[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Contents]
[Pages III-VII]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]



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                  CONTENTS
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  Federal Register / Vol. 88, No. 47 / Friday, March 10, 2023 / 
Contents  

[[Page iii]]




Agriculture Department
See Forest Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 14970-14971


Census Bureau
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    National Survey of Children's Health, 14975-14976
    The American Community Survey and Puerto Rico Community Survey, 
            14976-14978


Centers for Disease Control and Prevention
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 15025-15031, 15033-15034
Meetings:
    Commercial Fishing Occupational Safety Research Cooperative 
            Agreement; and Commercial Fishing Occupational Safety 
            Training Project Grants, 15034-15035
    Effective Community Conversations for Influenza and COVID-19 
            Vaccine Uptake, 15032
    Grants for Injury Control Research Centers, 15031-15032
    Research Grants to Inform Firearm-Related Violence and Injury 
            Prevention Strategies, 15032, 15034
    Research Grants to Rigorously Evaluate Innovative and Promising 
            Strategies to Prevent Firearm-Related Violence and 
            Injuries, 15035


Centers for Medicare & Medicaid Services
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 15035-15038


Children and Families Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    National Communication System for Runaway and Homeless Youth, 
            currently operated by the National Runaway Safeline Data 
            Collection, 15038-15039
    Office of Refugee Resettlement Unaccompanied Refugee Minors Program 
            Application and Withdrawal of Application or Declination of 
            Placement Form, 15039-15040


Civil Rights Commission
NOTICES
Meetings:
    Arkansas Advisory Committee, 14974-14975
Meetings; Sunshine Act, 14975


Coast Guard
RULES
Safety Zone:
    Missouri River Mile Markers 175.5-176.5, Jefferson City, MO, 14916-
            14918
NOTICES
Consolidated Port Approaches Port Access Route Studies, 15055-15056


Commerce Department
See Census Bureau
See Foreign-Trade Zones Board
See Industry and Security Bureau
See International Trade Administration
See National Oceanic and Atmospheric Administration


Committee for Purchase From People Who Are Blind or Severely Disabled
NOTICES
Procurement List; Additions and Deletions, 14991-14992


Consumer Product Safety Commission
NOTICES
Meetings; Sunshine Act, 14992-14993


Defense Department
See Engineers Corps


Education Department
NOTICES
Authorization of Subgrants for The Rhonda Weiss National Technical 
          Assistance Center to Improve State Capacity to Collect, 
          Report, Analyze, and Use Accurate IDEA Data in Accessible 
          Formats, 14993-14994


Energy Department
See Federal Energy Regulatory Commission
NOTICES
Request for Information:
    Foundation for Energy Security and Innovation; Correction, 14994


Engineers Corps
NOTICES
Environmental Impact Statements; Availability, etc.:
    Wilmington Harbor Navigation Improvement Project Integrated 
            Feasibility Study and Environmental Report, New Hanover and 
            Brunswick Counties, NC, 14993


Environmental Protection Agency
RULES
Air Quality Redesignation for the 2008 Lead National Ambient Air 
          Quality Standards:
    Canton, OH; Stark County, OH, 14920-14925
Air Quality State Implementation Plans; Approvals and Promulgations:
    Interstate Transport of Air Pollution for the 2015 8-Hour Ozone 
            National Ambient Air Quality Standards; Correction, 14918
Delay of Submittal Date for State Plans Required under the Affordable 
          Clean Energy Rule, 14918-14920
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Regulation of Persistent, Bioaccumulative, and Toxic Chemicals 
            under Toxic Substances Control Act, 15019-15020

[[Page iv]]

Application:
    Emergency Exemption; Metamitron, 15014-15015
Cancellation Order for Certain Pesticide Registrations and Amendments 
          to Terminate Uses, 15020-15023
Environmental Impact Statements; Availability, etc.:
    Weekly Receipt, 15018-15019
Requests to Voluntarily Cancel Certain Pesticide Registrations and 
          Amend Registrations to Terminate Certain Uses, 15015-15018


Federal Aviation Administration
RULES
Airworthiness Directives:
    Airbus SAS Airplanes, 14877-14880
    Embraer S.A. Airplanes, 14885-14887
    General Electric Company Turbofan Engines, 14871-14874
    MHI RJ Aviation ULC (Type Certificate Previously Held by 
            Bombardier, Inc.) Airplanes, 14883-14885
    Rolls-Royce Deutschland Ltd and Co KG (Type Certificate previously 
            held by Rolls-Royce plc) Turbofan Engine, 14880-14883
    The Boeing Company Airplanes, 14874-14877
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Reduction of Fuel Tank Flammability on Transport Category 
            Airplanes, 15115-15116


Federal Energy Regulatory Commission
NOTICES
Application:
    Green Mountain Power Corp., 15011-15012
Order:
    North American Electric Reliability Corp.; Approving Extreme Cold 
            Weather Reliability Standards EOP-011-3 and EOP-012-1 and 
            Directing Modification of Reliability Standard EOP-012-1, 
            14994-15011
Request for Extension of Time:
    Southern Natural Gas Co., LLC, 15012
Request under Blanket Authorization:
    ANR Pipeline Co., 15012-15014


Federal Housing Finance Agency
RULES
Orders:
    Reporting by Regulated Entities of Stress Testing Results as of 
            December 31, 2022; Summary Instructions and Guidance, 14871


Federal Railroad Administration
NOTICES
Meetings:
    Railroad Safety Advisory Committee, 15116
Updated Civil Penalty Schedules and Guidelines, 15116-15118


Federal Reserve System
NOTICES
Change in Bank Control:
    Acquisitions of Shares of a Bank or Bank Holding Company, 15024
Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 
          15023-15024


Fish and Wildlife Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Migratory Bird Surveys, 15065-15069
    Native Youth Climate Adaptation Leadership Congress, 15063-15065


Food and Drug Administration
RULES
Mammography Quality Standards Act, 15126-15171
New Animal Drugs:
    Approval of New Animal Drug Applications; Withdrawal of Approval of 
            New Animal Drug Applications; Change of Sponsor; Change of 
            Sponsor Name and Address, 14893-14908
PROPOSED RULES
Hearing:
    Proposed Requirements for Tobacco Product Manufacturing Practice, 
            14962-14963
Proposed Requirements for Tobacco Products Manufacturing Practice; 
          Tobacco Products Scientific Advisory Committee; Meeting, 
          14960-14961
Requirements for Tobacco Product Manufacturing Practice, 15174-15263
NOTICES
Emergency Use Authorization:
    Certain Medical Devices during COVID-19, 15051-15052
    In Vitro Diagnostic Device in Response to an Outbreak of Mpox, 
            15040-15051


Foreign Assets Control Office
NOTICES
Sanctions Action, 15120-15121


Foreign-Trade Zones Board
NOTICES
Proposed Production Activity:
    Foreign-Trade Zone 138; Intel Corp. (Semiconductor Products); New 
            Albany, OH, 14978-14979
    Foreign-Trade Zone 3; Phillips 66 Co.; (Renewable Fuels and By-
            Products); Rodeo, CA, 14979


Forest Service
NOTICES
Requests for Applications:
    The Community Forest and Open Space Conservation Program, 14971-
            14974


General Services Administration
NOTICES
Meetings:
    World War One Centennial Commission, 15024-15025


Health and Human Services Department
See Centers for Disease Control and Prevention
See Centers for Medicare & Medicaid Services
See Children and Families Administration
See Food and Drug Administration
See Health Resources and Services Administration
See National Institutes of Health
See Substance Abuse and Mental Health Services Administration


Health Resources and Services Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Grantee Customer Satisfaction Survey, 15053

[[Page v]]




Homeland Security Department
See Coast Guard


Housing and Urban Development Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Moving to Work Amendment to Consolidated Annual Contributions 
            Contract, 15059-15061
    Study of Childcare in Public Housing, 15061-15063
Privacy Act; Matching Program, 15056-15059


Industry and Security Bureau
NOTICES
Meetings:
    Materials and Equipment Technical Advisory Committee, 14979


Interior Department
See Fish and Wildlife Service
See Land Management Bureau
See National Park Service


International Trade Administration
NOTICES
Antidumping or Countervailing Duty Investigations, Orders, or Reviews:
    Certain Hot-Rolled Steel Flat Products from the Republic of Turkey, 
            14980-14981
    Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled 
            into Modules, from the People's Republic of China; 
            Correction, 14981
    Utility Scale Wind Towers from Indonesia, 14982-14983
Middle East Clean Tech Executive Led Trade Mission to Saudi Arabia, the 
          UAE, and Israel; Cancellation, 14981


International Trade Commission
RULES
Implementing Rules for the United States-Mexico-Canada Agreement 
          Implementation Act, 14887-14893
NOTICES
Investigations; Determinations, Modifications, and Rulings, etc.:
    Tin Mill Products from Canada, China, Germany, Netherlands, South 
            Korea, Taiwan, Turkey, and United Kingdom, 15080


Labor Department
See Occupational Safety and Health Administration
See Wage and Hour Division


Land Management Bureau
NOTICES
Meetings:
    Fort Wainwright, AK; Application for Withdrawal Extension, 15069-
            15070


National Highway Traffic Safety Administration
NOTICES
Petition for Exemption from the Federal Motor Vehicle Theft Prevention 
          Standard:
    Toyota Motor North America, Inc.; Approval, 15118-15120


National Institutes of Health
NOTICES
Meetings:
    Center for Scientific Review, 15054-15055
    Clinical Center, 15054
    National Cancer Institute, 15053-15054


National Labor Relations Board
RULES
Representation Case Procedures, 14908-14916


National Oceanic and Atmospheric Administration
RULES
Fisheries of the Exclusive Economic Zone off Alaska:
    Bering Sea and Aleutian Islands; Final 2023 and 2024 Harvest 
            Specifications for Groundfish, 14926-14956
PROPOSED RULES
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic:
    Reef Fish Fishery of the Gulf of Mexico; Amendment 54, 14964-14969
NOTICES
Environmental Assessments; Availability, etc.:
    Channel Islands National Marine Sanctuary; Availability of a Final 
            Management Plan, 14989-14991
Meetings:
    Gulf of Mexico Fishery Management Council, 14984-14985
    New England Fishery Management Council, 14983-14985
    North Pacific Fishery Management Council, 14986
    Pacific Bluefin Tuna United States Stakeholder, 14985-14986
Taking and Importing Marine Mammals:
    Incidental to Geophysical Surveys Related to Oil and Gas Activities 
            in the Gulf of Mexico, 14986-14989


National Park Service
PROPOSED RULES
Hunting and Trapping in National Preserves:
    Alaska, 14963-14964
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    National Park Service Virtual Visitor Study, 15072-15073
Intent to Repatriate Cultural Items:
    Hudson Museum, University of Maine, Orono, ME, 15073-15077
    Mukwonago Community Library, Mukwonago, WI, 15079
    Museum of Fine Arts, Boston, MA, 15071-15072
Inventory Completion:
    Department of the Interior, Bureau of Indian Affairs, Washington, 
            DC, 15078-15079
    Pittsburg State University, Pittsburg, KS, 15073
    Tennessee Department of Environment and Conservation, Division of 
            Archaeology, Nashville, TN, 15074-15075
    University of California San Diego, San Diego, CA, 15070-15071, 
            15077-15078


National Science Foundation
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 15102-15103
Meetings; Sunshine Act, 15101-15102


Nuclear Regulatory Commission
PROPOSED RULES
Draft Regulatory Guide:
    Criteria for Programmable Digital Devices in Safety-Related Systems 
            of Nuclear Power Plants, 14957-14958
Renewing Nuclear Power Plant Operating Licenses Renewing Nuclear Power 
          Plant Operating Licenses, 14958-14960

[[Page vi]]

NOTICES
Environmental Impact Statements; Availability, etc.:
    Northern States Power Co.--Minnesota; Monticello Nuclear Generating 
            Plant, Unit 1, 15103-15105
Meetings; Sunshine Act, 15103


Occupational Safety and Health Administration
NOTICES
Permanent Variance:
    McNally/Kiewit Joint Venture, 15080-15090
    Traylor-Shea Joint Venture, 15090-15100


Personnel Management Office
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Representative Payee Application/Information Necessary for a 
            Competency Determination, 15105-15106


Securities and Exchange Commission
NOTICES
Application:
    Confluent, Inc., 15109-15111
    JPMorgan Private Markets Fund, et al., 15109
Self-Regulatory Organizations; Proposed Rule Changes:
    New York Stock Exchange, LLC, 15106-15108


Small Business Administration
NOTICES
Disaster Declaration:
    California, 15112-15113
    Louisiana, 15112
    Muscogee (Creek) Nation; Public Assistance Only, 15111-15112


Social Security Administration
NOTICES
Privacy Act; Matching Program, 15113


State Department
NOTICES
Meetings:
    Conducting Anti-Trafficking Work Using a Racial Equity Lens, 15113-
            15114


Substance Abuse and Mental Health Services Administration
NOTICES
Meetings:
    Center for Substance Abuse Treatment, 15055


Surface Transportation Board
NOTICES
Acquisition and Operation Exemption:
    Grafton and Upton Railroad Co; CSX Transportation, Inc., 15114-
            15115


Transportation Department
See Federal Aviation Administration
See Federal Railroad Administration
See National Highway Traffic Safety Administration


Treasury Department
See Foreign Assets Control Office
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Annual Return/Report of Employee Benefit Plan, 15121-15122


Veterans Affairs Department
NOTICES
Privacy Act; Matching Program, 15122-15123


Wage and Hour Division
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Disclosures to Workers Under the Migrant and Seasonal Agricultural 
            Worker Protection Act, 15100-15101

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Separate Parts In This Issue
Part II
Health and Human Services Department, Food and Drug Administration, 
          15126-15171


Part III
Health and Human Services Department, Food and Drug Administration, 
          15174-15263

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Reader Aids

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      CFR PARTS AFFECTED IN THIS ISSUE
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 A cumulative list of the parts affected this month can be 
 found in the Reader Aids section at the end of this issue.
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  Federal Register / Vol. 88, No. 47 / Friday, March 10, 2023 / 
Contents  

  Federal Register / Vol. 88, No. 47 / Friday, March 10, 2023 / 
Contents  

  Federal Register / Vol. 88, No. 47 / Friday, March 10, 2023 / 
Contents  

[[Page vii]]



                          10 CFR
Proposed Rules:
50...................................................14957
51...................................................14958
52...................................................14957

                          12 CFR
1238.................................................14871

                          14 CFR
39 (6 documents)........14871, 14874, 14877, 14880, 14883, 
                                                     14885

                          19 CFR
206..................................................14887
207..................................................14887

                          21 CFR
510..................................................14893
520..................................................14893
522..................................................14893
524..................................................14893
526..................................................14893
528..................................................14893
558..................................................14893
900..................................................15126
Proposed Rules:
14...................................................14960
1120 (3 documents).....................14960, 14962, 15174

                          29 CFR
102 (2 documents).............................14908, 14913

                          33 CFR
165..................................................14916

                          36 CFR
Proposed Rules:
13...................................................14963

                          40 CFR
52...................................................14918
60...................................................14918
81...................................................14920

                          50 CFR
679..................................................14926
Proposed Rules:
622..................................................14964