgical patient. Surg Clin North Am. 2015;95(1):103-114
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>670</SU>
                             Gosain A, DiPietro LA. Aging and wound healing. World J Surg. 2004;28(3):321-326.
                        </P>
                        <P>
                            <SU>671</SU>
                             Landau M. Exogenous factors in skin aging. Curr Probl Dermatol. 2007;35:1-13.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>672</SU>
                             Greenhalgh DG. Management of the skin and soft tissue in the geriatric surgical patient. Surg Clin North Am. 2015;95(1):103-114.
                        </P>
                        <P>
                            <SU>673</SU>
                             Gosain A, DiPietro LA. Aging and wound healing. World J Surg. 2004;28(3):321-326.
                        </P>
                        <P>
                            <SU>674</SU>
                             Greenhalgh DG. Management of the skin and soft tissue in the geriatric surgical patient. Surg Clin North Am. 2015;95(1):103-114.
                        </P>
                        <P>
                            <SU>675</SU>
                             Ibid.
                        </P>
                        <P>
                            <SU>676</SU>
                             Gosain A, DiPietro LA. Aging and wound healing. World J Surg. 2004;28(3):321-326.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>677</SU>
                             Ibid.
                        </P>
                    </FTNT>
                    <P>
                        The applicant further explained that use of StrataGraft
                        <SU>TM</SU>
                         skin tissue can preserve limited donor sites for the treatment of other wounds, such as areas of FT injury and wounds in cosmetically sensitive areas. The applicant noted that it may also reduce the need for repeated harvest of autograft donor sites, potentially reducing the number of surgical procedures and total length of time to wound closure. The applicant explained that burn injury is associated with a high prevalence of posttraumatic stress disorder, ranging between 11 percent and 50 percent across studies,
                        <SU>678</SU>
                        <FTREF/>
                         and may also lead to anxiety and depression due to scarring and body image concerns.
                        <SU>679</SU>
                        <FTREF/>
                         Lastly, the applicant stated that use of StrataGraft
                        <SU>TM</SU>
                         skin tissue reduces pain while offering a comparable scar quality to autograft.
                        <SU>680</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>678</SU>
                             Summer GJ, Puntillo KA, Miaskowski C, et al. Burn Injury Pain: The Continuing Challenge. J. Pain 2007;8(7)533-548.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>679</SU>
                             Calotă DR, Niţescu C, Marinescu S, et al. Correlations between morphological appearance and psychosocial difficulties in patients with extensive burns who received allotransplant. Rom J Morphol Embryol. 2012;53(3 Suppl):703-711.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>680</SU>
                             Holmes JH, Shupp JW, Smith DJ, et al. T5: Preliminary analysis of a phase 3 open-label, controlled, randomized trial evaluating the efficacy and safety of a bioengineered regenerative skin construct in patients with deep partialthickness thermal burns. J. Burn Care Res. 2020;41(Supplement_1)S3-S4.
                        </P>
                    </FTNT>
                    <P>
                        The applicant provided two controlled and randomized studies, STRATA2011 and STRATA2016, to support its claims of substantial clinical improvement. The applicant stated that with the exception of subject age (STRATA2011, 18 to 64 years of age; STRATA2016, ≥18 years of age), the inclusion and exclusion criteria for the two studies were similar. According to the applicant, the STRATA2016 study (NCT03005106—Phase 3 trial—71 patients) 
                        <E T="51">681 682</E>
                        <FTREF/>
                         was a 12-month, open-
                        <PRTPAGE P="25328"/>
                        label, multicenter, controlled, randomized study that evaluated the efficacy and safety of StrataGraft
                        <SU>TM</SU>
                         skin tissue in promoting autologous skin tissue regeneration of severe thermal burns. The applicant explained that the STRATA2011 study (NCT01437852