Unknown. Temporary final rule

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--- schema: federal-register doc_type: fedreg source_file: FR-2021-05-12.xml --- 86 90 Wednesday, May 12, 2021 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26036-26039 2021-09973 Agricultural Marketing Agricultural Marketing Service PROPOSED RULES Increased Assessment Rate: Dried Prunes Produced in California, 25975-25977 2021-10018 National Organic Program: Origin of Livestock, 25961-25974 2021-09978 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Explosives Employee Possessor Questionnaire, 26069-26070 2021-10005 Animal Animal and Plant Health Inspection Service NOTICES Pest Risk Analysis: Importation of Fresh Mango Fruit from Colombia Into the United States, 25998-25999 2021-10042 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medicaid and Children's Health Insurance Program, 26042-26043 2021-10050 Request for Nominations:

Advisory Panel on Outreach and Education, 26039-26042 2021-10118 Coast Guard Coast Guard RULES Safety Zone: Pierce County Ferry Steilacoom II, Puget Sound, WA, 25949-25951 2021-10085 Commerce Commerce Department See Economic Analysis Bureau See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office Drug Drug Enforcement Administration NOTICES Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc., 26070-26071 2021-09988 Economic Analysis Bureau Economic Analysis Bureau NOTICES Request for Nominations:

Federal Economic Statistics Advisory Committee, 25999-26000 2021-10037 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Early Childhood Longitudinal Study, Kindergarten Class of 2023-24 Preschool Round Removal Change Request, 26018 2021-09977 Election Election Assistance Commission NOTICES Charter Renewal: Federal Advisory Committee, 26018-26019 2021-10023 Energy Department Energy Department See Federal Energy Regulatory Commission Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans;

Approvals and Promulgations: Michigan; Part 18 and Part 19 Revisions, 25954-25956 2021-10044 Pennsylvania; Regulatory Updates to Nonattainment New Source Review Permitting Requirements for 2012 Fine Particulate Matter National Ambient Air Quality Standard, 25951-25953 2021-10041 Exemption from the Requirement of a Tolerance: Sodium lauroyl sarcosinate, 25956-25960 2021-10000 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Michigan; Part 18 and Part 19 Revisions, 25978 2021-10043 NOTICES National Pollutant Discharge Elimination System: 2022 Issuance of General Permit for Stormwater Discharges from Construction Activities, 26023-26033 2021-09961 Privacy Act;

Systems of Records, 26033-26035 2021-10040 Federal Aviation Federal Aviation Administration NOTICES Intent to Rule on Request to Dispose 10.3 Acres of Land at Dillant-Hopkins Airport, Swanzey, NH, 26126-26127 2021-10060 Federal Communications Federal Communications Commission PROPOSED RULES Television Broadcasting Services: Medford, Oregon, 25979-25980 2021-10062 Redding, CA, 25978-25979 2021-10022 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 26035-26036 2021-10002 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 26019-26020, 26022-26023 2021-10008 2021-10009 Combined Filings, 26020-26022 2021-09987 2021-10007 Complaint: Spire Marketing Inc. v. Panhandle Eastern Pipe Line Company, LP, 26020 2021-10010 Federal Railroad Federal Railroad Administration NOTICES Petition for Waiver of Compliance, 26127-26128 2021-10051 2021-10052 Federal Reserve Federal Reserve System NOTICES Change in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 26036 2021-10016 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Wildlife and Plants:

Draft Habitat Conservation Plan and Draft Categorical Exclusion for the Santa Barbara County Distinct Population Segment of the California Tiger Salamander; Orcutt Hill Resource and Solar Project, Pacific Coast Energy Company, Santa Barbara County, CA, 26063 2021-10045 Draft Recovery Plan for the Rufa Red Knot, 26062-26063 2021-10064 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: State Enforcement Notifications, 26046-26047 2021-09968 Guidance:

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention, 26050-26052 2021-10061 E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials; International Council for Harmonisation, 26047-26048 2021-10066 M9 Biopharmaceutics Classification System-Based Biowaivers; International Council for Harmonisation, 26054-26056 2021-09962 Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management;

International Council for Harmonisation, 26043-26045 2021-09963 Q3D(R2)—Guideline for Elemental Impurities; International Council for Harmonisation, 26052-26054 2021-10011 Qualified Infectious Disease Product Designation—Questions and Answers, 26045-26046 2021-09986 S11 Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals; International Council for Harmonisation, 26056-26058 2021-09964 S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals;

International Council for Harmonisation, 26048-26050 2021-10017 Withdrawal of Approval of New Drug Applications: Lederle Laboratories et al., 26058-26059 2021-09980 Health and Human Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health NOTICES Meetings: Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, 26059 2021-10014 Homeland Homeland Security Department See Coast Guard Interior Interior Department See Fish and Wildlife Service International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Boltless Steel Shelving Units Prepackaged for Sale from the People's Republic of China, 26000-26001 2021-09999 Lightweight Thermal Paper from the People's Republic of China, 26009-26010 2021-10034 Determination of Sales at Less Than Fair Value: Thermal Paper from Germany, 26001-26003 2021-09965 Thermal Paper from Japan, 26011-26013 2021-09849 Thermal Paper from Spain, 26003-26006 2021-09967 Thermal Paper from the Republic of Korea, 26007-26009 2021-09966 Quarterly Update: Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty, 26010-26011 2021-10036 Request for Applications:

President's Advisory Council on Doing Business in Africa, 26006-26007 2021-09979 International Trade Com International Trade Commission NOTICES Complaint: Certain Electrolyte Containing Beverages and Labeling and Packaging Thereof, 26066-26067 2021-10003 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Botulinum Toxin Products, Processes for Manufacturing or Relating to Same and Certain Products Containing Same; Return of Bond, 26068-26069 2021-09990 Certain Collapsible and Portable Furniture, 26069 2021-09989 Cut-to-Length Carbon Steel Plate from China, Russia, and Ukraine, 26067-26068 2021-10004 Foreign Censorship Part 1:

Policies and Practices Affecting U.S. Businesses and Investigation No. 332-586: Foreign Censorship Part 2: Trade and Economic Effects on U.S. Businesses, 26064-26066 2021-09991 Justice Department Justice Department See Alcohol, Tobacco, Firearms, and Explosives Bureau See Drug Enforcement Administration Management Management and Budget Office NOTICES Designation of Databases for Treasury's Working System under the Do Not Pay Initiative, 26071 2021-10025 National Highway National Highway Traffic Safety Administration PROPOSED RULES Corporate Average Fuel Economy Preemption, 25980-25992 2021-08758 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Consolidated Vehicles' Owner's Manual Requirements for Motor Vehicles and Motor Vehicle Equipment, 26128-26133 2021-09984 Motorcycle Helmets (Labeling), 26136-26137 2021-09985 Petition for Exemption from the Federal Motor Vehicle Theft Prevention Standard: Mazda Motor Corp., 26137-26140 2021-09983 Toyota Motor North America, Inc., 26133-26136 2021-09982 Petition for Exemption from the Federal Motor Vehicle Theft Prevention Standard: North American Subaru, Inc., 26140-26143 2021-09981 National Institute National Institutes of Health NOTICES Meetings:

Center for Scientific Review, 26061-26062 2021-10020 National Cancer Institute, 26060-26061 2021-10027 National Center for Advancing Translational Sciences, 26060 2021-10021 National Institute of Mental Health, 26059-26060 2021-10026 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Atlantic Highly Migratory Species: General Category Restricted-Fishing Days, 25992-25997 2021-10028 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Protocol for Access to Tissue Specimen Samples from the National Marine Mammal Tissue Bank, 26014 2021-10048 United States Pacific Highly Migratory Species Hook and Line Logbook, 26014-26015 2021-10063 Permits: Marine Mammals and Endangered Species, 26013-26014 2021-09976 National Science National Science Foundation NOTICES Meetings: Committee on Equal Opportunities in Science and Engineering, 26071 2021-10033 Nuclear Regulatory Nuclear Regulatory Commission PROPOSED RULES American Society of Mechanical Engineers 2019-2020 Code Editions;

Correction, 25977-25978 2021-09997 NOTICES Meetings; Sunshine Act, 26071-26072 2021-10136 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Trademark Post Registration, 26015-26018 2021-09972 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 26072-26073 2021-10001 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Mother's Day (Proc. 10207), 26145-26148 2021-10215 National Hurricane Preparedness Week (Proc. 10205), 25943-25944 2021-10128 National Women's Health Week (Proc. 10206), 25945-25946 2021-10130 EXECUTIVE ORDERS Committees;

Establishment, Renewal, Termination, etc.: Climate Change Support Office; Establishment (EO 14027), 25947-25948 2021-10139 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Cboe EDGA Exchange, Inc., 26113-26115 2021-09970 DTCC Data Repository (U.S.), LLC, 26115-26124 2021-10065 Financial Industry Regulatory Authority, Inc., 26084-26109 2021-10055 MIAX Emerald, LLC, 26111-26112 2021-09975 National Securities Clearing Corp., 26112-26113 2021-10054 New York Stock Exchange, LLC, 26110 2021-10057 New York Stock Exchange, LLC, NYSE American, LLC, NYSE Arca, Inc., et al., 26082-26084 2021-09971 NYSE Arca, Inc., 26073-26081, 26110 2021-09969 2021-09974 Susquehanna Susquehanna River Basin Commission NOTICES Grandfathering Registration, 26126 2021-10031 Meetings, 26126 2021-10030 Projects Approved:

Consumptive Uses of Water, 26124-26125 2021-10029 Transportation Department Transportation Department See Federal Aviation Administration See Federal Railroad Administration See National Highway Traffic Safety Administration Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certification of School Attendance or Termination, 26143 2021-10032 Separate Parts In This Issue Part II Presidential Documents, 26145-26148 2021-10215 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. 86 90 Wednesday, May 12, 2021 Rules and Regulations DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2021-0313] RIN 1625-AA00 Safety Zone; Pierce County Ferry Steilacoom II, Puget Sound, WA AGENCY:

Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary moving safety zone for navigable waters within a 1,000-yard radius around the Pierce County ferry Steilacoom II. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the on-the-water military exercise. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Puget Sound or a designated representative.

DATES: This rule is effective from 8:30 a.m. through 2:30 p.m. on May 13, 2021. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to *https://www.regulations.gov,* type USCG-2021-0313 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule. FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email Chief Warrant Officer William Martinez, Sector Puget Sound Waterways Management Division, U.S.

Coast Guard; telephone 206-217-6051, email *SectorPugetSoundWWM@uscg.mil* . SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History 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. The Coast Guard was notified of the military exercise on April 7, 2021, and due to the evolving dynamic nature of the on-the-water exercise it was determined on May 4, 2021, that immediate action is needed to respond to the potential safety hazards associated with the exercise. The COTP determined this regulation is necessary to ensure the safety of the public. The Coast Guard lacks sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. 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 **Federal Register** . Delaying the effective date of this rule would be contrary to the public interest because this regulation is needed on May 13, 2021, less than 30 days after the Coast Guard received final details of the exercise, in order to ensure safety of the public, mariners, and exercise participants. III. Legal Authority and Need for Rule 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 Puget Sector Sound

(COTP)has determined that potential hazards associated with the on-the-water military exercise on May 13, 2021, will be a safety concern for anyone within a 1,000-yard radius of the Pierce County ferry Steilacoom II and the exercise participants. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the moving safety zone. IV. Discussion of the Rule This rule establishes a moving safety zone from 8:30 a.m. until 2:30 p.m. on May 13, 2021. The moving safety zone will cover all navigable waters within 1,000 yards of Pierce County ferry Steilacoom II. Part of this exercise includes the use of high speed Coast Guard and law enforcement vessel maneuvers and the use of blank fire ammunition. The duration of the zone is intended to protect mariners from the hazards associated with military training operations. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. As used in this section, a designated representative 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 Puget Sound

(COTP)in the enforcement of the safety zone. V. Regulatory Analyses 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. A. Regulatory Planning and Review 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). This regulatory action determination is based on size, location, and duration of the safety zone. Vessel traffic will be able to safely transit around this safety zone which would impact a small designated area of the Puget sound for a 6 hour period. The Coast Guard will transmit a Safety Marine Information Broadcast to mariners via VHF-FM marine channel 16 regarding the safety zone enforcement and publish in the Local Notice to Mariners information about details of the safety zone. In addition, the rule allows mariners to seek permission to enter the zone. To seek permission to enter, contact the COTP or the COTP's representative by VHF Channel 16. 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. B. Impact on Small Entities 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. While some owners or operators of vessels intending to transit the 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. 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 FOR FURTHER INFORMATION CONTACT section. 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, call1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. C. Collection of Information This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). D. Federalism and Indian Tribal Governments 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. 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. E. Unfunded Mandates Reform Act 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. F. Environment 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 moving safety zone lasting only 6 hours that will prohibit entry within 1,000 yards of Pierce County ferry Steilacoom II. 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. G. Protest Activities The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels. List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 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. 2. Add § 165.T13-0313 to read as follows: § 165.T13-0313 Safety Zone; Pierce County Ferry Steilacoom II, Puget Sound, WA.

(a)* Location.* The following area is a moving safety zone: All navigable waters within a 1,000-yard radius around the Pierce County ferry Steilacoom II.

(b)*Definitions.* As used in this section, a designated representative 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 Sector Puget Sound

(COTP)in the enforcement of the safety zone.

(c)*Regulations.*

(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.

(2)To seek permission to enter, contact the COTP or the COTP's representative by VHF Channel 16. 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.

(d)*Enforcement period.* This section will be enforced from 8:30 a.m. to 2:30 p.m. on May 13, 2021. Dated: May 5, 2021. P.M. Hilbert, Captain, U.S. Coast Guard, Captain of the Port Sector Puget Sound. [FR Doc. 2021-10085 Filed 5-11-21; 8:45 am]

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