[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[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. 89, No. 88 / Monday, May 6, 2024 / Contents  

[[Page iii]]




Agency for International Development
RULES
Acquisition Regulation:
    Planning, Collection, and Submission of Digital Information as Well 
            as Submission of Activity Monitoring, Evaluation, and 
            Learning Plan, 37948-37964


Agricultural Marketing Service
NOTICES
2024/2025 Rates Charged for Services, 37160-37165


Agriculture Department
See Agricultural Marketing Service
See Forest Service
See Natural Resources Conservation Service


Census Bureau
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Boundary and Annexation Survey, 37169-37172
    Redistricting Data Program, 37172-37174


Centers for Disease Control and Prevention
NOTICES
Hearings, Meetings, Proceedings, etc.:
    National Public Health Strategy for the Prevention and Control of 
            Vector-Borne Diseases in People, 37227


Centers for Medicare & Medicaid Services
RULES
Nondiscrimination in Health Programs and Activities, 37522-37703
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 37227-37230
Guidance:
    Inflation Reduction Act Medicare Drug Price Negotiation Program, 
            37229


Civil Rights Commission
NOTICES
Hearings, Meetings, Proceedings, etc.:
    Arizona Advisory Committee, 37168
    Puerto Rico Advisory Committee, 37168-37169
    Texas Advisory Committee, 37169


Coast Guard
RULES
Safety Zone:
    Presque Isle Bay, Erie, PA, 37134-37135
    Revolution Wind Farm Project Area, Outer Continental Shelf, Lease 
            OCS?A 0486, Offshore Rhode Island, Atlantic Ocean, 37130-
            37134
Special Local Regulations:
    Montlake Cut, Lake Washington, Seattle, WA, 37130


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


Defense Department
RULES
Privacy Act; Implementation, 37127-37130
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Combating Trafficking in Persons, 37226-37227
Environmental Assessments; Availability, etc.:
    DARPA's Reefense Program, Baker Point, FL, 37184-37185
Privacy Act; Systems of Records, 37182-37184


Drug Enforcement Administration
NOTICES
Importer, Manufacturer or Bulk Manufacturer of Controlled Substances; 
          Application, Registration, etc.:
    AndersonBrecon dba PCI Pharma Services, 37261
    AndersonBrecon dba PCI Pharma Services; Correction, 37260
    Entheogen Pharmaceuticals Inc., 37246-37247
    Lipomed, 37247-37251
    NSI Lab Solutions, Inc., 37257-37260
    Pharmaron Manufacturing Services (US) LLC, 37260-37261
    Pisgah Laboratories Inc., 37246
    Research Triangle Institute, 37251-37252
    Restek Corp., 37252-37257


Education Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    High School Equivalency Program Annual Performance Report, 37207-
            37208
Applications for New Awards:
    Education Innovation and Research Program Early-Phase Grants, 
            37185-37196
    Education Innovation and Research Program Expansion Grants, 37208-
            37218
    Education Innovation and Research Program Mid-Phase Grants, 37196-
            37207


Employment and Training Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Extension Package for Labor Condition Application for H?1B, H?1B1, 
            and E?3 Nonimmigrant Workers and Nonimmigrant Worker 
            Information Form, 37263-37264


Energy Department
See Federal Energy Regulatory Commission
RULES
Energy Conservation Program:
    Standards for Consumer Water Heaters, 37778-37946
Interpretation of Foreign Entity of Concern, 37079-37091
NOTICES
Privacy Act; Systems of Records, 37218-37223

[[Page iv]]




Environmental Protection Agency
RULES
Air Quality State Implementation Plans; Approvals and Promulgations:
    Nevada; Clark County Department of Environment and Sustainability; 
            Nonattainment New Source Review; 2015 Ozone Standard, 
            37137-37139
NOTICES
Access to Confidential Business Information by General Dynamics 
          Information Technology, 37223-37224
Pesticide Registration Review:
    Decisions for Several Pesticides, 37224
    Pesticide Dockets Opened for Review and Comment, 37224-37226


Federal Aviation Administration
RULES
Airworthiness Directives:
    CFM International, S.A. Engines, 37111-37113
    Rolls-Royce Deutschland Ltd and Co KG, 37109-37111
PROPOSED RULES
Airworthiness Directives:
    Airbus Canada Limited Partnership (Type Certificate Previously Held 
            by C Series Aircraft Limited Partnership (CSALP); 
            Bombardier, Inc.) Airplanes, 37144-37147
    Airbus SAS Airplanes, 37142-37144
NOTICES
Airport Property:
    Tallahassee Commercial (68J), a Privately Owned Airport for Public 
            Use Located in Tallahassee, FL; Intent to Initiate a 
            Deactivation Request, 37275-37276


Federal Energy Regulatory Commission
PROPOSED RULES
Standards for Business Practices and Communication Protocols for Public 
          Utilities, 37147-37157


Federal Highway Administration
RULES
Uniform Procedures:
    State Highway Safety Grant Programs, 37113-37116


Food and Drug Administration
RULES
Medical Devices:
    Laboratory Developed Tests, 37286-37445
Standards for the Growing, Harvesting, Packing, and Holding of Produce 
          for Human Consumption Relating to Agricultural Water, 37448-
          37519
PROPOSED RULES
Guidance:
    Enforcement Policy for Certain In Vitro Diagnostic Devices for 
            Immediate Public Health Response in the Absence of a 
            Declaration under Section 564, 37158-37159
NOTICES
Guidance:
    Consideration of Enforcement Policies for Tests During a Section 
            564 Declared Emergency, 37232-37234
    International Cooperation on Harmonisation of Technical 
            Requirements for Registration of Veterinary Medicinal 
            Products; Pharmaceutical Development, 37230-37231
Hearings, Meetings, Proceedings, etc.:
    The Tobacco Products Scientific Advisory Committee, 37231-37232


Foreign Assets Control Office
NOTICES
Sanctions Action, 37281-37282


Foreign-Trade Zones Board
NOTICES
Proposed Production Activity:
    PPC Broadband, Inc., Foreign-Trade Zone 90, East Syracuse, NY, 
            37174


Forest Service
RULES
Planning, 37135-37137
NOTICES
Environmental Impact Statements; Availability, etc.:
    White River National Forest, Colorado; Sweetwater Lake Recreation 
            Management and Development Project, 37165-37167


General Services Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Combating Trafficking in Persons, 37226-37227


Health and Human Services Department
See Centers for Disease Control and Prevention
See Centers for Medicare & Medicaid Services
See Food and Drug Administration
See National Institutes of Health
RULES
Nondiscrimination in Health Programs and Activities, 37522-37703


Homeland Security Department
See Coast Guard
PROPOSED RULES
Cyber Incident Reporting for Critical Infrastructure Act, 37141-37142


Indian Affairs Bureau
NOTICES
Rate Adjustments for Indian Irrigation Projects, 37238-37241


Institute of Museum and Library Services
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Library and Museum Reviewer Forms, 37266-37267
    National Medal for Museum and Library Service Nomination Form, 
            37265-37266


Interior Department
See Indian Affairs Bureau
See Surface Mining Reclamation and Enforcement Office


Internal Revenue Service
RULES
Clean Vehicle Credits:
    Transfer of Credits, Critical Minerals and Battery Components, and 
            Foreign Entities of Concern, 37706-37775
Relief Provisions Respecting Timely Allocation of Generation Skipping 
          Transfer Exemption and Certain GST Elections, 37116-37127

[[Page v]]




International Trade Administration
NOTICES
Antidumping or Countervailing Duty Investigations, Orders, or Reviews:
    Carbon and Alloy Steel Threaded Rod from India, 37174-37177
Hearings, Meetings, Proceedings, etc.:
    Environmental Technologies Trade Advisory Committee, 37177-37178


International Trade Commission
NOTICES
Complaint, 37243-37246
Investigations; Determinations, Modifications, and Rulings, etc.:
    Certain Cameras, Camera Systems, and Accessories Used Therewith, 
            37242-37243
Meetings; Sunshine Act, 37244


Justice Department
See Drug Enforcement Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Application and Permit for Permanent Exportation of Firearms, 
            37261-37262
    Survey of Sexual Victimization, 37262-37263


Labor Department
See Employment and Training Administration
See Occupational Safety and Health Administration


Maritime Administration
NOTICES
Hearings, Meetings, Proceedings, etc.:
    Decommissioning and Disposition of the National Historic Landmark 
            Nuclear Ship Savannah, 37276-37277


National Aeronautics and Space Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Combating Trafficking in Persons, 37226-37227


National Foundation on the Arts and the Humanities
See Institute of Museum and Library Services


National Highway Traffic Safety Administration
RULES
Uniform Procedures:
    State Highway Safety Grant Programs, 37113-37116
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Examining Distraction and Driver Monitoring Systems to Improve 
            Driver Safety, 37277-37280


National Institutes of Health
NOTICES
Hearings, Meetings, Proceedings, etc.:
    Center for Scientific Review, 37234-37235
    National Heart, Lung, and Blood Institute, 37235-37237
    National Institute of Dental and Craniofacial Research, 37235-37236
    National Institute of Mental Health, 37236
    National Institute on Alcohol Abuse and Alcoholism, 37234, 37237-
            37238


National Oceanic and Atmospheric Administration
RULES
Atlantic Highly Migratory Species:
    Atlantic Bluefin Tuna Fisheries; Closure of the Angling Category 
            Southern New England Area Trophy Fishery for 2024, 37139-
            37140
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Northeast Region Observer Providers Requirements, 37178-37179
    Tornado Watch/Warning Post-Event Evaluation, 37181
Hearings, Meetings, Proceedings, etc.:
    Fisheries of the South Atlantic; Southeast Data, Assessment, and 
            Review, 37179-37180
    Fisheries of the U.S. Caribbean; Southeast Data, Assessment, and 
            Review, 37180-37181
    Mid-Atlantic Fishery Management Council, 37179


Natural Resources Conservation Service
NOTICES
Field Office Technical Guides for Louisiana and Wisconsin, 37167-37168


Nuclear Regulatory Commission
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Public Records, 37267-37268
NUREG:
    Report to Congress on Abnormal Occurrences: Fiscal Year 2023, 
            Dissemination of Information, 37268-37269


Occupational Safety and Health Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Ionizing Radiation Standard, 37264-37265


Office of Financial Research
RULES
Ongoing Data Collection of Non-Centrally Cleared Bilateral Transactions 
          in the U.S. Repurchase Agreement Market, 37091-37109


Personnel Management Office
RULES
Postal Service Reform Act:
    Establishment of the Postal Service Health Benefits Program, 37061-
            37079
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Health Benefits Election Forms, 37269-37270


Pipeline and Hazardous Materials Safety Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Pipeline Safety: Mitigation of Ruptures on Onshore Gas Transmission 
            and Gathering, Hazardous Liquid, and Carbon Dioxide 
            Pipeline Segments Using Rupture-Mitigation Valves or 
            Alternative Equivalent Technologies and Blending of 
            Hydrogen Gas and Natural Gas within Gas Pipelines, 37281


Postal Regulatory Commission
NOTICES
New Postal Products, 37270-37271

[[Page vi]]




Presidential Documents
PROCLAMATIONS
Special Observances:
    National Day of Prayer (Proc. 10744), 37059-37060


Securities and Exchange Commission
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 37272
Meetings; Sunshine Act, 37271-37272


Small Business Administration
NOTICES
Disaster or Emergency Declaration and Related Determination:
    Texas, 37272-37273


State Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 37273-37275
Culturally Significant Objects Imported for Exhibition:
    Paris 1874: The Impressionist Moment, 37273


Surface Mining Reclamation and Enforcement Office
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Requirements for Coal Exploration, 37241-37242
    Requirements for Permits for Special Categories of Mining, 37241


Surface Transportation Board
NOTICES
Exemption:
    Abandonment and Discontinuance of Service Exemption; Union Pacific 
            Railroad Co., Missouri Eastern Railroad, LLC, St. Louis 
            County, MO, 37275


Transportation Department
See Federal Aviation Administration
See Federal Highway Administration
See Maritime Administration
See National Highway Traffic Safety Administration
See Pipeline and Hazardous Materials Safety Administration


Treasury Department
See Foreign Assets Control Office
See Internal Revenue Service
See Office of Financial Research


Veterans Affairs Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Application for Automobile or Other Conveyance and Adaptive 
            Equipment, 37282-37283
    Applications for Motor Vehicle Adaptive Equipment and Home 
            Improvements and Structural Alterations Services, 37282
    Report of Medical, Legal, and Other Expenses Incident to Recovery 
            for Injury or Death, 37283

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Separate Parts In This Issue
Part II
Health and Human Services Department, Food and Drug Administration, 
          37286-37445


Part III
Health and Human Services Department, Food and Drug Administration, 
          37448-37519


Part IV
Health and Human Services Department, Centers for Medicare & Medicaid 
          Services, 37522-37703
Health and Human Services Department, 37522-37703


Part V
Treasury Department, Internal Revenue Service, 37706-37775


Part VI
Energy Department, 37778-37946


Part VII
Agency for International Development, 37948-37964

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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.
 

  Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Contents  

  Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Contents  

  Federal Register / Vol. 89, No. 88 / Monday, May 6, 2024 / Contents  

[[Page vii]]



                           3 CFR
Proclamations:
10744................................................37059

                           5 CFR
890..................................................37061

                           6 CFR
Proposed Rules:
26...................................................37141

                          10 CFR
Ch. III..............................................37079
429..................................................37778
430..................................................37778

                          12 CFR
1610.................................................37091

                          14 CFR
39 (2 documents)..............................37109, 37111
Proposed Rules:
39 (2 documents)..............................37142, 37144

                          18 CFR
Proposed Rules:
2....................................................37147
38...................................................37147

                          21 CFR
112..................................................37448
809..................................................37286
Proposed Rules:
809..................................................37158

                          23 CFR
490..................................................37113
1300.................................................37113

                          26 CFR
1....................................................37706
26...................................................37116
301 (2 documents).............................37116, 37706
602..................................................37116

                          32 CFR
310..................................................37127

                          33 CFR
100..................................................37130
147..................................................37130
165..................................................37134

                          36 CFR
219..................................................37135

                          40 CFR
52...................................................37137

                          42 CFR
438..................................................37522
440..................................................37522
457..................................................37522
460..................................................37522

                          45 CFR
80...................................................37522
84...................................................37522
92...................................................37522
147..................................................37522
155..................................................37522
156..................................................37522

                          48 CFR
727..................................................37948
742..................................................37948
752..................................................37948
1602.................................................37061
1609.................................................37061

                          50 CFR
635..................................................37139