[Federal Register Volume 84, Number 63 (Tuesday, April 2, 2019)]
[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. 84, No. 63 / Tuesday, April 2, 2019 / 
Contents  

[[Page iii]]




Agency for Toxic Substances and Disease Registry
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 12607-12608


Agricultural Marketing Service
RULES
Federal Milk Marketing Orders:
    Class I Skim Milk Price Formula; Correction, 12483


Agriculture Department
See Agricultural Marketing Service
See Food and Nutrition Service
See Food Safety and Inspection Service


Alcohol, Tobacco, Firearms, and Explosives Bureau
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Furnishing of Samples, 12635-12636


Centers for Disease Control and Prevention
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 12608-12616


Centers for Medicare & Medicaid Services
PROPOSED RULES
Basic Health Program:
    Federal Funding Methodology for Program Years 2019 and 2020, 12552-
            12566


Civil Rights Commission
NOTICES
Meetings:
    Florida Advisory Committee, 12580
    Nevada Advisory Committee, 12580


Coast Guard
PROPOSED RULES
Safety Zone:
    Gastineau Channel, Juneau, AK, 12538-12539
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 12630-12631
Consolidated Cruise Ship Security Regulations, 12631


Commerce Department
See International Trade Administration
See National Oceanic and Atmospheric Administration


Defense Department
See Engineers Corps


Energy Department
See Federal Energy Regulatory Commission
PROPOSED RULES
Energy Conservation Program:
    Procedures for Use in New or Revised Energy Conservation Standards 
            and Test Procedures for Consumer Products and Commercial/
            Industrial Equipment, 12527
Meetings:
    Variable Refrigerant Flow Multi-Split Air Conditioners and Heat 
            Pumps Working Group; Test Procedures and Energy 
            Conservation Standards, 12528-12529


Engineers Corps
NOTICES
Environmental Impact Statements; Availability, etc.:
    Amite River and Tributaries--East of the Mississippi River, 
            Louisiana, Flood Risk Management Feasibility Study, 12602-
            12603
    Lake Pontchartrain and Vicinity General Re-Evaluation Report, 
            Louisiana, 12598-12599
    South Central Coast Louisiana Flood Risk Management Feasibility 
            Study, 12601-12602
    Upper Baritaria Basin, LA Study, 12596-12598
    West Bank and Vicinity General Re-evaluation Report, Louisiana, 
            12599-12600


Environmental Protection Agency
RULES
Air Quality State Implementation Plans; Approvals and Promulgations:
    Maryland; Amendment to Control of Emissions of Volatile Organic 
            Compounds from Consumer Products, 12508-12511
    New York Ozone Section 185, 12511-12513
Pesticide Tolerances:
    Metrafenone, 12516-12520
    Zoxamide, 12520-12524
Tolerance Exemption:
    2-methyl-2-[(1-oxo-2-propenyl)amino]-1-propanesulfonic acid 
            monosodium salt polymer with 2-propenoic acid, 2-methyl-, 
            C12-16 alkyl esters, 12513-12516
PROPOSED RULES
Modernizing Ignitable Liquids Determinations, 12539-12552


Federal Aviation Administration
RULES
Airworthiness Directives:
    Airbus Helicopters Deutschland GmbH Helicopters, 12486-12488
    Bell Helicopter Textron Canada Limited Helicopters, 12484-12486
IFR Altitudes; Miscellaneous Amendments, 12488-12490
PROPOSED RULES
Airworthiness Criteria:
    Glider Design Criteria for Alexander Schleicher GmbH & Co. 
            Segelflugzeugbau Model ASK 21 B Glider, 12529-12530
Airworthiness Directives:
    Diamond Aircraft Industries GmbH Airplanes, 12532-12534
    Gulfstream Aerospace Corporation Airplanes, 12530-12532


Federal Bureau of Investigation
NOTICES
Meetings:
    Compact Council for the National Crime Prevention and Privacy 
            Compact, 12636

[[Page iv]]




Federal Communications Commission
PROPOSED RULES
Partitioning, Disaggregation, and Leasing of Spectrum, 12566-12569
NOTICES
Media Bureau Lifts LPTV and TV Translator Application Filing Freezes, 
          12606


Federal Election Commission
NOTICES
Meetings; Sunshine Act, 12606


Federal Energy Regulatory Commission
NOTICES
Combined Filings, 12603-12605


Federal Highway Administration
NOTICES
Final Federal Agency Actions:
    Utah; Proposed Highway, 12662-12663


Federal Motor Carrier Safety Administration
NOTICES
Qualification of Drivers; Exemption Applications:
    Vision, 12663-12670


Federal Reserve System
NOTICES
Change in Bank Control:
    Acquisitions of Shares of a Bank or Bank Holding Company, 12606-
            12607
Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 
          12606


Federal Transit Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 12670


Food and Drug Administration
RULES
Implementing the Food and Drug Administration Food Safety Modernization 
          Act; Technical Amendment, 12490-12491
New Animal Drugs:
    Approval of New Animal Drug Applications; Changes of Sponsorship, 
            12491-12504
Removal of Certain Time of Inspection and Duties of Inspector 
          Regulations for Biological Products, 12505-12508
PROPOSED RULES
Content and Format of Substantial Equivalence Reports; Food and Drug 
          Administration Actions on Substantial Equivalence Reports, 
          12740-12791
Revocation of the Test for Mycoplasma, 12534-12537
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Generic Clearance for Quick Turnaround Testing of Communication 
            Effectiveness, 12617-12619
Charter Renewal:
    Technical Electronic Product Radiation Safety Standards Committee, 
            12616
Determination:
    ONFI (Clobazam) Tablets, 5 Milligrams, was not Withdrawn from Sale 
            for Reasons of Safety or Effectiveness, 12616-12617
Determinations that Products Were Not Withdrawn from Sale for Reasons 
          of Safety or Effectiveness:
    CHLOR-TRIMETON ALLERGY 12 HOUR (Chlorpheniramine Maleate) Extended 
            Release Tablets, 8 Milligrams and 12 Milligrams, 12625-
            12626
Establishment of a Public Docket:
    Post-Marketing Pediatric-Focused Product Safety Reviews, 12623-
            12624
Meetings:
    Limited Population Pathway for Antibacterial and Antifungal Drugs, 
            12621-12623
    Pulmonary-Allergy Drugs Advisory Committee; Cancellation, 12626
    Youth Tobacco Cessation: Science and Treatment Strategies; Public 
            Scientific Workshop, 12619-12621
Training Program for Regulatory Project Managers; Information Available 
          to Industry, 12624-12625


Food and Nutrition Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Federal Claims Collection Methods for Supplemental Nutrition 
            Assistance Program Recipient Claims, 12577-12580


Food Safety and Inspection Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Import of Undenatured Inedible Product and Samples for Laboratory 
            Examination, Research, Evaluative Testing, or Trade Show 
            Exhibition, 12576-12577
    Registration Requirements, 12575-12576


Health and Human Services Department
See Agency for Toxic Substances and Disease Registry
See Centers for Disease Control and Prevention
See Centers for Medicare & Medicaid Services
See Food and Drug Administration
See Substance Abuse and Mental Health Services Administration
NOTICES
Meetings:
    Biodefense Summit: Implementing the National Biodefense Strategy, 
            12628
    Pain Management Best Practices Inter-Agency Task Force, 12626-12627
Request for Nominations:
    National Biodefense Science Board, 12627-12628


Homeland Security Department
See Coast Guard
See U.S. Customs and Border Protection


Institute of Museum and Library Services
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Evaluation of the Museums for Digital Learning Project, 12636-12637


Interior Department
See Land Management Bureau

[[Page v]]




International Trade Administration
NOTICES
Antidumping or Countervailing Duty Investigations, Orders, or Reviews:
    Freshwater Crawfish Tail Meat from the People's Republic of China, 
            12585-12587
    Wooden Cabinets and Vanities and Components Thereof from the 
            People's Republic of China, 12581-12585
Initiation of Less-Than-Fair-Value Investigations:
    Wooden Cabinets and Vanities and Components Thereof from the 
            People's Republic of China, 12587-12592


International Trade Commission
NOTICES
Complaint:
    Certain Luxury Vinyl Tile and Components Thereof, 12633-12634
Investigations; Determinations, Modifications, and Rulings, etc.:
    Certain Electronic Nicotine Delivery Systems and Components 
            Thereof, 12634-12635


Justice Department
See Alcohol, Tobacco, Firearms, and Explosives Bureau
See Federal Bureau of Investigation


Land Management Bureau
NOTICES
Meetings:
    Northwest Resource Advisory Council, 12633


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


National Oceanic and Atmospheric Administration
RULES
Atlantic Highly Migratory Species:
    Commercial Aggregated Large Coastal Shark and Hammerhead Shark 
            Management Groups Retention Limit Adjustment, 12524-12526
PROPOSED RULES
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic:
    Spiny Lobster Fishery of the Gulf of Mexico and South Atlantic; 
            Amendment 13, 12573-12574
NOTICES
Endangered and Threatened Species:
    Take of Anadromous Fish, 12593-12595
Meetings:
    Mid-Atlantic Fishery Management Council, 12594-12596
    North Pacific Fishery Management Council, 12592
    Pacific Fishery Management Council, 12596
    South Atlantic Fishery Management Council, 12593-12594
Permit Applications:
    General Provisions for Domestic Fisheries; Exempted Fishing, 12595


National Science Foundation
NOTICES
Meetings:
    Proposal Review Panel for Materials Research, 12637-12638


Nuclear Regulatory Commission
RULES
Clarification of Export Reporting Requirements for Nuclear Facilities, 
          Equipment, and Non-Nuclear Materials, 12483-12484
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Specific Domestic Licenses to Manufacture or Transfer Certain Items 
            Containing Byproduct Material, 12643-12645
Applications and Amendments to Facility Operating Licenses and Combined 
          Licenses Involving Proposed No Significant Hazards 
          Considerations, etc., 12638-12643


Personnel Management Office
PROPOSED RULES
Federal Employees Health Benefits Acquisition Regulations:
    Self Plus One and Contract Matrix Update, 12569-12573


Postal Regulatory Commission
NOTICES
New Postal Products, 12645


Postal Service
NOTICES
Product Change:
    Parcel Return Service Negotiated Service Agreement, 12646
    Priority Mail Express Negotiated Service Agreement, 12646
    Priority Mail Express, Priority Mail, and First-Class Package 
            Service Negotiated Service Agreement, 12645
    Priority Mail Negotiated Service Agreement, 12645-12646


Presidential Documents
EXECUTIVE ORDERS
Government Agencies and Employees:
    Rates of Pay; Adjustments (EO 13866), 12851-12865
ADMINISTRATIVE ORDERS
Liberia; Extension of Deferred Enforced Departure for Liberians 
          (Memorandum of March 28, 2019), 12867-12868
South Sudan; Continuation of National Emergency (Notice of April 1, 
          2019), 12869-12871


Securities and Exchange Commission
RULES
FAST Act Modernization and Simplification of Regulation S-K, 12674-
          12738
NOTICES
Self-Regulatory Organizations; Proposed Rule Changes:
    NYSE American, LLC, 12649-12658
    NYSE Arca, Inc., 12646-12649
    The Nasdaq Stock Market, LLC, 12658-12660


Small Business Administration
NOTICES
Small Business Innovation Research Program and Small Business 
          Technology Transfer Program Policy Directive, 12794-12849


Social Security Administration
NOTICES
Public Availability of Social Security Administration Fiscal Year 2017 
          Service Contract Inventory, 12660

[[Page vi]]




Substance Abuse and Mental Health Services Administration
NOTICES
Certified Laboratories and Instrumented Initial Testing Facilities:
    List of Facilities that Meet Minimum Standards to Engage in Urine 
            Drug Testing for Federal Agencies, 12629-12630


Susquehanna River Basin Commission
NOTICES
Meetings:
    Actions Taken, 12661-12662
Projects Approved for Consumptive Uses of Water, 12660-12661
Projects Rescinded for Consumptive Uses of Water, 12660


Transportation Department
See Federal Aviation Administration
See Federal Highway Administration
See Federal Motor Carrier Safety Administration
See Federal Transit Administration


U.S. Customs and Border Protection
NOTICES
Quarterly IRS Interest Rates Used to Calculate Interest on Overdue 
          Accounts and Refunds on Customs Duties, 12631-12633


Veterans Affairs Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Veteran Employment Through Technology Education Courses Employment 
            Verification Form, 12670-12671

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Separate Parts In This Issue
Part II
Securities and Exchange Commission, 12674-12738


Part III
Health and Human Services Department, Food and Drug Administration, 
          12740-12791


Part IV
Small Business Administration, 12794-12849


Part V
Presidential Documents, 12851-12868


Part VI
Presidential Documents, 12869-12871

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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. 84, No. 63 / Tuesday, April 2, 2019 / 
Contents  

  Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / 
Contents  

  Federal Register / Vol. 84, No. 63 / Tuesday, April 2, 2019 / 
Contents  

[[Page vii]]



                           3 CFR
Executive Orders:
13856 (Superseded by EO 13866).......................12853
13866................................................12853
Administrative Orders:
Notices:
Notices of April 1, 2019.............................12871
Memorandums:
Memorandum of March 28, 2019.........................12867

                           7 CFR
1000.................................................12483

                          10 CFR
Ch. I................................................12483
Proposed Rules:
430..................................................12527
431 (2 documents).............................12527, 12528

                          14 CFR
39 (2 documents)..............................12484, 12486
95...................................................12488
Proposed Rules:
21...................................................12529
39 (2 documents)..............................12530, 12532

                          17 CFR
229..................................................12674
230..................................................12674
232..................................................12674
239..................................................12674
240..................................................12674
249..................................................12674
270..................................................12674
274..................................................12674
275..................................................12674

                          21 CFR
112..................................................12490
117..................................................12490
507..................................................12490
510..................................................12491
520..................................................12491
522..................................................12491
524..................................................12491
528..................................................12491
556..................................................12491
558..................................................12491
600..................................................12505
Proposed Rules:
16...................................................12740
610..................................................12534
1107.................................................12740

                          33 CFR
Proposed Rules:
165..................................................12538

                          40 CFR
52 (2 documents)..............................12508, 12511
180 (3 documents)......................12513, 12516, 12520
Proposed Rules:
260..................................................12539
261..................................................12539
266..................................................12539

                          42 CFR
Proposed Rules:
600..................................................12552

                          47 CFR
Proposed Rules:
1....................................................12566

                          48 CFR
Proposed Rules:
1603.................................................12569
1652.................................................12569

                          50 CFR
635..................................................12524
Proposed Rules:
622..................................................12573