Unknown. Regulatory determination
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/register/2022/09/01/2022-18990A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2022-09-01.xml --- 87 169 Thursday, September 1, 2022 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53749-53750 2022-18855 Agriculture Agriculture Department See Animal and Plant Health Inspection Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53710 2022-18893 Animal Animal and Plant Health Inspection Service RULES Possession, Use, and Transfer of Select Agents and Toxins:
Regulation of an Attenuated Vaccine Strain of Venezuelan Equine Encephalitis Virus as a Select Agent, 53647 2022-18990 Census Bureau Census Bureau NOTICES Inflation Measures for Adjusting Historical Income, 53710-53712 2022-18938 Meetings: National Advisory Committee, 53712 2022-18943 Coast Guard Coast Guard RULES Safety Zone: Fireworks Display; Lewis Bay, Hyannis, MA, 53664-53665 2022-18844 Gulf of Mexico, South Padre Island, TX, 53674-53676 2022-18922 Jon Cotton Wedding Fireworks, Round Island Channel, MI, 53672-53673 2022-18871 Kanawha River Mile Marker 58 to Mile Marker 59, Charleston, WV, 53665-53668 2022-18883 Ohio River Mile Marker 317.5 to Mile Marker 318.5, Catlettsburg, KY, 53668-53670 2022-18913 Swim, Columbia River, Cascade Locks, OR, 53670-53672 2022-18880 Safety Zones:
Annual Events in the Captain of the Port Detroit Zone, 53673-53674 2022-18954 PROPOSED RULES Special Local Regulation: San Diego Fleet Week Veterans Day Boat Parade; San Diego Bay, San Diego, CA, 53700-53702 2022-18907 Commerce Commerce Department See Census Bureau See Foreign-Trade Zones Board See Industry and Security Bureau See International Trade Administration See Minority Business Development Agency See National Oceanic and Atmospheric Administration See Patent and Trademark Office Commodity Futures Commodity Futures Trading Commission PROPOSED RULES Form PF;
Reporting Requirements for All Filers and Large Hedge Fund Advisers, 53832-53985 2022-17724 Consumer Product Consumer Product Safety Commission RULES Safety Standard for Frame Child Carriers, 53657-53662 2022-18786 Defense Department Defense Department See Navy Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Contractor Use of Interagency Fleet Management System Vehicles, 53747-53748 2022-18889 Charter Renewal: Department of Defense Federal Advisory Committee—Board of Visitors, National Defense University, 53737 2022-18942 Meetings:
Reserve Forces Policy Board, 53737-53738 2022-18953 Drug Drug Enforcement Administration NOTICES Importer of Controlled Substances Application: Wedgewood Village Pharmacy, LLC, 53789-53790 2022-18927 Education Department Education Department NOTICES Applications for New Awards: Project Prevent; Correction, 53739 2022-18872 Energy Department Energy Department See Federal Energy Regulatory Commission PROPOSED RULES Appliance Standards and Rulemaking Federal Advisory Committee: Commercial Unitary Air Conditioner and Commercial Unitary Heat Pump Working Group, 53699-53700 2022-18864 NOTICES Meetings:
Nuclear Science Advisory Committee, 53739 2022-18881 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Arizona; Revised Format for Materials Incorporated by Reference, 53676-53679 2022-18723 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Arizona; Revised Format for Materials Incorporated by Reference, 53702-53703 2022-18698 Missouri; Ameren Sioux Sulfur Dioxide Consent Agreement, 53703-53705 2022-18724 NOTICES Meetings:
Webinar of the Environmental Financial Advisory Board, 53743-53744 2022-18890 Federal Aviation Federal Aviation Administration RULES Airspace Designations and Reporting Points: Watersmeet, MI, 53656-53657 2022-18636 Airworthiness Directives: CFM International, S.A. Turbofan Engines, 53651-53654 2022-18923 MT-Propeller Entwicklung GmbH Propellers, 53648-53650 2022-19050 The Boeing Company Airplanes, 53654-53656 2022-18774 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:
FAA Acquisition Management System, 53823 2022-18926 Intent to Release Certain Properties from All Terms, Conditions, Reservations and Restrictions of a Quitclaim Deed Agreement Between the City of Melbourne and the Federal Aviation Administration for the Melbourne International Airport, Melbourne, FL, 53823-53824 2022-18940 Federal Communications Federal Communications Commission PROPOSED RULES Call Authentication Trust Anchor, 53705-53708 2022-18380 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 53744-53745 2022-18865 Radio Broadcasting Services: AM or FM Proposals to Change the Community of License, 53745 2022-18956 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Community Assistance Contact and Community Assistance Visits Reports, 53760-53761 2022-18931 Flood Hazard Determinations, 53756-53760 2022-18929 2022-18930 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals, 53740-53741 2022-18946 Combined Filings, 53742-53743 2022-18948 2022-18949 Environmental Assessments; Availability, etc.: Venture Global Calcasieu Pass, LLC; Venture Global Plaquemines LNG Uprate Amendment Project, 53739-53740 2022-18947 Environmental Impact Statements; Availability, etc.: Klamath River Renewal Corp., PacifiCorp; Lower Klamath Hydroelectric Project, 53743 2022-18945 Filing: Nighthawk Energy Storage, LLC, 53741-53742 2022-18950 Federal Financial Federal Financial Institutions Examination Council NOTICES Meetings:
Appraisal Subcommittee, 53745-53746 2022-18848 Federal Mine Federal Mine Safety and Health Review Commission NOTICES Hearing Health and Safety, 53746-53747 2022-18866 Federal Motor Federal Motor Carrier Safety Administration RULES Fees for the Unified Carrier Registration Plan and Agreement, 53680-53695 2022-18944 NOTICES Exemption Application: Hours of Service: Flat Top Transport, 53824-53825 2022-18935 Qualification of Drivers; Epilepsy and Seizure Disorders, 53825-53827 2022-18934 2022-18936 Federal Reserve Federal Reserve System RULES Rules Regarding Delegation of Authority, 53988-54026 2022-18203 NOTICES Change in Bank Control:
Acquisitions of Shares of a Bank or Bank Holding Company, 53747 2022-18941 Foreign Trade Foreign-Trade Zones Board NOTICES Approval of Subzone Status: DB Research Group, LLC Caguas, Puerto Rico, 53713 2022-18904 Gonzalez Trading, LLC, Toa Baja, PR, 53713 2022-18902 Patheon API, Inc., Florence, SC, 53712 2022-18901 Petro Air Corp., Carolina, PR, 53713 2022-18903 Authorization of Production Activity: AbbVie, Inc., Foreign-Trade Zone 22, Chicago, IL, 53714 2022-18900 General Services General Services Administration NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Contractor Use of Interagency Fleet Management System Vehicles, 53747-53748 2022-18889 Requests for Nominations: Office of Federal High-Performance Green Buildings, Green Building Advisory Committee, 53748-53749 2022-18897 Geological Geological Survey NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Surveys and Interviews to Evaluate and Improve the Cooperative Research Units Program Mission, Functions, and Goals, 53773-53774 2022-18894 Health and Human Health and Human Services Department See Agency for Healthcare Research and Quality See National Institutes of Health See Substance Abuse and Mental Health Services Administration RULES Select Agent:
Determination that Vaccine Strain, TC-83(A3G) of Venezuelan Equine Encephalitis Virus is a Regulated Strain of VEEV, 53679-53680 2022-18973 NOTICES 2005 Public Health Service Policies on Research Misconduct, 53750-53751 2022-18884 Secretarial Review and Publication of the 2021 Annual Report to Congress and the Secretary Submitted by the Consensus-Based Entity Regarding Performance Measurement, 54028-54122 2022-18906 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency Housing Housing and Urban Development Department RULES Section 108 Loan Guarantee Program:
Announcement of Fee to Cover Credit Subsidy Costs for FY 2023, 53662-53664 2022-19009 NOTICES Fiscal Year 2023 Fair Market Rents: Housing Choice Voucher Program, Moderate Rehabilitation Single Room Occupancy Program, and Other Programs, 53761-53773 2022-18905 Industry Industry and Security Bureau NOTICES Denial of Export Privileges: Michael Justin Huynh, 53715 2022-18892 Nicolas Armando Quintana-Saenz, 53714-53715 2022-18891 Meetings: Transportation and Related Equipment Technical Advisory Committee, 53718 2022-18896 Order Temporarily Denying Export Privileges:
Hans De Geetere, Nyckeesstraat 4; Knokke-Heist Support Corporation Management) a/k/a Hasa-Invest, Nyckeesstraat 4, 53716-53718 2022-18874 Interior Interior Department See Geological Survey International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Cut-To-Length Carbon-Quality Steel Plate from the Republic of Korea, 53728-53730 2022-18952 Finished Carbon Steel Flanges from India, 53722-53723 2022-18917 Heavy Walled Rectangular Welded Carbon Steel Pipes and Tubes from the Republic of Korea, 53725-53727 2022-18918 Initiation of Five-Year Sunset Reviews, 53727-53728 2022-18925 Opportunity to Request Administrative Review and Join Annual Inquiry Service List, 53719-53722 2022-18920 Prestressed Concrete Steel Wire Strand from the Republic of Turkey, 53723-53725 2022-18916 Sunset Review, 53718-53719 2022-18921 International Trade Com International Trade Commission NOTICES Investigations;
Determinations, Modifications, and Rulings, etc.: Brass Sheet and Strip from France, Germany, Italy, and Japan; Institution of Five-Year Reviews, 53785-53788 2022-18914 Certain Robotic Pool Cleaners and Components Thereof, 53788-53789 2022-18911 Paper Clips from China, 53783-53785 2022-18908 Stainless Steel Sheet and Strip from Japan, Korea, and Taiwan, 53780-53783 2022-18910 Steel Nails from the United Arab Emirates, 53777-53780 2022-18909 Uranium from Russia; Institution of a Five-Year Review, 53774-53777 2022-18912 Justice Department Justice Department See Drug Enforcement Administration Minority Business Minority Business Development Agency NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Online Customer Relationship Management/Performance Databases, 53730-53731 2022-18899 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Contractor Use of Interagency Fleet Management System Vehicles, 53747-53748 2022-18889 Identity Management System for Personal Identity Validation for Routine and Intermittent Access to NASA Facilities, Sites, and Information Systems, 53790-53791 2022-18887 NASA STEM Gateway (Universal Registration and Data Management System), 53792 2022-18885 Visitor Management System for Intermittent Access to NASA Hosted/Sponsored Events and Activities, 53791-53792 2022-18886 Meetings:
Advisory Council; Science, Technology, Engineering and Mathematics Engagement Committee, 53791 2022-18873 National Endowment for the Arts National Endowment for the Arts NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Blanket Justification for National Endowment for the Arts Funding Application Guidelines and Requirements, 53792-53793 2022-18878 National Foundation National Foundation on the Arts and the Humanities See National Endowment for the Arts National Institute National Institutes of Health NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: Cancer Therapy Evaluation Program Branch and Support Contracts Forms and Surveys (National Cancer Institute), 53752-53754 2022-18853 Meetings: National Institute of Mental Health, 53751-53752 2022-18955 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States: Northeast Multispecies Fishery; Fishing Year 2022 Recreational Management Measures, 53695-53698 2022-18996 NOTICES Meetings:
Advisory Committee Open Session on Management Strategy Evaluation for Atlantic Bluefin Tuna, 53731 2022-18868 East Coast Fishery Management Councils, 53735-53736 2022-18924 Western Pacific Fishery Management Council, 53732-53735 2022-18919 Taking and Importing Marine Mammals: U.S. Navy Construction at Portsmouth Naval Shipyard, Kittery, ME, 53731-53732 2022-18877 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53793-53795 2022-18847 Navy Navy Department NOTICES Meetings:
U.S. Naval Academy Board of Visitors, 53738-53739 2022-18888 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Criteria and Procedures for Determining Eligibility for Access to or Control Over Special Nuclear Material, 53795-53796 2022-18957 Patent Patent and Trademark Office NOTICES Patent Subject Matter Eligibility Guidance, 53736-53737 2022-18895 Securities Securities and Exchange Commission PROPOSED RULES Form PF;
Reporting Requirements for All Filers and Large Hedge Fund Advisers, 53832-53985 2022-17724 NOTICES Application: Deregistration under the Investment Company Act, 53812-53813 2022-18854 Self-Regulatory Organizations; Proposed Rule Changes: Fixed Income Clearing Corp., 53818-53822 2022-18860 MIAX Pearl, LLC, 53813-53818 2022-18858 National Securities Clearing Corp., 53796-53805 2022-18861 New York Stock Exchange, LLC, 53805-53807 2022-18857 The Depository Trust Co., 53807-53812 2022-18859 Substance Substance Abuse and Mental Health Services Administration NOTICES Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities which Meet Minimum Standards to Engage in Urine and Oral Fluid Drug Testing for Federal Agencies, 53754-53756 2022-18876 Transportation Department Transportation Department See Federal Aviation Administration See Federal Motor Carrier Safety Administration PROPOSED RULES Disadvantaged Business Enterprise and Airport Concession Disadvantaged Business Enterprise Program Implementation Modifications, 53708-53709 2022-18850 NOTICES Agency Information Collection Activities;
Proposals, Submissions, and Approvals: National Census of Ferry Operators, 53827-53828 2022-18937 Treasury Treasury Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 53828-53829 2022-18879 Unified Unified Carrier Registration Plan NOTICES Meetings; Sunshine Act, 53829-53830 2022-19020 Separate Parts In This Issue Part II Commodity Futures Trading Commission, 53832-53985 2022-17724 Securities and Exchange Commission, 53832-53985 2022-17724 Part III Federal Reserve System, 53988-54026 2022-18203 Part IV Health and Human Services Department, 54028-54122 2022-18906 Reader Aids 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.
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. 87 169 Thursday, September 1, 2022 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 121 [Docket No. APHIS-2022-0034] Possession, Use, and Transfer of Select Agents and Toxins;
Regulation of an Attenuated Vaccine Strain of Venezuelan Equine Encephalitis Virus as a Select Agent AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Regulatory determination. SUMMARY: We are notifying the public that the Animal and Plant Health Inspection Service (APHIS) has determined that the modified Venezuelan equine encephalitis virus
(VEEV)strain TC-83(A3G), which is a modification to the attenuated strain VEEV TC-83, has demonstrated increased pathogenicity and lethality and that the strain has the potential to pose a severe threat to animal health or animal products. We are advising the public that VEEV strain TC-83(A3G) is therefore a select agent and subject to APHIS' select agent and toxin regulations. DATES: Effective September 1, 2022. FOR FURTHER INFORMATION CONTACT: Dr. Randy Capsel, Science Officer, Division of Agricultural Select Agents and Toxins, Emergency and Regulatory Compliance Services, Animal and Plant Health Inspection Service, 4700 River Road, Riverdale, MD 20737; Telephone:
(301)851-3402; email: *Randy.T.Capsel@usda.gov.* SUPPLEMENTARY INFORMATION: Background The Agricultural Bioterrorism Protection Act of 2002, as amended (the Act, 7 U.S.C. 8401) provides for the regulation of certain biological agents and toxins that have the potential to pose a severe threat to animal and plant health, or to animal and plant products. The Animal and Plant Health Inspection Service (APHIS) has the primary responsibility for implementing the provisions of the Act within the U.S. Department of Agriculture. The Act also provides authority for APHIS to jointly regulate with the U.S. Department of Health & Human Services' Centers for Disease Control and Prevention
(CDC)biological agents and toxins that have the potential to pose a serve threat to both public health and safety and animal health or animal products. The regulations in 9 CFR part 121 (referred to below as the regulations) implement the provisions of the Act by setting forth the requirements for possession, use, and transfer of Veterinary Services select agents and toxins. In § 121.4 of the regulations, paragraph
(e)sets forth a process by which an attenuated strain of a select agent or toxin modified to be less potent or toxic may be excluded from the requirements of the select agent and toxin regulations in part 121 based upon a determination by APHIS' Administrator that the attenuated strain or modified toxin does not pose a severe threat to public health and safety, animal health, or animal products. Under § 121.4(e)(2), if an excluded attenuated strain is subjected to any manipulation that restores or enhances its virulence, resulting in a select agent that poses a severe threat to animal health or animal products, the resulting select agent will be subject to the requirements of the regulations in part 121. Venezuelan equine encephalitis virus
(VEEV)is a member of the genus Alphavirus in the family Togaviridae, and is a small, enveloped virus with a genome consisting of a single strand of positive-sense RNA. VEEV is a mosquito-borne virus that causes encephalitis or encephalomyelitis in all equine species and humans. Because it can affect both animals and humans, VEEV is listed as an overlap select agent in § 121.4(b) of the regulations and therefore is subject to regulation by both APHIS and CDC. On February 7, 2003, VEEV strain TC-83 was excluded from the regulations because mice vaccinated subcutaneously with VEEV strain TC-83 rapidly developed immunity to subcutaneous or airborne challenge with virulent VEEV. 1 Based on these findings, APHIS, in collaboration with CDC, determined that the attenuated strain did not have the potential to pose a severe threat to animal health or animal products. 1 See *https://www.selectagents.gov/sat/exclusions/overlap.htm.* However, based on a recent review by subject matter experts, APHIS has determined that a modification to the excluded, attenuated VEEV vaccine strain TC-83 has been shown to increase its virulence and pathogenicity. An adenine
(A)at position 3 in TC-83 has been shown to contribute to the attenuation of VEEV. In TC-83(A3G), the A has been changed to a guanine (G), which is found in all wild-type isolates of VEEV. The reversion of this nucleotide mutation to the wild-type nucleotide resulted in increased lethality in mice when compared to mice inoculated with the vaccine strain TC-83. Additional data determined that the pathogenic effects of TC-83(A3G) are more pronounced in young mice. As a result, the modification of the excluded, attenuated VEEV vaccine strain TC-83 to create VEEV strain TC-83(A3G) restores the virus's virulence and has the potential to pose severe threat to animal health or animal products. Therefore, VEEV strain TC-83(A3G) is subject to the regulations in part 121. Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4. Done in Washington, DC, this 29th day of August 2022. Anthony Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2022-18990 Filed 8-30-22; 11:15 am]
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- 9 CFR 121
- 7 CFR 2.22
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